EPISODE · Jul 8, 2026 · 1H 6M
#455 - Slow regulation is killing health tech innovation
from The Healthtech Podcast · host Dr. James Somauroo
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.Connect with Jamie: https://www.linkedin.com/in/jamie-cox-01458b3a/Learn more about Scarlet: https://www.scarlet.cc/Apply to be a guest: www.thehealthtechpodcast.comSubscribe to Healthtech Pigeon 🐦: www.healthtechpigeon.comGet in touch with James: www.jamessomauroo.comThis podcast was brought to you by SomX.
What this episode covers
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.Connect with Jamie: https://www.linkedin.com/in/jamie-cox-01458b3a/Learn more about Scarlet: https://www.scarlet.cc/Apply to be a guest: www.thehealthtechpodcast.comSubscribe to Healthtech Pigeon 🐦: www.healthtechpigeon.comGet in touch with James: www.jamessomauroo.comThis podcast was brought to you by SomX.
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#455 - Slow regulation is killing health tech innovation
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