The FDA Breakthrough Device Designation - Program Regulatory & Reimbursement Insights


Providing first-hand perspectives on the regulatory pathway, we will explore the FDA Breakthrough Device Designation program and the evolving reimbursement policy changes which medtech innovators should consider as they develop their reimbursement strategy, and when requesting designation as a breakthrough device.

  • An introduction to and discussion of the evolution of the program
  • Eligibility Criteria
  • Reimbursement for Breakthrough Devices – changes that impact coding, payment and coverage
  • CMS recently implemented for temporary payment and CMS recently proposed changes for coverage

John Doucet, Senior Director Neurology Regulatory Affairs, MCRA
Tonya Dowd, VP Reimbursement, Health Economics & Market Access, MCRA
John D. McDermott, Senior Director Reimbursement Strategy, MCRA

This session was delivered as part of the Investival Showcase 2020. Find out about the full event by downloading the brochure.