All Episodes
4/15/2026 · 50 min
Hugh Harvey on Radiology AI Startups, Regulation, Evidence & the Only Way to Win in Health Tech
Prove It! with Dr. Hugh Harvey, Regulatory Consultant, Hardian Health
Audio coming soon · 50 min
In 2015, Geoffrey Hinton said radiologists would lose their jobs to AI within five years. It's 2026 and we're still short of radiologists. Dr. Hugh Harvey has a few thoughts on that.
Paul Wicks sits down with Hugh — radiologist, ex-Babylon Health, builder of Europe's first CE-marked deep learning mammography device, and now regulatory consultant to over 150 medical device companies — for a masterclass on why most healthcare AI companies fail, and what the ones that survive actually do differently.
Plus: why there's no such thing as vibe-coding your way through medical device regulation.
Topics covered
- Why AI didn't replace radiologists, and what that really tells us about healthcare AI
- How software gets classified as a medical device (and why start-ups always try to game it)
- "Class one washing": the shortcut that makes your product less useful and gets you caught
- AI-generated fake regulatory documentation — it's happening, and it's worse than you think
- The health economics gap: why regulatory clearance is just the entry ticket, not the prize
- Digital thalidomide: why a small error rate at scale is an entirely different category of harm
- What the companies that actually make it do from day one
Chapters
- 00:00Introduction: the magic trick that doesn't work at home
- 02:00Why radiologists still have jobs in 2026
- 08:00From Babylon Health to Europe's first CE-marked deep learning device
- 16:00How software gets regulated as a medical device
- 26:00Class one washing: the shortcut that backfires
- 36:00AI-generated fake regulatory documentation
- 42:00The health economics gap
- 45:00Digital thalidomide: why scale changes everything about harm