Koen Cobbaert

Curing the System amidst Geopolitical Trade Wars: Regulatory Reform for Better Health and Innovation

In an increasingly interconnected world, the global medtech market is navigating a complex web of geopolitical tensions, regulatory reforms, and shifting trade dynamics. This panel aims to provide clarity on the evolving landscape, focusing on the intersection of regulation, innovation, and international trade.

With the European Union restructuring its regulatory frameworks, ongoing concerns over overregulation, and the shifting tariffs and policies between the U.S. and China, the medtech industry faces both significant challenges and opportunities. As regulatory bodies work to balance patient safety, market access, and innovation, industry leaders must adapt to remain competitive on a global scale.This session will explore the key forces shaping the medtech market today, including:

• Review of the European Commission's proposed legal text in view of addressing innovation and patient health
• The competitiveness of the EU medtech industry amidst global regulatory restructuring
• The impact of the legislative proposal in view of shifting geopolitics, global regulatory restructuring, medical supply chains and partnerships
• The evolving role of big tech in reshaping the healthcare landscape, from product development to patient care

Through expert insights, the discussion will highlight strategic approaches to navigating these turbulent times, with a focus on how regulatory reform can foster an environment of growth and innovation. Attendees will leave with a clearer understanding of the global medtech landscape, practical takeaways on navigating regulatory and geopolitical challenges, and a vision for the future of healthcare innovation on the world stage.

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.