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
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