Our founder, Doug Ferguson, has more than 25 years of medical device experience, working in the areas of regulatory and clinical affairs, compliance, research and development, and quality assurance. Doug has brought a wide variety of products from early development to commercialization via simple and complex regulatory/clinical pathways to gain worldwide regulatory approvals.

Doug started Metrowest Regulatory Associates in 2019 to focus on what he enjoys most, devising regulatory strategies. Metrowest Regulatory Associates assists companies in obtaining global regulatory approvals for their medical devices and combination drug-device products in the most expeditious manner possible.  

Prior to starting Metrowest Regulatory Associates, Doug held positions at Tryton Medical, Becton Dickinson and Company, Boston Scientific Corporation, and C.R. Bard, Inc. As Vice President of Regulatory, Quality, and Clinical at Tryton Medical, Inc., Doug led the company through the long and winding process to get the US approval for their US Class III bifurcation coronary stent device.  While at Boston Scientific Corporation, he spearheaded the effort to bring the company’s first drug eluting stent to worldwide markets, starting at the time of the first-in-man trial and serving as the principal liaison with the FDA and European notified body in obtaining approvals for this combination product. Doug also played a significant role in finalizing the company’s overall approach to creating global regulatory/clinical strategies, incorporating risk identification and minimization to facilitate timely approvals.

Doug holds a B.S. degree in Biomedical Engineering from the Johns Hopkins University and an M.S. degree in Biomedical Engineering from the University of Alabama at Birmingham.