The first, organized by Prof Rosanna Tarricone, Associate Dean for Government, Health and Not for Profit Division of the SDA Bocconi School of Management (Bocconi University, Milano), aimed to provide a comprehensive overview of the specific challenges of current HTA of medical devices, discuss how the current regulatory scenario is likely to change in the near future, and disentangle the potential impact on access to valuable medical technologies. The different backgrounds of the panelists contributed to the ongoing discussion, providing in-depth and multifaceted insights on how to inform more transparent, evidence-based decisions on medical devices and how to steer innovation to generate greater value to healthcare systems and patients.

Five HTA experts from different professional backgrounds, participated to the discussion:

• Claudius Griesinger (European Commission): an overview on the upcoming regulation change in the MD sector in the EU.
• Marcella Marletta (Ministry of Health, Italy): main structure and preliminary results of the national program for the HTA of medical devices in Italy.
• Adriana Velasquez Berumen (WHO): an overview of how evaluation, procurement, and access to MD technologies is managed in LMIC, and how HTA in that setting can improve access to cost-effective technologies in the future.
• Leandro Pecchia (Warwick University): early HTA approaches to guide sustainable R&D investments in the MD industry.
• Richard Charter (BD): a manufacturer's perspective on the challenges posed by current HTA approaches, regulatory reform ongoing in Europe and limited access to LMIC.