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Molly Folelette Story, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.