David L. West, PhD, MPH
Vice President, Medical Device Development, Quintiles Consulting
As a Vice President of Quintiles Consulting, Dr. West assists domestic and international medical device companies develop and implement strategic and regulatory plans for medical devices and combination products. Since 1994, he has been providing clients strategic and regulatory support throughout the product development and regulatory approval processes, identifying and reviewing both pre-clinical and clinical studies and offering expert assistance in the preparation of IDE, PMA, PDP, and 510(k) applications. Dr. West offers clients the benefit of 26 years of service as a commissioned officer in the U.S. Public Health Service, including 11 years in senior management positions at the Food and Drug Administration (FDA).
From 1985 to 1989, Dr. West was Associate Director, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), FDA. From 1989 to 1993 He was Deputy Director of ODE. In these two positions he was responsible for planning, managing and directing programs to ensure the safety and effectiveness of medical devices, including extensive review of IDE, PMA and 510(k) applications. During his tenure in these two positions, he exercised final FDA review and signature authority of for virtually all IDE and PMA applications, and for precedent-setting, complex or potentially controversial 510(k)s. Dr. West was a principal architect of the decision framework for FDA's evaluation and regulation of combination products of medical devices, drugs, and/or biologics and served on FDA’s first Combination Products Task Force. Dr. West earned his Ph.D. in Environmental Health (major) and Epidemiology (minor) at the University of Minnesota; his M.P.H. at the School of Public Health, University of Minnesota; and his BS in Mechanical Engineering at the University of California, Santa Barbara.
