Walk the Valley

Getting a medical device certified is a major milestone. But what happens when the product is ready and repeatable sales are still a long way off? In this episode of Walk the Valley, I’m joined by Mariusz Mąsior, CEO of Consonance, to explore the decisions that shape whether a MedTech product becomes a sustainable business.Drawing on his experience developing medical devices and building companies, Mariusz shares mistakes he has made himself, and continues to see founders repeat them. Wediscuss the assumption that a distributor will take care of sales, why clinical evidence alone may not secure adoption, and how apparently sensible decisions can lead to expensive rework.We also explore his idea that every startup has two products: the device customers use, and the company investors buy into. Understanding both changes how founders approach development, fundraising, and success.About the guestMariusz is an engineer and CEO of Consonance, a medical device development company working across product strategy, engineering, regulatory and quality requirements, and manufacturing. He brings experience from research, entrepreneurship, and the practical work of taking medical technologies to market.Links:https://consonance.tech/pl.linkedin.com/in/mariuszmasiorHosted and produced by: Katalin VikukWalk the Valley is a PsychWiser project.

Healthcare professionals can now build software simply by describing what they need to an AI tool. It opens up exciting possibilities for reducing administration and solving everyday frustrations. But what happens when those tools handle patient data or influence clinical decisions?In this episode of Walk the Valley, I’m joined by Helena Holma, co-founder and CEO of Leyr, and Claudia Dannehl, senior advisor at Key2Compliance, to explore what vibe coding means for healthcare.We discuss the opportunities for clinicians to build their own solutions, the risks they may overlook, and the questions that arise when a personal workaround becomes a tool used by others. From reviewing AI-generated work to validation, information security and responsibility, we look at what needs to happen beyond getting the code to run.We also ask a bigger question: what does the growing demand for homemade tools tell us about the healthcare systems people work in?In this episode • What vibe coding is, and how clinicians are using it • Why expertise still matters when reviewing AI-generated work • The difference between a working prototype and a validated tool • When an administrative shortcut raises medical-device questions • Patient data and information security as potential blind spots • Transparency and organisational oversight of home-built tools • Responsibility when tools are developed, shared or integrated • How education and regulatory guidance could support safer innovation • Why healthcare professionals need so many workarounds in the first placeAbout the guestsHelena Holma — LeyrHelena is a medical doctor and co-founder and CEO of Leyr, which helps digital health companies integrate with electronic health record systems. She brings both a clinical perspective and experience of the practical challenges of connecting new tools to healthcare infrastructure.Claudia Dannehl — Key2ComplianceClaudia is a senior advisor and consultant at Key2Compliance, supporting companies with regulatory requirements for medical devices. She brings more than a decade of experience in medical-device regulation.Links • Leyr: https://leyr.io/ • Key2Compliance: https://key2compliance.com/ • Claudia's LinkedIn: https://www.linkedin.com/in/claudia-dannehl/ • Helena's LinkedIn: https://www.linkedin.com/in/helenaholma/ The discussion explores general principles and the guests’ perspectives. Requirements depend on a tool’s intended purpose, how it is used and the applicable jurisdiction.Hosted and produced by: Katalin VikukWalk the Valley is a PsychWiser project.

A technically impressive product is only the starting point. To become investable, a company also needs to demonstrate that it is solving a meaningful problem, that customers care about it, and that the market opportunity is large enough to support the growth investors are looking for.In this episode, Karolina Liljeroth-Dorozynska shares what she learned from working on the investor side of the table and assessing deep-tech companies for investment readiness. We discuss how founders test their assumptions, identify the right customers, avoid overestimating their market, and build a convincing investment case.Karolina also explains what customer interest and pilot collaborations can signal before revenue arrives, where the Valley of Death appears for hardware companies, and why regulatory and clinical milestones create particular challenges for MedTech. We also discuss what makes a pitch deck stand out, how founders should choose the right investor, and why a company name deserves a culture check before entering a new market.About Karolina Liljeroth-DorozynskaKarolina Liljeroth-Dorozynska is a deep-tech advisor, investor and founder of Kadido. With a background in physics and experience as an investment manager at imec.xpand, she has worked at the intersection of science, technology, entrepreneurship and investment.Links • Karolina on LinkedIn: linkedin.com/in/karolina-liljeroth-dorozynska-505043b3 • Kadido: https://www.linkedin.com/company/kadido-ab/posts/?feedView=all • Referenced fund: https://www.imec-int.com/en/what-we-offer/venturingWalk the Valley is a PsychWiser project, produced by Katalin Vikuk.

Today, almost anyone can build a health app. Getting that app to communicate with the systems healthcare already uses is another matter entirely.In this episode, Katalin Vikuk speaks with Helena Holma, medical doctor, CEO and co-founder of Leyr, about the fragmented world of electronic health records and the hidden obstacles facing HealthTech companies trying to integrate with them.Helena explains why interoperability is not merely a technical challenge, why gatekeeping can be harder to overcome than the technology itself, and why Leyr is building a single integration layer connecting HealthTech products with multiple EHR systems.They also discuss the difficult journey from a PowerPoint presentation to a live customer, the importance of recognising which customers are genuinely committed, the dangers of providing unpaid consultancy, and why understanding healthcare’s financial incentives often comes down to one simple principle: follow the money.About Helena HolmaHelena Holma is a medical doctor, specialist in internal medicine, and CEO and co-founder of Leyr.After working clinically for ten years at a large emergency hospital in Stockholm, she moved into HealthTech and experienced first-hand how difficult it was to connect new digital products with electronic health records.Leyr provides a unified API that allows HealthTech companies to connect their products with multiple EHRs, EMRs and patient-journal systems without building and maintaining every integration separately.Chapters00:00 From medical doctor to HealthTech founder02:11 Discovering the hidden complexity of healthcare03:50 Who pays for EHR integration?05:42 Leyr’s customers and use cases06:51 Anyone can build a health app—but can it enter healthcare?07:27 The fragmented EHR landscape08:26 Building one API for multiple EHR systems10:30 Leyr’s two-sided market challenge11:45 Operating across Nordic healthcare markets12:27 The European Health Data Space13:19 From PowerPoint to the first live customer14:37 Why integration is not merely a technical problem16:25 Knowing when to cut your losses16:54 Antler, bootstrapping and the need for funding18:37 The shortage of soft funding for Swedish HealthTech20:11 The most important number Helena tracks20:40 Decisions that slowed Leyr down21:21 The danger of unpaid consultancy22:07 The founder mindset: trying one more time23:19 The interoperability blind spot nobody discusses24:25 Fundraising and Leyr’s global opportunity25:43 Founder advice and following the moneyResources mentionedLeyr: https://leyr.io/Connect with Helena Holma: https://www.linkedin.com/in/helenaholma/Antler: https://www.antler.co/General Data Protection Regulation — official text: https://eur-lex.europa.eu/eli/reg/2016/679/oj/engEuropean Health Data Space — European Commission overview: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_enAbout Walk the ValleyWalk the Valley explores what happens between promising healthcare innovation and real-world adoption. Through candid conversations with founders, investors, experts and operators, we examine the regulatory, clinical and commercial obstacles that determine which innovations reach patients.Subscribe for more conversations from inside healthcare’s valley of death.Host: Katalin VikukGuest: Helena HolmaProduced by: Walk the ValleyWalk the Valley is a PsychWiser project.This conversation is intended for general information and reflects the speakers’ experiences and understanding at the time of recording. It does not constitute legal, regulatory or investment advice.

What does it take to build a medical AI product when the technology is advancing faster than the regulatory framework around it? Katalin Vikuk speaks with Anette Wolff, QA/RA Manager at Medviso, about how the EU AI Act interacts with the MDR, the difference between closed and continuously learning algorithms, and why validation, documentation and regulatory maturity increasingly affect investment, procurement and hospital adoption. They also examine whether regulation disproportionately favours larger companies—and whether compliance can become a competitive advantage.AI Act: Constraint or Competitive Advantage?What does it take to build a medical AI product when the technology is advancing faster than the regulatory framework around it?In this episode, Katalin Vikuk speaks with Anette Wolff, QA/RA Manager at Medviso, about what the EU AI Act means in practice for medical-device companies. They explore the interaction between the AI Act and the Medical Device Regulation, the regulatory difference between closed and continuously learning algorithms, and why validation, data traceability, cybersecurity and documentation are becoming commercially important—not just compliance exercises.Anette explains why regulatory uncertainty affects startups differently from large incumbents, why clinicians may not be the main barrier to hospital adoption, and why involving regulatory expertise early can become a competitive advantage.About Anette WolffAnette Wolff is QA/RA Manager at Medviso, a Swedish medical-technology company developing software for quantitative MR and CT image analysis and advanced medical 3D modelling. Her work spans regulatory strategy, quality management and compliance for AI-enabled medical-device software across international markets.Resources mentionedMedviso: https://medviso.com/Connect with Anette Wolff: https://www.linkedin.com/in/anette-wolff-1843a94/EU Artificial Intelligence Act — official text: https://eur-lex.europa.eu/eli/reg/2024/1689/ojEU Medical Device Regulation — official text: https://eur-lex.europa.eu/eli/reg/2017/745/ojISO/IEC 42001 — AI management systems:https: //www.iso.org/standard/81230.htmlReuters investigation mentioned in the episode: https://www.reuters.com/investigations/ai-enters-operating-room-reports-arise-botched-surgeries-misidentified-body-2026-02-09/About Walk the ValleyWalk the Valley explores what happens between promising healthcare innovation and real-world adoption. Through candid conversations with founders, investors, experts and operators, we examine the regulatory, clinical and commercial obstacles that determine which innovations reach patients. Subscribe for more conversations from inside healthcare’s valley of death.Host: Katalin VikukGuest: Anette WolffProduced by: Walk the ValleyThis conversation was recorded in June 2026 and reflects the regulatory landscape and the speakers’ understanding at that time. It is intended for general information and does not constitute legal or regulatory advice.

In this episode of Walk the Valley, Kata talks with Tobias Böcker, former co-founder of Mojo, to unpack what really happens when a promising MedTech company gets almost everything right and still doesn’t make it.Tobias shares the full journey of building Mojo over seven years: from early funding success and clinical validation to hitting an unexpected wall in the market. With a CE-marked product, strong partnerships, and investor backing, the team seemed to have all the pieces in place … until reality proved otherwise.We zoom in on the hard lessons behind that turning point. Why solving a real problem isn’t always enough. How falling in love with your idea can blind you to market signals. And why understanding who pays — and why — is often more important than the technology itself.The conversation also explores Mojo’s pivot from B2B to direct-to-consumer during COVID, where the company achieved rapid growth and became a market leader only to face a different challenge: scaling in a space shaped by stigma, behaviour, and human psychology.This episode is an honest and nuanced look at the “almost made it” side of innovation — and what founders can learn from it.If you’re building in MedTech, this is a must-listen on market fit, go-to-market strategy, and the realities of navigating the valley of death.

In this episode of Walk the Valley, Kata sits down with Charlotta Tönsgård, healthcare entrepreneur, former CEO of Min Doktor, and a leading voice in digital health innovation in Sweden.Charlotta shares her journey from tech into healthcare, and what it really takes to build and scale companies in one of the most complex and slow-moving systems. From navigating leadership under pressure to stepping through public scrutiny, this conversation goes beyond the usual startup story.We explore the structural challenges that hold healthcare innovation back: from unclear incentives and slow procurement processes to the gap between innovation and real-world adoption. Charlotta also shares practical insights for founders: how to think about public vs private pathways, why building “in tandem” with the system matters, and how to avoid getting stuck waiting for decisions you don’t control.We also dive into the future of healthcare in Europe, including AI adoption, system productivity, and why the biggest risk isn’t moving too fast, but not moving at all.This episode is a candid and thoughtful look at what it takes to build healthcare, and why understanding the system is just as important as solving the problem.

In this episode, we sit down with Ingela Mauritzon, Founder and CEO of Fabola Learning and Strategy, a company dedicated to making medtech regulation accessible for startups, scale-ups, and investors.Ingela's journey into the world of regulation is anything but straight. From working at an international hospital in Beijing, to patient experience and lab work back in Sweden, to specialising in IVDs and regulatory science, she's now completing her PhD in the field.We get into one of the most underestimated challenges in medtech innovation: regulation. Why does it consume up to 80% of product development costs? Why is Europe so much harder to navigate than the US? And why is the innovation ecosystem still failing to give startups the regulatory support they need?If you're building in medtech, this one is essential viewing.

In this episode of Walk the Valley, we do something a little different. A round-table discussion with two guests who approach healthcare innovation from distinct but connected perspectives.We’re joined by Martin Broch Pedersen, Business Development Director at Health Tech Hub Copenhagen, who works closely with early-stage healthtech startups on regulation, reimbursement, and commercialisation through programmes like Health Tech Pathways. Martin focuses on building the support structures that help founders learn faster, adapt earlier, and survive the valley of death.We’re also joined by Nicolas Bouchet, Investment Manager at Health Tech Hub Copenhagen, who brings the investor lens. Nicolas explores how startups can turn attention into actual investment, what makes a company investable, and why strong business models matter more than visibility alone.Together, we unpack what it really takes to move from innovation to investment:* Why saving money long-term often means investing earlier* Why building product and market in parallel beats waiting for a “finished” product* What builds investor credibility, and why fitting into existing budget streams matters* Why knowing what you don’t know is one of a founder’s strongest assetsThis episode is for founders who want to understand the system they’re building in, and how working with it can be more powerful than trying to disrupt it.Links:https://healthtechhub.org/http://healthtechhub.org/investor-survey-2025/

In this episode of Walk The Valley, Will talks to Cathrin Johansson CEO of Medtech company MedVasc. We learn about her companies work to bring a catheter device to market, their decision to focus on the US market, and why starting early with regulatory is critical for startups.We dig into the challenges of fundraising in 2025, building long-lasting trust with investors, and keeping the balance of clinical need, regulatory timing, and commercial urgency. Cathrin also breaks down how she approaches leadership in a small team, how MedVasc is preparing for market entry, and what founders often underestimate when bringing a device from prototype to patients.