Adaptive and Evolving Ai-enabled Medical Devices

Description: Adaptive and evolving AI-enabled medical devices are crucial in moving away from the "one-size-fits-all" approach towards more individualized care, where diagnosis, treatments, and preventive measures evolve in synch with the latest scientific insights and are specifically targeted to each patient's needs and conditions. In addition, text-to-code functionality will allow domain experts with no coding skills to modify or create medical device software, unleashing an enormous innovation potential.

Whereas the industry has extensive experience controlling the adaptive design of specific traditional devices, we need to build trust when an AI system drives the design modification, and clinical implementation of that modification, through “learning” and “reasoning.” For such systems to be successful, our sector must build trust with patients, healthcare providers, regulators, and society.

This session identifies and dissects the boundaries, obstacles, solutions, and incentives our current legislative frameworks provide for market authorization of adaptive and evolving AI-enabled medical devices worldwide. Following a horizon scan and evaluation of current legislative initiatives that may facilitate building trust, the audience will receive concrete advice on what steps to take to gain market authorization for these devices.