Beyond Outcomes - Clinical Research Unfiltered

European medical device regulation is designed to protect patients—but does the current system provide innovators with enough clarity to develop the technologies patients need? In this episode of Beyond Outcomes: Clinical Research Unfiltered, Andreas Beust speaks with Prof. Tom Melvin, whose career spans medicine, law, regulatory authorities, European policy, and academic research. Together, they unpack the complex architecture of the European medical device system: the responsibilities of competent authorities and notified bodies, the growing influence of MDCG guidance and ISO standards, and the continuing uncertainty surrounding clinical evidence requirements. The conversation also explores early regulatory advice, structured dialogue, randomized trials, registries and real-world evidence, orphan and paediatric devices, artificial intelligence, in-silico models, and the lessons Europe could learn from regulatory systems in the United States, Japan, and the United Kingdom. At the centre of the discussion is a difficult question: How can Europe demand rigorous evidence for high-risk technologies while creating a more proportionate and predictable pathway for the thousands of other medical devices patients and healthcare systems rely on?

Healthcare is still largely built around snapshots: a blood test, a doctor’s visit, a single measurement at one moment in time. But biology is dynamic and our health data could be too. In this episode of Beyond Outcomes - Clinical Research Unfiltered, we speak with Agnes Musiol, founder of pheal, about the future of continuous health monitoring and the development of smart patches that can measure biochemical signals from sweat, interstitial fluid, or capillary blood. Together, we explore how continuous biomarker monitoring could transform prevention, chronic disease management, real-world data generation, and personalized healthcare. Agnes also shares the realities of building a medical technology startup in Germany: funding gaps, regulatory friction, the line between wellness and medical devices, the importance of early patient involvement, and the challenge of turning promising sensor research into usable products. A conversation about innovation, responsibility, regulation, and what it takes to move healthcare from reacting to disease toward helping people stay healthy.

In the first episode of Beyond Outcomes - Clinical Research Unfiltered, we sit down with Jan Elsner, founder of Skinuvita, to explore the personal and professional journey behind a digital health solution that brings medically supervised phototherapy into patients’ homes. Jan shares how his own experience with psoriasis shaped the mission behind Skinuvita, why the problem mattered more than the first idea, and what it really takes to build a medical device startup in a highly regulated environment. Together, we discuss the early founder journey, clinical validation, MDR certification, reimbursement with public health insurers, the emotional reality of startup life, and why healthcare innovation often depends not only on good technology, but also on persistence, partnerships, and a deep understanding of patient needs. This episode is a candid conversation about entrepreneurship, clinical research, medical devices, digital health, and the human side of bringing innovation to patients.