#18 - Hester Knol - From App to Medical Device: Why Certification Takes Forever

What does it really take to transform a health app into a certified medical device? In this episode, I sit down with Hester Knol, a clinical research expert with extensive experience in medical device regulation. Together, we delve into the complex journey of getting a digital health app through clinical trials, the hidden challenges faced by startups, and the rigorous planning and evidence required, even for low-risk tools, to ensure safety and efficacy before reaching patients.Key highlights include:- An in-depth look at the process of developing a medical device, from initial idea to regulatory approval, focusing on digital health applications.- The necessity of systematic literature reviews and the importance of generating evidence through clinical trials to demonstrate safety and performance.- The role of clinicians and healthcare professionals in shaping and legitimizing digital health solutions, including how their acceptance can significantly impact the success of new products.- The regulatory landscape, including the distinctions between different classes of medical devices and the implications of strict compliance requirements.- Insights into navigating the commercial landscape, how to engage with healthcare insurers and understand market dynamics to ensure viability and demand for new health tech products.If you're interested in the intersection of technology, healthcare, and regulatory challenges, this conversation is a must-listen!

What happens in the brain when we learn new information, and how can understanding fruit fly memory help us unlock the secrets of human cognition?In this episode, I had an insightful conversation with Prof. Dr. David Owald, an expert in neurobiology, who delves into the complexities of memory storage and learning processes as observed in the humble fruit fly. We explore how these simple organisms can reveal profound insights into the mechanisms of memory and how our brains function.Key highlights include:- The role of synaptic plasticity in memory formation and how David studies these processes at the molecular level in fruit flies.- The fascinating dynamics of the mushroom bodies in the fly brain and their critical role in how flies learn and remember odors.- An exploration of how sleep affects memory consolidation, emphasizing the surprising parallels between insect and human brains.- Insights into attention and decision-making, including how flies prioritize information and behavior based on their internal states.- Discussion on the challenges and triumphs of scientific research, including unexpected findings that can reshape our understanding of memory mechanisms.If you’re interested in how learning happens at the neural level, the parallels between different species, and the implications for understanding human memory, this episode is packed with valuable insights you won't want to miss!

How did we get from the first AI models to today's cutting-edge language models, and what’s next for AI infrastructure?In this episode, I sit down with Alex to explore the history of AI, from early perceptrons to GPT-4, and the often overlooked hardware and system engineering challenges behind modern AI.We discuss why building and training AI models today is far more than just code and data, it’s about scaling infrastructure, managing distributed GPUs, and creating robust pipelines for fine-tuning and domain-specific AI.Key highlights include: A deep dive into the evolution of neural networks, from perceptrons and backpropagation to transformers and LLMs. Why NVIDIA’s early involvement with AI hardware became a game-changer—and how GPUs moved from gaming to powering AI breakthroughs. The real cost and complexity behind training large models—and why fine-tuning, LoRA, and model distillation are critical for smaller players in AI. A behind-the-scenes look at AI infrastructure challenges: what it takes to train, distribute, and deploy models at scale. How Alex’s project Exalsius is building a platform to give AI startups and researchers better, more affordable access to distributed GPU compute, helping democratize AI development.If you’re curious about where AI is headed, and what it really takes to build models beyond the hype, this is a conversation you don’t want to miss!

How can we ensure AI systems are innovative, safe, and trustworthy? In this episode, I sit down with Arash Azhand, an expert in AI safety and assurance, to explore the challenges and strategies for building reliable AI systems. From safety in medical AI to continuous assurance practices, we dive into the processes shaping the future of trustworthy AI.  Key highlights include:  - Addressing regulatory gaps in AI for critical applications. - Tools and frameworks for making AI decisions more transparent. - Generative AI’s role in both cybersecurity risks and solutions. Curious about the future of AI and how it’s staying accountable? Catch the full episode to learn more!

Ever wondered how modern work frameworks can transform team dynamics and alignment?In this enlightening conversation, I chat with Hannah Scheiffele, an expert in organizational development and HR strategy, about the challenges and triumphs of implementing “New Work” concepts such as flexible work environments, both remotely and on-site. We delve into the effective use of frameworks like OKRs to align team efforts, discussing the need for personalization and strategic adaptation to ensure everyone moves in harmony towards common goals.Curious about making your team more cohesive, no matter where they work from? Check out the episode on your favorite platform.Enjoy!

Ever wondered how the EU is shaping the future of AI?In this episode, I sit down with Dr. Christian Herles, a legal expert and thought leader in digital law, to explore the impact of the EU AI Act on the world of artificial intelligence.Dr. Herles walks us through the intricacies of the EU AI Act—one of the most groundbreaking pieces of legislation in the AI space. We discuss how this regulation will influence innovation, address the ethical use of AI, and tackle critical issues like risk management and compliance. From legal liability in autonomous systems to safeguarding data privacy under GDPR, we cover the key challenges industries are facing today.We also look ahead to the future: How will AI regulation evolve as technology advances? What responsibilities do businesses and developers hold in ensuring the ethical use of AI? And how can companies navigate these new legal landscapes while continuing to innovate?Tune in for a deep dive into the intersection of AI, law, and ethics, and discover what the future holds for AI regulation in Europe and beyond.Enjoy!

Ever wondered how AI is reshaping industries right before our eyes? In this episode, I sit down with Sven Spöde, a PR expert and seasoned AI enthusiast, to discuss the transformative power of AI in the business world.Sven breaks down the five levels of AI development—from chatbots to fully autonomous systems—and we explore how businesses are already leveraging AI for growth. We dive deep into real-world applications, from improving workflows to empowering individuals and small businesses with AI tools like GPT models.We also discuss the future: What will Level 3 autonomy look like? How are traditional industries being disrupted? And what are the big questions we still need to answer as AI continues to evolve?Tune in for an insightful conversation about the impact of AI on business, the opportunities it’s creating, and the challenges that lie ahead.Enjoy!

Ever wondered how AI can be harnessed for the greater good? I talk to Dr. Paul Springer.Paul has a background in theoretical physics and years of experience as a management and IT consultant. He’s also the co-founder and managing director of MI4People, a non-profit that develops open-source AI solutions for humanitarian, social, and environmental issues.We dive into how AI can help tackle global challenges, the mission behind MI4People, and how technology can drive meaningful, positive change.Enjoy!

Ever heard of digital therapeutics? Most people haven't. I talk to Jonas Albert. Jonas is a market access and strategy specialist for digital health markets, with a big focus on digital therapeutics. He is currently working as managing consultant for fbeta, Germany's leading consultancy in the area of product conception, evidence generations, general market access and price negotiations for reimbursable digital therapeutics. We cover many topics starting with what digital therapeutics are and where the innovation lies. How do different countries approach the process and what are business opportunities in this area.Enjoy

How does willpower work and how do underlying factors such as cognitive control and motivation influence it? We talk to Dr. Roshan Cools about her research. We cover many topics ranging from reward and the role of dopamine as well as cognitive enhancers such as ritalin or adderall and if they are actually effective or not.  We also touched upon how UX design could impact cognitive control and how you should think about it.