The Real Risk Is Execution: What Investors Miss When They Fund Science Without Systems

with Roswitha Verwer and Károly Szántó

There is a familiar narrative in life sciences. A brilliant founder. A bold clinical vision. A problem worth solving. A deck that looks credible. Early enthusiasm. A seed round that closes on optimism. Then reality starts doing its job.

Timelines slip. Vendors go silent. Recruitment becomes harder than expected. Regulatory steps expand. Burn accelerates. The team grows without structure. Milestones drift. Confidence breaks.

And everyone later says the same thing: the science was promising, but execution failed. I want to challenge that framing.

In most cases, the science did not fail first. The operating system failed first. That is why I keep coming back to a simple thesis: in clinical innovation, execution is not a function. Execution is the moat.

This episode of Clinical Capital Conversations is a practical case study in that thesis. I sat down again with Roswitha Verwer, founder of YON E, and Karoly Szanto, who has been closely involved in building the fundraising and partnership strategy. We had met a few months earlier. This time, the question was direct.

What changed since the last conversation?

The answer was even more direct.

In roughly six months, YON E achieved the majority of the roadmap that was planned for next year.

As an investor, that is the kind of sentence you want to hear. But it is also the kind of sentence that should trigger skepticism, because it is rare. So we did what serious operators do. We unpacked how it happened.

What followed was not a motivational talk. It was a blueprint.

A blueprint for founders who want to scale responsibly. A blueprint for investors who want to reduce execution risk. And a blueprint for a sector that still struggles to fund women-led clinical innovation with the seriousness it deserves.

The most misunderstood risk in early-stage health innovation.

Let’s start with the part that matters to capital.

Investors are trained to analyze scientific risk and market risk. They spend hours on mechanisms, endpoints, competitive landscape, reimbursement, and strategic exits.

All of that matters. But the risk that quietly kills outcomes is execution risk.

Execution risk is the gap between what a plan says and what a team can actually deliver, repeatedly, under pressure, across borders, across vendors, across time zones, and across shifting constraints.

Execution risk is not abstract. It is operational.

It shows up as:

• Slow vendor response times

• Unclear ownership of deliverables

• Meetings without decisions

• Weak documentation habits

• Underpowered project management

• Fragile team culture

• Avoidance of hard performance conversations

• Lack of investor readiness when capital windows open

• Founder overextension

• A mismatch between vision and day-to-day reality

When execution risk compounds, capital efficiency collapses. Companies burn money without reaching proof points. Investors feel misled. Founders feel trapped. Science never gets a fair shot.

That is why I pay attention to systems. And that is why YON E’s recent progress is interesting. Not because acceleration is the goal. Speed without control is reckless. The interesting part is that their speed came from control.

How do you hit a 12-month roadmap in 6 months?

Roswitha explained that after the investment in August, the team had a roadmap for this year and next year. Within six months, they had already achieved most of what was planned for the following year.

They advanced through key phases, reached Phase 1 of TRL 4, completed TRL 2 and TRL 3 successfully, progressed the IP roadmap, and produced an additional publication that was close to going live.

Those achievements do not happen through hope. They happen through a management approach that treats time as a strategic asset. So what was the approach?

It came down to three pillars:

• Communication as a system

• Culture as a filter

• Accountability as a habit

Let’s walk through each.

Communication is not a style. It is infrastructure.

Founders love to say communication matters. Most do not operationalize it. Roswitha did.

She described something that sounds simple, but changes everything: if a vendor is critical to your roadmap, you cannot treat communication as optional.

They experienced friction with external partners, and the lesson was immediate. They added benchmarks and requirements to contracts for the next phase. One example was a 24-hour response expectation. Another was having a designated project manager. Another was weekly calls to mitigate risks and answer questions fast.

This is not about being demanding. This is about risk control.

In clinical and medtech development, delays are rarely dramatic at the start. They begin with silence. A report that should arrive this week arrives next week. A question that should be answered today is answered in ten days. Then the timeline bends. The bend becomes a break.

If you want to protect investor capital and patient outcomes, you need to compress feedback loops.

Tighter loops reduce surprise. Reduced surprise reduces risk. Reduced risk increases speed. This is why communication is infrastructure.

If you are an investor, this is a diligence question you can ask in plain language: How fast do your vendors respond, and what do you do when they do not?

If the founder cannot answer clearly, execution risk is already present.

Building a global team without losing control.

Remote teams are common now. High-performance remote teams are still rare. Roswitha’s model was not based on slogans. It was based on selection and structure.

She emphasized:

• Hiring people who speak up and ask critical questions

• Prioritizing personality and culture fit alongside experience

• Implementing company culture early through policies and onboarding

• Using a three-month training period as a mutual filter

• Creating cadence through weekly calls with divisions and individuals

• Investing in personal relationships, especially when the team meets in person

This matters more than founders realize. When teams are distributed, ambiguity expands. Without structure, you get fragmentation. Fragmentation kills output. Output kills fundraising. So the key is cadence.

When you hear a founder say, “We have weekly calls”, do not treat it as routine. Ask what those calls produce.

Do they produce decisions?
Do they produce accountability?
Do they produce clarity?

In YON E’s case, the structure included separate legal calls, finance calls, medical calls, and external partner calls. This is a management system designed to remove friction before it becomes failure. There is also a deeper point.

This is not just an operational discipline. It is investor signaling.

A company that can run weekly, cross-functional, cross-border operating rhythms is a company that can handle clinical complexity. It shows the investor that the founder is not building a fragile project. They are building an operating machine.

Meritocracy requires courage, not charisma.

Performance management is the part that founders avoid until it is too late. Roswitha did not avoid it. She described something that I respect, because it is hard.

When benchmarks and KPIs are not met repeatedly, she has a strict conversation, whether it is with advisors, operations, junior team, or even social media. The key is how she frames it.

She separates emotion and focuses on facts. She comes prepared with data and stats, so the discussion is not based on assumptions. She keeps it calm and aims to return to alignment by the end. This is what leadership looks like in execution heavy environments.

I mentioned meritocracy and how numbers never lie. That is true, but we also acknowledged the complexity. People are not numbers. Personalities differ. Conversations can be uncomfortable.

What I took from her approach is simple. If you want to build something meaningful, you cannot protect comfort at the cost of performance. Founders do not like this sentence, but investors should love it: You cannot scale outcomes with underperformance in the room.

There is another point here that is worth stating clearly. Training is not a perk. Training is brand protection.

Roswitha described training for the team on how to represent themselves, how to speak better, and how to communicate professionally by email and phone. She wants every interaction with YON E to reflect professionalism.

This is not cosmetics. This is trust building. In early-stage companies, the brand is not a logo. The brand is the behavior. And behavior is built through training.

Founder growth under pressure.

Karoly asked a question that many investors forget to ask. How did Roswitha develop as a leader during this intense period?

Her answer was pragmatic.

She learned to separate emotions when needed, especially when money and partnerships are on the line. She used to overthink conversations. Now she is clear on direction, stays lean on investments, and does not say yes to anything that is not feasible.

That is founder maturation in real time. It also touches something important in the current funding climate.

Female founders, especially in femtech, often face a double standard. They are expected to be confident but not too confident, ambitious but not too ambitious, and assertive but not too assertive.

Roswitha addressed this directly. She said it can be hard to have difficult conversations, especially as a woman, because she is often has them with men, and she is younger. She used to overthink how to address things. Now she approaches it as business and alignment.

From an investor's perspective, that is a risk reduction signal. Founders who cannot hold hard conversations cannot protect timelines. Founders who cannot protect timelines cannot protect capital.

The next milestones and the capital reality.

Operational progress does not remove the hardest variable in early-stage companies: funding timing.

YON E’s next steps are clear:

• Finish TRL 4, currently in Phase 1

• Raise an additional 600,000 for co-investments, targeted to close by March

• Close the seed round in the summer of next year

• Continue IP protection, publications, biocompatibility testing, sensor technology development

• Develop the prototype

• Advance regulatory roadmap

• Prepare for clinical trials next year if funding allows

Here is what I said in the conversation, and it remains true.

It is impressive to hit milestones early through work and discipline. But fundraising is not fully controllable. That is what makes it hard. You can do everything right operationally and still face delays in capital.

This is where investors should pay attention to the founder’s approach to investor readiness.

Roswitha described having a strong executive team in legal, finance, and regulatory, plus a Chief Clinical Officer. They run weekly executive meetings and quarterly alignment. That support allows her to keep divisions moving while staying ready for investment conversations.

This is a maturity marker. Too many founders treat fundraising as an activity. Serious founders treat fundraising as readiness.

Readiness means your packages are prepared, your runway is understood, your milestones are mapped to capital, and you can engage when the call comes.

Investors can spot this quickly if they ask the right questions:

• What are your next three de-risk milestones?

• What is the cost and timing for each?

• What changes if the round closes 60 days later than planned?

• Who owns each workstream?

• What external dependencies can break your timeline?

If the founder can answer, you are not just funding science. You are funding execution.

Why femtech fundraising is still harder than it should be.

Now we get to the uncomfortable part. I asked Karoly how easy it is today to fund early-stage femtech. He was blunt. It is difficult. He confirmed that it is more difficult for a female founder. He also made an important distinction.

Once Roswitha gets an investor meeting, she can turn it around. The problem is getting the meeting in the first place.

That tells you what the problem is. It is not a capability. It is access. Then he described the market structure problem.

Many medtech investors either invest very early or they prefer to join during or after clinical phases. YONE is in between. They have identified investors who are excited to join later, but they need partners now.

This is where many promising companies stall. If you are an investor, this is the gap where value is created, but only if you are willing to do the work.

Karoly also highlighted the noise in fundraising. Cancelled meetings, unanswered emails, delays, excuses, and opportunistic agents who appear to be investors but are actually selling paid services.

Founders experience this as exhaustion. Investors should see it as a market inefficiency. Market inefficiency creates an opportunity for serious capital.

I asked the broader question: Why is it so hard for female leaders and femtech companies to raise money?

Roswitha’s answer was grounded in a lived pattern. History, gender inequality, and ego in some rooms. She shared a specific detail that is worth reflecting on. In earlier days, she included a male team member in meetings because she noticed investors took her more seriously when he was present, even though the pitch was identical.

That should bother anyone who claims to invest on merit. She also described the challenge of talking about vaginal health with investors who are uncomfortable. She noted that femtech was often confused with fintech early on, and that it took years for the ecosystem to even understand the category.

Here is the point I want to make as an investor and operator. Discomfort is not diligence. If you avoid a category because it makes you uncomfortable, you are not rational. You are biased. And bias is expensive.

The best investors do not run away from what they do not personally experience. They run toward what is structurally mispriced.

Femtech has been structurally mispriced, partly because too many decision makers do not take the time to understand it, and partly because too many are unwilling to engage seriously with women-led leadership.

That is changing slowly. Not fast enough.

Why accelerators often fail founders.

This part of the conversation matters for founders. Roswitha described a frustrating reality: many accelerator programs use startups for marketing.

She gave an example of a US program where they were told investors would be present, the program would be valuable, and it was signed as a promise. They traveled, spent money, and on pitch day, there were very few attendees, including people selling unrelated services.

Then she made a statement that many founders will quietly agree with. She does not know any startup that got meaningful investment through an accelerator. That may be harsh, but it highlights a real issue. Many ecosystems confuse activity with progress. Meetings are not progress.
Progress is milestones, proof, and credible partners.

If you are a founder, measure programs by outcomes, not by badges.

If you are an investor, measure founders by how they allocate time. Founders who protect time are founders who protect capital.

What kind of capital fits this stage

Near the end of the transcript, Karoly described what they agreed was the ideal co-investor partner. Value-driven partners. Two groups stood out:

• High net worth individuals who invest because they believe in a cause, not only as a financial activity

• Family offices that care about impact, legacy, and long-term partnership, not transactional rounds

This aligns with what I see globally. In hard tech and clinical innovation, the best early partners are not always the loudest funds. They are often the ones who understand time, who respect diligence, and who build relationships. This is consistent with my own approach.

ROI matters. We all live in the real world. But ROI without values can create misalignment that breaks companies. The best partnerships are values-aligned and execution-aligned.

That is why I invested quickly when I saw the uniqueness of the model and the team. And that is why I see this as a case study for how the conservative investment model should evolve.

Clinical innovation needs operators in the capital stack.

The real lesson for investors.

Let me translate this episode into investor language. If you want asymmetric returns in life sciences, stop underwriting stories and start underwriting systems.

Underwrite:

• How decisions are made

• How risks are identified early

• How vendors are managed contractually

• How team cadence is built

• How performance is measured

• How uncomfortable conversations happen

• How capital is translated into milestones

• How fast the organization learns

When I hear a founder say, “We hit next year’s roadmap in six months,” I do not get excited by speed alone. I get excited by the question behind it. What operating system produced that speed? In YONE’s case, the system included:

• Explicit communication requirements

• Structured weekly coordination across divisions

• Early culture definition and training

• Performance management tied to facts

• Investor readiness supported by a strong executive team

• A clear milestone-driven funding plan

That is what de-risk looks like in practice. This is also why having domain-aligned investors matters. Karoly noted that my involvement is not only financial, but clinical and scientific, and that belief is validation because there is skin in the game. That is the model I believe will win. Not capital alone. Capital plus operating leverage.

The real lesson for founders

If you are building in biotech, medtech, clinical infrastructure, or femtech, here is what I want you to take away.

1. Treat communication like product quality.
   If a vendor is slow, your timeline is slow. Put expectations into contracts. Build tight loops.

2. Build cadence before you build headcount.
   Weekly calls are not the point. Decisions are the point. Accountability is the point.

3. Train professionalism early.
   Every email, every call, every deliverable is part of your brand. Your brand is your trust.

4. Separate emotion from alignment.
   Hard conversations do not make you cold. They make you responsible. Use facts, not assumptions.

5. Fundraising is not a sprint. It is readiness.
   The market can be irrational. Your job is to be ready when the window opens

6. Choose partners, not money.
   Find value-aligned co-builders. That is how you avoid misalignment that drains time and focus.

Where the conversation ends, and the work begins

YON E is raising 600,000 to keep the development engine moving, with a clear view toward a seed round in the summer of next year. Their operational execution has created credibility. Their next challenge is capital timing, and that is where the right investors can create outsized value.

If you are an investor reading this, here is my invitation. Do not just ask whether the science is exciting. Ask whether the team can execute. And if you find a team that can, do not wait for everyone else to validate it. The brave ones harvest, as Karoly said, and history supports that.

If you are a founder reading this, here is my challenge. Build an operating system that earns trust before you ask for it. Because in clinical innovation, trust is the currency that buys time, and time is the asset that buys outcomes.

That is what Clinical Capital Conversations is here to explore. Not hype, not slogans, not trend chasing.

How real therapies reach real patients, through real systems, funded by real partners.

Timecode:

00:00 Introduction and Welcome

00:21 Achievements and Progress

01:38 Lessons for Startup Founders

02:56 Building a Strong Global Team

04:44 Handling Underperformance

09:36 Future Challenges and Milestones

13:28 Fundraising Challenges for FemTech

27:36 The Importance of Value-Driven Partnerships

31:29 Conclusion and Gratitude

Links:

Peter M. Kovacs LinkedIn: https://www.linkedin.com/in/petermkovacs/

Peter M. Kovacs Personal Website:https://www.petermkovacs.com/

PMK Group Website: https://www.pmk-group.com/

Guests:

Roswitha Verwer: https://www.linkedin.com/in/roswitha-verwer-b2b636137/

Károly Szántó: https://www.linkedin.com/in/karolyszanto1/

Transcript:

Peter M. Kovacs: So we talked about the very important stakeholders, which are the startups and spinoff companies, how they are suffering, how we can find the gap, how we can solve the gap, and how we can build them up and support them to reach the visibility and the exit level. And also to get attractive for the investors.

We also have a very important stakeholder in our model: the co-investors. What kind of co-investors do we work with, what kind of co-investors are we expecting to collaborate with? What are the main differences for us between the different types of investors? How do you see this?

Károly Szántó: I would start maybe not with the types, because as we discussed earlier, there are ways to work together with angel investors, institutional investors, VCs, and in some cases corporate venture capital and other investor types. I think, again, it's about the value proposition—whether there are strong synergies between the investor partners. We collectively invest a lot of time and professional services, as well as capital from your side, Peter. So we have skin in the game. I think this is the most important part: how you can prove that you believe in something. You have skin in the game. Otherwise, if we screw up, it'll hurt all of us. This is the commitment and dedication apart from everything we have said. Our professional de-risking and risk mitigation is our core offering.

I see two kinds of investors that could be interesting. One is not so much domain-specific, but maybe in their investment thesis, med-tech is one focus among other deep tech interests. Because they're not so specialized, they need a partner who does specialize in this to provide the knowledge and experience.

Peter M. Kovacs: And the experience.

Károly Szántó: Exactly. Decades of experience in that segment to validate and to de-risk. So we can bring that to the table, but not purely as a service provider, because then that would be weak.

Peter M. Kovacs: There's no additional value. Not enough additional value.

Károly Szántó: Yes, exactly. And then the other type is deeply embedded into the med-tech or biotech domain already. We can double down on the segment, and most probably we'll find strong synergies in the execution part—in the regulatory, the go-to-market, the clinical, the testing, and all that. So I think these are the two ways to approach it.

And because we are dealing with early-stage investments like pre-seed and seed mainly, at least in this region, angel investors have a place on the cap table. One great thing about angel investors is they're usually very hands-on, and we need hands-on support. There is no such thing as too much support. But then if you look at the other extreme on the scale, which would be corporate venture capital—perhaps from a pharmaceutical company—again, they are very valuable. From that perspective, they can provide professional input and guidance on how to navigate and how to build a company that will eventually be very attractive for a pharma company, maybe seven to ten years down the line. How do you see the other conditions of an ideal partner?

Thijmen Meijer: I would also like to loop in family offices that are very specific on deep tech and med-tech. Usually, they are run by somebody that has exited actually, or has family wealth deep inside biotech or med-tech, and doesn't want to go blindly with a VC but wants to have professional investors to mitigate that risk completely.

Peter M. Kovacs: I see that family offices are extremely well represented in Singapore. In Singapore today, there are over 2,200 family offices for a 6 million population country. It's a huge number. I see that family offices focus more on the personal part. I accompanied one of my biggest portfolio companies to a family office event, and they want to spend a couple of days with you to know you very well. The personal touch is very important for them.

Also, it was very interesting that I've seen many times family offices focusing on a dedicated disease or a dedicated tech because they have some relationship in the past or their family is related because of some illness or some other experience—positive or negative. I see family offices as significantly different from VCs and institutional investors. Their financial due diligence is a bit different, and this personal touch is a bit more important. I see that very early-stage companies could be more successful not because of the ticket size, but because of this personal touch. If you find a very good founder and CEO with the personality that can present this impact, it's more touchable for a family office or angel investor than VCs. Based on my own experience, VCs are often just about numbers.

Károly Szántó: I love that you brought in the family offices. They are very much value-driven and impact-driven, and they are deeply committed to whatever they're committed to because of personal reasons of the founder or the family. But on the other hand, they are very difficult to approach. It's not a quick game; it's a relationship. I remember a couple of days ago you mentioned your event with family offices, and I had similar experiences. When you get in contact with a family office, you must not talk about business first. It's about values.

Peter M. Kovacs: Build a friendship.

Károly Szántó: Absolutely. And then if it resonates and it's built up authentically and there is a match, then of course you will find ways to collaborate. But it's not transactional. Whereas with a VC, it's absolutely New York style: go, no-go.

Thijmen Meijer: And an intro as well. Everybody said to get an intro from somebody else they know—friends or family within or outside of the family office—who can vouch for you and basically say, "This is a good one." No cold emails, no cold calls. Don't send a 14-page slide deck or anything like that. Really build up that relationship. That was quite interesting to hear.

Peter M. Kovacs: Also, I see quite a difference between the same type of investors. For example, a family office in Asia versus a family office in Switzerland. Based on cultural differences, it's even more difficult in Asia because the culture to build this friendship is even more intense than in Europe or the US because of tradition.

What do you see as the best partner for us? I see a difference in that I talk with many potential partners in Asia, as I mentioned before, and some of them understand the model and how significantly we can decrease the risk—the financial risk and professional failure of the company. Some of them understand and are more than happy to collaborate and see something new. But many of them just don't get it. Maybe I couldn't deliver the message well, or not yet. Some of them cannot think out of the box because they are still in the conservative model, just checking the numbers. How do you see it here in Europe?

Károly Szántó: This year I got in contact with some high-net-worth individuals, very successful in real estate. I was introduced to them; it was not a cold call. We started to talk, and our discussion naturally went into the investment side. They considered themselves experienced in investment, and then I found they had absolutely no understanding of how venture capital works, which is okay. I explained it, and they just couldn't get their head around it. They were like, "If you invest so much money, why would you only have 10% ownership or 20%?" The whole logic of venture capital was out of scope for them.

One thing I learned is that I would rather be very honest with myself and the other person: maybe I like you as a person, but the way we operate is so different that it won't work. We cannot force it. Also, I think once we build up something bigger and we can present it, they would be happy to join in later as followers.

Family offices are called "patient money" by many investors because they have patience; they have time. They're not VCs. They want to leave a legacy; it's a whole different story. I think one nice way to build up a lasting relationship with a family office is to suggest they join in from time to time with a smaller ticket directly into one of the startups that we invested in. This way we can learn about each other and fine-tune our collaboration model. If it works and we are aligned, then we can take it to the next level, which usually is launching a VC of our own and positioning the family offices as LPs. Many family offices have tried themselves as a VC, directly investing, and 99.9% of them regretted it. They're not equipped operationally for due diligence or portfolio management.

They still want to be involved, so the best way is them becoming LPs. More and more family offices are realizing they shouldn't do it on their own, so they form syndicates. They join together and work as a fund of funds and invest in several offices. I think this is the right way to go. But then again, it's value-aligned. Does this syndicate share the same values with us? Do they want to make an impact through biotech and med-tech? If yes, that's already good. Then there is the geographical focus and stage. Some are only interested in growth stages, while some will be interested in early stages. We need to go out and spend time with these people, not selling anything, but rather just asking the right questions.

Peter M. Kovacs: Offering an opportunity for them. I think very few players on the market are able to work in this field and provide this objective risk mitigation. If somebody understands what the real risks in med-tech and biotech are, they can understand the support that we are providing.

Károly Szántó: Thankfully, I read a lot of statistics and reports on VC to understand the trends, and our investment thesis is very much supported by statistics lately. What happened in venture capital is that the successful players became giants, but their business model has shifted because they are continuously charging the 2% management fee for their LPs. I just read that Andreessen Horowitz, one of the largest and most successful, pulled in $700 million only in management fees because they are managing billions and billions. The motivation is not really aligned. If your entire business model as a VC is to charge a management fee, then you become comfortable and values are misaligned.

Also, the return on investment decreases. What is interesting is that micro-funds and small funds—below 50 million euros or let's say even 80 million—produce much higher returns. Why is that? Because they're very motivated, effective, down-to-earth, and they cannot allow themselves to fail. The management fee will not save you if you're running a 50 million fund. You need to actually make miracles.

Now LPs are also reading these statistics, so they learn. There is a new wave of LPs opening up to emerging managers managing small funds below 50 or 80 million. I believe these funds must be vertical and domain-specific. The industry-agnostic approach is over. The way we come together and what we offer is supported by these trends. We are in the right direction at the right stage. Our narrative should be that we are de-risking, executing, and eventually producing higher returns and making much more impact.

Peter M. Kovacs: Hopefully, we prove that we were pioneers in this field and we can introduce a successful model for the ecosystem. I can just wish good luck for all of us and we'll continue from here. Thank you.

Károly Szántó: Thank you. Thank you, Peter.