ARTICLE SUMMARY:
Often-overlooked regulatory and related reimbursement considerations for device companies pursuing the popular Breakthrough Device pathway from John Doucet, former Policy Lead for the Breakthrough Device Program at FDA.
John Doucet, PhD, views the popular FDA Breakthrough Device Program (BDP) from a unique perspective: he led the program from 2018 through August of this year, where he had a hand in the granting or denial of more than 200 Breakthrough requests. Doucet’s first-hand experience offers valuable insights for device companies that may be pursuing this regulatory pathway.
