Walk the Valley

Katalin Vikuk

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Entrepreneurship
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The podcast that breaks barriers to healthcare innovation

Sep 10

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? 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 Wolff Anette 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 mentioned Medviso: 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/oj EU Medical Device Regulation — official text: https://eur-lex.europa.eu/eli/reg/2017/745/oj ISO/IEC 42001 — AI management systems:https: //www.iso.org/standard/81230.html Reuters 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 Valley Walk 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 Vikuk Guest: Anette Wolff Produced by: Walk the Valley This 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.
Apr 8

Tobias Böcker ex Mojo on nuances of understanding your buyers

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.
Mar 24

Charlotta Tönsgård on leadership resilience and healthcare system realities

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.
Mar 12

Ingela Mauritzon, Founder and CEO of Fabola Learning and Strategy

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.
12/22/2025

Martin Broch Pedersen and Nicolas Bouchet Health Thech Hub Copenhagen

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/
12/02/2025

Cathrin Johansson CEO MedVasc

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.
11/11/2025

Zdravko Obradovic CEO Clinical Trials Bid

In this episode of Walk the Valley, Kata talks with Zdravko Obradović, CEO and founder of Clinical Trial Bid and EBS Clinical Research, about how the Balkans are reshaping the landscape of clinical trials.Zdravko takes us from the fax-machine era to the rise of AI-driven trials, showing how automation and smart systems can cut timelines from years to months without compromising safety. He shares how Serbia offers a compelling edge (shorter approvals, stronger investigator networks, and 30–40% lower costs) backed by a story of boosting recruitment from 42 to 126 patients in just nine weeks.We also dive into his mission to make clinical research more accessible through Clinical Trial Bid, an AI-powered platform that helps startups plan, connect, and execute trials faster and smarter.The takeaway? The future of clinical research isn’t just faster, it’s fairer. When technology removes barriers, even small innovators can bring life-changing ideas to market. Clinical Trials Bid https://ctb.health/ EBS Clinical Research https://ebscro.com/ Zdravko's LinkedIn: https://www.linkedin.com/in/zdravko-obradovic-md-813218a6/
10/22/2025

Prof. Elisabeth Carlson Department of Care Science, Malmö University

In this episode of Walk the Valley, Will sits down with Professor Elizabeth Carlson, Head of Research and Education at Malmö University’s Department of Care Science. With a background as both a nurse and academic, Elizabeth offers a grounded yet forward-looking perspective on how healthcare is evolving. They discuss how the pandemic reshaped healthcare education, forcing a rapid shift to digital learning, and how that momentum continues to influence care delivery today. The conversation explores the promises and limitations of AI in healthcare, the rise of decentralised care, and the challenges of balancing innovation with human connection. Elizabeth also reflects on what healthcare might look like 50 years from now, from robotic assistance to precision health. And why, despite all the technology, relationships between caregivers and patients will always remain the heart of healthcare.

The podcast that breaks barriers to healthcare innovation

Creator

Katalin Vikuk
Years Active

2025 - 2026
Episodes

21
Rating

Clean
Copyright

© Katalin Vikuk
Show Website

Walk the Valley