MedTech Safety
Bio
Susan W. Neadle, MS, BS, FRAPS, FAAO, is a recognized international authority in combination products, medical devices and digital health, with over 35 years of industry experience. After retiring from a distinguished 26-year career at Johnson & Johnson in strategic and technical roles, she founded Combination Products Consulting Services LLC, where she leverages her extensive expertise to provide strategy, quality, regulatory affairs, and technical design excellence services to the bio/pharma, biotech and medical device industries.
Susan chairs the AAMI Combination Products Steering Committee and plays leading roles in numerous industry-working groups, including Combination Products Coalition, ISPE, TOPRA, AFDO/RAPS and MediPhorum. She is also a respected educator, teaching combination products, integrated risk management, and quality system curricula through her consulting business and at UMBC, AAMI, and DIA, among others. Her significant contributions to the industry have earned her several prestigious awards, including Fellowships in the Regulatory Affairs Professional Society and American Academy of Optometry, 2022 ISPE Joseph X. Philips Professional Achievement Award, 2021 TOPRA Finalist in the Futures category for Regulatory Excellence, and the Johnson Medal for Research & Development Excellence from Johnson & Johnson.
In 2023, Susan published “The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems,” through Taylor & Francis/ CRC Press. This comprehensive guide provides helpful information and best practices on combination product lifecycle from pre-market development and regulatory pathways, through post-market, making it an essential resource for professionals in the field.
Through her consultancy and active participation across industry forums, presentations and workshops at numerous venues, and authorship of chapters, books, whitepapers, and technical standards, Susan continues to advance the field, driving innovation and leading critical conversations in the industry.