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Legal & Regulatory Feature

Courtesy of Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)

MCRA: Training FDA About Real-World Device Experience

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, November 17th, 2017

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Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is trying to clear things up when it comes to industry, device costs, and innovation. The group announced that it has recently delivered the second of three training workshops for the U.S. Food and Drug Administration (FDA).

According to the folks at MCRA, “This workshop was focused on innovation, and the complexities involved due to the many stakeholders and the milestones required for value creation.”

“The Experiential Learning Program (ELP) is a learning opportunity designed to help all levels of FDA within the Center for Devices and Radiological Health (CDRH) to better understand real-world experience as it relates to the design, manufacture and commercialization of medical devices.”

“It aims to collaboratively explore device technology and obtain the necessary knowledge to enhance the review process and support communication between sponsors and the CDRH review staff. MCRA has been selected to deliver three ELP workshops on clinical development, medical device innovation and reimbursement in the medical device industry.”

“At the most recent ELP workshop on innovation, MCRA's experts shared insights and case studies on key topics impacting the medical device industry today, specifically taking into account the substantial size of the device industry and the increasing concerns of rising healthcare costs, the Centers for Medicare and Medicaid Services (CMS), the U.S. FDA, and numerous other governmental and private stakeholders that all have a seat at the table in influencing whether industry has proved safety, efficacy, and cost effectiveness over existing treatments.”

“MCRA also discussed the rise of clinical evidence requirements on most technologies, both new and existing, and the increasing investment required for successful commercialization, which is putting additional strain on both companies and investors.”

MCRA General Manager David Lown told OTW, “MCRA was honored to educate the FDA on the viewpoints of industry and the consulting world on innovation. The FDA was very impressive in their desire to understand the dynamics outside of their day-to-day activities, and as well as in elucidating the FDA programs that have been enacted towards assisting the innovation process. I believe the market is moving towards all stakeholders needing to work together for the purposes of defining innovation and determining how to bring it to market. I think the FDA is one constituent that is ready to take on that challenge.”

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