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.
Speaking on the impact of programs like ELP, MCRA's General Manager, David Lown said, "MCRA is proud to be selected by FDA to participate in its ELP program. It confirms the value of our experience and the expertise our consultants deliver to over 500 medical device clients globally. Our hope is that FDA benefits from our shared knowledge in helping device companies identify and manage the opportunities and challenges in today's marketplace."
For more information on MCRA, please visit www.mcra.com
Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA's integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.
David W. Lown
212.583.0250 ext. 2111