Balancing Speed and Safety in Medical Device Regulation

This chapter discusses the critical balance between rapid approval and safety in the regulation of biopharmaceuticals and medical devices, emphasizing the need for a broader focus on confidence in market operations. It features a guest who shares insights from their transition from patent law to regulatory affairs, particularly in the realm of AI-enabled medical technologies. The dialogue explores the complexities of regulatory frameworks, the significance of continuous testing, and the potential benefits of innovative strategies like regulatory sandboxes to foster technological advancements while safeguarding public health.