Our guest is Mr. Korey Johnson (https://www.linkedin.com/in/koreyrjohnson/), Managing Partner at Bold Insight (https://boldinsight.com/), which is a consulting company focusing on User Experience and Human Factors research. The interview was recorded on Dec 15, 2023.

Further Reading/watching:

International Electrotechnical Commission (IEC). IEC 62366-1 Medical devices – Part 1: Application of usability engineering to medical devices. Geneva, CH; 2015. Available from: https://www.iso.org/standard/63179.html

International Electrotechnical Commission (IEC). IEC 62366-2 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices. Geneva, CH; 2016. Available from: https://www.iso.org/standard/69126.html

U.S. Food and Drug Administration (FDA): Center for Devices and Radiological Health. Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff. 2016. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

U.S. Food and Drug Administration. FDA; 2023[Office of the Commissioner. Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/application-human-factors-engineering-principles-combination-products-questions-and-answers

American National Standards Institute. ANSI/AAMI HE 75:20 09 (r2018). 2018. Report No.: 75. Available from: https://webstore.ansi.org/standards/aami/ansiaamihe752009r2018?gad_source=1

Lew G, Schumacher RM Jr. AI and UX: Why Artificial Intelligence Needs User Experience. 1st ed. Apress; 2020. Available from: https://www.amazon.com/AI-UX-Artificial-Intelligence-Experience/dp/148425774X/

U.S. Food and Drug Administration (FDA) Center for Devices, Radiological Health. Digital Health Software Precertification (Pre-Cert) Pilot Program. 2023 May. Available from: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program