Lisa Simone Email & Phone Number

Lisa joined FDA in 2010 to provide software and biomedical expertise for regulatory guidance, regulatory submissions and software policy. She's since expanded her focus to include emergency response activities and has been an incident response lead for COVID medical device shortages and Ethylene Oxide Sterilization. Focus areas include analyses medical device sterilization, incident response, characterizing software recalls, adverse events and medical device failures; policy development to assess device software using risk-based approaches (software-only/SaMDs and traditional medical devices); guidance for cybersecurity, mobile medical apps, design considerations for home use, and risk management; and process improvement initiatives for premarket review of software and instrumentation. She is also Co-chair for the development of AAMI's SW91 standard, "Classification of Defects in Health Software."Prior to joining FDA, Lisa held various leadership roles in industry, non-profit and academia in several fields including medical device design, mobile communications, industrial automation and rehabilitation. She designed products and led international teams from pure research and product concept through delivery, revived a failed product line, managed value engineering for three medical device subsidiaries, published a technical mysteries book, received state and federal funding for rehabilitation and wearable systems, and developed and taught university engineering design courses. The Wharton School and University of Pennsylvania's School of Engineering and Applied Sciences (Executive Masters in Technology Management)Rutgers University (PhD and MS in Biomedical Engineering; BS in Electrical Engineering)She enjoys scuba diving, underwater photography and trail running.

Listed skills include Medical Devices, Fda, Biomedical Engineering, Cross Functional Team Leadership, and 23 others.