This webinar will inform and educate medical device innovators on the FDA Breakthrough Device Designation program and the evolving reimbursement policy changes which innovators should consider as they develop their reimbursement strategy and when requesting designation as a breakthrough device.


You can also see the slides here.


MCRA will provide firsthand perspectives on the regulatory pathway from John Doucet, PhD, MCRA’s Sr. Director Neurology who was the Former FDA Policy Lead, Breakthrough Device Program (MCRA hires the former leader of the FDA Breakthrough Device Programme - Neurology Division Manager) as well as insights on reimbursement considerations from Tonya Dowd, Vice President, Reimbursement, Health Economics & Market Access and John McDermott, Senior Director, Reimbursement Strategy.

This session will cover:

  • Background of the Breakthrough Device Designation Program – an introduction and evolution of the program
  • Eligibility Criteria
  • Reimbursement for Breakthrough Devices – changes that impact coding, payment and coverage
    • CMS recently implemented for temporary payment
    • CMS recently proposed changes for coverage
  • Commonly Asked Questions & Helpful Resources

Expert Speakers


John Doucet, Ph.D., Senior Director, Neurology Regulatory Affairs, MCRA

John Doucet, Senior Director Neurology Regulatory Affairs, MCRA 300x
  • Recent former FDA policy lead who managed the breakthrough device programme
  • Additional prior roles at FDA include: Acting Director of IDE Program, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch
  • 10+ years of FDA and neurology devices experience
  • Expertise in neurology devices covering psychiatric disorders & acute/chronic pain
  • Expertise in regulatory submissions including 510(k), IDE, PMA, HDE, 513(g), Q-Submissions, & De Novo

Tonya Dowd, MPH, Vice President, Reimbursement, Health Economics & Market Access, MCRA

Tonya Dowd, MPH, Vice President, Reimbursement, Health Economics & Market Access, MCRA 300x
  • 30+ years of reimbursement, health economics & market access experience
  • Former Global Franchise Director of Healthcare Economics and Market Access within Johnson & Johnson's medical device division
  • Healthcare company and consulting experience includes Covance, Quorum Consulting, Allergan, Johnson & Johnson (Ethicon Endo-Surgery, Biosense Webster, Cerenovus), HeartFlow, iRhythm and Glaukos, among others.
  • Expert in upstream product plan development and downstream execution of reimbursement strategies

John D. McDermott, Jr., MBA, Senior Director, Reimbursement Strategy, MCRA

John D. McDermott, Senior Director Reimbursement Strategy, MCRA 300x
  • 30+ years of industry experience in market access strategy, reimbursement, patient access programs, and health economics and outcomes research (HEOR)
  • Former Vice President, Covance Market Access Services
  • Expertise in Medicare payment systems, new-technology payment, coding applications, and payer and provider market research
  • Broad experience in many therapeutic areas, including cardiology, wound care, orthopedics, inflammation, and oncology


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