MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA


  • MCRA has assisted its Clients in obtaining over 60 breakthrough device designations in the last 2 years, which is about 20% of all such designations granted by the Food and Drug Administration during this time period.

WASHINGTON, June 22, 2022 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, and Quality Assurance support is excited to announce its role in the successful granting of over 60 breakthrough device designations by the Food and Drug Administration.

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 While Medicare Coverage for Innovative Technologies (MCIT) was repealed late last year, there are still several benefits only breakthrough technologies are eligible for on the payment side, including the New Technology Add on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

John Doucet, PhD., Vice President, Regulatory Affairs at MCRA and former Policy Lead of the Breakthrough Device Program at FDA said, "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. 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 said "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."

Tonya Dowd, MPH, Vice President, Head of Reimbursement, Health Economics and Market Access (RHEMA) at MCRA said, "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."

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

About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and served nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices and medical device cybersecurity. 

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB) founded MCRA in 2004. VB is headquartered in New York City and specializes in merchant banking activities for the neuromusculoskeletal industry as a full life cycle investor, investing in all stages in companies from inception through growth. VB is dedicated to financing healthcare innovation globally. 

For more information, please contact:

Alyssa Howard
Vice President, Business Development
Phone: 215.870.3952