With approximately 20 years of experience in orthopedics, medical devices, combination products, and regulatory affairs, Dr. Kevin B. McGowan is a Senior Director of Regulatory Affairs at MCRA. At MCRA, he leads strategy and FDA interactions for numerous novel medical devices, combination products, and biologics, including devices that create biological products, recombinant proteins for bone repair, human cell and tissue products (HCT/P), adhesion barriers, and cellular products.
Dr. McGowan specializes in FDA interactions and strategy, development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices, biologics, and combination products, specializing in novel products that require clinical data.
Dr. McGowan received his doctorate from the University of California - San Diego in Bioengineering with a research focus on cartilage repair and extracellular matrix metabolism. He also received a Bachelor of Science in Engineering from Duke University with a major in Biomedical Engineering.
Prior to joining MCRA in August 2008, Dr. McGowan worked in orthopedic and medical device research, specializing in developing biological strategies to treat both traumatic injuries and degenerative joint diseases in the knee. Throughout his professional career, Dr. McGowan has authored numerous peer-reviewed articles, abstracts, and book chapters on US regulatory processes and strategy, cartilage repair, and clinical trial processes.
Dr. McGowan leads MCRA's biologic, human cell and tissue, and combination product US regulatory affairs team, as well as contributing to MCRA's orthopedic and spine regulatory groups. Dr. McGowan's work at MCRA focuses primarily on novel technologies and therapeutics for which clinical data is necessary.