Videos Library

How to balance evidence demands between US and International Markets

Related topics: MedTech, Europe, USA, Market Access & HEOR

This free video is available for registered users


Planning for a global product launch means a coherent evidence plan and value dossier must address the needs of multiple geographies. This session will review the evolving perspectives of US payers on evidence for medical devices, and contrast these trends with major EU markets and Japan. Specific topics to be addressed will include:

  • US Medicare and private payer bundled payment models.
  • New bundling of In Vitro Diagnostics under Medicare outpatient rules.
  • British requirements for Specialised Services.
  • French programs to generate real world evidence.
  • Germany’s trial regulation.
  • Japan’s new HTA requirements.

Stephen Hull
Principal and Founder
Hull Associates, USA


Subscribe or unlock this video to download the presentation slides. If you already have an account, please log in.


This is the presenters’ personal opinion and does not necessarily represent true facts, the official views or policy of their organisation, nor the views of Evidence Life Science.