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What if you could cut the time it takes to develop a medical device in half? Or do in one hour what used to take a full day? In this episode, I sit down with Prof. Dr. Christian Johner, founder of the Johner Institut GmbH and one of Europe's most recognized experts in medical device, regulatory affairs and software. He has spent decades helping manufacturers navigate regulatory hurdles, and recently, he has turned his focus to something that is changing everything: generative AI and large language models in medical device development. The discussion with Prof. Johner is precise, direct, and a little bit scary in how clearly he sees where this is all going. Here is what you will learn: 🞄 Why AI is a multiplier for your competencies, but also your incompetencies 🞄 How to "tame" AI to produce precise, reproducible outputs with structured data 🞄 Why the biggest time losses in MedTech development have nothing to do with the development itself 🞄 The four competencies you need to actually use AI effectively in a medical devicecontext 🞄 Why Christian's #1 advice is simply: just start 🞄 His bold prediction that continuous device updates will replace the current regulatory gateway model entirely If you work in MedTech and you are not yet using AI in your development process, this episode will change how you think about that decision. If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda... ⏱️ TIMESTAMPS: 00:00 – Introduction 01:13 – Who is Christian Johner and what is the Johner Institute? 02:21 – Where is the biggest time loss in medical device development? 06:20 – What is generative AI and how does it work? 07:35 – Which tasks in MedTech can AI actually accelerate? 08:14 – Why some people get worse results with AI (and how to fix that) 13:38 – How to "tame" AI for precise, reproducible outputs 25:21 – The four competencies you need to use AI effectively 28:10 – AI as a multiplier: the widening gap between teams 29:12 – Societal implications: fascinated and scared at the same time 33:01 – The future of medical device development: continuous updates 38:56 – When regulation becomes code 39:56 – Concrete advice for 2026: where to start right now 🔗 CONNECT WITH PROF. DR. CHRISTIAN JOHNER: Johner Institute: https://www.johner-institut.de LinkedIn: / christianjohner 🔗 CONNECT WITH US: 🎧 Subscribe to the Gradical Podcast for insights on MedTech materials and innovation 🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast... 🟢 Spotify – https://open.spotify.com/show/4vNQ6rP... 📺 YouTube – / @gradicalgmbh 🌍 Learn more about Gradical: https://gradical.ch/ 📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch #GradicalPodcast #MedTech #MedicalDevices #AI #GenerativeAI #MedicalDeviceDevelopment #RegulatoryAffairs #LLM #AIinHealthcare