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What does it really take to turn a digital health idea into a regulated, reimbursed medical product?

In this episode of Beyond Outcomes - Clinical Research Unfiltered, Andreas Beust speaks with Lenka Šomvárska, Co-Founder of Vitadio, about the long and often unpredictable journey from a wellness startup to a digital therapeutic for people with type 2 diabetes.

Lenka shares how Vitadio pivoted from wellness and obesity into diabetes, why the team deliberately chose the more demanding path of becoming a regulated medical device, and what they learned while generating clinical evidence, obtaining CE marking, navigating the transition from MDD to...

What happens when the career you once imagined for yourself no longer feels like the right one?

In this episode of Beyond Outcomes – Clinical Research Unfiltered, Michelle Mudge-Riley shares her journey from medicine and pathology to entrepreneurship, consulting, and ultimately leadership in biotech. What began as a difficult decision to step away from the traditional physician career evolved into a new way of creating impact for patients—through clinical development.

The conversation moves from career transformation into the realities of biotech: balancing strong science with business strategy, choosing development pathways, interpreting clinical data, working across regulatory environments, and understanding what...

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,...

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...

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,...