MCRA, a medical device focused regulatory advisory firm and clinical research organization (CRO), says it has successfully helped grant over 60 breakthrough device designations by the U.S. FDA.

The FDA Breakthrough Device Program is intended to help patients with life threatening or irreversibly debilitating diseases receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for their conditions. Devices that receive the breakthrough designation are granted priority review and more frequent interactions with the Agency to promote faster device development and review through to commercialization.

The program is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request.

Obtaining the breakthrough designation for MCRA clients has led to them having more collaborative and frequent engagements with FDA through the special interactive mechanisms reserved for breakthrough devices. It has also led to reimbursement benefits for MCRA clients.

While Medicare Coverage for Innovative Technologies (MCIT) was repealed late last year, there are still several benefits only breakthrough technologies are eligible for on the payment side, including the New Technology Add on Payment (NTAP) and Transitional Pass-Through Payment. 

“While at FDA, I witnessed and supported the rapid growth of the Breakthrough Device Program, evaluated designation decisions for a diverse array of device technologies and patient populations, and gained valuable insight into how to obtain the designation and subsequently utilize the unique interaction mechanisms reserved for breakthrough devices,” says John Doucet, PhD, VP, Regulatory Affairs at MCRA and former Policy Lead of the Breakthrough Device Program at FDA. “Working with my colleagues now to achieve this milestone affirms my decision to join MCRA and help our clients develop and commercialize better treatment and diagnostic options for patients.”

Glenn Stiegman, MCRA’s senior vice president, Clinical and Regulatory Affairs added: “The Breakthrough Device Program is intended to promote new and more effective medical products for Americans who desperately need them. John’s arrival, when combined with MCRA’s broad and deep regulatory, clinical, and reimbursement expertise, has attracted clients developing a variety of cutting-edge device technologies to relieve suffering in key clinical areas such as cardiovascular, neurology, oncology, digital health, orthopedics, robotics, women’s health, urology, respiratory, wound care and more. This milestone for breakthrough device designations is one indication of MCRA’s goal to accelerate the pace of device development in all clinical areas and specifically for patients with life threatening and irreversibly debilitating conditions.”

MCRA says it looks forward to continuing to support innovation in the medical device industry by helping clients navigate novel pathways to commercialization.

Tonya Dowd, MPH, VP, head of Reimbursement, Health Economics and Market Access (RHEMA) at MCRA says: “Having breakthrough status for a device opens the potential opportunity for increased payment for facilities purchasing these breakthrough devices. MCRA’s RHEMA team has worked alongside our regulatory team to successfully achieve this parallel pathway for regulatory and reimbursement.”