Beyond Outcomes - Clinical Research Unfiltered

Andreas Beust

Beyond Outcomes - Clinical Research Unfiltered is a podcast exploring the real stories, challenges, and decisions behind clinical research, medical innovation, and healthcare transformation. Hosted through open conversations with experts, founders, researchers, and industry leaders, the podcast goes beyond polished success stories to uncover what it really takes to bring ideas, trials, technologies, and treatments closer to patients. From regulatory hurdles and clinical operations to entrepreneurship, digital health, patient impact, and lessons learned along the way, Beyond Outcomes offers an honest look at the people and processes shaping the future of healthcare.

Episodes

  1. Oct 15

    From CRO Founder to Business Angel: Rethinking Clinical Research and Leadership

    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 on developing clinical trial technology, introducing risk-based thinking, and building partnerships across different business cultures. The conversation also takes a critical look at how clinical research has changed. From paper case report forms to electronic data capture and artificial intelligence, Andreas discusses where technology has helped—and where he believes over-documentation and risk avoidance still distract from meaningful trial quality. Can AI reduce unnecessary work, or will it simply make it easier to demand more? Beyond clinical trials, Andreas explains why he chose to hand over operational leadership, how he separates personal identity from professional status, and what he now looks for in startup founders. It is an open conversation about entrepreneurship, ego, clinical evidence, financial responsibility, and creating value for patients, clients, and the next generation.

    From CRO Founder to Business Angel: Rethinking Clinical Research and Leadership

  2. Sep 15

    From Wellness App to Digital Health Application: Building a Digital Therapeutic in Europe

    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 MDR, and entering Germany through the DiGA pathway. But regulatory approval and reimbursement are only part of the story. The conversation explores what happens after a product becomes reimbursable: commercialization, physician adoption, scalability, pricing, evidence requirements, product updates, and the challenge of operating across fragmented European healthcare systems. It is also an open conversation about startup reality: opportunity costs, product-focused mistakes, venture capital, changing business models, perseverance, and why healthcare founders need to think about market access and long-term strategy much earlier than they often do.

    From Wellness App to Digital Health Application: Building a Digital Therapeutic in Europe

  3. Aug 14

    From Pathology to Biotech: Unlocking Impact Beyond Patient Care

    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 trial results actually mean for patients. Michelle emphasizes that clinical development is where science and business have to come together if an innovation is ultimately going to reach patients. They also explore patient-reported outcomes, global trial populations, bridging strategies, real-world evidence, and the challenge of turning complex clinical information into meaningful decisions. But this episode is also about something more personal: being willing to question your career path, seek mentors, put yourself in uncomfortable situations, accept rejection, and actively shape what comes next.

    From Pathology to Biotech: Unlocking Impact Beyond Patient Care

  4. Jul 15

    Who Decides What Evidence Is Enough? The Reality of Medical Device Regulation

    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?

    Who Decides What Evidence Is Enough? The Reality of Medical Device Regulation

  5. Jun 15

    Beyond Snapshot Diagnostics: The Future of Continuous Health Monitoring

    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.

    Beyond Snapshot Diagnostics: The Future of Continuous Health Monitoring

  6. May 15

    How One Founder Turned a Personal Disease Into a Medical Device Company

    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.

    How One Founder Turned a Personal Disease Into a Medical Device Company
  • 6 Episodes

About

Beyond Outcomes - Clinical Research Unfiltered is a podcast exploring the real stories, challenges, and decisions behind clinical research, medical innovation, and healthcare transformation. Hosted through open conversations with experts, founders, researchers, and industry leaders, the podcast goes beyond polished success stories to uncover what it really takes to bring ideas, trials, technologies, and treatments closer to patients. From regulatory hurdles and clinical operations to entrepreneurship, digital health, patient impact, and lessons learned along the way, Beyond Outcomes offers an honest look at the people and processes shaping the future of healthcare.

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