Regulation, AI, and Geopolitics: Insights from Our Latest Fireside Chat

Regulation has dominated healthcare headlines this year, with the FDA and other agencies drawing intense attention. As part of our latest Averin Webinar, I was joined by three leading regulatory experts to help cut through the noise: 

• Peter Hutt – Former FDA Chief Counsel, widely regarded as the ​“dean” of FDA law
• David Shulkin – Former Secretary of Veterans Affairs and longtime healthcare executive
• Daniel Troy – Managing Director at Berkeley Research Group, Former FDA Chief Counsel

We had a very candid conversation — under Chatham House rules — about what is really happening inside the regulatory system and how it will shape the future of healthcare and biotech.

Regulation vs. Reality

A central theme of the discussion was the gap between perception and reality. On the one hand, there have been few substantive changes to regulation or policy since January. On the other hand, there has been a noticeable uptick in FDA warning letters and enforcement actions, alongside reports that the day-to-day environment is very different from years past. 

Nonetheless, the FDA is still actively advancing innovation, with Averin-backed Biolinq’s recent De Novo clearance of its needle-free CGM standing out as an example of the agency’s willingness to create entirely new categories.

Forces Reshaping Innovation

Two powerful external forces are also reshaping the landscape.

The first is artificial intelligence. There is a clear consensus that AI is not just a novel tool but will be a fundamental shift in how businesses operate. It is transforming workflows, data management, and decision-making, while also raising questions about talent. Companies must attract people who can bridge traditional expertise with AI fluency, and regulators face an even greater challenge as they work to build the capacity to evaluate AI-enabled products.

The second is geopolitics, particularly the decoupling of supply chains and innovation pipelines from China. What was once a background consideration is now central to strategy. Dependence on overseas manufacturing and components is increasingly seen as a risk, forcing companies to rethink sourcing, resilience, and long-term planning.

The Call for Clarity

Across all of these threads — enforcement trends, AI integration, and shifting global dynamics — the need for clarity stood out. Innovators thrive when the rules of the road are well understood. Whether it is how the FDA will evaluate AI-enabled products or how companies should navigate supply chain realignment, uncertainty itself is often the greatest challenge.

Multiple forces are converging: heightened scrutiny, rapid technological change, and global realignment. The task for innovators is not simply to respond to any single shift, but to navigate their convergence with strategy and conviction.