Quality and Regulatory Affairs Advisor
Don has over 25 years of experience in the medical device industry. He has held high level positions in Operations, Design & Development, Quality and Regulatory Affairs. Don started his medical career in the infusion device business with McGaw where he managed software development and Quality Assurance. He then held positions of Vice President of Regulatory Affairs and Quality Assurance with startup companies Bridge Medical, CardioNet, Mission Medical, Alveolus, Tandem Diabetes Care and most recently, Ivera Medical which was sold to 3M in March 2015. For these startup companies, Don has worked with executive management and Boards of Directors to establish and execute the regulatory strategy required to increase valuation. Don prepared submissions and worked with FDA to gain clearance of IV disinfection devices, Non-vascular stents, Cardiac monitoring devices, Insulin Pumps and disposables, large volume infusion pumps, irrigation pumps, infiltration pumps, and syringe pumps. Don spent 10 years in the medical device contact design and manufacturing services business as VP GM with MedSource and Flextronics Medical where he worked directly with high profile medical device customers, design teams and Operations sites to bring many types of new medical devices device to market. Don has a BS degree in Biomedical Engineering from Texas A&M University and is an active member of the Biomedical Engineering academic advisory Board.