Susan W. Neadle FAAO, FBCLA
President, Combination Products Consulting Services LLC
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. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, J&J’s highest honor for excellence in Research & Development. Most recently, Susan was recognized as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence.
Susan has a consistent track record of developing and managing world-class global teams and delivering outstanding results. She has played integral leadership roles in product and process development, quality and regulatory affairs spanning the life cycle of several dozen new products, helping to open new markets, achieving market dominance both with new products and products that competed operationally. She has redefined and deployed business models and led integration of cross-functional requirements to meet disruptive health authority regulations, while ensuring maintenance of business growth momentum. She inspires research and development, technical operations, regulatory and quality professionals to develop and deliver innovative, high-quality products that consumers, health care providers and patients need and love.
Among her industry advocacy work, Susan serves as Chair of the ISPE Combination Products CoP.