#454: Slow regulation is killing health tech innovation

<p>In this episode of The Healthtech Podcast, James is joined by Jamie Cox, Co-Founder and CTO of Scarlet — Europe's only notified body specialised in software and AI medical devices. Jamie shares how a frustrating experience building AI triage software at Babylon Health led him and co-founder James Dewar to a radical idea: build a notified body from the ground up, designed specifically for iterative software development. They explore why the current regulatory system creates artificial bottlenecks for health tech founders, what it actually means to regulate an LLM as a medical device, and why making certification faster and cheaper could fundamentally reshape who gets to bring products to market.</p><p><br /></p><p>Connect with Jamie: <a href="https://www.linkedin.com/in/jamie-cox-01458b3a/" rel="ugc noopener noreferrer" target="_blank">https://www.linkedin.com/in/jamie-cox-01458b3a/</a></p><p>Learn more about Scarlet: <a href="https://www.scarlet.cc/" rel="ugc noopener noreferrer" target="_blank">https://www.scarlet.cc/</a></p><p><br /></p><p>Apply to be a guest: www.thehealthtechpodcast.com</p><p>Subscribe to Healthtech Pigeon 🐦: www.healthtechpigeon.com</p><p>Get in touch with James: www.jamessomauroo.com</p><p><br /></p><p>This podcast was brought to you by SomX.</p>