Episode 13 · International

Regulatory strategy for founders and policy makers

Hugh Harvey · Founder, Hardian Health

Apr 2025

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Regulatory strategy for founders and policy makers

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About this episode

Practical breadth and depth on the global state of regulation from someone at the cutting edge of regulatory policy. The EU versus FDA divide, what only ~40% of African countries even having medical device regulations means for founders, why regulatory debt is a company killer, and what regulators could do better.

Regulation Policy AI Global South

“What's the cost of not being compliant? Well, it's everything - it's your entire business model.”
Hugh Harvey

What we cover

01The global state of medical device regulation: EU vs FDA and the deregulatory shift under Trump
02Why only ~40% of African countries have medical device regulations - and what this means for founders
03Cybersecurity: medical health data sells for more than financial data on the black market
04The five stages of regulatory grief - and how to reach acceptance
05Regulatory debt: why leaving it late becomes insurmountable
06The driving test analogy: practical mindset for founders approaching regulation
07What to do when deploying in a country with no regulatory framework
08What regulators could do better: proactivity, transparency, and funding capacity
09LLMs in healthcare: massively overrated for reasoning, but not without promise

About the guest

Hugh Harvey

Founder, Hardian Health

Hugh Harvey is a former radiologist who transitioned to the digital health industry. After working at Babylon Health and serving as Clinical Director at Kheiron Medical - where the team secured Europe's first CE mark for a deep learning-based breast cancer detection device - Hugh founded Hardian Health to help companies navigate regulatory pathways for AI and digital health solutions.

Chapters

00:00Introduction and background

04:22The state of regulation in healthcare

06:36Why so regulated?

09:24Global perspectives on regulatory approaches

16:53Harmonisation of global standards

19:34Recommendations for regulators

31:53Regulatory strategy for founders: the driving analogy

42:14What if there is little or no regulatory enforcement where I operate?

43:59The five stages of regulatory grief

47:44Hugh's spicy takes

Transcript

Working in digital health?

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Shubs consults on clinical leadership, evidence strategy, and digital health market access. If this conversation sparked something, it is worth a conversation.

Shubs takes on consulting work with startups, investors, and global organisations across digital health.

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Joe Alderman · NHS Anaesthetist and NIHR Clinical Lecturer in AI, University of Birmingham

Joe Alderman has a rare double view: anaesthetist by night, AI academic by day. His insights on what it takes to deploy and monitor AI in healthcare - with a lens on not leaving people behind - are relevant wherever in the world you are. We cover health data poverty, the STANDING Together initiative, algorithmic bias, LLM safety for patients and clinicians, anti-patterns in the industry, and what people building in low-resource settings specifically need to think about.

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#10B·

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