Regulatory strategy for founders and policy makers

Practical breadth and depth on the global state of regulation from someone at the cutting edge of regulatory policy. 

Shubs welcomes Hugh Harvey, founder of Hardian Health and a regulatory expert in digital health. Shubs and Hugh discuss the complex landscape of medical device regulation worldwide, with emphasis on how these frameworks impact digital health innovation in low and middle-income countries (LMICs). 

Guest Background

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 they 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.

Key Discussion Points

The Global State of Medical Device Regulation

• Regulatory Variation: Hugh explains the significant differences in regulatory approaches between regions like the EU (stricter) and the US (increasingly deregulatory)
• (Some) LMIC Contexts: Only about 40% of African countries have actual medical device regulations, with only South Africa having comprehensive frameworks
• Cybersecurity Risks: Medical health data sells for more than financial data on black markets, making robust regulation essential for protecting patients

Challenges for Digital Health Innovators

• Founder Misconceptions: Many startups allocate insufficient resources for regulatory compliance. Regulatory compliance should represent 5-10% of a company's overall budget.
• Regulatory Debt: Postponing regulatory considerations creates compounding challenges that become increasingly difficult to address later down the line
• Large Language Models: Hugh's skepticism about LLMs in healthcare, noting they're "massively overrated" for medical reasoning tasks and face significant regulatory hurdles, and yet Hugh sees some promise over the hill. 

Practical Guidance for Digital Health Companies

• Getting the mindset right: Thinking about it in the same way you might approach a driving test. 
• Universal Standards: Quality management systems (ISO 13485) are increasingly harmonized globally
• Approach in LMICs: Thinking about deploying in an place where there is little to no regulatory structure? You might want to consider securing certification in countries with established regulatory pathways prior, and then work with the local government.

What Regulators Could Do Better

• Proactivity: Regulators should be more proactive in providing guidance on novel technologies
• Transparency: More open sharing of regulatory decisions would help the entire industry move forward
• Capacity: Governments should increase funding for regulatory bodies to reduce backlogs and improve efficiency

Chapters

00:00 Introduction and Background
07:05 The State of Regulation in Healthcare
09:57 Why so regulated?
13:03 Global Perspectives on Regulatory Approaches
21:51 Harmonization of Global Standards
24:59 Recommendations for Regulators
38:48 Regulatory strategy for founders: The Driving Analogy
50:03 What if there is little or no regulatory enforcement where I operate?
51:57 The Five Stages of Regulatory Grief
55:59 Hugh's spicy takes 🌶️

Key Quotes

• "Regulations are written in blood... the reason that the FDA even exists is because of thalidomide."
• "What's the cost of not being compliant? Well, it's everything, it's your entire business model."
• "The attack surface vector, especially under these generative AI models, is huge, vast, and frankly, completely unknown."

Hugh provides a compelling case for embracing regulatory requirements as not just necessary obligations but strategic advantages. While acknowledging the challenges of navigating complex regulatory landscapes, particularly for innovators working in regions with limited frameworks, he offers practical guidance on approaching compliance as a foundation for long-term success in digital health. You can find Hugh and his work at hardianhealth.com

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