Koen Cobbaert
Aiheet
Curing the System amidst Geopolitical Trade Wars: Regulatory Reform for Better Health and Innovation
AI adaptation and evolvement under medtech regulations
Adaptive medical devices are transforming healthcare by shifting from a “one-size-fits-all” approach to truly personalized care. Meanwhile, emerging text-to-code capabilities empower domain experts without programming skills to develop or modify medical device software, unlocking vast innovation potential. While traditional adaptive designs are well-managed, the regulatory science for AI-driven change is still in its infancy. Building trust among patients, providers, regulators, and society will be crucial for the success of these adaptive systems. In this session, Koen Cobbaert explores the regulatory science that supports adaptation, the interplay between foundation models and their providers, the role of predetermined change control plans, and medical device production systems. The session concludes with an overview of the remaining gaps in regulatory science and strategies for overcoming them.