These are the PhDs, the postdocs, the research engineers, the people who spent a decade in a lab perfecting an algorithm, a biomarker, a sensor, a material — something technically exceptional. Then one day, they look at what they built and think:

And they are, almost without exception, walking into this with zero visibility into the world they’re about to enter, because being a very good scientist and being the right person to build a company are two completely different things.

So today we will talk about why this path is genuinely tougher than transitioning from physician to founder, and what to do about it.

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Why is this harder than the physician's path?

A physician-founder at least starts with something priceless: they sit in the room where the problem happens. They know the workflow, even if they don’t fully understand the buying decision. They have clinical credibility already and they know, instinctively, what “this doesn’t fit how I actually work” feels like.

You don’t have that. And that’s not a bad thing - it’s just the honest starting position. You are, technically, brilliant. And you are, commercially and clinically, starting from zero.

You probably do not know how a hospital actually makes a purchasing decision. You don’t know what a procurement committee cares about. You don’t know what “reimbursement code” even means in practice, let alone how to build a strategy around one. You’ve likely never sat in a clinic and watched how a device actually gets used (or ignored) in the middle of a twelve-hour shift.

And on top of all that, you’ve spent your career in a world where credibility is earned through publications and peer review, not through visibility, relationships, and trust-building in an industry that runs almost entirely on those three things.

So here is the first, most important thing to accept: your technology is not your business. It’s just the raw material for one.

The number one mistake many scientists make: falling in love with the technology.

I am a biomedical engineer, among many things. Of course I’m over-obsessing over what I am building! I get you. But this is the single most common failure mode I see in scientist-founders (and in myself), and it happens quietly, over years, without anyone noticing until the money runs out.

You didn’t start with a clinical problem. You started with a capability — an algorithm that’s more accurate, a sensor that’s more sensitive, a molecule that behaves in an interesting new way. That’s an incredible starting point from a scientific point of view. Yet, it’s a dangerous starting point commercially, because it tempts you to go looking for a problem that fits your solution, instead of the other way around.

If you can describe your technology in exhaustive technical detail, but you struggle to describe, in one sentence, whose day becomes better and who has to pay for this — you’ve built a capability, not a company.

So before anything else: go find the clinical problem your type of technology could solve. Don’t assume you already know it.

Stage 1: You need a translator before you need a prototype.

You need to find a clinical co-founder or a deeply embedded clinical advisor, and you have to do it now, not after you’ve built something.

Someone who lives inside a hospital, who can tell you, honestly, whether what excites you technically means anything to the person who would actually use it. Someone who can translate your capability into a clinical problem statement, and translate clinical reality back to you in language you can actually build against.

This is not a “nice to have for later” - without this person, you will spend years building the most technically elegant solution for a problem nobody in the hospital is prioritizing.

Stage 2: Go sit where your technology gets used.

Once you have a clinical translator, use them to get you into real clinical environments. Sit in a clinic. Sit in an OR if that’s relevant. Watch a full shift if you can. You are not there to pitch anything. You are there to observe what actually happens, and how far it is from what you imagined.

This is the equivalent of the physician-founder’s “test the idea far from home” step, testing whether your idea survives contact with any hospital at all.

Bring specific questions into these observations:

• Where exactly, in this workflow, would my technology actually get used?

• What does the person using it need to already trust it, before they’d let it near a patient?

• Who in this hospital would actually decide whether to adopt something like this and who’s paying?

You’ll walk out of your first few of these sessions with a very different, much more useful, and often much smaller version of your original idea.

That’s the process finally starting to work for you.

Stage 3: Prototype, then hand it to the clinicians.

Now you build something, guided by what you actually observed, not by what impressed you in the lab. Take it back to the same clinicians who helped you see the real workflow. You’re testing something specific here: does this fit into how they actually work, or did the engineering instinct quietly take back over and build the version you wanted to build?

Expect to be told your interface is wrong, your integration point is wrong, your assumptions about who touches this device are wrong. This is the cheapest correction you will ever get.

It’s infinitely more expensive after certification, after manufacturing, after you’ve hired a sales team to sell something clinicians can’t use.

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Stage 4: Now build the company strategy

This is where scientist-founders often try to do it alone, because everything up to now has been solvable through their own expertise and effort. This part isn’t. It requires domain knowledge you simply haven’t had the chance to build yet.

1. Decide what kind of company you’re building. Exit, or long-term lifestyle business? This decision shapes your IP strategy, your hiring, your investor conversations, and unlike a technical decision, there’s no lab experiment that tells you the right answer.

2. Decide your market before you finalize your product. USA, Europe, or a smaller focused region - each one comes with a completely different regulatory pathway, a different buyer, a different commercial motion. You cannot Google your way to this decision. Talk to people who actually operate in the market you’re considering, because the assumptions that feel obvious from a research background are frequently wrong in practice.

Stage 5: Reimbursement is not a business-side check mark. It’s the business model.

If you’re building for consumers, direct-pay, or wellness, this section doesn’t apply to you. For everyone else building something a clinician or hospital will use, you need a working answer to: who pays for this, through which system, and at what rate.

This is genuinely one of the hardest concepts for scientist-founders to internalize, because in research, a better result speaks for itself. In healthcare commerce, a better result that isn’t reimbursed simply doesn’t get bought — no matter how exceptional it is.

Stage 6: Regulatory and quality strategy - embedded from day one.

You already understand rigor. You’ve lived by it your entire career. The shift you need to make is understanding that regulatory and quality strategy in MedTech isn’t a validation step you complete once the science works — it’s an architecture decision you make in parallel with the science itself, because it shapes your data collection, your documentation, your timeline, and your budget from the very beginning.

In parallel, think about:

• What classification and regulatory pathway you’re actually walking into, and what clinical evidence it demands

• What your Quality Management System needs to look like, built alongside the product, not retrofitted under deadline pressure

• What budget you need reserved specifically for this, because it is neither cheap nor optional

Bring in regulatory and quality expertise early. This is not a place to learn by trial and error, as the cost is measured in years.

Stage 7: Map the ecosystem.

Here’s where the gap really shows. A physician-founder at least knows some names — a KOL, a department head, a hospital administrator they’ve crossed paths with. You’re likely starting this map from a blank page.

Go build it deliberately: who are the big players in this space? Who distributes into the hospitals or into the markets that you’re targeting? Who might eventually acquire you, and what does their roadmap look like?

Use your clinical co-founder and advisors to open these doors — you will not open them from a research background alone, and that’s fine. That’s exactly why you need them.

Stage 8: Visibility.

Here’s a hard truth: in academia, your credibility was built through publications, citations and peer review. None of that automatically transfers to commercial and clinical trust, and this is the single biggest visibility gap scientist-founders face compared to physician-founders, who at least have some standing in a clinical room already.

You need to build, from scratch, a presence that makes an investor, a hospital, or a potential partner trust you before they’ve met you. That means:

• Getting your clinical co-founder or advisors visibly attached to the company, publicly

• Publishing and speaking about the clinical problem, not just the technical achievement

• Showing up at the clinical and industry conferences your future buyers actually attend

• Making sure that when someone looks you up, what they find signals “this person understands the world they’re entering”, not just “this person is a brilliant scientist”

If you build something excellent and nobody outside your lab knows it exists, don’t expect anyone to buy it. This applies to you even more than it applies to a physician-founder, because you’re starting your visibility from a smaller base in this particular world.

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Stage 9: Now, and only now, build the final product — in parallel with everything else.

By this stage, you have a clinical translator embedded in the company. You understand the real workflow. Your market and business model decisions are made deliberately, with help. Your reimbursement thesis exists. Your regulatory and quality strategy is embedded. Your ecosystem map is built. Your visibility is underway.

Now you build the final product — in parallel with your Quality Management System, your regulatory technical documentation, your partnerships, and your continued visibility-building.

What this means for you

If you’re a scientist or engineer standing at the edge of this decision, here’s the logic behind it:

1. Separate your technology from your business. The technology is the raw material. The problem it solves is the real business.

2. Find a clinical translator before you build anything further.

3. Go observe the real clinical environment

4. Prototype, then return to the clinicians who told you the truth

5. Get help deciding your business strategy and market — this isn’t solvable through expertise alone.

6. Build your reimbursement thesis before you assume better science means automatic adoption.

7. Embed regulatory and quality strategy from day one, with real expertise

8. Map an ecosystem you don’t yet know by using the people who do.

9. Start building visibility now

10. Build the final product in parallel with your QMS, your technical documentation, your partnerships, and your visibility.

This path is genuinely harder than the physician’s version, and I won’t pretend otherwise. You’re not just learning a new skill — you’re learning an entirely new world, often for the first time, while trying to keep a company alive.

The scientists and engineers I’ve watched succeed at this all did one thing in common: they stopped building alone, and brought in (very early-stage) the people who have experience and have done that in the past.

If you’re a researcher, scientist or an engineer somewhere on this path, I’d like to hear more about what you’re building. Drop a comment, send a message, or save this for the week you actually need it.

And, as I always say: The best thing we can do for the next generation of scientist-founders is hand them the full map before they pay to learn it by themselves.

Hi, I’m Alina. I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside — strategy, brand positioning, regulatory readiness, investor narratives, and the messy gap between having a great idea and building a successful company.

If this resonates, let’s talk: Book a call / Send me a message

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And I always ask the same first question back: “Who have you talked to outside your own hospital?”

There are two possible answers: either silence, which is the worst one, or “yes, with a couple of colleagues and friends,” which is also not the best one.

So let’s talk about that (but not the pitch deck or LinkedIn version). I’ll try to give you the useful one, so people know what to expect before jumping into the entrepreneurial role.

If you allow me, I’ll start by breaking a myth.

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You are not your best customer. You’re your worst one.

You are a young doctor full of passion for what you do. You built a solution for a problem doctors have. So naturally, you assume you understand the customer better than anyone else ever could. You don’t. You understand the problem — and that’s a completely different thing.

Why are you actually the worst person to validate your own product?

Because you don’t pay for it. You don’t sit in a procurement meeting defending a budget line. You don’t get asked by a CFO to justify the cost against a competing line item. You don’t have to convince a hospital administrator that this specific workflow change is worth the disruption. You experience the pain, but you will never experience the buying decision the way your actual customer will.

That gap — between feeling the problem and owning the purchase — is where most young physician-founders build the wrong company without realizing it for the first two years.

So the first thing you need to separate, before anything else: are you designing for the person who suffers, or for the one who pays for it?

Stage 1: The idea is not automatically the final product. Go test it - far from home.

You have an idea. Good. Now resist the single strongest urge you’ll have: don’t build anything yet.

Instead, go have conversations, but not with your colleagues down the hall, who share your training, your national guidelines, your reimbursement system, your hospital politics. Talking to them will mostly confirm what you already believe, which feels good and tells you nothing.

Go find doctors in a different country. Ideally, a different continent.

Why does the distance matter so much? Because you’re not testing whether the problem is real — you’re testing whether it’s universal, or whether it’s actually a symptom of your specific system, your specific hospital’s inefficiency, your specific country’s workflow.

A problem that only exists in one healthcare system is not a company. It’s a local fix, and local fixes rarely survive contact with a market strategy.

Have these conversations before you’ve written a single line of a product spec:

• Does this problem exist the same way in their setting, or is it shaped differently by their system?

• How are they solving it today — a workaround, a competitor product, or just living with it?

• Who around them would actually make the purchasing call, if a solution existed?

You’re not looking for compliments. You’re looking for the version of your idea that survives outside your own hospital walls.

If it doesn’t survive that conversation, you just saved yourself two years.

Stage 2: Build the prototype, then hand it back to the same people.

Once the idea holds up across different systems and different doctors independently describe the same underlying pain, now you build something. Not the final product, but a prototype, the roughest version that lets someone experience the concept.

Take it back to the same doctors you spoke to in Stage 1, because now you’re testing something different: does the solution you imagined actually match the problem they described, or did you quietly build the thing you personally wanted, dressed up as the thing they needed?

This is where physician-founders get humbled, and it’s a good thing. You will hear versions of:

• “This doesn’t fit how I actually work”

• “We tried something similar, here’s why it failed”

• “Interesting, but I’m not the one who’d decide to buy this”

Only once the prototype survives a second round, across doctors who have no reason to be polite to you because they don’t know you personally, you have something worth building a company around.

Stage 3: Now, and only now, build the company strategy.

This is the point where you stop thinking like a clinician solving a problem and start thinking like a founder building a business. There is a specific order to this, and getting it wrong is part of the reason why the failure rate of MedTech start-ups is between 75–90%.

1. Decide what kind of company you’re building.

Are you building this to exit — to eventually be acquired by a larger player — or are you building this as a lifestyle business you intend to run and grow for the next twenty years?

There’s no wrong answer here, but there is a wrong sequence: deciding this later, after you’ve already built a product, hired people, and picked partners. This single decision shapes your IP structure, who you hire, which investors you talk to, and how fast you’re expected to move.

2. Decide your market before you decide your product’s final form.

USA? Europe? A smaller, focused regional market?

Big markets come with big competition, longer sales cycles, and more capital required to get inside. Smaller or underserved markets can mean faster traction, but a lower ceiling. You have to choose deliberately, because your regulatory pathway and your reimbursement strategy will look completely different depending on where you decide to plant your flag first.

This is not a decision to make from your hospital’s break room. Talk to people who operate in that specific market. What works in one healthcare system does not transfer automatically to another.

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Stage 4: Reimbursement — unless you’re going direct-to-consumer.

If you’re building for private pay or a consumer-facing wellness product, skip this section. For everyone else: this is a now problem.

Before you spend meaningful money on the final product, you need a clear response for: Who pays for this? Through which system? Under which code, if one exists? At what rate?

A brilliant therapy that a hospital cannot afford to adopt isn’t a business yet — it’s a very expensive proof of concept. Sketch this out early, even in draft form, because it will quietly redesign your product decisions before you’ve made them irreversible.

Stage 5: Quality and regulatory strategy

Once your market and your reimbursement thesis are taking shape, quality and regulatory strategy stop being “something we’ll figure out before submission” and become part of the architecture of the company itself.

This means thinking, in parallel, about:

• What regulatory pathway and classification are you actually walking into, and what does the clinical evidence requirement look like for that class?

• What does your quality management system need to look like from day one?

• What funding and budget do you need reserved specifically for this?

Physicians tend to underestimate this stage badly, because clinically, you already trust the rigor of evidence. What’s new is understanding that regulatory and quality strategy is not just a technical checkbox — it’s a budget line, a timeline, and a hiring decision, all three decided early.

Stage 6: Map your ecosystem before you need it.

Independent of your specific product, go build a real mapping of the space you’re entering: the big players, the distributors who already have relationships inside your target hospitals or markets, the potential partners who could get you in doors you cannot open alone.

You are not doing this to find your competitors. You’re doing it to find who you might partner with, who might distribute for you, and — eventually — who might be the company that acquires you. This map should exist long before you need any of these relationships, because in MedTech, trust and relationships take years to build, not weeks.

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Stage 7: Now, and only now, spend the real money.

By this point, you know your market. You know your reimbursement thesis. Your regulatory and quality strategy is embedded, not improvised. Your ecosystem map exists. This is the point where you actually start building the final product — and it happens in parallel with several other things:

• Building your Quality Management System properly

• Building your regulatory technical documentation for certification

• Building your partnerships and distribution relationships

• Building your visibility

All of them alongside the product. Not after.

Clinical excellence does not automatically translate into commercial visibility. The hospital CMO who might champion your pilot, the investor who might write the check, the distributor who might carry your product — they will all, at some point, look you up. What they find is either a door opening or a door quietly closing.

Start building that presence now, in parallel with everything else, not after the product ships.

What should you do next?

If you’re a physician standing at the edge of the entrepreneurial decision — whether you’ve just started thinking about it, or you’ve already jumped and you’re a few months into building — follow this step by step:

1. Separate the problem from the buying decision: you feel the pain, but you are rarely the one who pays.

2. Test the idea far from home: different doctors, different countries, before you build anything.

3. Prototype, then return to the same people: let them tell you if you built what they actually described.

4. Decide exit or lifestyle, and pick your market, before you finalize the product.

5. Build your reimbursement thesis before you spend serious money.

6. Embed quality and regulatory strategy into the company, not into a future to-do list.

7. Map your ecosystem — partners, distributors, future acquirers — early.

8. Build the final product in parallel with your QMS, your technical documentation, your partnerships, and your visibility.

I know this isn’t the “fast” version, it’s the boring version, but it is also the safe one.

This is how you’re building a company that stands a chance, instead of a beautifully built product that nobody buys.

If you’re a physician somewhere on this path, I’d genuinely like to hear where you are. Drop a comment, send a message, or save this for the week you actually need it.

My motto has always been:

The best thing we can do for the next generation of physician-founders is to help them map their journey before they pay to learn it themselves.

Hi, I’m Alina. I’m a MedTech Business Advisor for start-ups and scale-ups. My daily role is to work with founders and C-level executives on the things that make or break a company before it’s visible from the outside — strategy, visibility, regulatory readiness, investor narratives, and the messy gap between having a great idea and building a successful company.

If you would like to meet: Book a call / Send me a message

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#1. Hi, Paola! Thank you for accepting to spend the time with us! Just to give our readers some context - tell us what you are building right now?

P: Hi everyone! My name’s Paola and I’m the CEO of MediRapp.

Our software EchoRapp aims to make high quality echocardiography (heart ultrasounds) accessible to all. Once the echos are acquired, EchoRapp supports clinicians in automating measurements, which are then fed into the reporting layer of our software. It takes 350+ measurements from the echos and translates them into guideline-guided reporting. EchoRapp then provides a full-text report that can be exported to any electronic health record system.

But this is only the beginning: EchoRapp enables multiple clinicians to collaborate on the same echos, it educates junior fellows on how to apply guidelines in echo reporting, and it allows researchers to query measurements across their entire patient history. And so much more!

#2. That sounds to me like you’re absolutely rocking in Digital Health! What’s the background that got you here?

P: It’s a bit of a mixed bag! But when the opportunity to step into this role showed up, all those elements came together and helped me prepare for the position I’m in today.

I studied chemical engineering for my Bachelor’s at McGill University in Canada, then transitioned to a Master’s in Management, Technology and Economics at ETH Zurich in Switzerland - with the idea that I wanted to explore as many different fields as possible to then commit to one career path. I worked for Microsoft, Bosch, On Running and BlackRock.

The result of my quest: I decided to pursue a PhD in Digital Health Epidemiology at the University of Zurich. I then topped this off with a Research Fellowship at EPFL in Switzerland in Responsible AI in Healthcare.

Logical, right? It was for me. In my role I find myself using the technical, research, programming and business skills on a daily basis. I make connections between these fields that very often surprise me.

It keeps me curious in the job that I do. It’s genuinely fun.

#3. Is it hard to build a cardiology business from zero?

P: It really is. But not necessarily for product-related reasons, which is what most people would assume is the most difficult part. With the help of AI, it has never been easier to turn an idea into functioning software in weeks, if not days.

But this is exactly the part that gives me the biggest sense of responsibility. I entered this role with the driving motivation that I wanted to serve back to society in the field that I dedicated five years of my research career to and believe in the most, which is through digital health. Having worked on the ins and outs of digital health research from an individual level to a system level, I understand firsthand the risks that come with integrating technologies in everyday practice.

The biggest misconception is that you can simply hand clinicians a new technology and expect it to become part of their everyday work. My responsibility is to build a product that fits the reality of clinical practice and gives clinicians the confidence and autonomy to use technology carefully and responsibly.

#4. If you had to name the most challenging chapter of your CEO experience so far, what would it be?

P: By far the most challenging (humbling) chapter was the 7ish months as a team of only 3 (with the help of amazing consultants) towards getting MDR certification. The level of resilience, readiness to work relentlessly, and sheer drive that you need to get to the finish line I could best assimilate to getting a second PhD!

Importantly though, this process has been invaluable for us. Being a startup in a regulated environment forced us to behave like a company. This structure is what gave us the foundation to hire more people to join the team, to guide them, and to get the ball rolling with getting EchoRapp out to clinics.

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#5. How does a normal Tuesday look for you, especially now, when the company is very close to obtaining the MDR certification? I could only imagine it’s such an intense moment for you and for the entire team.

P: Funny that you ask about Tuesdays: they’re the days we have our weekly catch-ups with our regulatory consultants and our notified body! But they’re also the days that I have my twice-a-week catch-ups with our wonderful new hires, Cindy and Andrei. And probably more calls :) such is the life of a CEO. I then spend my evenings usually catching up on some work, answering emails, and spending some quality time with the family and friends.

Back on the topic of MDR, it’s been an intense time. We’re at the very end of the last query rounds with our Notified Body and we’re more motivated than ever to close these remaining small gaps off and get to the finish line. Getting MDR is definitely a marathon, not a sprint, I can tell you that much!

#6. Let’s move a bit from the challenges towards more positive aspects. Could you please share with us 3 things at work that genuinely make you happy or that you find exciting?

P: When I first considered taking on this role, someone asked me why I wanted to step up to the challenge. My answer was simple: I had spent most of my career studying, testing and validating the ins and outs of digital health. If I could put those learnings into practice and make a difference, even for just one person, I would feel incredibly fulfilled.

That translates directly into the three things about my work that I find most fulfilling:

1. I get to work on a product that has the potential to improve or save the lives of hundreds of millions of people living with cardiovascular disease.

2. I get to build a team and culture with people who are just as motivated as I am to make a difference in this space.

3. I get to learn something new every day.

#7. You’re a scientist, a CEO, a people’s leader, and a mother, among many other things. How do those identities live daily under the same roof?

P: The two building blocks that allow me to do what I do are adaptability and support. When I stepped into the new roles of CEO and mother, I quickly learned that structure is a necessary foundation for getting things done properly. But without adaptability and, importantly, an openness to the unknown, that structure can only take you so far. At least, that’s true for me.

Having a proper support structure is just as important. During my PhD, much of my success in academia came from the meaningful and authentic collaborations I built with my peers. We helped each other, whether that meant providing critical feedback on a manuscript or developing a convincing rebuttal during peer review.

I’ve carried those lessons into my life today. I have amazing friends who are always a phone call away when I need to switch off and take a break. I have a wonderful team at MediRapp who I can rely on, and who actively go out of their way to support one another in their everyday work. I have my co-founder Schlomo who, above all, is also my friend. And I have my husband, who is my greatest pillar of support.

The last thing I’ll say, as cheesy as it sounds, is that I’m unapologetically myself. I know that I wear a lot of hats, which means that I’m also aware that I cannot do everything perfectly. I commit to everything I put my mind to, relentlessly at times, with no excuses. But I’m the first person to ask for help if I need it.

#8. I’m curious about your hobbies. It’s well known that you can learn a lot about people’s core values from the activities they invest their free time in and their interests - outside of the classical Job Title. Anything exciting you’d like to share with the community?

P: Not exactly a hobby, and definitely not exciting for many, but for me going for long walks is the ultimate tool to zoom out of my everyday life, relax and reflect. This usually involves walking up a pretty steep hill from my place to a forest and walking for, at times, hours with my family.

There’s something about the movement that gives way to starting longer, clear-headed conversations. Some of the biggest decisions I’ve made in the past years were deeply reflected upon, discussed and decided during these walks.

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#9. If you could give a piece of advice (personal or business-related) to Paola from a year ago, what would that be?

P: To start underthinking sooner! A lot of us (especially women) are conditioned to overthink every single detail of our lives and our work. I think this is the reason I connected with health research so much: it’s a field entirely built on thinking about every possible confounder or source of bias that can affect the research question at hand. Then spending months perfecting an analysis and then a manuscript over multiple iterations to account for any possible “what-if.”

What I learned very quickly as I entered these new roles in the past year (my job and motherhood) is that overthinking takes too much energy. It’s important to quickly distinguish between the decisions that need that level of deep analysis, and the ones that can be tackled and decided quickly. When I get brain fog, I try to remind myself: “Less overthinking, more underthinking!”

#10. Who had a very positive impact in your journey and how exactly did that shape the way you support others now?

P: My co-founder, Schlomo. When we met, one of the first things we agreed on was that the foundation of a strong co-founder relationship is deep trust and, on a lighter note, friendship. Friendship in the sense of knowing that, despite all the hardships that come with entrepreneurship, the other person will always be honest with the other and have their back (or tell them that they’re blatantly wrong, which fits the mold too!).

This has also shaped the culture we’re building at MediRapp. Everyone on the team is ambitious, strong-willed, and hardworking. But above all, they are kind and always willing to help one another. They are honest, able to admit when something is wrong, and committed to finding solutions together. It’s where ambition meets authenticity.

#11. You and your team are setting up a very good example in terms of supporting the young generations of cardiologists. What do you think leadership in healthcare owes to the people coming up behind it?

P: Young cardiologists are part of a new knowledge generation. Their understanding of cardiology is still shaped by textbooks, residencies, and mentorships that have trained generations of cardiologists, but it is also shaped by technology.

They can access and absorb more knowledge than was possible just a few years ago, and they know how to adopt new technologies and make them work for them in ways that older, or not-so-young, generations may not even imagine.

They should be empowered to practice cardiology in the way they know and have learned best. That requires a paradigm shift, one that combines the strength of traditional methods with newer, digital and technology-forward approaches.

#12. A short piece of advice for young women (engineers, researchers, physicians) who want to build a business in healthcare but don’t know where to start?

P: Network, network, network! If you have an idea, be bold, talk about it with anyone who will listen to you and be ready to face lots of rejection. Along the way you will meet people who you connect with, see potential in you and your work, and will open the right doors for you.

#13. If people would like to connect with you, what’s the easiest way for them to do that?

P: Email me at paola.daniore@medirapp.ai or send me a message on LinkedIn. Happy to share my story and learnings to anyone if it can help them along their entrepreneurial journey in MedTech!

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That's a wrap on our first interview! If Paola's story resonated with you, share it with someone building (or thinking about building) in HealthTech.

More stories like hers, soon!

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I’m Alina — MedTech Business Advisor and Editor of #NoPitchDeck.

For the Founders who are interested in getting their story out-there, drop me a message at draghici.alina@proton.me or here > Send me a message

We were sitting across from each other, going through the system together. She was flipping through procedure after procedure and I could see it happening in real time — the realization that half of these documents described processes her company didn’t even run yet. Six months of work. €20K gone. A team of 7 people with zero capacity to maintain any of it.

We had to start over. Nobody warned her this would happen. A consultant built her a system that looked impressive in a folder and walked away.

That’s the part that still bothers me, years later.

So let’s be honest about what a QMS actually needs to be — especially if you’re early-stage, under-resourced, and nobody around is being straight with you about this. Most of what gets sold to early-stage Founders isn’t built for them, it’s built for medium-big companies with defined departments, to satisfy someone else’s audit history and someone else’s team size.

A QMS is not supposed to be complex, expensive, or buried in 70+ SOPs. And at this stage, you definitely don’t need an eQMS.

Two types of early-stage founders walk into my world weekly.

The first has a brilliant product, a real clinical need, and €40K less in the bank than they should. Six months ago someone sold them a “complete” quality system. Today they have 80+ SOPs, version control chaos, and a team that stopped following half the procedures because nobody has time to maintain them. They think compliance is done. It isn’t. It’s just invisible — until the audit.

The second has maybe 20 documents. Plain language, built around what their team actually does today. Their Notified Body audit went smoothly. Their team can explain the system. They’re spending their energy on the product — where it belongs.

Same regulation. Same standard. Completely different reality.

The difference isn’t experience or budget. One Founder confused volume with compliance. The other understood what ISO 13485 actually asks for — and it’s significantly less than most people in this industry will tell you.

If your QMS gives your team headaches, can’t be maintained in a few hours a month, or describes activities you don’t even perform yet — something has gone wrong. Not with your team. With the system someone built for you.

The biggest myth in MedTech compliance

ISO 13485 does not tell you how many SOPs to write. Seriously — go read it yourself.

The standard defines what you need to control. A Notified Body auditor doesn’t walk in and count your folders. They look for evidence that your processes are defined, followed, and getting better over time. And even an Auditor it looks suspicious when you have too many SOPs - how are you going to maintain those over time?

One procedure that covers complaint handling end-to-end is worth ten times more than five fragmented ones nobody has opened since approval day.

The best QA people I’ve worked with share exactly one skill: they take genuinely complex things and make them clear. The ones who can’t do that? They make things complicated — and call it thoroughness.

This isn’t just a quality problem anymore, it’s a survival problem.

You’re probably a team of 5 to 10 people. The same person writing your risk management file is also on calls with clinicians, reviewing the pitch deck, and chasing a supplier who changed a component without telling anyone.

Every hour spent on documentation that adds zero real value is an hour not spent on design validation, clinical evidence, or finding your first paying customer.

Here’s what happens: a Founder gets handed an enormous QMS and feels relief. At least compliance is done. Six months later a supplier changes a component and they need to update 14 documents just to process it. They don’t have the capacity, so nothing gets updated. Now the system is both overwhelming and out of date — and the audit is in three months.

I’ve watched companies hit Series A still carrying a QMS nobody had touched since it was built, because opening it felt like pulling a loose thread on a sweater — you don’t know what unravels.

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What you actually need

For most early-stage companies — single product, small team, pre-market — your core QMS is 10 to 20 well-written procedures. Not 80. Here’s what those cover.

• Your Quality Manual and Quality Policy — one document. Who you are, what you make, how your system works.

• Document and Record Control — how documents are created, approved, changed, and how long you keep them.

• Design and Development Controls — this one deserves real depth. Inputs, outputs, reviews, verification, validation, transfer, change control. Keep it modular.

• Risk Management — ISO 14971 is your companion standard. You need a plan, a structured process, and evidence it actually feeds into your design decisions — not just a document sitting in a folder.

• Supplier and Purchasing Controls — who are your critical suppliers, how did you qualify them, and what happens when they change something without telling you. One procedure. One approved supplier list.

• Production Controls or Software Lifecycle — defined processes, work instructions where things can go wrong. If you’re a software device: your build, test, and release process, proportionate to what you actually do.

• Nonconforming Product and CAPA — something went wrong. What do you do, and how do you make sure it doesn’t happen again?

• Internal Audits — once a year minimum. Document it. This is your early warning system.

• Management Review — once a year minimum. Leadership looks at quality data, objectives, complaints, CAPA status, audit findings. Document what was discussed and what was decided.

• Post-Market Surveillance — once you’re on the market, you need a PMS plan and a process to collect, analyze, and act on what comes back from the field.

Clear, organized, searchable. Not voluminous.

Build it in layers, not all at once

Think of your QMS like a backpack you carry on a long hike. Pack only what you actually need for the terrain ahead. Every extra item you throw in because “it might be useful” is weight you’ll feel by hour three. And when you really need to move fast, you’ll wish you’d left it behind.

Layer 1 — The Foundation (build this first)
Quality Manual, Document Control, Record Control, Management Responsibility.

Layer 2 — The Product Layer (build as your device develops)
Design Controls, Risk Management, Supplier Control. Start lean, add detail as complexity demands it.

Layer 3 — The Operations Layer
Production Controls or Software Lifecycle, Labeling and Traceability, Installation and Servicing if applicable. Every document you create is a commitment to maintain it.

Layer 4 — The Surveillance Layer
Complaint Handling, Vigilance, PMS Plan, CAPA, Internal Audits. These are your living processes — they improve as real data comes in.

Build what you need, when you need it. Don’t try to build a Fortune 500 quality system on a seed-stage budget with a 6-person team.

The red flags.

For the Founders who are first time encountering QMS, here’s some red flags you should pay attention to:

🚩 More than 30 SOPs for a single-product early-stage company. Almost always means someone copy-pasted a corporate template and called it your QMS. It isn’t. It’s theirs.

🚩 SOPs that describe activities you don’t actually perform yet. Every document you maintain is a commitment. Don’t make commitments to processes that don’t exist.

🚩 If your team members can’t explain your CAPA process in two sentences, it’s too complicated. The test of a good quality system is whether the people who use it actually understand it.

🚩 Version history that makes no sense.

🚩 Nobody ever asked you what you can exclude. ISO 13485 explicitly allows for clause exclusions — parts of the standard that don’t apply to your product or organization. Make sure you have this conversation with the people you entrust your QMS to.

Exercise to run:

Sit down with your QA/RA lead — or do this yourself if that’s you — and go through three questions:

• Which of our procedures has nobody actually used in the last 3 months?

• Which procedures reference activities or functions that don’t exist in our company yet?

• If a new team member joined tomorrow, how long would it take them to understand our quality system from the documents alone?

The answers will tell you exactly where your QMS is carrying dead weight.

Quarterly exercise: schedule a 90-minute QMS health check with leadership. What’s changed? What procedures need updating? What’s collecting dust? Make this a recurring habit.

One last thing — for the younger people reading this

Some of you are fresh out of a biomedical engineering program or a regulatory affairs master, handed a QMS project at a start-up with very little guidance, staring at a blank screen.

Start here: OpenRegulatory has published FREE QMS templates on GitHub. Free, minimal, and built exactly for your situation. Use them as a base, then build what your specific product actually needs on top.

And remember, you don’t need to know everything. BUT - you need to know what the standard actually requires, what your specific product demands, and what your team can realistically maintain.

Start there. Everything else is just noise.

And if someone more senior tells you that a seed-stage startup with 6 people needs 70 SOPs — ask them calmly: which clause requires this? Where does Notified Body guidance mandate this level of documentation for a company of our size and risk profile?

Watch what happens. Often, they can’t answer.

Your quality system is and will continue to be a tool. It should make your team better at building safe, effective devices — not slower, more stressed, and buried in documents nobody reads.

I’m Alina — MedTech Business Advisor.

This is a conversation I have with Founders every single week. If you recognized your QMS in any of what you just read — probably we need to have a talk.

Please feel free to send me a message or book a discovery call below.

Book a call / Send me a message

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Therefore, what follows in this week’s article are two different perspectives of the same AI Act deadline shift and its implications for the healthcare start-ups ecosystem. So let’s get into it.

& the impact of AI Act on regulatory, commercial and growth strategies

If your MDR or IVDR conformity work already covers risk management, cybersecurity, human oversight, post-market surveillance, and data governance, that work can count toward satisfying the equivalent AI Act requirements, instead of triggering a fully separate assessment.

With that in mind, you need to know your actual deadlines, because they moved (again):

• Transparency obligations — disclosing to a patient that they’re interacting with AI stay live from August 2026 = now.

• Obligations for providers and deployers of high-risk AI systems will now apply from 2 December 2027 for standalone AI systems (Annex III)

• For AI systems embedded in a product (Annex I) the deadline has been moved to 2 August 2028.

The teams that use these months will arrive audit-ready. The teams that treat it as a snooze button end up exactly where the old deadline would’ve put them.

Commercial/Here’s the thing that catches Founders off guard

Investors and hospital procurement teams are starting to ask about AI Act directly, the same way they now ask about your regulatory pathway before almost anything else.

Let me give you some cheating code. There is a management standard most Founders in healthcare haven’t come across yet, and it’s extremely useful: ISO/IEC 42001, the international standard for AI management systems. Many start-ups use this to build trust in their industry, but also around strategic and commercial purposes.

How this can help:

• Demonstrate responsible AI development and deployment to enhance your reputation.

• Build trust with investors, regulators, and customers (B2B, B2C, B2G).

• Reduce operational friction and enable agile AI innovation.

• A structured AI management system to manage risks, enhance efficiency, and navigate regulatory landscapes with confidence.

• Demonstrating that AI systems are proactively governed.

I always advise the early stage start-ups which invested significant budget into developing a solution to focus on standards, certifications and management systems, because the way you build is more important than what you’re building.

/Post-market surveillance & resources

Traditional PMS was built for stable, deterministic software: you test it, it works the same way every time, you monitor for edge cases. AI doesn’t behave that way. The same input can produce a different output six months later, as data drifts or the model updates. Regulators expect this to be watched continuously, not checked once at certification and forgotten.

Build PMS that actually covers:

• real-world performance monitoring and algorithm drift detection

• complaint trending specific to AI-driven decisions, not just device malfunctions

• cybersecurity monitoring for the AI system itself

• a clear, written threshold for what counts as a “significant” model update requiring re-assessment, versus one that doesn’t

On another note, besides the processes, there are also 3 capabilities that didn’t exist on a typical MedTech Founding team five years ago, but now quietly determine your company’s future:

• Someone who owns AI risk continuously

• Someone who can translate between regulatory language and engineering reality.

• Someone accountable for post-market AI monitoring, even part-time.

Can’t hire for it yet? Upskill someone you already have. Get your regulatory lead literate in how the model is trained and monitored. Get your engineer literate enough in compliance language to flag drift before it becomes a submission problem. That cross-training is cheap and easy to manage compared to a failed conformity assessment.

/How expensive “we have sufficient time, it’s not a priority now” gets

Non-compliance under the AI Act carries tiered fines, up to €35 million or 7% of global annual turnover for the most serious violations, down to €15 million or 3% for most high-risk breaches, with lower caps for SMEs and start-ups, but still real money at the exact stage you can least afford it.

The fine is the visible cost, but it’s not just that. Misclassifying your system, or being caught unprepared during a conformity assessment, can mean suspended deployment, forced recalls, or a stalled market entry (the kind of delay that costs the fundraising round or the hospital partnership that was waiting on that market access).

Once a gap like this surfaces in due diligence, it’s not just a simple delay anymore. It’s a credibility question. And speaking of credibility in healthcare, I’ll let Emma go in more details on it.

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& the impact of AI Act on patients

Here is the part of the rule taking effect on 2 August 2026 that stopped me.

Article 50 says people must be told when they are interacting with an AI system. Healthcare gets exceptions. Systems used by trained health professionals to support a medical diagnosis are excepted on grounds of obviousness, and so is the technical processing or reconstruction of medical images.

Obvious to the clinician.

The exception was written from the clinician’s side of the desk. And the person sitting on the other side of it, the one the output eventually lands on, is not the person the exemption was drafted for.

I have spent thirteen years in clinics, and I want to be fair to the drafters here, because they are right about the clinician. A radiologist knows the reconstruction is algorithmic. A physician using decision support knows what she is looking at. Telling her would be noise. That part of the reasoning holds.

What it does not reach is the patient who was never in that conversation. She is told her scan was reviewed, her plan was set, her escalation was or was not triggered. Whether a model shaped any of that is, for her, simply not in the room.

And disclosure was never the same thing as comprehension. Every clinician learns this early, usually the hard way. You explain a procedure, the patient nods, and three questions later you realize she understood something adjacent to what you said. The patient who nods because nodding is polite. The patient who asks nothing because she does not want to be the difficult one. The patient who says yes in the room and then reads about it in the car afterwards, alone, with worse sources than you would have given her. Article 50 is a telling requirement, and telling is the easy half.

So the rule matters, and it does less clinical work than its coverage suggests.

Now the bigger date, the one that moved.

High-risk obligations for embedded medical AI now land on 2 August 2028, pushed there by the Digital Omnibus on AI, Regulation (EU) 2026/1744. That is two years of additional room, and is right that the time is useful.

What the extension does not touch is when patients meet the product. A woman starts a program next Tuesday. The model shapes what her clinician sees, or what her app does with her check-in, on the same Tuesday it always would have. Compliance dates are negotiable, the way all dates set by committees are negotiable. The encounter is not.

I wrote about this in “Clinical maturity vs regulatory” and the AI Act has just handed the argument a very literal example:

Read the high-risk requirements next to the questions I ask in an audit and you’ll observe the overlap is real.

The Act asks for human oversight. I ask who actually takes over when the product runs out of the road, and how that handoff happens at four o’clock on a Friday.

The Act asks for accuracy and robustness. I ask robust against which patient, because a system tuned on the compliant and the articulate will meet the woman who pushes through pain, the one who stops at the first discomfort, and the one who tells you what she thinks you want to hear.

The Act asks for post-market monitoring and drift detection. I ask what happens in the two weeks a product is quietly wrong, producing outputs that are plausible and slightly off while every dashboard stays green.

This is the lens I bring through clinicalmaturitylens.com, the framework I built for looking at digital health systems as if real patients have already arrived.

The Act asks whether a process exists. The Lens asks what the process does when a real patient hits it. Those are different questions and you need both answered.

Which brings me to the requirement I keep circling.

Human oversight assumes a stable human. Article 14 treats the clinician as the check on the system, the point where a person catches what the model got wrong. I have come to think that assumption needs work, and it is the thread I contributed to Before the Recommendation, written with Henri Hommersom, Mujahid Altamimi and Sarah Curtright.

A clinician who has spent eight months inside a system’s recommendations is no longer a neutral check on it. Her attention has been shaped, her ordering has been shaped, and the record of what she decided will be accurate and completely silent about all of that.

We have words for the patient who under-reports, who over-reports, who tells you what she thinks will help her case. We are only now building one for the clinician whose judgement has been quietly bent by the tool she is overseeing. Both are inputs. Both degrade.

The 2 August date is genuinely the easiest part of this to prepare for. It is a disclosure line, and disclosure lines get written, reviewed and shipped. The part I would put a person on this quarter is the threshold mentioned, the written definition of what counts as a significant model update.

That number decides how long a product is allowed to be quietly wrong before anyone is required to look, and it is being set in a lot of companies right now by people who have never watched a patient absorb a wrong answer and go home with it.

Put someone clinical in that room.

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/Last note

The deadlines prolongation gives companies sufficient time to build governance properly instead of building it in a 100m sprint. What 's half makes clear is what that governance actually needs to be watching for: not just whether a process exists on paper, but how the process behaves first time when a real patient or a clinician encounters it.

Compliance dates get negotiated by committees, but what happens with the clinicians, patients, and even with your business after a tool is deployed cannot be negotiated.

If you're a start-up Founder reading this, there’s a couple of things you can do this quarter: run multiple analyses, check what it’s already covered from other certifications/standards, and put down in one sheet what counts as a “significant” model update for your product. When a Notified Body, hospital or investor will come with questions, you will be prepared.

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Hi, I’m Alina. I am the Editor of AliDrg MedTech Insights. When I’m not publishing here, I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside. If you would like to talk or if you have a great story to tell: Book a call / Send me a message

Co-published with | PT & Clinical Product Consultant Clinician since 2013, now working with digital health teams on the part most products underestimate, real-world patient behaviour. Creator of Clinical Maturity Lens, details at clinicalmaturitylens.com

Sources:

• EU Commission — AI Act regulatory framework overview — the official policy page, including how the AI Office and national authorities enforce this.

• AI Act Service Desk — the Commission’s own support tool for compliance guidance, including sector-specific questions.

• Draft Commission guidelines on classifying high-risk AI systems — practical examples for determining whether your device is actually high-risk, straight from the source.

• Commission guidelines on transparency of AI-generated content (Article 50) — Article 50 applies 2 Aug 2026; healthcare exceptions for trained-professional diagnostic support and medical image processing.

• Digital Omnibus on AI, Regulation (EU) 2026/1744 — OJ 24 Jul 2026, in force 27 Jul 2026. Annex I embedded systems deferred to 2 Aug 2028, Annex III standalone to 2 Dec 2027.

• AI Act Article 14, human oversight

• Before the Recommendation, SSRN — Hommersom, Paraschiva, Altamimi, Curtright. My credited thread is signal integrity.

• clinicalmaturitylens.com

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Here's what that looked like for one Founder I worked with last year. They had a really interesting product and what caught my attention was the technology itself (as I’m a MedTech nerd by blood and a biomedical engineer by diploma). After 12 months spent by the team to come up with something functional, the product was (what they called) sales ready.

And that’s when they ended-up in a meeting with me, planning to discuss commercial topics. A meeting where I found out they never spoke to a Notified Body before, they didn’t have a single proper-running pilot in a hospital, there was no regulatory pathway embedded into the strategy and the company had put zero effort towards any type of certification so far. They built the whole thing in isolation, assuming that once the product was functional, it would prove itself.

Shocking news: the product was completely invisible and the relationships didn’t sort themselves out. They took another year to build, from a standing start, while the product was sitting finished and unused.

The story I’m sharing is not a singular exception, this is a frequent situation I encounter as a Business Advisor, and it saddens me profoundly to see great science built in the shadows.

If you’re part of a start-up, I want to tell you something that’s going to sound backwards coming from someone who’s spent a decade helping people bring medical devices to market:

I get it. Founding teams fall in love with the device, the algorithm, the diagnostic and building the whole thing - it makes sense, because that part got you here. But I’ve watched too many good devices die quietly in a drawer, usually because nobody built anything around the science itself. No regulatory relationships. No clinical partners. No community. Nobody to call when the Notified Body goes quiet for two months and you’re just staring at your inbox. No network of investors or people working close to investors who can guide you in the preparation for raising rounds.

So today, we’ll go together through the unglamorous thing that actually decides whether your MedTech company makes it - or it becomes just another great idea in the valley of death.

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I just got back from Asia, and it sharpened something I'd already suspected — starting with the Hong Kong Science and Technology Parks Corporation (HKSTP). They operate on an alternative, self-sustaining one-campus model where infrastructure acts as an economic multiplier. The results are impressive (reference here) and their way of working is even more so, but those results exist because in Asia, they prioritize the infrastructure around businesses before creating the business itself.

1. What “infrastructure” actually means for a start-up

When I say infrastructure, I don’t mean your tech stack, I mean the human and reputational architecture around your business:

• Your identity — who you are and what you stand for

• Your public presence — do people in the industry know YOU before they know your product?

• Your partnerships — hospitals, clinics, distributors, other companies, business associations, NGOs, patient associations/advocacy groups.

• Your community — people who’ll vouch for you, warn you, and open doors for you when you’re not there.

• Your access — to the right rooms: investor dinners, closed-door regulatory working groups, industry associations, accelerator cohorts.

A lot of Founders confuse the org chart and the product roadmap with the actual business. They’re not the same thing. The roadmap is what you planned on paper. The relationships and reputation you’ve actually built are the decisive factor for whether a door opens or not.

You can have a beautiful plan and still get stuck, over and over, if you’ve never built anything with the people who control access.

2. In healthcare specifically, infrastructure has a very concrete shape

This isn’t vague “networking.” In MedTech, infrastructure means having real access to:

• Clinical experts who’ll tell you honestly whether your device solves a real problem, not a theoretical one.

• Legal and regulatory specialists who know the difference between MDR Class IIa and IIb before it costs you eighteen months.

• Compliance and quality people who build your QMS before an auditor forces you to.

• Clinical trial partners — sites, CROs, KOLs who will actually enroll patients for you.

• IT and AI expertise — because if your device touches software, and increasingly it does, you’re now also dealing with the AI Act on top of MDR.

• Partnerships — with other companies for co-marketing or distribution, with clinics for pilot sites, with NGOs and patient associations for credibility and real access to patients.

Every one of these is something you either already have a person for, or you don’t. And if you don’t, you’ll find out exactly how much that costs you at the worst possible moment.

3. Why infrastructure has to come before the product

The European Commission’s own 2026 Notified Body survey found 33,175 applications submitted against only 17,549 certificates issued — roughly 15,000 applications still sitting in the pipeline across the 51 active notified bodies.

Based on the Feb 2026 reported data, for 62% of the Notified Bodies say it takes 13-18 months to issue a new QMS certificate, while 30% report 6-12 months. For the more complex MDR QMS+PRODUCT certificates, it takes longer still: 51% of NBs report 13-18 months, and 31% report 19-24 months.

You’re realistically looking at 9 to 24 months from first contact to certificate in hand, depending on how complex your device is.

A device that goes to market six months late loses roughly 33% of its profit potential over five years. A device that’s 50% over budget but launches on time only loses about 4%.

And what makes you late? Almost always the process around it: the regulatory relationship you didn’t have, the clinical site you had to cold-call instead of already knowing, the advisor/consultant you brought in during month fourteen instead of month one.

Connections don’t just feel nice. They save you time and in medtech, time is the one thing you cannot buy back once it’s gone. If you already have a notified body relationship, a regulatory advisor on retainer, a hospital contact who’ll run your feasibility study, and an investor who’s seen this movie before, every one of those phases gets shorter, or at least more predictable. If you don’t, you’re trying to build all of that while the clock is already running.

Industry analyses put medical device start-up failure somewhere between 75% and 98%, and the reasons quoted over and over aren’t “the science didn’t work”. They’re regulatory delay, no real go-to-market plan, missing clinical or regulatory expertise, teams that built the product before they built the relationships that would get it actually used by anyone.

Founders know what the market needs, but don’t always know how to apply that knowledge correctly, because knowing how things actually move in healthcare lives in people, not in a spec sheet.

4. Infrastructure doesn’t just save one start-up — it lifts many, at the same time

This is the part Europe genuinely needs to fix, and it’s the part I keep coming back to after my trip to Asia and seeing how they operate.

The ultimate goal isn’t to build a company, it’s to build the infrastructure that hundreds of companies plug into at once. A shared asset that, once it exists, makes the next company’s path shorter and cheaper too. One regulatory relationship, built once, can shorten the runway for five companies. One hospital partnership, negotiated once, can host pilots for a whole cohort.

This is exactly why hubs and accelerators exist in the first place, and exactly why so many of them disappoint Founders. They act as a mechanism of education, of support, of guidance, but in many cases they get you only so far - because nobody involved has the resources to act as an actual infrastructure player.

In Asia, the time and resources people spend get channeled into one hub instead of being scattered across a fragmented market. That’s why those professionals move faster. They understood that if you want to build a city, you need roads and electricity before you build the neighborhood.

What I’d actually do about it

Building the product first feels productive. It feels like progress, but that doesn’t mean it is progress. In a regulated industry where the fastest path to certification is still measured in years, the real problem is the infrastructure around yourself.

The Founders who win aren’t the ones who built the best device alone in a room. They’re the ones who, by the time the device was ready, already had the regulatory relationship, the clinical partner, the community, and a room full of people who already knew their name — and, ideally, who built enough of that infrastructure that the next Founder behind them didn’t have to start from zero either.

And if you’re early in your career reading this, wondering where you fit, this is it. Every relationship I’ve described has a person behind it, and none of them were born knowing how a Notified Body works or how to run a clinical pilot. Somebody guided them along the way. Be that person for someone else, someday.

Building a MedTech company and not sure which relationships to prioritize first? Send me a message — happy to map it out with you.

A few of us have started building exactly that: a partnership network, so the next Founder doesn't have to start from zero. If that's useful to you, the door's open.

We're building this for them.

That's it.

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The story line goes like this: they built a product they loved, picked a market second, and then tried to reverse-engineer a strategy around both to make profit. By the time they realized the order was wrong, they’d already spent 18 months, a round of funding, and a significant chunk of their mental health going in the wrong direction.

So let me save you some of that.

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The basic question we all should ask from the beginning.

Before you touch your product roadmap, before you pick a regulatory pathway, before you decide which hospital to pilot in — you need to answer one question:

This might sound stupid, like a preference or something you should think about after first 3 years. It’s not, trust me. In fact it’s a strategic decision that absolutely defines everything downstream: the product architecture, who you hire, which partnerships you build, what hospitals, how you structure your IP, which markets you enter and in what specific order.

(A) If you’re building for exit (meaning you want to be acquired by Medtronic, Philips, Abbott, Siemens Healthineers, or Boston Scientific someday) then from day one you need to build like the person who’s going to buy you is already watching. Because they kind of are.

That means your product needs to fit into their ecosystem, not just solve a problem in isolation. Your data architecture, your integration capabilities and your regulatory dossier need to make sense on their roadmap, not just yours.

Many founding teams treat exit as a future event to prepare for eventually. They build the company, then at some point they “start thinking about exit”. That’s like building a house and deciding after the walls are up that you want it to be a hotel. You can try to retrofit it — but it’s expensive, slow, and the foundation is wrong.

And there’s another thing: the data suggests that 90% of early stage CEOs will not be the right CEOs for the scale-up phase.

Brutal, but true. The skills that make you a great Founder (scrappiness, vision, doing everything yourself, moving fast on instinct) are often the exact things that slow a company down when you start scaling. Knowing this doesn’t mean you should panic, it means that you should build your leadership infrastructure with the same intentionality you build everything else. Think about who you need around you, not just now, but for the next stage of the company.

(B) Building for lifestyle (meaning you want to run this company long-term, generate sustainable revenue, serve a specific patient population or hospital segment for the next 20 years) is a completely different animal, and there’s nothing wrong with it.

Some of the most impactful MedTech companies I’ve seen are not unicorns. They’re profitable, focused, and genuinely changing outcomes in their niche. But again, the strategy looks completely different.

Decide which one you are, then build everything else around that answer.

Europe and USA are not the same game.

This is the part where I need you to really pay attention, especially if you’re a young founder who’s been reading a lot of American start-up content.

The playbooks do not transfer!

If you want to build in the US market (whether you’re American or European) you need to start by understanding how everything works. Not just the FDA pathway. The whole ecosystem. How procurement actually works in a GPO environment. Which hospital systems are innovation-friendly and which ones are not so much. Where your clinical validation sites should be. Which consultants actually open doors versus just invoice you and call it “market launch”. What a US reimbursement strategy looks like for your specific device category and moreover, how successful adoption actually looks like.

All of this comes before you start testing assumptions about product-market fit. Strategy and infrastructure first - ideation and validation second.

Now let’s walk through Europe, a €170 billion market, the second largest in the world after the US. A market that is profoundly fragmented. Each country has different reimbursement systems, different procurement cultures, different relationships with innovation, different hospital budget cycles, different languages, and increasingly different regulatory nuances even within the MDR framework.

Many founders are now bypassing Europe entirely and going directly to the US. Not because Europe is a bad market, but because the regulatory environment in Europe has become genuinely unpredictable.

As Advisors, we also have a hard time doing our job, because sometimes you cannot advise a company to go into uncertain adventures across Europe, when the US market is bigger and the pathway is clearer. That’s not a knock on Europe — it should be, instead, a very powerful signal. If you want to build here, you need to go in with eyes open and a strategy that accounts for that unpredictability.

If you think a great product solves the problem — think again. Just because you have a good therapy doesn’t mean it’s economically viable for the hospital.

Reimbursement isn’t a detail you figure out after you’ve built the product or already obtained the certifications. It’s a strategic question you answer before you start building.

These aren’t back-office questions. They are the entire business model.

If you’re building for European public hospitals, you are navigating tender processes, budget constraints, clinical evidence requirements, and procurement committees that move on their own clock. You need to be financially, mentally and commercially prepared for that.

If you’re building for European consumers or digital health — completely different conversation. Faster, more flexible, but also noisier and harder to build trust in.

If you’re targeting a specific region within Europe — say the DACH market, or CEE — you need to understand that specific ecosystem: the local distributors, the clinical champions, the reimbursement bodies, the language of the market.

You cannot land in Europe without the right partner, because the market is built on relationships, trust, and local knowledge that takes several years to develop. Finding the right people - is the infrastructure you build before you build anything else.

Infrastructure before ideas. Always.

This is probably the single biggest mindset shift I try to give Founders.

Most people think of strategy as: I have an idea → I validate it → I build the product and the infrastructure around it.

The order should be: I know where I’m going → I build the infrastructure for that destination → then I start validating ideas inside that structure.

Infrastructure in MedTech means your regulatory strategy, your reimbursement model, your IP position, your clinical evidence roadmap, your commercial partnerships, your advisory network. Even the relationships you're building with companies that might acquire you someday.

Another important part of the infrastructure is testing out ideas.

Before you build anything — and I mean anything — go have three conversations. Find a KOL who does your target procedure two hundred times a year. Find a procurement officer from a mid-size hospital in your target market. Find a reimbursement specialist who knows the codes for your device category. Then sit with each of them, shut up, and listen. Not a survey. Not a focus group. A real conversation.

What you'll hear almost always falls into one of three buckets:

"The problem is real but your solution doesn't fit the workflow" — go back and redesign.

"We tried something like this, it failed because of X" — you just saved yourself 18 months.

Or "interesting, but the buyer isn't who you think it is" — your entire commercial strategy needs to shift.

That feedback, gathered before you've committed to a development sprint, is worth more than any market research you'll ever pay for. Your expert ecosystem is your most underused asset. Use it before and while you build — not after.

Nobody funds a product. They fund people.

Let me say that again: Nobody. Funds. A. Product.

They fund a team they believe in, with a track record they can point to, operating in a space they understand, with enough visibility in the market that the investment feels like a calculated bet.

I’ve watched brilliant products die because the team was invisible. And I’ve watched mediocre early-stage products get funded because the founders had built enough credibility, enough presence, enough of a name in the right rooms, that investors felt safe backing them.

That’s not cynical. That’s just how trust works in business.

So before you spend a single euro on a technical prototype — before you open a JIRA board, before you write your first technical specification — ask yourself:

Because the investor who’s going to write you a check in 18 months is going to Google you. The hospital CMO who’s going to champion your pilot is going to Google you. The regulatory consultant you want as an advisor is going to Google you.

What comes up in that search is either a door opening — or a door closing.

Visibility is infrastructure. Build it like one.

This doesn’t mean becoming an influencer overnight. It doesn’t mean posting every day about your morning routine. It means showing up consistently, with substance, in the spaces where your future stakeholders already are.

In practice, that looks like:

• Publishing what you actually know — not what you think people want to hear

• Speaking at one conference a year where your buyers actually go. Not the start-up ones. The clinical ones.

• Writing about the real problems in your domain — the uncomfortable ones practitioners complain about but nobody publicly addresses

• Getting quoted in industry publications, even small ones

• Building a LinkedIn presence that makes people think: this person actually knows what they’re talking about

And it’s not just you. Your whole team needs to be visible. If you’re the CEO and your CMO is invisible, your CTO is invisible, your medical advisor is invisible — you look like a one-person show. Investors fund teams, so make your team visible.

Here’s what happens when you build your public presence before you need it: by the time you’re ready to raise, the warm introduction already exists. By the time you approach a hospital for a pilot, they’ve already seen your name somewhere. By the time you’re pitching a strategic partner, they already have an opinion of you — and it’s a good one.

Most founders start building their public presence when they desperately need something — funding, a partnership, a first customer. At that point you’re building from zero, under pressure, with a deadline. That’s the worst possible time and the worst possible energy to be putting into it.

Start now. Before you need it. Before you’re ready. Before you even have a product. Because by the time you have something to sell, you want a market that already knows who you are.

Your marketing strategy is credibility architecture.

Once your infrastructure is in place and your team is visible, you hit the next wall most founders smash into face-first: they assume the market will discover them.

It won’t.

MedTech is one of the most trust-dependent industries on the planet. The procurement committees will not buy from strangers. Hospital CMOs don’t take cold emails seriously. KOLs don’t champion your device because your website looks nice.

In this industry, you are not selling a product. You are selling confidence. Confidence that your solution works. That you’ll be around in five years. That your clinical data holds up. That your team knows what they’re doing.

So you’ll need:

a) Clinical credibility - your first marketing asset, not your website, not your pitch deck. Before you can sell to anyone, someone credible has to publicly say your product works. Who are the two or three names in your target specialty that, if they stand behind your solution, make every other conversation ten times easier? Find them early. Involve them in your evidence generation. Make them partners, not paid consultants. That difference matters more than you think.

b) Commercial credibility - where most founders get lost. They hire a sales rep, hand them a brochure, and wonder why nothing moves. In MedTech, you’re never selling to one person. You’re navigating a full buying committee — the clinician who wants it, the procurement officer who controls the budget, the IT team who has to integrate it, the CFO who needs the ROI story, the compliance team who needs the documentation. Your message has to speak to all of them, differently, at different moments. And your first five customers are not won by marketing, they’re won by you, personally, showing up and having the hard conversations.

c) Market credibility - what happens when the first two are working. Your data is published. Your founders are quoted. Your company shows up at the right conferences (not as attendees! but as speakers). The right investors, hospital networks, and potential acquirers start forming an opinion of you before you ever reach out to them. This is where brand starts to matter in MedTech.

What this means for you, right now.

If you're early stage, here's how it actually works:

1. Start with where you want to end up. Exit or lifestyle? Pick one, commit to it, let it shape every decision that follows.

2. Pick your geography and go deep. Understand one market properly and learn how to build for that specific market.

3. Build your local infrastructure — partners, advisors, clinical relationships, regulatory expertise, reimbursement knowledge.

4. Build visibility for yourself and your team — before you have something to sell!

5. Build your marketing credibility in three layers — clinical, commercial, market.

6. Pressure-test every assumption with domain experts before you write a single line of code or a single technical specification.

7. Then, and only then, start your development sprint — because now you’re building for a real buyer, in a real context, with a market that already knows who you are.

I know this isn’t the “ hot trends 💅 ” version of start-up advice you see all over the internet. It doesn’t make for a great pitch deck slide either. But it’s the version that keeps you from burning two years on a product that will never see the light of day.

And in MedTech, time is not something you can get back.

If something in here hit differently, I'd like to hear about it. Drop a comment, send a message, or just save this for the moment you need it. And if you know a founder who's currently building in the wrong order, share it with them.

The best thing we can do for the next generation in this industry is hand them the full picture before they learn it the expensive way.

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Hi, I’m Alina. I am the Editor of AliDrg MedTech Insights. When I’m not publishing here, I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside. If you would like to talk or if you have a great story to tell:

Book a call / Send me a message

A start-up can access funds through diverse methods, including bootstrapping, angel investors, venture capital, and government grants. Non-dilutive funding allows start-ups to raise capital without surrendering any equity or ownership stakes.

Below are a part of the active open calls for the June–September 2026 across Europe, after the article I published in march was extremely popular » March-May Calendar

*Have in mind that the calendar is dynamic, therefore I advise you to always check the official websites!

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1. Future of Health Grant 2026 — Switzerland

Application deadline: 31 July 2026

Focus: Digital health platforms, AI patient monitoring, preventive care, digital therapeutics, healthcare accessibility tools, data interoperability.

For: Early-stage start-ups and research spin-offs in healthtech, medtech or digital health. International start-ups with swiss market entry plan are eligible. Three cumulative tiers: Ignition CHF 10,000 (3 months), Proof of Concept CHF 30,000 (6 months), Validation CHF 50,000 (12 months) — up to CHF 90,000 total, fully non-dilutive.

https://future-of-health.org/

2. EIC Accelerator 2026 — Open Call (EU-wide)

Application window: Stage 1 (short proposal) open year-round. Stage 2 (full proposal) cut-off dates: 8 July 2026 and 2 September 2026.

Focus: Deep tech and breakthrough innovations including health technologies: medical devices, digital health, AI-powered diagnostics, pharmaceutical innovations, biotech.

For: EU/Associated Country SMEs and start-ups. Grant up to €2.5M (non-dilutive) + optional equity up to €10M.

https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en

3. NIHR Invention for Innovation Programs — UK

• NIHR i4i FAST — expected Autumn 2026. Up to £100k, 6–12 months, single-stage application, no NHS partner needed. Theme revealed at launch — you can’t write the application in advance but you can be ready. Minimum TRL 5 required.

• NIHR i4i PDA — expected Autumn 2026. The most significant non-dilutive UK instrument for medtech and digital health. A funded PDA gives you independently validated NHS clinical evidence — the strongest commercial asset you can hold for NICE submissions, NHS procurement, and investor due diligence.

  https://www.nihr.ac.uk/funding-programmes/invention-for-innovation

4. Eurostars Call 11 — International R&D for Innovative SMEs

Application deadline: closes 10 September 2026

Focus: Any civilian technology sector — healthtech, medtech, digital health, biotech, diagnostics all qualify. Market-close R&D projects at TRL 4–7.

For: Innovative SMEs leading international R&D consortia. Minimum: 2 independent entities from 2 different Eurostars countries. Funding via national agencies; fully non-dilutive.

https://www.eurekanetwork.org/programmes-and-calls/eurostars/eurostars-call-for-projects-september-2026/

5. Business Finland — Sprint Grant (Finland)

Application deadline: 31 August 2026

Focus: New innovative solutions for international markets — healthtech explicitly included. First R&D grant for start-ups or significant new innovation direction for established companies.

For: Finnish small companies. Start-ups under 5 years with no prior Business Finland funding, or established companies pursuing a major new direction. Non-dilutive grant. Being the first ever call means unusually low competition.

https://www.businessfinland.fi/en/services/funding/calls/2026/sprint-grant-funding-call/

6. Health~Holland — Biotech Call 2026

Application deadline: 25 September 2026

Focus: Cell and gene therapies (CGT) and Organ-on-Chip (OoC) technologies translating research into practical applications

For: Dutch companies and research organizations in international consortia. Health~Holland has allocated €1.5M PPP subsidy for Dutch participants. International partners can be from specific countries only. Non-dilutive. Directly relevant for digital medicine and diagnostics start-ups operating in or partnering with Dutch organizations. Low external visibility outside the Dutch life sciences community.

https://www.health-holland.com/funding-opportunities/eureka-biotech-call-2026

7. KMU-innovativ: MedTech & Biomedizin — Autumn Round

Application deadline: 15 October 2026

Focus: Medical devices, digital health applications (DiGA), in-vitro diagnostics, explicitly redefined in the February 2026 BMBF guidelines

For: German SMEs (EU definition). Collaboration with a German research institution is recommended but not mandatory. Funding rate up to 80% of eligible R&D costs. Two-stage process; program runs twice per year (April and October). Requires German company registration or a German R&D partner.

https://www.bmftr.bund.de/SharedDocs/Bekanntmachungen/DE/2026/02/2026-02-06-bekanntmachung-medizintechnik.html

8. Portugal Startup Voucher — Digital & Technological Products (Portugal)

Status: Current call running — evidence of target completion deadline: 30 June 2026.

Focus: Digital and scalable business models, products or services with a strong digital or technological component, healthtech and digital health qualify

For: Portuguese-registered start-ups. Fixed amounts per beneficiary, non-dilutive. Managed via Startup Portugal. Health-focused digital start-ups regularly qualify under the digital/tech product category.

https://startupportugal.com/programs/vouchers-for-startups-new-digital-technological-products/

9. MSCA Postdoctoral Fellowships 2026 — EU-wide

Application deadline: 9 September 2026

Focus: Any health-related research discipline — medical devices, digital health, clinical science, AI in health, life sciences.

For: Host organizations (companies, hospitals, research institutes) in EU/Associated Countries hosting an experienced researcher. For medtech and digital health start-ups specifically: hosting an MSCA Fellow brings world-class research talent into your company at significant EU co-funding — salary and research costs covered for up to 24 months. Total 2026 budget: €399M, approximately 1,600 fellowships funded. Non-dilutive for the host organization.

https://marie-sklodowska-curie-actions.ec.europa.eu/calls/msca-postdoctoral-fellowships-2026

10. InnoMedCatalyst Accelerator — 2nd Edition (Romania, EU Consortium)

Status: 2026 cohort active — Demo Day 1: 16 June 2026, Piatra-Neamț, Romania (Rubik Hub). Demo Day 2: 17 September 2026, Madeira, Portugal. Register interest now for the 2027 edition (call expected January–March 2027).

Focus: 5P digital precision medicine — AI diagnostics, medical robotics, telemedicine, personalized medicine. Technologies at TRL 4–6.

For: Start-ups, spin-offs and SMEs from the 8 eligible countries above. Free program, no equity taken. Top 4 teams pitch at HealthTech Investor Summit 2026 (Bruges).

https://medicnest.eu/innomedcatalyst/

11. Innosuisse — Startup Innovation Projects

Application deadline: Rolling — quarterly decision rounds. Summer 2026 round relevant for this window.

Focus: Any sector including healthtech, medtech, digital health. Direct grants to pre-market Swiss startups — no research partner required.

For: Swiss-registered startups at pre-market stage. Fully non-dilutive. Four decision rounds per year — submit approximately 9 weeks before the relevant Innovation Council meeting. Highly underused outside ETH/EPFL networks despite being one of the most accessible non-dilutive instruments in Switzerland.

https://www.innosuisse.admin.ch/en/start-up-innovation-projects

12. (Optional*) Tenity Digital Health Accelerator (EPFL Innovation Park)

Applications: Next edition expected March 2027 — applications anticipated Autumn 2026

Focus: Digital health pre-seed start-ups — from idea to first financing round

For: Pre-seed healthtech start-ups globally. Success-based fee model only: capped at CHF 100,000 or 2% equity, charged only if you close a financing round.

The success-based fee model means zero upfront equity or costs — exceptional for founders who want Swiss ecosystem access and the EPFL investor and mentor network without standard dilution.

https://www.tenity.com/program/digital-health-accelerator/

13. (Optional*) British Heart Foundation — Translational Award (UK)

Application deadline: 5 August 2026 (preliminary outline) — UK-based institutions only

Focus: Development of novel, innovative technologies and medicines toward cardiovascular health benefits — medtech devices, digital cardiology tools, therapeutics, all qualify

For: UK-registered research institutions and companies from proof-of-concept stage through to commercial readiness. No upper funding limit — sized to the project scope over 1–3 years. Two-stage process: preliminary outline assessed by August, full application by invitation. Non-dilutive. Applications also assessed on commercial viability alongside scientific merit — explicitly designed with market-readiness in mind.

https://www.bhf.org.uk/for-professionals/information-for-researchers/what-we-fund/translational-grant

That’s all for June-September (or at least for now). Wishing you all best of luck and always remember:

Feel free to share with your peers and network if you find the information relevant.

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Curated by: • MedTech Advisor

Note: The information included above is presented to be accurate as of 14th of June 2026. The author is not responsible for any changes in the program’s timeline. Always verify on the official websites the dates, application eligibility and other details.

Every time a MedTech start-up gets acquired for a significant number, LinkedIn floods with posts about whatever narrative happens to be hot that week. AI, digital health, the next big wave. Everyone rushes to align themselves with the story.

I’ve been watching this pattern for years, and what I can tell you (from inside of the advisory conversations that don’t make it onto LinkedIn banners) is:

They got there because they made a set of decisions, years earlier, that most Founders either don’t know about or keep postponing. They got there by building something that a strategic buyer couldn’t say no to, on every dimension that matters: reimbursement, evidence, team, brand, financial structure, and market access.

Those things are not “exciting” to post about, I know, but they are - however - the difference between a company that gets a call, and one that spends years waiting for one that never comes.

So let me walk you through the mindset and the elements that often get missed.

Before anything else, let’s look at where we actually are in 2026: record money, minimal volume, capital concentrating into fewer assets. This is not a market filled with opportunities for everyone. This is a highly challenging market that rewards a tiny number of exceptional companies and quietly passes on the rest.

In practice, that means the bar for what counts as fundable or acquirable has moved significantly — while most Founders are still playing by 2021 rules. If you’re building right now, you need to understand which side of that line you’re on.

The answer, in two words: de-risked execution.

Large companies come to small players because they want growth, because they want an asset that has largely been de-risked. This is one element that should sit at the core of your business.

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Ignore the trends. Seriously.

What is trending in conference keynotes and LinkedIn posts is not the same thing as what creates acquisition value. Those are two completely different markets. One is attention, the other one is capital.

AI in MedTech is everywhere: digital health platforms, remote patient monitoring, precision diagnostics etc. Real fields, real opportunities. But also fields where hundreds of companies are piling in because the narrative is loud, not because they have a specific clinical insight, a specific capability, or an unfair advantage in that space.

Strategic buyers are looking for something far more boring and far more valuable: a company that found a real market opportunity, built conviction based on what they actually know and are uniquely positioned to do, and then executed with enough discipline that the results speak for themselves.

The Founders who exit well are almost always the ones who ignored the noise and stayed focused on something specific: a clinical problem they understood deeply, a market they had relationships in, a capability nobody else had.

What strategic buyers are looking for

When Medtronic, Boston Scientific, Stryker looks at your start-up, they are not having a conversation about innovation. They are having a conversation about risks. The meta-question every internal BD team has to answer before any process moves forward is this:

And in 2026, two other questions sit next to it:

Both of those questions need a clear yes before anyone gets on a plane.

Nobody is looking into near-term revenue contribution. Strategic fit doesn’t just mean “your product is adjacent to ours.” It means that your technology, your clinical data, your market access, and your team can accelerate their business.

A very good example is Axonics, which was acquired by Boston Scientific in 2024 for $3.7 billion. Founded in 2012, FDA approved in 2019, targeting a therapy category that existed for decades. What Axonics did was take a real, validated clinical need and execute on it with such completeness that anybody could plug the entire company into their commercial infrastructure from day one. While other founders were chasing trends, they built a clean regulatory pathway, established reimbursement strategy, and got 100,000+ real patients. Recurring revenue growing at pace. A sales motion their reps could run immediately. A data room with no structural surprises.

That is not luck. This is business strategy executed over a decade of deliberate, compounding decisions and - of course - hard work.

Reimbursement is the entire strategy.

I have had this conversation more times than I can count. A Founder shows me a beautiful product, solid clinical rationale, clean regulatory pathway. And when I ask about reimbursement, they say: “We’re working on it.”

That phrase should terrify you. It terrifies me.

Reimbursement is not something you work on after the product is built and you’re running demos for doctors on it. It is something you design into the strategy from the very beginning — because a medical device without a billing code is not a product. It is a prototype with a CE mark.

Think about what happens when a clinician wants to use your device in a hospital system. The procurement committee asks how it gets paid for. If the answer is complicated, uncertain, or “we’re pursuing a new code,” adoption stalls. If adoption stalls, your commercial numbers don’t grow. If your commercial numbers don’t grow.. you know how this story ends.

In 2026, good US/EU reimbursement alignment is a major de-risking factor for any company looking to build in these two markets.

What “reimbursement execution” actually looks like:

Existing codes actively being billed. Payer coverage decisions in place in your key markets. A health economics study showing your device reduces costs or improves outcomes in a way payers care about. Commercial accounts that are billing successfully.

Not a slide that says “reimbursement path identified.” Actual billing data. Actual payer conversations. Actual numbers.

Financial discipline — probably the hardest part for Founders

Strategic buyers aren’t just evaluating your clinical story, but they’re looking for the quality and predictability of your business. Subscription-based or usage-driven models are significantly more attractive than one-time capital equipment sales (because it’s forecastable).

Healthy gross margins matter enormously. A product with strong clinical outcomes and thin margins creates post-acquisition headaches that the buyer has to fix.

Validated cost savings or reduced clinician workload are extraordinarily powerful right now. This is not just a clinical talking point, it is a story that payers respond to, that procurement committees use to justify the purchase, and that a buyer’s existing sales team can take into their current conversations.

Most early-stage MedTech companies price their device, add a training fee, and call it a business model. That is not recurring revenue. That is a one-time sale with a support ticket and you are building a different kind of asset than what strategic buyers are actively looking for.

Stop selling a product. Build a solution they can plug in.

A product is something a buyer has to figure out how to place inside their existing portfolio. A solution, built around a product, with clinical training, service infrastructure, workflow integration, and a reimbursement story that works — is something they can plug directly into their commercial engine and make it productive from day one.

Think about it from the acquirer’s side. They have established sales reps with relationships in specific clinical departments, they have distributor agreements, they have hospital partnerships already in place.

What integration-ready actually looks like: A clinical training program that gets a sales rep productive in under 90 days. A workflow or data integration that connects with EHR systems the acquirer already uses. Patient outcomes data that continues generating real-world evidence on an ongoing basis, not just at launch.

Each of these reduces integration cost, compresses time-to-value for the buyer, and increases what they are willing to pay.

Brand, KOLs, and partnerships. This is your commercial infrastructure.

I've watched a Founder spend 3 years building something genuinely important, get to the point where a strategic buyer was circling — and lose the conversation because nobody on the buyer's clinical team had ever heard of them. Because they had built in silence and they were invisible.

That thinking is expensive. Not in a metaphorical sense. In a literal, euro-and-dollar sense.

Brand in MedTech is not about just “looking good”! It is about being known by the right people before you need them to know you. And partnerships are not just distribution deals, they are third-party proof that your product works in the real world, integrates into existing workflows, and was credible enough for someone else to bet their reputation on.

When a corporate development team evaluates acquisition targets, they are not just reading your financials. They are calling the KOLs they know: “Have you heard of this company? Do you use their product? What do the surgeons say?” They are checking whether your name comes up at the right congresses without you being in the room. They are looking at which hospital systems work with you and whether those are relationships they would want access to.

This takes years to build. Years.

A strategic partnership is not just a commercial win. It is a proof point, a de-risking mechanism, and an acquisition signal.

You open doors they can’t open on their own

This is the dimension I think is most underestimated by Founders building in MedTech. Large companies have extraordinary reach, but they also have extraordinary inertia. Getting inside a new hospital system, a new clinical department, a new geography takes them a long time (procurement politics, change management cycles, long sales cycles, internal slow decisional process).

You, as a start-up, can sometimes move in spaces they can’t. You built relationships with a specific clinical community before that community was commercially important. You got into hospital networks that weren’t on anyone’s radar three years ago. You have direct access to decision-makers that their national accounts team has been trying to reach for 18 months.

That is a real, dollar-value asset. The question you want a buyer asking internally is: “How long would it take us to build what they already have?”

If the honest answer is three to five years and tens of millions in commercial investment — the acquisition price starts to look very rational.

Your data room is who you actually are

You can have a great product, strong revenue, real brand recognition — and still kill a deal in due diligence.

A data room is the moment a buyer’s team starts verifying your story, and the gap between your story and your documentation is where deals frequently die.

IP with unclear ownership. Clinical claims not backed by the scientific data. Financial records that are clean in the summary but messy in the detail. Reimbursement codes gaps or regulatory submissions unfulfilled. Key person dependencies with no succession plan. And in 2026, new on the list: AI-embedded products without documented validation pathways, cybersecurity gaps, or missing interoperability compliance.

Most of these problems don't arrive with a warning label. IP ownership gets blurry when a co-founder leaves and the assignment paperwork was never properly done, clinical claims drift when marketing writes copy based on pilot data the submission doesn't fully support.

Most Founders only look at their data room when they’re in an active M&A process. By then, it is too late to fix the structural things. You can clean up documents. You cannot retroactively build two years of clean financials, resolve an IP dispute, or generate the clinical evidence you never ran.

Data room readiness is a governance discipline. You build it over years, not in a sprint when someone calls you.

The team — because none of this happens without the right people

Every single thing I’ve described above (reimbursement strategy, financial discipline, solution architecture, brand building, data room quality) happens because the team understood it mattered, planned for it, and executed on it.

That does not happen by accident, and a buyer who does proper diligence can tell the difference between a team that built something deliberately and a team that got lucky. That distinction is worth real money.

When a strategic acquirer looks at your leadership team, they are asking a very specific question:

Not in a generic sense. Specifically: do they understand the regulatory landscape they are operating in? Do they know how hospital procurement works? Have they built clinical evidence pipelines before? Do they have real relationships in the clinical community? Can they run a division of our company?

There is also a practical post-acquisition question that rarely gets discussed openly: if the value of your company is partly in market access and clinical relationships, and those relationships live in the heads of two or three people who might leave — that is a risk flag, not an asset. A team with documented processes, distributed relationships, and clear succession thinking is a fundamentally different acquisition target.

The best team signals are not on your org chart. They are in the decisions that were made three years before the acquisition conversation started. The reimbursement strategy that was built early. The brand that was invested in before anyone asked for it. The data room that was kept clean from the beginning. The commercial model that was built to scale beyond the founding team.

A buyer doing serious diligence will find all of it, and they will price it accordingly.

One more thing

Founders who have spent four or five years building their technology sometimes have a genuinely hard time hearing that what they built is not acquisition-ready. Because they have invested everything: their time, their money, years of their life, and the investment feels like proof that the value is there.

A buyer does not see it that way. A buyer sees the risk that remains — not the effort that was spent. Those are completely different calculations.

If your target horizon is an acquisition in four to five years, the reimbursement strategy needs to start now. The brand and KOL work needs to start now. The data room discipline needs to start now. The commercial model architecture needs to start now.

Start looking at your company through a buyer’s eyes right now. Not the optimistic version, but the critical one.

Ask yourself: if I were a corporate development director at a very large MedTech company, what would make me hesitant? What would I flag as a risk? What would I need to see that I don’t see yet?

Answer those questions honestly. Then go and fix the answers.

If this landed — share it with a founder who needs to read it before someone else has to tell them the hard way.

Which part are you most behind on right now? Drop it in the comments. I read everything.

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Hi, I’m Alina. I am the Editor of AliDrg MedTech Insights. When I’m not publishing here, I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside. If you would like to talk or if you have a great story to tell:

Book a call / Send me a message

And today, I’m not going to write just another article with industry updates or market trends. Instead, I’ll take you on a very personal journey — the one that brought me here.

How it all started

Last September, I was doing what I always do - talking to people, exchanging ideas, answering questions that landed in my DMs at 11pm on a Friday. Nothing unusual. Just... me being me and helping out my peers whenever I can.

A very strange thing happened within one week: three different people told me the exact same phrase:

My immediate reaction was somewhere between flattering 💅 and absolutely not.

At that time, the path I was projecting for my career was simple. The plan was to find a global program manager role, BDM, maybe even a QARA Market Lead position, keep learning, keep growing, maybe relocate. Basically just keep moving inside the corporate track I knew so well.

Before we jump into this story, let me give you some context.

I’ve spent 8+ years doing things in MedTech that most people don’t combine in one career.

Regulatory. Quality. Project management. Program management. Building a new entity from scratch. Then I transitioned into a commercial role and I ended up as a Business Development Manager across Central-Eastern Europe, +19 countries, over 32 partners and more people than I can ever count.

Every move I made in my career was strategic. I always jumped into areas where I had zero experience on purpose, to keep my brain busy.

Somewhere in that chaos - juggling local, regional, and global projects simultaneously, navigating time zones from Bucharest to Shenzhen to Seattle, I absorbed something that’s hard to define. It’s not just knowledge, it’s pattern recognition. It’s knowing why something breaks before it actually breaks.

I was very happy and I genuinely loved my job, but it felt like something was still missing.

So here we are, in September 2025, with 3 people telling me that I should suddenly become a solopreneur and even better than that: a MedTech Business Advisor for start-ups ecosystem.

As my CV can also confirm, I came from big corporations (Stryker, Philips, Zimmer Biomet), from environments where budgets are usually approved three levels above you and funding is someone else’s entire department. I had absolutely no idea how the start-up ecosystem worked, it just felt like a complete black box. A different industry inside our industry.

I knew MedTech from the inside. I’ve been raised in this industry. I built Quality Management Systems from zero, regulatory strategies, commercial operations, new value propositions, and I managed for years the cross-border complexity.

But the innovation ecosystem? The logic that governs how start-ups are born, funded, supported, launched into a market? That was a grey zone.

And I don’t sit comfortably in grey zones.

First step into the Ecosystem

From October to December I got my certification in accessing European Funding, to genuinely understand the mechanisms behind it. Then I started learning about different sources of funding available and talking to people in the ecosystem about their current challenges.

I don’t even know how many hundreds of hours of discovery calls I’ve had till now. Founders at every stage. Start-up teams. Professionals in the ecosystem. Investors trying to make sense of MedTech-specific risks. Researchers spinning out of academia with brilliant technology and zero commercial instinct. Students with a simple idea and zero direction. Young professionals hitting invisible walls they couldn’t even name.

I asked more questions than I answered. I listened more than I spoke — which, if you know me at all, is really saying something!

A few patterns kept coming up every week and among all, one that hit harder.

First-time MedTech Founders have to do everything simultaneously: manage a team, build a product, navigate compliance (which in MedTech is not optional), pitch investors, apply for grants, talk to the media, show up at conferences, do demos, post on Linkedin, recruit new people.

Keep their team motivated.

Keep themselves motivated.

Handle the mental weight of building for patients, for real people, and do all of that while being first-timers.

This role can be very very lonely at times.

But here’s what made it worse: the level of awareness in this industry is pretty low.

A lot of people enter this industry with the idea to build innovation, without properly understanding the healthcare economics. Some of them did not have where to go for advice, knowledge was not publicly accessible, they didn’t know whom to ask for a second opinion, or maybe they were just having a hard time to recruit experts.

Here’s something I didn’t expect to learn along the way: the gap between large MedTech companies and the start-up ecosystem is not just a funding gap or a resource gap.

It’s a translation gap.

The knowledge that feels like routine to a senior BDM, a Regulatory Affairs lead, or a Quality Manager (the whole shebang you do on autopilot) is exactly what a first-time Founder is desperately searching for. People have been sitting on a goldmine without realizing it. I know, because I was too.

“Occasionally consulting” lasted about three weeks.

At this time I learned that traditional consulting is not something I want to pursue as a career. I always had disruptive ideas and followed uncommon ways of working. I always loved to bring creative solutions that work in other industries into healthcare, despite some people’s skepticism.

One of the general truths is that: I am creative by birth and engineer by choice. I enjoy building from scratch, so I started leaning more and more towards Advisory role and long-term partnerships.

The more I learned, the more I realized this wasn’t a side quest anymore. This wasn’t something I could do on the weekends, or while I was searching for a full-time role elsewhere.

This felt like a new identity.

Not the Instagram version of it, with the pretty “core values” quotes, but the uncomfortable kind:

Because MedTech is not just a market, it’s an infrastructure for human health. The devices being built today are the standard of care in ten years. The Founders are struggling right now to understand MDR compliance, to build a QMS that doesn’t collapse under an audit, to tell their story to an investor who doesn’t understand why regulatory takes so long. All these Founders are building something that matters.

They deserve better support than they’re currently getting.

Knowledge access and open-source

I had to do something about it, and in February 2026 I launched AliDrg MedTech Insights on Substack. For Free.

Every week I write here about the real side of this industry: the compliance traps, the commercial blind spots, the funding instruments that people don’t use because nobody explained them properly and the operational decisions that look small but aren’t. About the human side of building something difficult in a heavily regulated industry.

I write like I’d explain it to my friends over coffee, because that’s what I always wanted to do. I never liked to speak in frameworks, methodologies and jargon young Founders do not understand (and I am certified in Lean, Agile and Six Sigma - as a side note).

I wanted to be a normal person, a Mentor, someone who’d just sit down with them and explain clearly: here’s what’s actually happening, here’s why it matters, here’s what I would do if I were in your shoes.

The response has been... not what I expected.

The messages I got back were consistently the same:

The feedback came in faster than I expected, and it moved me. I am beyond grateful for the community around me: lovely people, great professionals, open-minded and always eager to learn new things.

I plan to keep my publications free. People find it useful and that was exactly the goal.

The people who know me personally - also know that I always promoted open-source and free-access to educational resources and will continue to do so. I also strongly believe that innovation built in communities can be pushed across the borders faster than anything else you’ve seen. But - we will be talking about this during the next episode.

What’s next?

We’re in June now, I am around 8 months into this journey, my Substack passed 540+ organic subscribers and I owed my small community a story about ✨how we ended up in this situation✨.

A MedTech nerd who built a career by walking into rooms she knew nothing about, in roles others were scared of. Who absorbed years of quality, regulatory, program management, and commercial operations across some of the largest companies in the industry. Who decided to spend hundreds of hours in conversations and make a real impact in the industry for upcoming generations.

I never planned any of this, but I am trying my best to inspire and motivate others to become better. To do better. Not in isolation - but in communities.

So, if you’re a first-time Founder feeling like you’re building the plane while flying it, and running out of altitude — I see you.

And if you have a great story worth sharing, I would love to hear it - my DMs are always open.

Because the thing I learned from all those hundreds of hours of discovery calls is simple:

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Hi, I’m Alina. I am the Editor of AliDrg MedTech Insights. When I’m not publishing here, I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside. If you would like to talk or if you have a great story to tell:

Book a call / Send me a message

This year, I want to challenge existing facts and data, mainly because what’s happening in MedTech right now cannot be considered anymore a “trend cycle”.

In the 2026 MedTech Trends Article, I talked about the signals: FDA slowdowns, portfolio break-ups, workforce pressure, surgical robotics opening up and the hospitals being under financial stress.

Those signals? In 2027, they will become the ground.

Here’s what you should be prepared for, whether you’re a Founder, a CEO, an investor, or someone early in their career trying to figure out which table to sit at.

*The views expressed in this article are solely my own and do not represent the position of any organization I am affiliated with. While the projections and analysis presented are informed by publicly available data and referenced sources, they reflect my personal professional judgment and forward-looking perspective. Readers should exercise their own discretion when applying these insights to business or clinical decisions.

1. MedTech AI & regulations

Let me ask you something. Have you ever studied hard all year, then realized you studied the wrong subject one week before the exam? That’s where a large chunk of the industry will be with the European AI Act.

As of August 2027, full compliance obligations for high-risk AI systems (including medical devices) will be in effect. From this date, providers must integrate AI Act obligations directly into their MDR/IVDR conformity processes, ensuring that technical documentation, risk management, and post-market monitoring are aligned under both frameworks.

Think about what that actually means in practice. If you have AI embedded in your device (diagnostic imaging software, a decision-support algorithm, a patient monitoring system), you are now operating under two regulatory frameworks simultaneously: the MDR/IVDR and the AI Act. MedTech groups have been warning that this overlap could slow innovation and complicate compliance if the two frameworks are not harmonized.

The good news? We’re in the transition. And transitions are expensive, but they’re also where you gain or lose ground on competitors.

A parallel transition will shape FDA’s internal structure and how they will be operating next year, by using artificial intelligence based tools to streamline many of their internal processes. If you’re planning to launch or build in USA, you should keep an eye on the progress, as it is expected to have significant reduction of the timeframes for submissions by next year.

What to do: If you haven’t done a GAP analysis against both MDR/IVDR and AI Act requirements, it is time!

2. Surgical Robotics — The era of the specialist robot has arrived

For years, the surgical robotics conversation was basically one name: Intuitive Surgical. That era will be over, and what’s replacing it will be so much more interesting.

The robotic-assisted surgery systems market projection is $12.76 billion in 2026 and is forecast to reach $23.86 billion by 2031 — a 13.33% CAGR, driven by rising demand for minimally invasive procedures, rapid AI integration, and the expansion of 5G-enabled telesurgery networks.

But the number that should actually catch your attention isn’t the headline figure - it’s what’s happening inside it:

• neurosurgery is projected to expand at a 16.11% CAGR through 2031, as spine and cranial robots secure regulatory clearances and demonstrate superior accuracy in early outcomes data.

• the robotic cardiology surgery market size has grown rapidly in recent years. It is estimated to grow from $0.84 billion in 2025 to $0.98 billion in 2026, with robotic interventions demonstrating reduced procedural risks and enhanced surgical outcomes.

• sports medicine is gaining momentum: Oxford’s Podium Institute presented haptic actuator and personalised soft robotic orthosis research at IEEE RoboSoft 2025, demonstrating how rehabilitation robotics and surgical robotics are converging on the same underlying technology (wearable haptic devices, stretchable sensors, personalised orthoses for injury recovery). The athletic population is becoming a serious clinical target, and the IP being built here will cross over into mainstream MedTech faster than most people would expect.

• soft tissue robotics is slowly and quietly becoming the frontier nobody is talking about loudly enough. Johnson & Johnson submitted OTTAVA to the FDA in January 2026 specifically as a soft tissue robotic system, and their May 2026 pivotal clinical data met all primary endpoints.

Side note: because I am a complete medtech nerd, even today while writing this article, I was reading a study freshly published on “Facial Nerve Repair Using a Microsurgical Robot System” - ran by a team of researchers and surgeons in Japan. A procedure that did not even exist few years ago worth reading about.

The competition in surgical robotics is quietly shifting from the platform to what’s at the tip of the arm. End-effectors (modular, haptic-enabled, procedure-specific) are becoming the real differentiation layer. And the access model is changing too: robotics-as-a-service and leasing are opening the door for community hospitals. The specialist robot era isn’t just about which specialty, it’s about what the robot can do, and who can now afford to use it.

What to do: If you’re building or competing in this space, your clinical story needs to be very specific. Map the intersection of underserved specialties and underserved care settings.

3. Women’s Health — the biggest underserved market in MedTech is finally getting attention

For decades, MedTech built products tested primarily on male patients, funded by predominantly male investors, led by predominantly male executive teams, and we called the results “clinical evidence”. Women were systematically underserved by default, and defaults in regulated industries are incredibly hard to change.

That is finally changing! And the market opportunity it’s revealing is enormous.

The global women’s health market size was estimated at $53.48 billion in 2025 and is projected to reach $75.42 billion by 2033, growing at a CAGR of 5.1 % from 2026 to 2033. Women represent the vast majority of healthcare decision-makers, spending nearly 30% more per capita than men on healthcare. And yet, as of 2025, about 75% of clinical trial participants are men. Only 4% of biopharma R&D funding was allocated to conditions specific to women.

This market has been chronically under-researched and under-funded. That is a structural gap that is now becoming a structural opportunity.

VC investment in U.S. and European women’s health companies grew in the last years, and this should send a clear signal to every strategic MedTech player that women’s health commands serious multiples when built with clinical rigor.

FemTech is evolving from wellness and cycle-tracking apps into a data-driven healthcare sector delivering meaningful clinical impact — covering fertility, maternal care, menopause, and digital therapeutics, moving decisively away from generic wellness toward precision and personalization.

Cardiovascular disease in women is underdiagnosed and undertreated. Autoimmune conditions disproportionately affect women. Menopause, which affects 100% of women who live long enough, has essentially no approved device-based interventions. Every one of those is a white space.

What to do: If you’re a Founder, treat women’s health with the same analytical rigor you’d apply to any category with a massive underserved population and growing investor appetite.

4. Agentic AI - From copilot to colleague

In 2024, everyone was talking about generative AI. In 2025, the word “agentic” started appearing in every pitch deck. In 2027, the gap between companies that actually deployed it and companies that are still running pilots will start to show in the numbers.

Hospitals plan to leverage AI primarily for medical record analysis, clinical imaging, and revenue cycles. But here’s where it gets nuanced: while there’s significant promise for agentic AI in healthcare, legacy organizations are always slow to embrace the newest innovations.

The proper infrastructure in majority of the European hospitals is missing.

This is a classic feedback loop problem. AI adoption requires data. Good data requires clean systems. Clean systems require investment. Investment requires demonstrated ROI. But ROI requires adoption. You can see where this gets stuck.

What to do: the companies that will win identified the one decision that, if made 20% faster or more accurately, changes a patient outcome or a margin. Start there.

5. Neurology and Cardiovascular — where the money is flowing

These two therapy areas have always been large. What’s going to change in 2027 is where the innovation is happening, and it’s no longer just implants and ablation catheters.

In neurology, the trend to watch is closed-loop neuromodulation. More closed-loop neuromodulation devices are expected to gain regulatory approval, described as adaptive systems that have shown improved outcomes and show promise for replacing traditional static devices.

Global neurostimulation devices market size was valued at $6.8 billion in 2025. The market is projected to grow from $7.4 billion in 2026 to $14.2 billion by 2034, exhibiting a CAGR of 8.5% during the forecast period. The convergence of neurology with AI-powered imaging, intraoperative navigation, and robotics will be creating entirely new procedural categories.

In cardiovascular, the global market was valued at $74 billion in 2025 and is projected to grow from $79 billion in 2026 to $152 billion by 2035, at a CAGR of 7.5%. That’s a market nearly doubling in a decade — and the growth is not coming from the traditional implants.

Other areas you can keep an eye on:

Pulsed Field Ablation (PFA) - which is considered to be an effective alternative to traditional thermal-based catheter ablation for AFib, with a potentially improved safety profile.

Remote cardiac monitoring - the global market is expected to reach $33 billion by 2034, growing at a CAGR of 10.17%, driven by wearable sensors, mobile applications, and cloud-based analytics enabling real-time tracking outside traditional clinical settings.

What to do: In neurology, watch closed-loop and AI-adaptive systems closely, that’s where differentiation is being built. In cardiovascular, the commercial question is no longer “can we do this procedure?” but “can we do it here, for this payer, with this reimbursement code, in this care setting?”

6. Reimbursement is the new regulatory

Reimbursement is quietly becoming the most important strategic variable in MedTech in 2027. At MedTech World North America 2026, investors and banking leaders said it pretty clearly:

MedTech capital is increasingly flowing toward companies that demonstrate reimbursement strategy, usability, and workflow integration, not just innovation.

That’s a due diligence checklist.

Lawmakers have proposed a reimbursement pathway specifically for AI-enabled devices and the sector needs to get technologies to patients at scale. Medical devices demonstrating lower readmission rates through connected health and proactive data monitoring are now well-positioned with providers and payers as CMS drives adoption of outcomes-based reimbursement.

Read that again. The payer is now asking: does this actually reduce readmissions? Does this actually save staff time? Does this actually change the total cost of care?

The healthcare system is explicitly comparing the future it wants (preventive, distributed, lower cost) with where it is today, and only funding the bridge between those two states.

If your value story is still built around features and clinical specs, you’re selling to the wrong conversation.

What to do: Build your reimbursement strategy into product development, not as a post-approval afterthought. If your product prevents something rather than treats something — learn the language of the total cost of care. And the biggest hidden line item in that total cost of care equation? The people delivering it.

7. The workforce crisis is still a design problem

Everyone keeps talking about the MedTech talent shortage like it’s a pipeline issue - it’s not. If it’s a pipeline problem: you recruit harder, you pay more, and post more LinkedIn jobs.

If it’s a design problem, you have to rebuild: how work is structured, what tools people use, and what the value exchange actually looks like.

According to the World Economic Forum, 60% of the global workforce will need upskilling and reskilling before 2027. The World Manufacturing Foundation reports that 74% of companies face an acute shortage of skilled workers, while 94% expect to hire or repurpose workers through increased smart manufacturing adoption. In MedTech specifically, 45% of frontline manufacturing workers say the opportunity to work in a more modern, digital environment would factor into their decision to leave their current employer.

They’re not leaving because competitors pay more. They’re leaving because the work environment is designed for 1995. Paper-based documentation, manual device history records, systems that require three logins to get one data point. In a world where these people have smartphones, smartwatches, and instant access to everything in their personal lives, they walk into their day-to-day jobs and travel back in time.

The MedTech AI talent gap illustrates this sharply. MedTech hasn’t designed a value proposition competitive with Google, Nvidia, or well-funded digital health startups. They’ve invested so heavily in traditional talent management structures (job bands, annual reviews, siloed LMS training modules, paper-based SOPs) that they keep allocating resources to a system that isn’t working, rather than redesigning it.

What to do: Adjust your environment not just for compliance, but in such way that talent follows modern tools. Build upskilling pathways tied to the actual systems your people use daily, not generic e-learning modules. And the next time someone proposes a new AI initiative, ask: “What’s the people plan for this?” If there isn’t one, the tech plan will fail.

8. The home is the new hospital

I’ve been hearing “hospital at home” for 10 years. The difference in 2027 will be that the clinical evidence will support it at scale, and the reimbursement infrastructure is finally catching up.

The global remote patient monitoring devices market size was valued at $59.92 billion in 2025 and is projected to grow from $71.29 billion in 2026 to $289.77 billion by 2034, exhibiting a CAGR of 19.16% during the forecast period.

Remote patient monitoring can cut hospital readmissions by up to 30%, reduce emergency room visits by up to 78%, and save thousands of $ per patient/annually for the healthcare systems. Readmission reduction data is corroborated in peer-reviewed literature (2025) and NCBI systematic reviews.

Predictive clinical analytics platforms can now forecast potential health events with up to 75% accuracy. Bio-integrated wearables are making continuous data collection seamless. Virtual ward infrastructure, combining real-time physiological alerts with remote nursing oversight, is proving that patients with complex conditions can be safely managed outside the hospital at a fraction of the cost.

The care model shift is from hospital-as-default to home-as-first-choice, hospital-as-last-resort. And this has downstream implications that most MedTech companies have not yet fully modeled.

What to do: Honestly assess what percentage of your addressable market is in the home and ambulatory setting by 2030. If the answer is “significant and growing”, build a parallel commercial pathway now, while your hospital relationships are still strong enough to give you distribution advantages.

9. Longevity and preventive medicine

Five years ago, if you walked into a serious MedTech investor meeting and said “longevity,” you got politely escorted out. It sounded like biohacking. It sounded like wishful thinking dressed up in lab coats.

As per Market Research Future analysis, the Longevity industry is projected to grow from $23.5 billion in 2025 to $63.03 billion by 2035, exhibiting a compound annual growth rate (CAGR) of 10.37% during the forecast period 2025 - 2035.

The global wellness market is projected to exceed $8.5 trillion by 2027. The longevity economy, specifically aging, prevention, and healthspan extension is projected to reach $1.4 trillion by 2029 at a 12.7% CAGR. What’s actually moving for MedTech specifically? Biological age diagnostics, precision prevention platforms, metabolic health monitoring.

But here’s the honest caution — and this is where I’ll push back on the pure euphoria. Not all longevity bets are created equal. The longevity market still lacks clear regulatory frameworks, standardized outcomes, and unified clinical guidelines. Stanford’s Center on Longevity explicitly flags this in multiple publications.

There is a distinction that matters: the companies winning are those building diagnostics and monitoring tools that plug into existing clinical workflows and generate reimbursable evidence. The companies failing are those building utopian care models that require patients to pay cash and bypass insurance entirely.

What to do: If you’re in diagnostics, remote monitoring, or preventive care - your value story aligns with where institutional capital is moving. Map your product to the longevity framework: does it detect something earlier? Does it change a behavior? Does it prevent an acute event? Those three questions are the investor thesis in this space. And if your answer to all three is yes, get your reimbursement strategy locked before you think about your fundraising.

The bottom line for 2027

Here’s the simplest explanation of where MedTech will be in 2027:

Healthcare is moving from volume to value, from hospital to home, from reactive to preventive, from generic to specific. Every trend in this article is either an accelerant of that shift, or the consequence of resisting it for too long.

The surgical robot niche is the industry finally admitting that “general purpose” was never the right answer for precision medicine. Women’s health is the industry finally correcting a 50-year research debt that was also a 50-year market miss. The longevity thesis is investors finally pricing the economic reality of an aging population into asset allocation. The AI Act is the industry finally being held accountable for the systems it deploys in clinical settings. The reimbursement shift is the industry finally being measured on outcomes instead of volume. The workforce design problem is the industry finally understanding that talent follows the environments, not the salary.

None of this is happening by accident. It’s happening because the pressure (financial, regulatory, clinical, social) has finally exceeded the inertia. The fear of changing a commercial model that works today is blinding them to the model that won’t work in three years.

You don’t need to do everything at once, but you do need to pick the right 1% to start with.

The question isn’t whether you see the next year’s trends. It’s whether your next decision will reflect them.

Hi, I’m Alina. I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside — strategy, brand positioning, regulatory readiness, investor narratives, and the messy gap between having a great idea and building a successful company.

Let’s talk: Book a call / Send me a message

MedTech Trends in 2027 © 2026 by Alina Draghici is licensed under CC BY-NC-ND 4.0

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Yes, I know what you’re thinking: wait, doctors shouldn’t be paying for the product, procurement should. Exactly. And that one sentence tells me everything about where the real problem is.

In today’s article we will walk through the strategy, the practical advice, the list of questions you have to ask yourself constantly if you’re building in MedTech in Europe (and not only).

Your ICP (Ideal Customer Profile) is your answer to a lot of the problems: who is the specific person or organization I am selling to, what is their exact problem, what triggers them to act on it, and how do they buy?

Not a category, not a segment, not statistics, BUT a real person with a job title, a budget constraint, maybe with a strict and annoying boss to answer to, on a random Tuesday when your product either fits or it just…doesn’t.

Most first-time Founders — especially in MedTech — skip this and jump straight to building the product. And honestly, in the early phase that’s totally understandable. But the moment you start thinking about pilots, partnerships, or investors, the absence of a real ICP becomes the thing that quietly kills your momentum.

I often ask Founders early in our advisory sessions: walk me through the last three sales conversations you had — who were you actually talking to?

The answer is almost always minimum three completely different people: a hospital procurement officer in one city, a department head somewhere else, a private clinic owner in a third. Different sizes, different problems, different budget cycles, different languages around value.

That is NOT a customer profile. That’s a prospecting diary, and there’s nothing wrong with exploration, as long as you know that’s…well, just exploration.

As an Advisor, I find it quite dangerous to call it ‘a go-to-market strategy.

Before you build your ICP

When do I need an ICP? Before the product or after?

The answer is: you need two different things at two different stages, and confusing them is one of the most common early mistakes people do.

Stage one is problem-solution fit. This is where you validate that the clinical or operational problem you’re solving actually exists, that it matters to real people, in real hospital environment, and that your proposed solution makes sense to them. At this stage, your ‘ICP’ is really just a defined hypothesis: who feels this problem most acutely, and what would they pay — in time, money, or workflow disruption — to solve it?

You don’t need a refined profile here. You need honest conversations with at least 20-30 clinicians or decision-makers in your target environment.

Stage two is product-market fit. This is where your ICP gets specific. You have something that works — a prototype, a pilot result, early clinical data. Now the question is: who exactly is the most natural buyer, in what type of institution, through what purchasing process, and at what price point?

This is the ICP that feeds your go-to-market, your investor narrative, and your commercial hiring decisions.

Why this costs more than you think

In healthcare, getting a qualified lead through the door costs somewhere between €300 and €1,000 depending on your segment, product category, market and how you’re reaching them. Your follow-up cost: the time, the demos, the proposals — adds on top. If you’re selling to hospitals or health systems, for complex devices and software platforms the sales cycle takes around 12 to 24 months, in some cases maybe even longer.

Now run that through a vague ICP.

You spend to reach the wrong person. That person passes you to someone else. That someone else asks for a demo. The demo works - cool, congrats - but the person in the room doesn’t control the budget. Six months later you’re starting over, and you’ve burned not just the deal but the runway to learn from it properly.

Before you keep reading: how many of your last ten sales conversations were with the right person, the one who actually controls the budget? Multiply the hours you spent by ten. That's your ICP tax. Most Founders don't calculate it. They should.

The most expensive thing in MedTech isn’t a failed regulatory submission, it’s a great product pitched to the wrong person, in the wrong language, at the wrong moment.

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The thing most start-ups get completely wrong: hospitals don’t buy. People inside the hospitals buy.

In MedTech and HealthTech, the person who uses your product, the person who wants your product, the person who signs the purchase order and the person approving the budget are almost never the same human being.

Hospital purchasing looks like this for most devices and software platforms: there is a budget cycle — usually annual, sometimes tied to a fiscal year that doesn’t match the calendar year. Purchases above a certain threshold, often €15,000 to €30,000 (thresholds vary by country and institution type) go through a formal procurement process involving a committee of four to eight people. That committee evaluates clinical need, integration requirements, cost, vendor stability, regulatory status, post-sale support etc.

A single ‘no’ from any one of them can stall or kill the deal. This is not a warning, it’s a map.

In most MedTech environments you are dealing with at least four distinct people (previous article):

1. The Executive Buyer - with budget authority. They evaluate total cost of ownership, and they want to know you’ll still exist in three years.

2. The Clinical Champion. Surgeon, cardiologist, chief nurse, head of radiology - whoever sits closest to the problem your product solves. They care about patient outcomes and whether your device fits how they already work. They cannot approve the purchase alone.

3. The Quiet Blocker. IT lead, health IT manager, CISO, integration architect. They will not appear in your initial meetings, but they will appear at the worst possible moment with a list of questions about data governance, cybersecurity, integrations and GDPR compliance. If you haven’t thought about their concerns before they ask, you will lose time with this - guaranteed.

4. The End User. Nurse, technician, junior doctor, lab assistant. Their daily experience with your product is your product’s real proving ground. Contracts get signed above their heads all the time in healthcare. If they resist adoption, it doesn’t matter who signed the contract.

One product. Four different conversations.

If you have zero customers yet: this is still useful. Your job at this stage is to identify which of these four people feels the problem most acutely, and start your discovery conversations there. That person becomes both your validation source and your first ICP anchor. Don’t try to talk to all four simultaneously in early discovery. Pick the one with the most to lose from the problem not being solved.

If you’re building a wearable or consumer-facing health platform: your committee shifts. The clinical champion might be a GP who recommends the device. The executive buyer might be the patient themselves or a family caregiver managing a chronic condition. The quiet blocker becomes a reimbursement pathway, an app store algorithm, or a data privacy regulation. Map those too, as they’re just as real, and first-time Founders in this space almost always underestimate the reimbursement question.

Six questions that actually build your ICP

1. Who lit up — and why?

The person who actually moved without being pushed, who asked follow-up questions, introduced you to someone else without being asked, or came back unprompted with more questions of their own.

Pull everything you know about them: exact job title, institution type and size, geography, the specific problem they described in their own words, and — critically — what triggered them to be looking for a solution at that particular moment.

If you have zero customers yet, replace this with ‘who had the most emotional reaction during a discovery conversation?’ Someone who leaned forward. Someone who said ‘we’ve been trying to solve this for two years’. That reaction is your first ICP signal.

2. What does their Tuesday look like?

A job title is a label. A person is a day.

What does your buyer’s actual working Tuesday look like? Where does the friction appear? A head nurse managing a cardiology ward doesn’t experience the same Tuesday as a hospital CFO reviewing quarterly spend. One is drowning in operational decisions, the other is in back-to-back budget meetings preparing for a board presentation.

Your product has to solve something in their actual Tuesday. Not in a theoretical clinical workflow. Not in a PowerPoint. In the real sequence of tasks, pressures, and interruptions that defines their week.

What does a personal win look like for them (not for the hospital but for them specifically)? A published case study that advances their career? Fewer escalation calls after hours? A departmental budget that finally justifies itself to the CFO? That answer is the core of your messaging.

3. What is the trigger — not just the pain?

Pain points are useful. Trigger moments are what convert a prospect into a buyer.

The difference: a hospital has been aware of the problem your product solves for years (the pain). The trigger is the specific event that makes them act on it now instead of next year.

Concrete examples of real triggers in MedTech: a failed external clinical audit that exposed a process gap. A new procurement window opening after a budget cycle reset. A competitor hospital announcing a digital transformation initiative that made leadership suddenly feel behind. A new EU MDR obligation creating compliance pressure. A department head who moved from another institution and wants to replicate something they saw work there. A serious adverse event that nobody wants to see repeated.

Build your ICP around people whose triggers are structural and recurring, not one-time events. The problems that have existed in healthcare for twenty years are the ones most likely to produce a buying decision this quarter and next year and the year after.

4. Where do they actually go for information?

A hospital CFO and a cardiology department head do not read the same things, attend the same events, or trust the same sources.

The CFO reads healthcare finance benchmarking reports, follows procurement policy updates, and pays attention to what peer institutions are doing. The cardiologist is at ESC Congress, reads JACC and EHJ, and trusts clinical data reviewed by someone they respect in their specialty.

If you’re producing LinkedIn content and white papers for an audience that makes decisions at medical conferences based on peer referral, you are shouting in the wrong room.

For wearable and digital health Founders: your buyer may trust YouTube reviews, condition-specific patient communities, or a GP’s recommendation more than your clinical white paper.

5. Who does your champion have to convince internally — on your behalf?

Your clinical champion will go back into a room and justify this purchase to their CFO, their IT lead, their procurement committee. Do you know the three questions that CFO will ask? Do you know what the IT lead will flag? Have you given your champion the right tools they need to win that conversation?

The real sale often happens in a room you’re physically not in. Your job is to prepare the person who will be. At the end of every good meeting with a clinical champion, ask them directly:

“When you bring this to your procurement committee, what’s the hardest question you’ll have to answer?”

Their answer tells you exactly what to put in your next follow-up, and exactly where your proposal is weak.

6. When they’re having a bad quarter, do they need you more or less?

Budget cuts. Staff shortages. A failed audit. Regulatory inspection. When your ideal customer is under institutional pressure, does your product become more necessary or less?

If the answer is less, your ICP is pointing you toward a fair-weather buyer. They’ll engage when things are easy and disappear when they’re not. That’s a painful commercial base to build on.

The best ICPs are built around customers whose problem intensifies under pressure. Those are the ones who renew, expand, and refer through difficult periods, not just the good ones. In MedTech, where everything moves slowly, you want customers whose relationship with your product deepens over time, not one that evaporates at the first budget review.

Your ICP is not a document. It’s a feedback loop.

The companies that scale build a feedback loop between every market interaction and their ICP. Every conversation, every lost deal, every pilot that didn’t convert, every unexpected success. The ones that plateau built their ICP in a strategy session, put it in a deck, and revisited it only when a board member asked about it.

Watch out for confirmation bias! Once you’ve built your ICP, your brain starts finding evidence everywhere that it’s correct. Actively look for the conversations that didn’t fit your profile but went well anyway and the ones that fit perfectly on paper but led nowhere. Those are where the real learning is.

After every single sales or discovery conversation, write down two sentences: one thing the conversation confirmed about your ICP + one thing that challenged it. That’s it. Do that consistently for six months and you’ll have more real insight than most companies get from a year of CRM reports.

A note specifically for wearable and digital health Founders

If you’re building a wearable medical device or a consumer-facing health platform, there’s an extra layer that most first-time Founders in this space miss entirely.

You are running two completely different ICPs at the same time. The prescribing or recommending clinician — your B2B channel. And the end patient or user — your B2C or D2C channel. These two people have almost nothing in common except that they both need to trust you. And they build that trust through completely different mechanisms.

The clinician wants clinical evidence, regulatory status, and evidence that this integrates with their existing patient management workflow. They’re time-poor, peer-influenced, and deeply skeptical of anything that creates more work for them. The fastest path into their world is a respected peer who’s already using your product, not your marketing, not your demo video.

The patient or end user wants to know whether this will actually change something in their daily life. They decide based on how the product works when they’re tired on a Sunday morning, whether their data feels safe, and whether it fits with the devices they already own. They’re also increasingly aware that their health data has commercial value. They will switch if they feel that trust has been broken.

And then there is the reimbursement question, the one that most first-time wearable Founders discover too late, usually when an investor asks it in a pitch meeting.

Who actually pays for your device? Does insurance cover it? Is it prescribed and reimbursed through a clinical pathway? Does the hospital purchase it and distribute it? Does the patient pay out of pocket?

Each of these answers produces a completely different commercial model, a different regulatory strategy, and a different ICP. A wearable ECG monitor prescribed by a cardiologist and reimbursed by an insurer has an entirely different go-to-market than the same device sold direct-to-consumer on a subscription model. Same technology, different business, different ICP, different everything.

Figure out your reimbursement pathway before you define your ICP. Otherwise you’re building a sales strategy on a foundation that doesn’t exist yet.

Three questions to test where you actually are right now

I will leave you with some homework to do:

Question 1. Can you name the specific job title of the person who signs the purchase order for your product in your target institution — not the person who wants it, the person who approves the budget?

Question 2. What are the three questions your clinical champion’s boss will ask them before approving this purchase?

Question 3. When your ideal customer is having a bad quarter — budget cuts, staffing pressure, a failed audit, a regulatory inspection — does your product become more necessary or less?

If you struggled with any of those, you have work to do. Most MedTech start-ups are exactly in this position.

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Hi. I am Alina and I work with MedTech and HealthTech Founders on business strategy, commercial operations, investor narrative, and the decisions that look small early on but determine everything later.

If you answered “I’m not sure” to any of the questions above, that’s the conversation we should be having. And if this gave you something real - share it with one Founder in your network who’s still working from a slide instead of a real strategy.

Book a call / Send me a message

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The evidence is not wrong, it’s just answering the wrong question — for the wrong audience — at the wrong stage.

Let me give you some context: a 2024 scoping review published in PLoS ONE, covering a decade of MedTech start-up research, identified the regulatory complexity and the high capital requirements as the two defining challenges that consistently separate the companies that scale from those that don’t.

Not technology. Not the teams. Regulations and capital, and how you navigate both simultaneously.

MedTech start-ups face numerous challenges including stringent regulatory environments, complex market dynamics, and high capital requirements for product development and commercialization.

Most Founders treat these as two separate problems. The ones who actually manage to survive treat them as one.

What you should know from the start

Regulatory evidence and commercial evidence are not the same thing.

The clinical data that earns you a CE mark or 510(k) clearance is not automatically the data that convinces a payer to reimburse you, a hospital to buy you, or a surgeon to change how they operate.

Those are entirely different conversations, and they need different evidence. And if you are building for one (usually the regulatory one, because that’s the most visible deadline) you’ve done only half of the job at full price.

This article is primarily written through a European lens — CE marking, MDR, notified bodies — but the ladder logic holds regardless of geography. The specific requirements differ between the EU and the US.

Clinical evidence serves multiple critical purposes:

• regulators need proof of safety and effectiveness

• payers require evidence of clinical and economic value

• physicians want proof that your device actually improves patient outcomes

And here’s the trap that catches even experienced teams: once you’ve spent €1 million on a trial, the sunk cost pressure to keep it going — to add another arm, another endpoint, another study site — becomes enormous. You stop asking “is this the right evidence?” and start asking “how do we justify what we’ve already spent?”

The answer isn’t to avoid clinical evidence, but instead to stop treating it like a single achievement and start treating it like a ladder.

The Evidence Ladder — 4 layers

Think about it like this: you wouldn’t build a house starting with the roof. You lay the foundation, go up one floor, check it holds, then go higher. Clinical evidence works exactly the same way. Each layer is designed to be cheap enough to survive, and strong enough to open the next door.

Companies that excel at clinical evidence generation are those that treat it as a strategic investment, not a regulatory hurdle. They plan comprehensively, execute rigorously, and communicate effectively by turning clinical data into a competitive advantage.

Here’s what that looks like in practice.

Layer 1 — Bench and feasibility data

Here we’re going to have lab tests, computational modelling, bench testing under controlled conditions, basically any early first-in-human feasibility with five to fifteen patients. This is your “does the thing actually work” evidence.

The objective at this phase is to demonstrate basic safety and feasibility. Small sample sizes, single-arm design, focus on safety endpoints and detailed device performance data. Timeline: six to twelve months.

What this gets you: an investor conversation that doesn’t embarrass you, and a first clinical champion curious enough to want in.

What this doesn’t get you: payer coverage, clinical adoption, or a notified body sign-off. Don’t try to make this layer carry the weight it wasn’t built to carry.

One warning I give to every Founder reading this: you will fall in love with your bench data. You’ll think it’s so compelling it speaks for itself. It will just open a door. That’s all. Don’t stop there.

Layer 2 — Observational and real-world evidence

This is the layer most European Founders skip, and it’s the one that often delivers the highest commercial return. So what do we have here? Chart reviews. Claims analysis. Literature reviews. Registry data. Cohort studies. Conjoint analysis with payers to understand what they actually weight when making coverage decisions.

These sound less impressive than a clinical trial but they’re not. Observational studies generate real-world evidence and hypothesis generation that’s directly usable for future reimbursement decisions. This is the format payers actually use internally when they’re deciding whether to cover a technology. If your evidence isn’t in a language they recognize, it won’t matter how rigorous the methodology is.

The regulatory wind is shifting too: the FDA's December 2025 guidance significantly expanded acceptance of real-world evidence for initial approvals. This isn't just a commercial play anymore, it is becoming a regulatory one. Worth mentioning that EU is moving in the same direction but at a different pace.

There’s another reason this layer matters enormously and it’s rarely talked about: it shows you (early, cheaply, before you’ve committed millions) whether the market will pay for what you’re building.

Leverage existing data - this will completely shift the commercial conversation before you’ve touched your main clinical budget. That’s what this layer is for.

Layer 3 — Prospective single-arm studies

We finally reached the most stressful part for Founders: real patients, real outcomes, real clinical settings on a normal working day — not a controlled environment performing at its best.

This is the layer that earns CE marking under MDR for many Class IIa and IIb devices. It’s what generates your first KOL publications. It’s what lets you stand in front of a room of clinicians and say “here is what happened with real patients”, and have the paper to back it up.

The objective at this phase is to demonstrate safety and effectiveness for regulatory approval. Larger sample sizes, primary effectiveness endpoints, follow-up periods appropriate to the device. Key outputs: regulatory approval, initial publications, reimbursement dossiers.

This is also where your feedback loop begins: post-market surveillance, PMCF data, real-world performance that continuously refines your clinical claims and feeds your next Layer 4 study design with better endpoints than you would have chosen if you’d started there.

Critical point: do not skip Layer 2 to get here faster. Your Layer 2 work tells you what to measure in Layer 3. Skip it and you’ll spend eighteen months collecting outcomes that answer questions payers stopped caring about two years ago.

The order matters.

Layer 4 — Randomized Controlled Trials

Yes. Eventually. For some devices and some markets, there’s no substitute.

RCTs are the gold standard for efficacy: they control for confounding variables and provide statistical power for definitive conclusions. They’re used for regulatory approval, reimbursement, and major publications.

This is the top of the ladder. You climb to it. You don’t start there.

Why founders keep jumping straight to Layer 4

Because someone scared them.

An investor in a board meeting said you need a “proper” clinical trial or nobody serious will look at you. A senior advisor nodded, and now there’s a fear sitting in the room that, if you don’t have an RCT, you look like amateurs and you’ll lose the deal, lose credibility, lose the window.

So the Founder builds the most expensive, most complex evidence package they can afford. Not because the strategy demands it, but because of the fear of being dismissed.

Here’s what the data shows: capital is available for MedTech. Investors are actively funding the space, with particular appetite for AI-enabled and robotic devices. But that capital follows evidence of progression, and progression is not the same as one enormous, expensive study. It’s a sequence of smaller, deliberate evidence steps that show your entire system is working, stage by stage.

Investors fund Founders who understand the system.

Before you design any study, answer these three questions

If you were sitting across from me over coffee right now, before we touched a single study design, I’d ask you:

• What’s the cheapest evidence that moves my specific next conversation?

  Not the most impressive. Not the most complete. The minimum that opens the next door, with the specific person you need to walk through it with you next.

• Who is actually making the decision I need to influence right now?

  A notified body? A payer? A clinical champion? An investor? Each needs different evidence. Design for where you actually are, not for some imagined final state three years away.

• What would make this evidence useless?

  This one stops most people cold. If you can’t answer it, you don’t know your audience well enough to design the study. Consult with regulators and payers early in order to understand their evidence requirements before you design, not after.

Building trust around your evidence

Here's the part that surprises most Founders when I tell them:

Good observational data that’s been sitting in the literature for two or three years is often more persuasive to a payer than an RCT you published three months ago - mainly because it’s been read, discussed, challenged, and survived. Because clinicians have had sufficient time to argue about it in their departments and come out the other side still believing it.

Evidence that has stood up over time carries a weight that fresh data simply doesn’t have yet. Real-world evidence offers lower cost than RCTs, larger, more diverse patient populations, reflects actual clinical practice and can be generated continuously. Continuously. It doesn’t stop when the study closes. It keeps building the case, month after month, in the real world where your device actually lives.

What this means for you?

If you’re at seed or pre-Series A and someone is pushing you toward an RCT — think twice. Ask them to name the specific coverage decision, in which geography, for which payer body, this trial is designed to unlock. If they can’t name it specifically, it’s not a strategy. It’s just peer pressure.

If you’re at Series A with bench data but no payer conversations — stop and go get Layer 2 evidence before you commit to Layer 3. It will reshape your endpoints, your study design, and your entire value story.

If you’ve already spent significantly on a trial and commercial traction still isn’t there, don’t add more to it. Adding evidence to a study that isn’t answering the right question is just expensive repetition. Pause. Go back to your payers and your clinicians. Ask them what they actually need to see. Then build that, separately, and preferably cheaper.

The founders who get this right share one habit.

They treat every “no” from a payer or clinician as data. They design evidence to answer the real question in front of them right now, not the theoretical question they imagine someone will ask three years from now.

It feels slower at the start.

It is significantly faster in the long run, because you’re not rebuilding evidence from scratch when you finally get in the room with the decision-maker who actually matters.

If you’re sitting with a study design decision right now or someone on your board just said the words “we need a proper RCT”, before you commission anything, ask yourself the three questions above. If you can’t answer all three specifically, you’re not ready to design the study yet.

If you want to think it through with someone who already had these conversations, let’s talk: Book a call / Send me a message

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Hi, I’m Alina. I work with MedTech Founders and C-level executives who are technically brilliant and commercially stuck — helping them turn regulatory complexity into a competitive advantage before it becomes a crisis.

As my readers explicitly asked me to write about trends, well … this year is different. The same topic getting flagged in multiple reports is no longer a trend, it is a signal.

Here’s what’s actually happening with this industry - and more importantly, what it means for you (as a CEO, Founder, start-up or professional).

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1. The FDA is overwhelmed - launching into USA is slower now

The FDA went through a government shutdown. Senior reviewers, people with 20+ years of experience — were furloughed, which is more or less equal in impact with layoffs. Backlogs were building up, obviously, and when operations resumed, the agency shifted to “written response only” mode to manage the pile.

What does that mean in practice?

It means the informal coffee-style dialogue you used to have with FDA reviewers before a formal submission is gone - or at minimum, severely delayed. The collaborative back-and-forth that helped you fix problems early? You should expect less of it.

The FDA is also going through several transitions, which means that launching into USA is slower now. They are in the process of upgrading their internal tools (Elsa 4.0 - AI tool used by reviewers, investigators, and field staff across the agency). In parallel, they are building a platform - HALO (Harmonized AI & Lifecycle Operations for Data). If previously the reviewers could hardly identify gaps in 400 pages in PDF, it will become very easy to detect them in HALO, so pay attention.

How to save time: Audit your submissions with the same rigor you’d apply to a clinical study. Assume you will get written responses only. Design your dossier to be self-explanatory, clean, clear, because you may not get the chance to explain it verbally.

2. The portfolio breakup in large companies

Medtronic is spinning off its diabetes division. J&J is separating DePuy Synthes. BD is merging its biosciences unit with Waters Corp. Philips is selling Emergency Care. Siemens is exploring divesting its diagnostics arm.

This is not a coincidence. This is a structural general reset.

Large MedTech companies built themselves into sprawling portfolios over 20 years. For the Founders and mid-size companies, this is the opening you’ve been waiting for.

Newly independent divisions need new partners, new supply chains, new commercial relationships. They’re free to collaborate with companies that were previously off-limits because of parent company conflicts. Private equity is circling these assets, bundling them, and building focused portfolios.

What to do: Map which divested assets are adjacent to your space. Watch where PE money flows — that’s your signal about which assets are being positioned for growth. And if you’re a start-up, ask yourself: could a newly independent division become your distribution partner, acquirer, or co-development ally?

3. The workforce problem in MedTech is real

All the large MedTech companies consistently report difficulty attracting and keeping the tech talent they need, as you’ve probably seen in all the declarations. The issue is not with the talent or people, it's a value exchange problem — and most large companies do not want to admit that yet.

With the entire AI wave and tech being more and more present into healthcare, the demand is clear — software engineers, data scientists, AI specialists, cloud architects, cybersecurity experts. The problem? Google, Microsoft, and well-funded start-ups are offering more money, more flexibility, treating employees better, offering stocks or equity, etc.

What's less visible, but equally serious: experienced MedTech professionals (people with 15 to 20 years in the industry) are quietly exiting. Not into retirement, but into tech, energy, and automotive. Industries that pay differently, move faster, and treat expertise as a competitive asset.

We also need to address another layer, which is skills level & training of the professionals. Clinical and operational talent is also under severe pressure. Nearly 40% of today’s job skills may become outdated because of AI and automation — meaning the workforce you have today needs continuous upskilling just to stay relevant.

What to do: Compete on mission, complexity, and impact. A skilled engineer building a wound-care AI algorithm that improves patient outcomes has a story that no social media ad platform can match. Tell that story loudly. Build up-skilling programs, explore borderless hiring, partner with universities, and make your employer brand as strong as your product brand.

4. Surgical Robotics: the market is opening more

For years, Intuitive Surgical owned this space. Da Vinci was the only game in town for soft tissue robotics.

That era is ending.

Medtronic’s Hugo just got FDA clearance for urologic procedures. J&J’s OTTAVA just completed the clinical study 3 days ago. Smaller players — Moon Surgical, Distalmotion, CMR Surgical — are carving out niches with lighter, cheaper systems. India’s SS Innovations filed a 510(k) for a lower-cost robot. China’s MicroPort MedBot is scaling value-oriented systems globally.

Meanwhile, the space is expanding beyond traditional robotics. HistoSonics raised $250M for incisionless histotripsy. Petal Surgical emerged from stealth with over $25M in total funding to develop incisionless robotic surgery using proprietary acoustic liquefaction technology. The interventional playbook is being rewritten, from cutting to energy-based image-guided therapies.

The challenge that remains? Reimbursement. ROI is built on outcomes, efficiency, and service line strategy — not per-case premiums, and that will not change quickly.

What to do: If you’re building in this space, your story needs to be about outcomes and total cost of care, not just about the technology. And watch the Ambulatory Surgery Center’s channel closely. As capital burden models evolve, ASCs represent a massive untapped market for right-sized robotic systems.

5. Diagnostics and the Sleep Market

Diagnostics — Point-of-Care testing is growing at 6-7% annually, expanding from emergency departments into pharmacies, clinics, and homes. The liquid biopsy market is a $7-8 billion global opportunity, growing fast (non-invasive, repeatable, biomarker-rich). All of these tests are becoming the standard of care, not speciality tools.

Sleep — Clinicians have known for decades that sleep is as fundamental as nutrition and exercise. The data just wasn’t there. Now it is. Wearables and AI are generating unprecedented volumes of sleep data. Beacon Biosignals raised $86M. Eight Sleep raised $100M Series D. Investors are paying attention.

Both of these spaces share a common thread: they’re moving healthcare from reactive to proactive. From treating disease to detecting and preventing it.

That shift from hospital to home and from treatment to prevention is the single biggest structural change happening in healthcare right now.

What to do: If your product or pipeline touches diagnostics, sleep, or remote monitoring, you’re in the right place at the right time. The question is execution. Can you build the evidence, achieve the integration, and tell the value story clearly enough to get reimbursed and adopted at scale?

6. Cybersecurity

In 2026, cybersecurity is a board-level issue. Ransomware attacks on hospitals are increasing globally. When a hospital’s systems go down, patient care is disrupted, medical errors increase, lives are at risk.

That’s not a data breach - it’s a patient safety event.

The EU Cybersecurity Reserve launched in 2026. HIPAA Security Rule enforcement is tightening in the US. And for MedTech companies specifically, cybersecurity certification is now a prerequisite for EHR integration — meaning it’s a market access issue, not just a compliance checkbox.

What to do: Treat cybersecurity the same way you treat clinical evidence — as a foundational requirement, not an afterthought. Assign ownership at the executive level, build it into your product design. Get certified early!

7. Health systems are broke — and that’s your problem too

Let’s talk about your customer’s reality for a second (or more seconds).

The hospitals and health systems you’re selling to are under massive financial pressure. That matters to you directly, because a financially stressed hospital buys differently. Procurement cycles get longer, value justification requirements get harder and the “we love your technology” conversation stops translating into signed contracts.

But here’s the other side of it: health systems aren’t just cutting costs, they are also actively transforming their care model. Outpatient is growing, virtual care is expanding and remote monitoring is moving from pilot to standard. Deloitte’s data shows 64 % of health system executives expect AI-driven workflow automation to be their primary source of cost savings in 2026.

They’re not looking for a device. They’re looking for a solution that fits into a leaner, more distributed, more preventive model of care.

If your value story is still built around hospital throughput and inpatient workflow - you’re selling to a model that’s shrinking.

What to do: Reframe your value proposition around the care model your customers are building toward, not the one they’re currently running. Show ROI in terms of reduced length of stay, lower readmissions, staff time saved, and outpatient-compatible workflows. And if your product can move care from hospital to home — lead with that.

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Healthcare is being fundamentally restructured.

The hospital at the center, treating disease after it happens, financed by volume » that model is breaking down under its own weight. What’s replacing it is distributed, data-driven, preventive and AI-enabled.

For MedTech companies, the opportunity is enormous. But the gap between companies that are building for this future and companies that are still operating by yesterday’s assumptions is widening fast.

The question isn’t whether you see the trends, it’s whether you’re controlling the signals and keep building for the future.

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Hi, I’m Alina. I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside — strategy, brand positioning, regulatory readiness, investor narratives, and the messy gap between having a great idea and building a successful company.

If this resonates, let’s talk: Book a call / Send me a message

Sources: IQVIA MedTech Trends Shaping 2026 (February 2026) | Deloitte Global Health Care Outlook 2026 (December 2025)

Founders watch how a successful SaaS Founder raised their Series A. Or they read on a LinkedIn post how a digital health company cracked a hospital system in the US… Or they follow the playbook from someone in their accelerator cohort who closed a deal with a major VC Funding company.

And then they copy it. Not necessarily intentionally or consciously, but they just absorb the logic and assume “reasonably” that what worked there will work here as well.

This is called reasoning by analogy. It’s a cognitive process of solving problems or understanding new concepts by drawing parallels to familiar ones, based on structural similarity. In the most industries, it is actually a useful shortcut, because you do not need to reinvent the wheel each time. But in MedTech, it might generate for you more problems than you can solve.

MedTech is not SaaS or any other industry. In the majority of the scenarios, the customer is not the user, the user is not the payer, the payer is not the decision-maker. Unless you’re building wearables, of course.

The person who actually benefits from your product (the patient) does not appear until somewhere around step four of a process that most analogies completely skip over. The actual route looks nothing like what you have been told.

In MedTech, before a single patient ever benefits from your device, you need to win three completely different people, during three different conversations, while getting different definitions of “yes”.

Confuse them and I promise you, you risk it’s over before it even starts.

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Customer #1: The Investor

So many Founders I had the chance to talk came into the meeting with the concept that “customer” is only 1, and that’s either the doctor or the patient. Sorry to break it to you, but your very first customer is not a clinician. It is not a hospital.

Your first customer is a venture capitalist, a business angel, a family office, or a grant committee - and they are evaluating something completely different from what you think.

They are not buying your device. They are buying your probability of exit.

They are making a bet - not on whether your device works (though that matters), but on whether you and your team can navigate a decade of regulatory complexity, clinical trials, reimbursement battles, and competitive pressure, and come out the other side with a return.

What does that mean in practice? They need three things from you:

1. A credible market size

2. A de-risked regulatory pathway

3. A team they believe in — this is often the deciding factor. Not the technology. The team. Investors back people first, and they are watching for subtle signals: how you handle a hard question, whether you know what you do not know, whether you have built something before.

You will see, with time and experience, that some investors are not thinking “how much could I gain?” They are thinking “how bad does this look if it fails?” Your job is to reduce the fear of loss, not to amplify the promise of gain. De-risk the team, de-risk the regulatory path, de-risk the market assumption.

Customer #2: The Clinical Champion

Now the real work starts. The clinical champion (your lead surgeon, cardiologist, department head, whoever is first to stake their professional reputation on your device) lives in a completely different universe from your investor.

They do not care about your cap table and other financials. They care about one thing: will this work when I need it to, and will I look good or look stupid for using it?

Clinicians have built careers on being the person who has the best outcomes among their peers. Asking them to try something new is asking them to carry risk on their patients, on their standing among their network, on their department’s public image. Never underestimate how heavy that feels for them.

So what do they actually need?

• Evidence specific to their patient population

• Ease of use that fits their existing workflow

• Peer credibility

If you have no network yet, here is how to start:

You do not need a famous KOL on day one. Go to one specialty conference in your indication area, attend the poster sessions, not just the keynotes.

The signal you’re looking for is specific: a clinician who is already publishing, presenting, or speaking publicly about the exact problem your device addresses. That frustration is already on record. They are not starting from neutral, they are looking for a solution, which means the conversation is fundamentally different from cold outreach.

Watch for a second signal in your first meeting: do they ask about their patients specifically, or do they stay abstract? A champion will almost immediately bring it back to a particular case, a particular population, a complication they see repeatedly.

Go sit in their clinic for a day before you build your next presentation. Remember that what keeps them up at night is not what keeps you up at night, and until you know the difference, you are pitching yourself, not them.

Customer #3: The Payer

You walk into a hospital procurement meeting and you realise you have been preparing for the wrong exam entirely. By this point, you have spent few years and significant capital just to get here. The pressure to finally get that first real commercial contract is enormous. And that pressure is exactly what makes Founders do the wrong thing in those meetings.

>Hospital administrators want to know about reimbursement codes: is this procedure or product reimbursed under the national tariff? At what rate? Will it improve the department’s budget position or drain it?

>Procurement committees want total cost of ownership: training costs, consumables, servicing, integration with existing systems - all of it goes on the same page.

>Health systems want vendor reliability: are you going to be around in five years? What happens to their patients if you get acquired and the product gets discontinued?

The language in this room is purely financial and operational, and if you walk in talking outcomes to someone managing a capital budget under pressure from six directions (under an economic & workforce crisis), you will lose them in the first five minutes and never get back on track.

If your reimbursement code does not exist yet

This is more common than people admit, especially for digital or combination devices. Do not wait for a code to appear before engaging payers. Instead, find the closest existing code and build a budget impact model showing device cost versus the cost of the complication it prevents. Payers understand avoided cost.

Lead with the number that answers the question they are actually asking: does this save us money inside the system? The reimbursement conversation becomes significantly shorter once you have answered that first.

The mistake that kills the most partnerships early-stage is Founders pitching the wrong story to the wrong customer.

What success looks like for each customer is not just different, it is sometimes in direct tension. An investor wants a fast path to scale; a clinical champion wants a slow, careful introduction with rigorous follow-up; a payer wants cost savings that might only come from exactly the volume efficiencies that take years to build.

The real skill is the ability to speak to what that specific person actually needs to hear to say “yes”.

The practical tool: your 3 customer canvas

Before you build a pitch deck (and before you design a single slide) draw this out on one page. Three columns. Three questions for each. Print it. Stick it on the wall next to your desk. Update it every quarter as your answers get sharper.

Investor / Clinical champion / Payer

What makes them say yes?

What evidence satisfies them?

What kills the deal immediately?

These three customers don’t exist in isolation. They are actively talking to each other, often before you’re in the room.

Your investor will ask whether you have clinical validation before writing a check. Your clinical champion will ask whether the institution actually intends to purchase before staking their reputation. Your payer will ask whether the company has backing and will still exist in five years before approving a contract.

This means the system has a compounding quality in both directions. Run it the other direction and it accelerates. The goal is to build momentum in all three simultaneously, not sequentially.

The patients are why you are doing this. I know that. You know that.

But they are not your first customer. They are your north star, the reason you wake up and do the hard things every day. Getting to them requires winning three separate conversations, in the right order, with the right language, with the right evidence prepared for each discussion.

Know your customers! Get the language right! Build 3 versions of pitch, customized for your audience, and you will see how the interest will spark the room.

Good luck!

Hi, I’m Alina. I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside — strategy, brand positioning, regulatory readiness, investor narratives, and the messy gap between having a great idea and building a successful company.

If this resonates, let’s talk: Book a call / Send me a message

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“The most dangerous place in MedTech isn’t failure. It’s being technically excellent and completely unknown.”

I’ve spent hours and hours of discussions with Founders who had genuinely world-class technology, a brilliant team, a clear strategy and huge potential.

And they were invisible.

Not failing, not struggling technically, just... not on anyone’s radar. No one talking about them anywhere because no one knew who they are. When I asked them about their brand, they’d point to a logo and a website.

That’s not a brand.

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What a brand actually is — and what it isn’t

Let’s make this simple, because this word gets abused constantly.

Your brand is not your logo.

Your brand is not your tagline. It’s not your color palette, not your pitch deck cover, nor the “About Us” page on your website.

Your brand is what people say about you when you’re not there.

It’s the feeling someone gets when they hear your company name. The first three words that come to mind when a clinical partner tries to explain who you are to a colleague. The reason someone would share your article at 11pm with the message “you need to read this, this is brilliant”.

That’s a brand. And in MedTech, where trust is the currency for everything, it is the entire infrastructure on which you start building your business.

A product solves a problem. A brand creates belonging. And belonging compounds faster than anything else we’ve ever seen.

The invisibility cost

Among many things Founders don’t calculate, here’s one more: the cost of being invisible. It doesn’t show up on a P&L. It doesn’t appear in your burn rate. But it’s real, and it’s expensive.

Every month you operate without a recognized identity, you are:

• Losing the best candidates to companies that have a clear mission and a public presence

• Starting from zero in every investor conversation because no one has heard of you

• Fighting for attention in hospitals where your competitor has already built familiarity through content and community

• Missing the warm introductions that never happen because nobody thinks to mention you when an opportunity comes up

This is what loss aversion looks like in brand terms. You’re not just missing upside, you’re also bleeding opportunities every single day you stay quiet.

The start-ups that succeed aren’t always the ones with the best technology. They’re the ones people know, trust, and talk about — before they even launch commercially.

I always tell Founders: build in public, build a community, build an identity, follow your values, take people with you on this journey. If you’re building in the shadows, for whom are you even building? For the community of for your own validation?

Identity is not what you make. It’s what you mean.

Here’s the test I give every founder I work with:

If your company disappeared tomorrow, would anyone write about the loss?

Would someone post on LinkedIn and say “this team was doing something important, and I’m genuinely sad they’re gone”?

If the answer is no, you don’t have an identity yet. You have just a product.

The brands that last in MedTech — and I mean the ones that survive regulatory hell, funding winters, and competitive markets — they don’t win because of a cool feature. They win because of what they represent to a specific group of people.

Think about it the same way you think about the companies whose products you personally use and refuse to replace. It’s rarely about specs. It’s about what belonging to that brand says about your values, your taste, your beliefs.

MedTech buyers — investors, hospital systems, clinical champions — are no different. They are also humans. They also buy identity before they buy products.

What does your company stand for? Not your mission statement. Not your investor narrative. What do you actually believe about how this industry should work? Who are you fighting for? What are you willing to say publicly that makes some people uncomfortable?

That is your identity. And you need to build it before you launch, not after.

Why building in public is scary

I know what you’re thinking. “We’re in stealth. We can’t share that” or: “We’re a regulated company. We can’t say anything without legal review.”

I’ve heard both a hundred times. And both are, in most cases, a story Founders tell themselves to avoid the discomfort of being visible before they feel ready.

Building in public doesn’t mean publishing your clinical data before submission. It doesn’t mean revealing your IP or your regulatory strategy.

It means sharing the journey in a way that builds genuine trust over time.

What does that look like in practice?

• The Founder who writes honestly about what they learned from their first failed hospital pilot

• The CTO who explains the real technical tradeoffs of building for clinical environments

• The regulatory lead who shares what navigating MDR actually feels like from the inside

• The CEO who talks about why they started this company - not the polished version, the real version

Every one of those pieces of content is a trust deposit. It accumulates. It works for you 24 hours a day. And it creates something that no amount of paid advertising can replicate: a community of people who believe in what you’re building before they’ve ever used your product.

That is your commercial infrastructure. And most MedTech Founders are leaving it completely untouched because they only focus on the science.

Why you should do it anyway

One article doesn’t change your brand. One LinkedIn post doesn’t build an audience. One honest piece of content doesn’t create a community.

But 52 weeks of consistent, useful, honest content creates something that investors notice, that talent responds to, and that clinical partners remember.

The discipline is hard, I know.

I’ve watched this play out with Founders I advise. The ones who commit to visibility early, before they feel ready, before they have commercial traction. Those are the ones who launch into a warm market. The ones who wait until everything is “ready” to start talking about their company are launching into silence.

There is no such thing as too early to build your brand. My question is why you did not build it already?

The most dangerous assumption in MedTech is that great science will find its own audience.

It won’t. It never did. It needs a story, a voice, and a consistent human presence behind it.

The Founders I’ve watched struggle most are the ones who spent five years building something extraordinary and then launched into a market that had no idea who they were.

The Founders I’ve watched win are the ones who built in parallel — the product and the story, at the same time.

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The practical framework

Questions to answer before you do anything else (brand audit):

1. If I removed your logo and your product name from your website, would anyone know who you are and what you believe in?

If the answer is no, you don’t have a brand yet. You have a product description. The two are not the same thing.

2. In the last 90 days, has anyone outside your immediate network mentioned you, shared your content, or introduced you to someone because of what you stand for, not because of what you sell?

If the answer is no, you are not yet building in public. You are existing in private.

3. Can you write, in one sentence, what your company believes about this industry that not everyone would agree with?

Not your mission. Not your value proposition. A belief. Something with an edge to it.

If you can’t write that sentence, your positioning isn’t clear yet, not to the market, and not to yourself.

Here’s what you can do about it:

1. Get clear on what you actually stand for.

Not “better patient outcomes”. Everyone says that. Something more specific, something someone might disagree with, a belief about how this industry should work that you’re willing to defend publicly.

If your positioning doesn’t exclude anyone, it doesn’t attract anyone either.

2. Build one channel seriously before you build many.

Post consistently for 90 days before you decide it’s not working. Most Founders give up in week three. The ones who keep going in week 12 are the ones who start seeing compounding returns.

3. Assign domain voices to your team.

Your team has networks you’re not activating. The CTO should be writing about clinical-grade engineering. The regulatory lead should be sharing what navigating EU MDR actually looks like. Each person reaches a different audience.

4. Share the journey, not just the milestones.

Milestones are press releases. Journeys are brand-building. The hard decisions, the pivots, the lessons - those are what make people feel connected to what you’re building.

5. Show up before you need anything.

The trust you build when you have nothing to ask for is the most valuable currency in this industry.

Last note:

It’s not about the product. It has never been about the product. It’s about what people feel when they think of you - and whether they think of you at all.

Brand is not a nice-to-have in MedTech. Build it like you build your QMS: with intention, consistency, and long before anyone is asking to audit it.

The invisible start-up doesn’t fail because of the technology.

It fails because nobody knew it existed.

Don’t let that be your story.

Hi, I’m Alina. I work with MedTech Founders and C-level executives on the things that make or break a company before it’s visible from the outside — strategy, brand positioning, regulatory readiness, investor narratives, and the messy gap between having a great idea and building a successful company.

If this resonates, let’s talk: Book a call / Send me a message

Subscribe now

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They walk out with nothing. And the worst part? They usually have no idea what went wrong. Or they leave the room thinking the investors are asking for too much.

Most of the time, it wasn’t the product slide. It wasn’t even the market slide. It was the story - or more precisely, the complete absence of a coherent one.

I spend my days working as a Business Advisor for healthcare start-ups (crazy job to do), so you would think I get to see a large number of impressive product ideas and impressive decks. You are true with the product part. Unfortunately, a lot of the pitch decks I am seeing are far away from “impressive”.

Founders! Your pitch deck is not a documentation exercise. It is not a technical report. It is not a place to prove how hard you’ve worked. It is a storytelling tool with one job: to make a specific person, in a specific room, feel specific enough conviction to say yes.

Around 85% of MedTech decks I’ve seen so far were built for the wrong person, in the wrong order, telling the wrong story or no story at all.

This article is my attempt to fix that. Slide by slide. So pick up the pen and start taking notes.

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Before you open any design tool, answer this first

Way before you touch a single Canva template, I need you to write down the answer to one question:

• Who is this deck actually for, and what do you need them to do?

I know, it sounds obvious. It is not. Founders routinely build one deck and then they bring it everywhere. This is a big NO. Each one of the audiences you have wants something fundamentally different from you.

An investor wants: market size, team expertize, a credible path to clinical adoption, and a realistic picture of returns, clear regulatory planning, a strong partnership ecosystem.

A strategic partner wants: ecosystem fit, integration logic, and whether working with you makes their life harder or not.

A licensing conversation is focused on: IP strength, clinical evidence quality, and scalability without them needing to build anything themselves.

You cannot optimise one deck for all three. So before you build anything - define the objective. Write it at the top of a blank page. I am preparing this deck to raise investment from [type of investor], and by the end of it I need them to feel [specific outcome].

Everything else follows from that answer.

In this guide, we’re focusing on raising investment. Because that’s usually what brings a Founder to the table — and it’s where the most mistakes happen.

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The slide architecture

I will share with you the structure but keep in mind, you do not need 8 slides or 100, you need a structured narrative that would make sense!

I am not saying this is the best framework on the planet.

I am saying that this is the most basic knowledge to cover and Founders should go into an Investor meeting with a well-prepared deck.

So let’s start with it already.

Slide 1 — Cover slide: micro-elevator pitch

First impressions happen faster than you think. Investors have seen hundreds of decks. Your cover is the first signal of whether you understand what you’re doing.

What it needs: the name of your company, a clean high-resolution image of your device or product, and one short tagline (what I call a micro-elevator pitch).

The test for a good tagline: can someone who has never heard of your company read it and understand in ten seconds what you do, who you do it for, and why it matters?

Not: “An AI-powered multi-modal platform for clinical workflow optimisation.”

Yes: “We reduce post-surgical readmissions by 40% with a wearable that any ward nurse can deploy in under three minutes.”

If I read your cover and I’m not immediately curious to turn the page, you’ve already lost me and there’s no recovery for that.

Slide 2 — The Team: why are you the best people?

Some investors want this upfront. I agree with them 180%, especially if you are seeking to raise more than 250k EUR on this round.

Here’s why: at early stage in MedTech, investors are not betting on a product, they are betting on the people who will navigate one of the most complex regulatory, clinical, and commercial environments in the world. They need to believe in you before they believe in the device.

I keep repeating to start-up teams: it was never about the product.

What this slide needs: why you are personally connected to this problem. Was it a clinical gap you witnessed firsthand? A family experience? A decade inside a hospital system watching the same broken workflow repeat itself?

This is not the place for a list of logos and titles. It is the place for visual storytelling. Make me understand why this specific team exists to solve this specific problem.

Why should I invest in you or even listen to your presentation if I have no clue about who you are?

Slide 3 — The Problem

This is the slide where most MedTech Founders make their most expensive mistake. They jump straight to clinical data. They show up statistics, cost-to-system numbers, complication rates, and they lose half of the room before the story has even started.

Start with the human cost first. Show me what it actually feels like to be the patient, the clinician, or the caregiver trapped inside this broken system. The stress of a misdiagnosis. The inefficiency of a workflow that hasn’t changed in fifteen years. The moment a doctor has to choose between two bad options because the right tool doesn’t exist yet.

Then layer in the data. The numbers. The scale. whatever you have in the back pocket.

This is what I call the dynamic cost of the problem - not just what the problem is, but what it actively generates for the world every single day this remains still unsolved. Without urgency, an investor has no reason to act now rather than next quarter.

The grass is still green outside, with or without this investment, you know?

Make me feel the problem. Then prove to me with numbers how big it is.

Slide 4 — The solution model

This is not the product slide yet. This is the slide where you explain your approach; the logic behind how you’ve chosen to solve this problem, and why that logic is better than the alternatives.

Think of it this way: before I understand what you built, I need to understand why you built it this way. What is the mechanism? What assumptions does your solution rest on? And how does that compare to what people were doing before you arrived with your crazy idea?

This slide is where a lot of Founders lose technically-sophisticated investors, not because they can’t explain the technology, but because they skip the reasoning and go straight to the answer. Explain the thinking.

Slide 5 — The product

Now you can show me the product: what it does, how it works from a technology standpoint, do an animation short demo on half-slide, I don’t care, just help me understand the core architecture and what makes it technically differentiated.

Keep it digestible. You are not writing a technical specification, you are creating a picture of what the product is and why that technology is the right choice for the problem.

If your investor wants to go deeper, save the details for due diligence.

Slide 6 — Product Development

This is the slide that separates MedTech pitches from every other kind of pitch: clinical validation, regulatory pathway, manufacturing, scalability, any technical risk that a serious investor needs to know about — and your plan for managing it.

Do not hide the regulatory reality. Every experienced MedTech investor already knows this is hard. What they are looking for is whether you know how hard it is, whether you’ve thought it through, and whether your team has the experience to navigate it.

If you gloss over this slide, you will lose the room at Q&A when someone asks about your MDR compliance strategy and you stumble. If you own this slide (clinical evidence plan, regulatory classification, timeline, notified body relationship etc.) you gain credibility that no amount of polished design can buy you.

This is MedTech. The hard stuff is not a liability, it’s your biggest advantage, so show it.

Slide 7 — Product Features + Ecosystem Integration

Pick the four strongest features of your product. Not ten. Not seven. Four.

More than that is just noise.

The part that separates a generic technology pitch from a MedTech pitch is: ecosystem integration (this is not optional, it is critical). Hospitals do not replace systems, they integrate into them. EHR compatibility, clinical workflow fit, interoperability with existing device infrastructure - this is where your product either survives in the real world or dies quietly in a pilot programme.

Show me that you understand adoption in healthcare is half technical and half political. Show me the integration logic. Show me what this product looks like inside the ecosystem it has to live in.

Slide 8 — The Demo

This is the most underused slide in most decks I see and it drives me mad each single time. I don’t want to see another feature list. I want to feel what it is like to use your product, from user pov.

Use whatever format works: a video clip, annotated screenshots, a user journey map, a simulation, any prototype generated with AI in 1 hour. The goal is to make the product tangible. To close the gap between “this exists in your deck” and “this exists in the outside world.”

The best demos I’ve seen don’t just show the product working. They show the difference it makes to a real person.

That is what stays in an investor’s mind when they’re comparing 12 business opportunities on a Thursday afternoon.

Slide 9 — Why we win

This is your competitive advantage slide - but reframed. The title I always recommend is exactly this: Why we win. Not “our competitive advantages”, not “market differentiation”, not ,,Why we’re better than our competition”.

Why we win. It is a more honest framing and it forces a more honest answer.

What you need to show here: your regulatory advantages, your clinical evidence edge, your go-to-market network, your unit economics at scale, and why each of these things is genuinely difficult for a competitor to replicate.

I’ve seen too many Founders answer this slide with the classical table that always gives me a stroke. Every single soul knows the features comparison matrix. Myself? I would delete it from the surface of the Earth with the first occasion. majority of features get copied in .. 3 days, small budget and 3 bored R&D engineers.

Strategic position is harder to copy.

What has already been proven? A published clinical study. CE marking in your first market. A signed hospital system as a paying pilot. These are the signals that tell an investor this is not a bet on potential, it’s a bet on demonstrated execution.

Proof of durability matters more than promises of future performance.

Slide 10 — Competition: understand it better than anyone

Most Founders get backwards on this slide: they treat competition as a threat to minimise. Experienced investors treat it as a proof point to interrogate.

If there’s genuinely no competition, there’s likely no market. If there’s significant competition, the question is why you win.

Use this slide to demonstrate that you understand the competitive landscape better than anyone sitting across from you. What are incumbents missing? Where are the clinical or commercial gaps that your product specifically fills? What is the unexploited potential that others have failed to see?

Show me a genuine analysis. Show me you’ve done the work.

Slide 11 — The Market: build it from the bottom up

I wrote an entire article about this recently and I’ll say the same thing I said there.

Drop the concentric circles with a large number inside them!!! That is not market analysis.

TAM, SAM, SOM done correctly means: targeted users, their profiles, their buying behaviour, the specific market opportunity (locally first, then regionally, then globally) with each number derived from patient count × average selling price, not from “we need 2% of the $400B chronic disease market”.

Show me the math that builds from that customer towards the opportunity. That is the slide that tells me whether you understand your own commercial strategy, or you’re performing the appearance of understanding it.

Slide 12 — Business Model and Unit Economics

Do not turn this into a ten-minute financial deep dive. Keep the main deck clean.

Revenue model. Pricing logic. Key unit economics. That’s what belongs here.

The full three-year financial model (cash burn, runway, pro forma P&L, sensitivity analysis, capital efficiency metrics) lives in your appendix. Investors who are serious will ask for it. Save it for that conversation.

What belongs on this slide is enough to establish two things: how you make money, and whether the economics of that model are fundamentally bulletproof at scale.

If you have a capital equipment component and a recurring consumables stream, model them separately. They are different business dynamics and blending them obscures the cash flow profile investors specifically need to evaluate.

Slide 13 — Go to Market: Product-led, milestone-driven

This is where vision meets execution, and where I can usually tell within 30s whether a Founder has actually thought this through or is just presenting a dream.

Show me the roadmap: 6, 9, 18, 24 months from a product perspective. Which clinical settings are the first ones? Which geographies? Which channel partners or distribution relationships? What are the specific triggers that determine when you move from one stage to the next?

You are not trying to capture Europe in year one! You are building compounding momentum; deliberate, evidence-backed steps that create a feedback loop between clinical adoption and commercial proof points.

Founders describe market entry as if it’s a single event. It isn’t. It’s a sequence of decisions, each one enabled by the last. Show me that sequence. Show me you know the order of operations.

Slide 14 — Fundraising: The real reason everyone is in the room

Be direct. Be specific. Be clear.

How much are you raising? What will you accomplish with it - specifically? What milestones will it unlock? What does a successful deployment of this capital look like at month 18?

The best fundraising slides I’ve seen do two things simultaneously: they paint a vivid picture of where the company will be when this capital is properly deployed, and they are completely honest about where the company is today and what the gap is. That contrast creates urgency without desperation.

What destroys this slide: vague language.

“We are raising to scale the business and pursue commercial traction”.

Great, I’m happy for you, but that tells me nothing.

Show me exactly what you will build, hire, prove, and achieve with the specific amount you’re asking for.

Slide 15 — The Close

Company name. Contact email.

That’s it.

You have told the story. End it cleanly, with confidence. Do not add a wall of text here. Do not summarise everything you just said. If the deck worked, the investor already knows what to do next.

If you feel the need to add more here, it usually means you don’t yet trust the story you built in the previous fourteen slides. Go back and fix the story.

The Appendix: your credibility vault

For a MedTech deck, the appendix it is one of the most important things you bring to a meeting with investors, and most Founders drop 3 slides in there and good luck.

Here is what should be put there, ready to be pulled-up in the moment an investor asks a hard question:

• Full team and board experience map — investors are looking for domain expertise. Show every person, their background, their specific relevance to this problem.

• Go-to-Market detailed breakdown — the full strategy behind the summary on the slide.

• Regulatory and compliance status — your current classification, the pathway, the timeline, what’s done and what’s pending.

• Sustainable competitive advantages — documented, not just claimed.

• 3-Year Financial Model deep dive — revenue model, unit economics, operating expenses, pro forma P&L, cash burn and runway, key milestones and triggers, sensitivity analysis, comparable exits and valuation, capital efficiency metrics, assumptions summary.

• Customer or clinical references — if you have them, this is gold.

• Competitive landscape deep dive — your full analysis, not just the summary on the slide.

• TAM/SAM/SOM documentation — the full methodology, sources, and bottom-up build. With mathematics!

• Risk and mitigation plan — device-specific. Show me you’ve thought about what could go wrong and how you handle it.

• Manufacturing and scale plan — especially relevant if you have hardware.

You won’t present any of this proactively. But when a sharp investor says “walk me through your regulatory pathway” or “show me the unit economics at 10,000 units” — you flip straight to it without hesitation.

That transition — from narrative to detail in under ten seconds — is the moment you go from Founder to the most credible CEO in the room.

The thing that actually decides whether you get funded or not

I want to close with something that doesn’t appear on any slide.

Investors don’t fund decks. They fund conviction. They fund trust in the team.

Your deck is the scaffolding that lets your conviction stand on something visible. Every slide is a chance to demonstrate that you understand this problem more deeply than anyone else in that room. That you’ve thought through the risks and chose to run toward them anyway.

Demonstrate that you have the team, the strategy, and the resilience to navigate one of the most demanding industries in the world - the rest will follow.

Good luck!

If this was useful — share it with a Founder who’s preparing for their first investor meeting. Or a young person in MedTech who’s been told this kind of knowledge is only available to those who already know the right people.

It shouldn’t be. That’s the whole point.

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Hi! I’m Alina. I work with Health Founders and leadership teams on the things that make or break a company before it’s even visible from the outside — team structure, regulatory strategy, investor readiness, and the messy gap between having a great idea and running a fundable company.

If this resonates, let’s talk: Book a call / Send me a message

Subscribe now

And then the reality hits. MedTech is not same as tech, despite of the naming. Nobody explained them properly that now you are building in a completely different world.

This article is a guidance point. It’s the things I wish someone had said out loud before I’d seen Founders and Investors lose time, money, and honestly - the trust in each other - over expectations that were never aligned from the start.

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1. The product isn’t ready when the product is ready

In software, when your product works you ship it, you get users, you get feedback, you scale-up. The people who know how to take advantage of the speed are the ones who succeed.

In MedTech, when your product finally works, you’re actually just getting started.

Before a single hospital can legally use that device (and you can legally sell it), the company needs to:

- prove it’s safe and effective (not in a pitch deck, but in very-strong clinical data)

- be reviewed by a third party - a Notified Body (their queues are long, their standards are high, and they do not care about your go-to-market timeline)

Based on the type of device, class and intended scope, you are looking into 12 up to 36 months to get the device certified, from the moment the technical documentation gets submitted. Class IIb or III devices are the ones taking longer, with more clinical evidence required and expert panel involvement on top.

This is how the system works. It is like that because previously, a lot of high-risk products were sold into hospitals without being “under proper control”, hurt people and the entire Europe realized we need to have clear rules to follow.

What you should ask before investing: what device class is this, what’s the regulatory pathway, and is that timeline honestly reflected in the financial model? how the regulatory timeline is correlated with the clinical pilots & budget?

2. Device class is the whole strategy.

Class I is a bandage. Class III is an implant. And everything in between sits on a spectrum of regulatory scrutiny, clinical evidence requirements, post-market obligations, and costs.

The class of the device tells you:

• How long it will realistically take to reach the market

• How much clinical evidence the company needs to generate (and pay for)

• Whether a Notified Body needs to review the technical file (Classes IIa, IIb, III - yes)

• How much post-market surveillance will cost every single year after launch

• What happens to the whole business if one safety signal shows up in the data

A Founder who doesn’t know this with clarity and confidence is a red flag. Not because they’re dishonest or unprepared, but because regulatory strategy is business strategy in this industry. They’re not separate things.

3. CE mark is not the finish line, it’s the starting gun

You’re a young investor, passionate about technology and healthcare, and you’re in a room listening to a Founder proudly presenting that they got the CE mark. Amazing news. Now they can sell.

But — selling to who? Through what channel? At what price? And who’s actually paying? What is the actual revenue model? Do they have an annual revenue forecast?

In this industry, the distance from “I would love to have this technology in my department” to “Let’s start the procurement procedure/Let’s sign the contract” is similar with the distance from the Earth to the Moon. Nevertheless, people still went around it recently.

In MedTech, the buyer, the user, and the payer are almost never the same person (unless you’re building only for consumer health).

A surgeon uses the device. A hospital procurement committee decides to buy it. And a national health system or insurance body decides whether to reimburse it or not. Three completely different conversations, three completely different timelines, three completely different decision-makers.

Reimbursement is where dreams go to have a mojito on the beach while waiting. Getting a new procedure or device covered by a national health system can take years after CE mark. And hospital procurement cycles? Budget decisions are often made in October for the following year. If your device shows up in November, you’re waiting 11 months for the next window.

This is not pessimism. These are just the rules of the game.

The companies that win are the ones who start the reimbursement and access conversations in parallel with regulatory submissions for certification — not after.

And the investors who thrive are the ones who understand that revenue growth in MedTech looks like a staircase, not like a hockey stick.

4. The team needs to include people who’ve done this before

I see a lot of founding teams that are brilliant: deep clinical expertise, strong technical skills, genuine passion for the problem they’re solving. And then:

• the regulatory affairs function is not there, or minimally represented

• the quality management system gets built reactively

• nobody on the team has actually navigated a Notified Body audit before

In MedTech, what kills companies is rarely bad science. It’s the operational complexity around bringing a safe, compliant product to market, and doing it sustainably.

A quality management system (QMS) is not just a document you file away. It’s a living system that governs how the company makes decisions, tracks complaints, responds to safety signals, manages suppliers, and handles product changes.

If it’s not embedded in the culture from day one, it becomes a monster to fix later, and fixing it during a Notified Body audit is the worst possible time.

When you’re looking at a MedTech team, the question isn’t just “do they understand the clinical problem?”

It’s “do they have the operational depth to build a regulated company?” Those are two completely different skill sets, and you need both.

5. The capital requirement is almost always more than the model predicts

MedTech is capital intensive in ways that don’t show up neatly in a three-year financial model.

Clinical studies cost money.

Notified Body fees cost money.

Quality system maintenance costs money.

Post-market surveillance (which is ongoing and mandatory) costs money.

And these costs don’t stop when you’ve raised your first round. They continue through every round, every product iteration, every new market.

A Founder who shows you a model where they reach profitability in year three of a Class IIb device company (with no follow-on raise) either has something genuinely magical going on, or the model has a gap. Either way, it’s worth a very detailed conversation.

If you’re writing a check into MedTech, build in the assumption that you’ll need to support a follow-on round. And make sure the Founders have thought about bridge scenarios before they need one.

6. What good traction looks like before there’s any revenue

In MedTech, none of the metrics you are used to matter. The signals I’ve learned to look for:

• Is the regulatory submission actually filed, or just “in preparation”?

• Has a Notified Body been formally appointed?

• Are there clinical study agreements signed with named institutions, or just letters of intent?

• Are Key Opinion Leaders (the surgeons, the department heads, the clinical champions) and DOLs (Digital Opinion Leaders) actually involved in the study design, or just listed on a slide?

• Has any reimbursement groundwork been laid, even informally?

These are the real progress indicators in a pre-revenue MedTech company. If a Founder can’t answer these questions with specifics, that tells you something important about the operational maturity.

7. What returns actually look like

If you’re coming from SaaS, you’re probably calibrating to 3–5x multiples over a 7 to 8 year horizon. Reset that model entirely. In MedTech, a full investment cycle — from early check to meaningful exit — typically runs from 7 up to 14 years.

The J-curve is deeper, and it stays negative longer, because the capital requirements don’t stop after product-market fit. They continue through every regulatory milestone, every new market entry, every post-market obligation. If your fund structure or your LPs aren’t built for that kind of patience, MedTech will punish you regardless of how good the company is.

8. Where the exits actually come from

In tech, you know the exit archetypes by heart. In MedTech, strategic acquisitions are the primary path. IPOs happen, but they’re rare, heavily scrutinized, and almost never the right move for a company that hasn’t demonstrated commercial traction across multiple markets.

Licensing deals exist in specific therapeutic areas, but they’re not a primary exit strategy for device companies. What this means practically: you need to understand, from day one, who the likely acquirer is and what that acquirer needs to see before they move. Clinical evidence that maps to their portfolio gaps. Commercial proof points in markets they care about. Regulatory status in geographies where they operate.

How advantages in this industry look like:

Proprietary clinical evidence is one of the strongest defensible assets in this industry. A dataset that took four years and three hospital partnerships to generate is not something a competitor can shortcut.

First-mover position on a reimbursement code is another - being the reference technology when a national health system defines a new reimbursement category creates structural advantage that’s very difficult to displace.

And regulatory pathway itself can be a huge bonus: a company that has navigated a Class IIb or Class III approval process has built institutional knowledge, a validated QMS, and a Notified Body relationship that took years to establish.

All the above and many more can switch from advantages to barriers quite fast. They just don’t show up in the frameworks you’re used to using.

Geography is strategy, not a footnote

CE mark and FDA are not interchangeable, and the choice of which market to enter first is one of the most consequential strategic decisions a MedTech company makes. The EU pathway, under MDR, has become significantly more rigorous since 2021, but for many device classes, it remains faster and less costly than the FDA route, making it the preferred first market for early commercial proof.

The US market is larger and often commands higher reimbursement rates, but the FDA pathway — particularly for Class III devices — can add years and tens of millions in additional clinical spend. As an investor, you need to understand which flag the company is planting first, why, and whether their regulatory and commercial team has actually operated in that geography before. A European regulatory strategy run by someone who has only worked with the FDA is a risk. So is the reverse.

So what does a good MedTech investment actually look like?

A realistic timeline. A team that has domain expertise, not just clinical, but also regulatory and commercial strong experience. A regulatory strategy that’s already in motion, not on a slide! A reimbursement plan that’s been started. A financial model that’s been stress-tested by someone who’s actually seen how these things play out.

None of this means MedTech is the wrong bet. Honestly, it’s one of the most meaningful places to put capital. The outcomes you’re funding (better diagnostics, earlier detection, smarter monitoring) change lives. That’s not something you can say about most industries.

But it’s a long game. And the investors who do well in it are the ones who came in knowing that, and built their thesis around it.

Hi! I’m Alina. I work with Health Founders and leadership teams on the things that make or break a company before it’s even visible from the outside — team structure, regulatory strategy, investor readiness, and the messy gap between having a great idea and running a fundable company.

If this resonates, let’s talk: Book a call / Send me a message

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But I want to have a different conversation today.

Every time I post about those programs, I watch the same thing happen. 3000 people click, 70 people share it, it goes viral and everyone gets super excited about the free access to knowledge. Then roughly 200 people apply to the exact same calls, with the exact same framing, competing with each other for the same limited budget.

That’s not a strategy. That’s a crowd.

The most creative and smart Founders I’ve seen are looking somewhere the crowd isn’t. And the gap between “popular program” and “completely unknown program” in terms of actual opportunity? It is enormous.

So this is the other list, the one we do not see it circulating too often. The one most Founders will never find unless someone hands it to them directly.

Let’s get into it.

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1. THCS — Transforming Health and Care Systems Partnership

THCS is a Horizon Europe co-funded European Partnership involving 32 national funding agencies across 26 countries, with a combined budget of over €35 million.

The call theme is “Access to Care” - funding projects that improve equitable access to health and care services, and provide policy- and decision-makers with the knowledge and tools needed to support resource reallocation.

Why does nobody know about it? Because it doesn’t have a marketing budget. Most MedTech Founders glance at the title and assume it’s “not for them”. Trust me, it is.

Go and read more below:

https://www.thcspartnership.eu/funding/jtc-2026-access-to-care.kl

2. EP PerMed — European Partnership for Personalized Medicine

This one is almost invisible in the MedTech start-up conversations. Which is wild, because it has 19 funding organisations across 16 countries and a total budget of nearly €15 million.

The scope is exactly where healthcare is going: multimodal health data, multimorbidity management, real-world clinical testing of personalised solutions. If you’re building in AI-assisted diagnostics, chronic disease management, or digital biomarker tools - this is for you.

The program also runs a JTC2026 (CARMEN2026) — a Joint Transnational Call specifically on personalised medicine for cardiovascular, metabolic and kidney diseases. Budget: €38 million across participating countries.

Go and read more below:

https://www.eppermed.eu/funding-projects/calls/jtc2026/

3. Future of Health Grant 2026 — Switzerland

This one is specifically interesting for Founders who want to enter the Swiss market, and for everyone else it’s a proxy example of a category of programs that exist in almost every European country.

The Future of Health Grant gives equity-free funding from CHF 10.000 to CHF 50.000 per stage, cumulatively up to CHF 90.000, with access to Swiss healthcare provider pilot opportunities. Targets: telemedicine, patient analytics, preventive care, digital therapeutics. International applicants with a Swiss market entry plan are explicitly welcome.

Go and read more below:

https://future-of-health.org/

4. DayOne Accelerator — Basel

I included this one because it represents a category that’s criminally underused: pharma-focused accelerators.

DayOne is a 3-month program in Basel specifically for digital health, medtech, and techbio startups that are targeting Pharma R&D collaboration. The program runs mostly online with a 2-day in-person bootcamp. Up to three companies can receive investment post-cohort.

Most MedTech Founders never think of a pharma accelerator as a funding source. They think of it as a partnership program. Big mistake. The line between strategic partnership, paid pilot, and funding is blurry in pharma innovation programs, and blurry usually means founder-friendly when you negotiate it well.

Go and read more below:

https://www.dayone.swiss/accelerator/

5. The Netherlands MIT R&D Collaboration Fund

This is a country-specific example I include deliberately, because it’s one of the most consistently underused programs in Europe, and because it represents a template that exists in almost every EU member state.

The MIT (MKB Innovatiestimulering Regio en Topsectoren) fund in the Netherlands gives €50k–€350k for SME-led R&D collaboration projects. Life Sciences & Health is one of the priority sectors. The process is fast, the criteria are clear, and the competition is genuinely low compared to EU-level programs because most non-Dutch founders never think to apply to Dutch national programs.

Here’s the thing nobody says out loud: you don’t have to be Dutch to benefit from national programs. You need a Dutch partner. And a Dutch partner — a hospital, a university, a distributor, a research institute — is both findable and highly motivated to participate because it increases their access to national funding.

Go and read more below:

https://ignite-group.com/grant/mit-rd/

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6. Super Sapiens Europe — Italy

This one I genuinely love sharing because almost nobody outside Italy knows it exists.

Super Sapiens Europe is a deep tech program backed by a consortium of Italian research infrastructure and industrial partners. It funds TRL 2–9 startups across eight domains (including health-tech) with a combination of equity investment, non-dilutive grants, proof-of-concept validation with industrial partners, commercial contracts, and access to 4,000+ sqm of lab infrastructure across Italy.

For a MedTech Founder building on a hard-tech foundation (novel sensing, advanced materials, biotech-device convergence) this is rare. The lab access alone is worth the application effort for any hardware-heavy company that doesn’t have a proper validation environment.

Go and read more below:

https://supersapienseurope.com/

7. ZIM (Zentrales Innovationsprogramm Mittelstand)

ZIM is one of Germany’s most important SME innovation funding programs, and it has a feature that almost no other European program has: you can apply at any time. No submission windows, no batching cycles, no waiting six months for the next call to open.

It funds R&D projects - individual company projects, or collaborative projects with other companies and research institutions. Up to 60% of eligible costs, on a maximum of €690k. Processing time is typically around three months.

What makes it relevant for MedTech founders outside Germany: you don’t have to be German to benefit from it. ZIM funds collaborative projects with international partners. If you’re building with a German research institution or co-developing with a German hospital, your German partner can access ZIM funding for their part of the project - which often changes the economics of the whole partnership.

Go and read more below:

https://www.eura-ag.com/en/funding-programmes/zentrales-innovationsprogramm-mittelstand-zim

8. CDTI Innovación

CDTI is Spain’s State Innovation Agency. €1.8 billion in 2026 across grants, loans, venture co-investment, and public procurement. MedTech and health are explicit priority sectors.

The flagship programs:

NEOTEC — non-repayable grants up to €250k (or more if you have a doctoral researcher on the team) for tech-based startups under 3 years old. No equity. No repayment. Purely competitive based on the quality of your R&D plan.

PID (R&D Projects) — partially repayable loans covering up to 85% of your project budget, with a non-repayable tranche of 10–33%. For companies developing new or significantly improved products or processes. TRL range 2–6.

MISIONES Ciencia e Innovación — up to €145 million for large collaborative R&D projects specifically addressing socio-economic challenges including health. If you’re anchoring or joining a Spanish health consortium, this is where serious money sits.

Spain is aggressive about funding health tech right now. The CDTI also participates in Eurostars, which creates an interesting route — a Spanish SME partner in your consortium can bring CDTI co-funding alongside the international Eurostars grant.

Go and read more below:

https://www.cdti.es/en/innovation

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9. Bpifrance (i-Lab, i-Nov, France 2030 Health)

Bpifrance is France’s public investment bank and the operator of the France 2030 plan - a €54 billion investment program, of which €7.5 billion is specifically allocated to health. That is not a small number.

For MedTech founders, three programs are worth knowing:

i-Lab — a competition for tech startup creation projects, companies under 2 years old (or pre-creation).

i-Nov — co-finances R&D and innovation projects with total costs between €1M and €5M, for single-partner startups and SMEs.

Tiers Lieux d’Expérimentation MedTech - a France 2030 call that specifically funds the creation of collaborative testing spaces bringing together hospitals and medical device companies around surgical robotics and implantable devices.

The broader Bpifrance ecosystem also includes dedicated MedTech and digital health VC funds (Medtech Innovation Fund, Patient Autonome) that co-invest alongside private rounds.

Go and read more below:

https://www.bpifrance.com/

Alternatives: Hospital & University clinical innovation budgets

This is the one that has no website, no deadline, no LinkedIn announcement.

Most University Hospitals (especially academic medical centers) have internal innovation budgets. They’re used to fund clinical pilots, feasibility studies, co-development agreements with industrial partners. Typical size: €50k to €300k. Typical process: a conversation, not a form.

The academic hospitals in Leuven, Amsterdam, Copenhagen, Munich, Paris, and virtually every major city have these. They’re allocated through relationships with the head of innovation, the medical director of R&D, or through the tech transfer office if your technology has academic lineage.

Why it’s powerful: you don’t just leave with money. You leave with a clinical reference site, real-world data, a clinical champion, and the most credible slide in your investor deck.

Why nobody does it: because it requires relationship-building instead of form-filling. And most Founders in the grant-hunting mindset only look for things with application portals.

The pattern across all of these

Look at what these programs have in common:

• they might be not on the main EU funding dashboards

• they’re administered through national bodies, academic partnerships, or industry consortia

• they require either a cross-border partner, a specific market commitment, or an actual human relationship to access

• they have real budgets and low competition - precisely because of the friction that filters out everyone who’s only following the same path.

If you only apply to what everybody else applies to, you’ll get what everybody else gets: a long waitlist and a maybe a rejection letter.

The programs above are not charity nor consolation prizes. Several of them are strategically better than the headline programs - faster, more flexible, and more likely to give you the combination of capital and validation that actually moves your company forward.

If you want to read more about the popular programs, you can find the first article from the series below:

Pick your markets first. Then find the national programs that fund innovation in those markets. Then find the partners who unlock them.

That is the business strategy you should be following.

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Hi! I’m Alina. I work with Health Founders and leadership teams on the things that make or break a company before it’s even visible from the outside — team structure, regulatory strategy, investor readiness, and the messy gap between having a great idea and running a fundable company.

If this resonates, let’s talk: Book a call / Send me a message

Subscribe now

Note: The information included above is presented to be accurate as of April 9 2026, the author is not responsible of any changes in the program’s timeline. Always verify on the official websites the dates, application eligibility and other details.

There’s two types of examples around MedTech start-ups ecosystem:

• one start-up with a brilliant product, certified and having real clinical evidence - but fourteen months after their commercial launch they’re still in a conference room explaining to a hospital procurement committee why their device is worth considering.

• another start-up with an okay product, objectively less refined, who is expanding into its fourth hospital network because one intensivist in Germany won’t stop talking about it at clinical conferences.

The difference isn’t the technology. The difference is that one Founder built a community and the other one is still trying to build a sales pipeline.

This article is about the difference between those two scenarios, future trends, practical examples and things you should not do, unless you want a fast-track ticket straight into the Valley of Death.

Let’s start from basics: what is actually “community-led growth”

You’ve heard of product-led growth - Notion, Figma, Slack model. The product is so good, so frictionless, that it spreads itself. One user onboards five colleagues, those five colleagues onboard an entire department, the department standardizes it and somehow everybody in the company and in the group of friends is using it.

Community-led growth is the next layer. It’s what happens when the people using your product become the main distribution channel without you paying them. They do it because you gave them something worth belonging to - a shared identity, shared knowledge, shared stakes in the outcome.

The Founders who create ecosystems around them sell belonging to a community, to a network, access to partnerships & opportunities.

The MedTech Founders are sitting on the exact same potential, with clinical champions instead of fitness enthusiasts, with department heads instead of power users, with patient advocacy groups instead of brand fans - and they are doing almost nothing with it.

I kept telling to all the start-ups I talk to daily that “it’s not about the product”. And some of them, for the next 3 hours, still use the time to convince me their product simply brilliant.

Clinical adoption in hospitals is not a sales problem. It’s a community problem. And until you understand that distinction, you will keep throwing money at the wrong solutions.

Trends to chase in 2026-2027 or they will be chasing you

Hospital C-suites are entering 2026 under significant financial pressure. Capital budgets are declining, procurement committees are more conservative than in the previous years. A forecast from March 2026 found that executives are prioritizing AI-based clinical solutions at over 3x the rate they did in 2023, while simultaneously anticipating real declines in capital investment.

What does that mean for you? It means that the room you’re pitching into has less budget, more scrutiny, and more competing priorities than it did two years ago. The old playbook (build clinical evidence, find a distributor, hire a sales rep, attend conferences) is not broken, it’s just terribly slow comparing to the times you’re building your business in.

The organizations getting through procurement in this environment aren’t always the ones with the best data. They’re the ones with the strongest internal champions, the ones where someone inside the hospital has already integrated the solution before the sales rep. ever walked in.

What is a top strategic priority for health systems? Fostering a culture of clinical entrepreneurship: clinicians with specialized insights driving innovation and meaningful change, when they feel supported to do so.

That clinician who wants to make a difference and is looking for something worth putting the time and effort in? That’s your community of one, waiting to become a community of ten.

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Build a clinical community that actually grows

Before we get into how to build it, let me tell you what it needs to contain. Most Founders, when they hear “community,” immediately think: newsletter / LinkedIn group / occasional webinar. That is absolutely not a community. That’s a mailing list with a better branding.

A real community that drives clinical adoption has 4 elements:

1. Identity. Members need to feel like they belong to something. This is actually the hardest part to engineer, and the most powerful when you get it right.

2. Knowledge that flows. The community needs to be a place where clinical insight circulates - peer-to-peer, not top-down. Not your white papers. Not your marketing copy. Real-world data, use cases, protocol variations, workflow adaptations. Things that are only possible to share when there’s a trusted space to share them in.

3. Stakes. The best communities have members who benefit directly from the community’s success. Equity, authorship, co-publication credit, access to data, speaking opportunities at major conferences. When a clinical champion has something personally meaningful riding on the community’s credibility, they show up differently than someone you’ve just added to a LinkedIn group.

4. A visible enemy. Every strong community is united by something they’re moving away from. For your clinical community, the “villain” might be the old standard of care that leaves patients underserved, the administrative friction that wastes a clinician’s time, the lack of accessible data that forces decisions without evidence. Name it clearly and you give your community something to fight together.

How to build it — step by step

Step 1: Find your one

Every community starts with one person. Not a KOL. Not the most prominent name in the specialty. The person who is genuinely excited about what you’re solving, who stays on your calls ten minutes past the scheduled end, who asks questions about your roadmap, who forwards your papers to colleagues without being asked.

They are almost never the most famous person in the room. They’re the most passionate.

Those people are probably already in one of your pilot sites. Find them, and before you do anything else, ask them one question:

“If we built a place where clinicians using our technology could share what they’re learning with each other, would you want to help design it?”

The ones who say yes immediately are your Founding members.

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Step 2: Design the identity before you build the platform

I cannot stress this enough. Do not open a Slack group. Do not start a LinkedIn page. Do not send a “launching our community!” newsletter.

Design the identity first.

What is this group called? Not “[Your Company Name] Users.” Something with meaning. Something a clinician would be proud to have in their bio. Something that signals belonging to a community of practitioners who are ahead of the curve, who care about outcomes, who are shaping the future of their specialty.

In MedTech, you have the clinical credibility that consumer tech brands spend millions trying to manufacture. Use it.

Step 3: Give them something they can’t get anywhere else

Being an Ambassador has to give you something valuable: early access to features, a direct line to the product team, co-authorship opportunities on published content, invitations to beta programs, and genuine visibility in a global professional network.

For your clinical community, the equivalent assets exist and you’re probably underusing all of them:

• Early access to data.

• Co-authorship and co-presentation.

• Protocol access and customization support.

• A direct line to your product roadmap.

Step 4: Build the feedback loop deliberately

The most powerful dynamic in any community-led model is the feedback loop. Community generates real-world data → data improves the product → improved product generates better outcomes → better outcomes give community members more to share → community grows.

You have to engineer every connection in that chain.

In practical terms, this means building a structured mechanism for your community members to report back what they’re seeing clinically (a monthly five-question form, a quarterly structured call, a shared case repository). Something that makes the community’s collective experience visible and actionable.

The feedback loop also applies to your product team internally. Whatever your community is telling you, your engineering and clinical affairs teams need to hear it in real time. Not at the quarterly board review. In real time.

Step 5: Give them the words to spread it

One of the underrated tactical failures in community-led growth is expecting members to know what to say and to whom. They don’t. You have to give them the language.

When a clinical champion wants to recommend your technology to a colleague, they need to be able to answer three questions in thirty seconds: What does it do? Who is it for? Why does it matter?

Build a simple “clinical champion toolkit”:

• three to four slides

• two or three key data points

• a brief video they can forward

• one-paragraph email templates for different scenarios (introducing to a department head, sharing with a QI committee, presenting to a procurement team)

This sounds basic. It is basic. Most of the MedTech companies don’t do it, which is why their clinical champions default to forwarding the company brochure — which sounds like marketing — instead of a peer-to-peer recommendation, which sounds like truth.

The 2026-2027 context

Two trends are converging right now that make community-led growth not just smart, but necessary.

First: hospitals are increasingly looking for clinical entrepreneurship from within. Deloitte, BCG, and Vizient’s 2026 health system reports all point to the same direction: the health systems that will adapt successfully to financial pressure, AI adoption, and care model redesign are the ones that foster clinically-led innovation from their own workforce.

A clinical champion in your community isn’t just good for you, they’re exactly what their hospital is looking for internally. You can position yourself as the enabler of that career moment.

Second: capital budgets in hospitals are declining while scrutiny is increasing. That means more competition for less budget, with more internal stakeholders involved in every decision. The fastest way through that process is not a better sales pitch, it’s a clinical champion.

In 2026-2027, the MedTech companies that grow are going to be the ones that their clinical community sells for them. Everything else is going to feel like swimming upstream.

Mistakes to avoid

Peloton built one of the most powerful consumer communities in history, and then nearly destroyed it by treating the community as a marketing channel instead of a genuine ecosystem.

When Peloton started optimizing for pure growth metrics (more members, more content, more engagement) without maintaining the quality and authenticity that made the community worth belonging to in the first place, the trust eroded. The community didn’t disappear, but it stopped being the growth engine it once was.

The clinical equivalent of this mistake is building a “user community” that exists primarily to generate testimonials and case studies for your marketing materials. Clinicians are smart, they will sense within three meetings whether the community exists to serve them or to mine them. If it’s the second, you’ll get only a polite participation and no real advocacy.

The standard is simple: your community members should receive more value than they contribute. If that calculus is reversed, you have a marketing program, not a community.

What to do this week

If you’re an early-stage Founder reading this, and you don’t have a community yet, here’s what you can do:

• This week: go back through your pilot site contacts and identify the one or two clinicians who showed the most genuine enthusiasm. Send them a personal note (not a newsletter, a personal note) and ask if they’d spend 30 minutes helping you think through how to share what they’ve learned with their peers.

• This month: run one informal peer-to-peer session. Not a webinar with a product demo, but a genuine clinical conversation between two or three practitioners who are using your technology, where you are the host but not the main speaker. Record it. Share the recording within the group. See what questions emerge that you weren’t expecting.

• This quarter: define the identity. Give this group a name, write a one-paragraph description of what they are and what they stand for; that has nothing to do with your company’s commercial objectives and everything to do with their clinical mission. Share it with your founding members and ask if it resonates.

Over the next six months: Build the toolkit. The co-publication pipeline. The protocol library. The structured feedback loop.

The clinical champion who’s been quietly telling colleagues about your device — the one doing it for free, without being asked, because they genuinely believe in what you’ve built — that person is the most valuable commercial asset you have.

The question is whether you’ve built something worth belonging to.

Start there. Everything else follows.

Drop a comment with where you are on this journey — 0 (haven’t started), 1 (have a pilot champion but no structure), or 2 (actively building) & mention your main challenges.

Hi! I’m Alina. I work with Health Founders and leadership teams on the things that make or break a company before it’s even visible from the outside — team structure, regulatory strategy, investor readiness, and the messy gap between having a great idea and running a fundable company.

If this resonates, let’s talk: Book a call / Send me a message

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