Beyond Outcomes - Clinical Research Unfiltered

What does it take to build a clinical research company—and how do you know when it is time to let someone else lead it?
In this episode of Beyond Outcomes – Clinical Research Unfiltered, Andreas Beust speaks with Andreas Grund, founder of GCP-Service and business angel, about his journey from academic research to CRO entrepreneurship, international collaboration, and investing in medical-device startups.
Andreas shares how GCP-Service grew from a one-person operation into an international business, why adapting to clients’ needs shaped his approach, and what he learned about trust, responsibility, and managing a growing team through uncertain times. He reflects...

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,...