Session (CTI)

Medical devices (including diagnostics, implants, and therapeutic technologies) play a critical role in modern healthcare but present unique challenges for evaluation. Iterative design changes, operator-dependent performance, and broad clinical applications often limit the generalizability of pre-market trial data and complicate conventional health technology assessment (HTA) methods. This forum will explore how evolving regulatory and HTA frameworks are adopting a lifecycle approach to evidence generation, integrating pre-market studies with structured post-market surveillance, real-world evidence (RWE), and registries. This model supports adaptive, ongoing assessment of device safety, effectiveness, and value. While focused on medical devices, the discussion will extend to the growing digital health ecosystem. Technologies such as software as a medical device (SaMD), digital therapeutics, and remote monitoring tools increasingly blur the lines between software and devices. These innovations require ongoing outcomes-based evaluation and increased methodological rigor, prompting regulatory and HTA systems to evolve accordingly. Digital tools, such as including AI-enabled diagnostics and connected monitoring platforms, can enhance evidence generation by enabling improved data capture, real-time monitoring, and continuous evaluation. However, their utility depends on integration into robust, transparent frameworks that uphold established regulatory and methodological standards. This session will convene experts from regulatory agencies, HTA bodies, and industry to discuss how evaluation systems can adapt to a dynamic technological landscape. Panelists will share strategies for aligning regulatory, HTA, and payer expectations to foster a policy environment that promotes timely access to high-value medical and digital health technologies.