Susan is Principal Consultant/ Owner of Combination Products Consulting Services, LLC. She has over 30 years of experience in the medical device/pharmaceutical/biotechnology industry. Susan partners with industry, applying her extensive Design-to-Value, Design & Process Excellence and Program Management skills, coupled with her combination products, medical devices, IVD and digital health expertise, to enhance the effectiveness, efficiency and consistency of medical product lifecycle management from development, submission and review through post market, in a dynamic global regulatory environment. She holds numerous patents and publications, and frequently speaks in public venues.