STAT July 23, 2024
The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious conditions that may offer improvements over available therapies.
Once breakthrough drugs and devices are approved, however, devices face a far less predictable pathway and a longer timeline to achieving reimbursement, including coverage by payers such as Medicare, compared to breakthrough pharmaceuticals, even though both involve years of development, significant investment, commitment of resources, running of clinical trials, and market launch preparations.
This unpredictable pathway and longer timeline to achieving coverage and reimbursement for breakthrough devices, sometimes lasting years, creates both financing and commercialization challenges for breakthrough device manufacturers. More importantly, it creates an...
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