One in three women will develop some form of incontinence.
It usually starts with pregnancy, childbirth, or menopause: events that happen to women.
Incontinence ranks as the second most disruptive chronic condition on quality of life, behind epilepsy, and 65% of the women who have it report a real impact on how they live.
Yet, most of what the public sees about any of this is the commercials for the pads everyone knows by name.
That gap, between how common the problem is and how little gets said about it, is where Leonie van de Kamer is building Certain.
She is the CEO and co-founder of this Dutch MedTech startup, which is developing a patient-controlled valve placed in the female urethra for stress urinary incontinence. Her solution fills the space between the two options women are usually given: disposable pads that manage the symptom, or the surgery many will avoid if possible.
In this episode, we trace how the technology behind it started as something else entirely, why Certain became its own company, and what it takes to fund a medical device that doesn’t exist yet.
Start listening by pressing play below. Or keep reading for practical takeaways, highlights, and trends from the episode.
Practical Takeaways for Founders
Prior to building Certain, Leonie had a career in clinical trials. It taught her what successful Go-To-Market strategies for MedTech products look like. Her rich experience shows up in the lessons founders can take from this episode.
How one valve became part of two companies
The idea behind Certain did not start with incontinence. The valve was built at Choice as a hormone-free contraceptive that could be placed in the fallopian tubes. When contraception proved a difficult sell to US investors, an investor suggested a second use for the same technology, one with a faster route to market. Incontinence was the answer. What matters is the option they chose instead of pivoting: Certain was spun out as a separate company with a license to the shared valve. When your core technology solves more than one problem, a spin-out lets both stories stay alive, each with its own market and investors.
Directing the company like an orchestra
Leonie is a generalist and describes her CEO role as directing an orchestra. But that doesn’t mean she hired specialists to help her build everything. She prides herself on keeping a lean core team with deep technical expertise and contracting missing expertise if needed. As Leonie puts it, no early-stage medtech startup can afford to hire every discipline a medical device demands. A founder’s job is to direct the right expertise at the right moment, not to hold all of it personally.
Getting funding for the unsexy: market validation
Leonie points to a step founders skip too often: market validation. Without it, she says, teams end up building something clinicians won’t use, and insurers won’t reimburse. Part of Certain’s pre-seed round is earmarked for a validation study, testing the design with clinicians and patients and checking with insurers whether the device would be paid for. She is already working with the largest insurer in the Netherlands, which has shared real data on current incontinence costs. Validating demand and reimbursement early is unglamorous, and it is what stops you from building something no one will buy.
These takeaways separate what a founder controls from what they don’t: how you structure the venture, who you rely on, and what you verify before the build.
When you know a founder who is building in MedTech, share these lessons with them using the buttons below.
Or scroll down for magic moments.
Highlights and timestamps
| Time | Highlight |
|---|---|
| 00:00 | Introduction |
| 03:20 | Introduction and background of Leonie van de Kamer |
| 05:17 | Leonie’s journey from medicine and entrepreneurship |
| 08:13 | Inspiration behind Certain’s incontinence device |
| 13:22 | Technical challenges and design considerations |
| 18:26 | Market strategy and spin-out process |
| 23:15 | Societal impact and addressing taboo in women’s health |
| 28:20 | Regulatory classification and approval pathway |
| 33:21 | Funding strategies and investor relations |
| 43:23 | Building a lean team and quality management |
| 53:20 | Market opportunities in the UK and Europe |
| 1:03:15 | Future milestones and strategic partnerships |
| 1:13:10 | Closing thoughts and connecting with Leonie van de Kamer |
The Episode In an Infographic
3 Magic Moments In The Episode
The most magical thing about the valve is, of course, that it gives agency and quality of life back to women with incontinence. And then there are these moments from the episode.
The audacious question that redirected her career
At the end of her work in clinical trials, Leonie found herself in a job that had become too corporate. And then she met Peter, an innovator with an idea that caught her. Rather than wish him luck and leave, she asked him a blunt question: was he looking for someone with her skills to join him? He was. That question gave her a second career in building medical technology.
Reframing incontinence as a life event
Leonie reframes what incontinence actually is. It is not a personal failure or an illness someone catches. It is the result of the events a female body goes through: pregnancy, childbirth, menopause. Naming these as major life events rather than medical faults does something special. It moves the conversation away from shame, and it frames what millions of women live with as a natural need for better support.
Giving back the control women lost
The clearest description of what the device does is her own: it gives back the sphincter that no longer closes on its own. What that means is easier to feel when you picture life without it: a woman avoiding social situations, managing smell, planning her day around something she can’t control. What Certain aims to hand back is discreet, carried in a handbag, and it lets her take part in the world again.
These moments matter because each one turns on agency: her decision to change direction, the refusal to treat a female body as defective, and the return of a control that incontinence takes away.
🗣 Which of these moments did you find truly magical? Was it how she dared to ask the question that redirected her career? Or how Certain aims to give women back control over their urine and improve their quality of life? Or was it perhaps the reframe of incontinence as a life event? Drop your magic moment below or slide into the DMs on LinkedIn or Instagram!
The Quote from the Episode
"The most important job for us is to break open the taboo."
— Leonie van de Kamer
It would be easy to read this as a line about stigma, and it is. But Leonie means it as a business point too. Certain is building a product for a problem most people won't say out loud, in a category where many women don't know a solution is possible. In that situation, getting people to talk about the problem is not separate from building the company but part of the job.
Leonie puts education alongside developing the technology itself, one of the core tasks of a women's health company right now, because a market that doesn't know it has options is a market that can't buy from you yet.
For founders in any underserved or taboo space, that reframes what looks like advocacy into something closer to demand generation: talk about the problem openly, and you build the market you will later sell to.
If you know a founder (or investor) needs to hear this quote, use the buttons below to tell her about the episode.
3 Trends I’m Seeing Across Conversations
Certain sits at the intersection of three patterns that keep coming up on the podcast. Each one shows up in a different guest's work, which is what makes them worth naming.
Wellness apps are giving way to regulated medical devices
Certain is not a tracker or a symptom app. It is a medical device going through the full MDR and FDA regulatory path, the slow and expensive route that a wellness product avoids. Leonie treats that regulatory burden as the point, not the obstacle: clearing it is what separates a real treatment from the pads and diapers she calls symptom maskers. That connects directly to Karen Berg in episode 161, who argued that clinical validation is a moat. A product that has done the hard regulatory work is far harder for a fast follower to copy, and far easier for a serious investor to back. One founder, one investor, the same conclusion: in health, the regulatory pathway is a competitive advantage, not just a cost.
The data gap in women's health is as much about taboo as technology
When Certain's team worked on the contraceptive valve, they found the fallopian tubes had barely been studied. On the incontinence side, the silence runs the other way: women accept pads and say nothing, so their experience never reaches medical records or research. The taboo and the data gap are the same problem seen from two angles. Beata Wandachowicz-Krason made this explicit in episode 155, arguing that the barrier to better women's health data is more cultural than technical. The tools to collect and share it responsibly exist; what is missing is the cultural safety for women to speak, and a system that stops treating their suffering as normal. Leonie is describing the front end of exactly that gap: a condition so unspoken that the people living with it never become data.
Women are taught to negotiate against themselves
Leonie points out how easily women accept incontinence as something to manage quietly, reaching for pads rather than asking whether a real solution exists. Lowered expectations, absorbed early, become the default. She runs counter to it in her own founder behavior, telling investors plainly that she is aiming for FDA approval and a strategic exit within five years rather than shrinking the ask to what feels safe. That pattern is what Ana Herrero-Wallace named in episode 157: girls raised to be cautious enter the system already negotiating against themselves. The same conditioning that teaches a woman to stay quiet about her body teaches a founder to ask for less than she needs. Naming it is the first step to refusing it.
Across these three episodes, the same lesson appears in different forms: regulation is the moat, the taboo is the data gap, and the lower expectations women absorb reach all the way into the funding ask. Certain is being built against all three at once.
🗣️ How do you look at these trends? I’d love to hear from you in the comments.
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Coming Up On Women Disrupting Tech
Healthcare has never been more advanced. We know more about the human body than ever before. AI is transforming medicine. Yet healthcare costs continue to rise, chronic disease is increasing, and many people are no healthier than they were decades ago.
In episode 163, Dr. Robin Blackstone argues that technology is not the real problem. The healthcare system was designed more than a century ago to rescue people once they become ill, not to keep them healthy. We explore why prevention is still undervalued, how today's financial incentives reward disease rather than health, and what a fundamentally different healthcare system could look like.
In this preview, Robin explains why we spend just 30 minutes a year with a doctor while our health is shaped during the other 5,700 waking hours. It is a powerful illustration of why today's healthcare system still rewards treatment over prevention.
If you're building the future of healthcare, this conversation will challenge how you think about innovation, prevention, and the role of AI.
So subscribe to Women Disrupting Tech below to find the full conversation in your inbox on 30 July at 8am CET.
What I Want to Leave You With
Incontinence is common, but rarely seen as a health problem. One in three women experiences some form of it, and the market's answer is a pad that masks the leakage and a commercial that pretends the problem is charming. Certain exists because Leonie looked at that gap and saw room for an actual device.
What makes the story of Certain interesting is that the valve she is building was built to prevent pregnancy. It was only later that an investor connected it to a problem no one was rushing to solve. That is also the lesson for founders: a technology you already have may answer a question you never thought to ask, and the largest openings often sit exactly where a subject stays unspoken.
Underneath all of it is female agency. A valve a woman opens and closes herself. A founder who aims to have FDA approval in five years. A condition she can treat rather than hide. Certain gives women back a measure of control, and it is built by a woman who took the same control over her own path.
Listen to the full conversation with Leonie van de Kamer on Spotify, Apple Podcasts, or YouTube. And if you are a female founder navigating a funding conversation, take a look at FundingCoach.ai.
About Leonie van de Kamer
Leonie van de Kamer is the CEO and co-founder of Certain, a Dutch medtech startup developing a patient-controlled valve for female stress urinary incontinence.
She joined Choice, the company Certain spun out of, after meeting its founder, Peter van de Graaf, drawn in by the idea and the energy behind his valve technology.
Before joining Choice, Leonie spent more than seven years in clinical research for medical devices, across project management, clinical trial management, regulatory affairs, business development, and quality assurance. Over eight projects and more than twenty clients, she advised on the strategic decisions behind bringing a device to market, ending up as a business developer for Europe working with clients on their regulatory strategy. That mix of practical, networking, and leadership experience is what she now brings to running a company of her own.
You can connect with Leonie on LinkedIn.
About Certain
Certain is an Amsterdam-based medtech startup developing a device for female stress urinary incontinence. It is a physician-placed, patient-controlled valve worn in the urethra, designed for long-term, reversible use, and it sits in the space between the two options women are usually given: disposable pads that manage the symptom, or the surgery many prefer to avoid.
Female urinary incontinence affects tens of millions of women, and the existing options force a trade-off between disposables that mask symptoms and invasive surgery. Certain does not aim to replace surgery. It aims to widen the range of treatments available, giving women a durable option that keeps their own control over when the valve opens and closes.
The valve technology behind Certain began at Choice, where it was developed as a hormone-free contraceptive, before being adapted for incontinence and spun out into a separate company. Certain is currently raising a €600k pre-seed round to finalize its prototype, run market validation with clinicians, patients, and insurers, and begin its regulatory path.
You can learn more about Certain on their website or by following them on LinkedIn.
Listen to Episode 162 on Spotify, Apple or YouTube
Further Reading About This Episode
For more on the broader trends behind this episode:
Why the UK halted surgery with meshes
This House of Commons briefing sets out the scope of the restriction and where it stands now, and this NHS page shows what women are told about their options today.
Why Europe probably will not follow the UK
The British Society of Urogynaecologists argued the suspension contradicted the evidence base, pointing to the mid-urethral tape as the most researched incontinence procedure available and to data suggesting 95% of women remain free of complications. Read more about their argumentation.
Innovation in battling stress urinary incontinence
This 2025 review covers newer approaches including stem cell and laser therapy, alongside the case for more personalized diagnosis.
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