Human Factors/ Usability is the analysis of how users interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. Required documentation will be explained.
This discussion conforms to the ISO 62366 standard, the FDA Guidance, and the new FDA Draft Guidance document.
The impact of the new draft guidance on the existing FDA requirements for an HF program will be discussed.
The FDA will only approve devices that are designed so that it is difficult for people to accidentally harm themselves or others even if they use the device improperly. The FDA has replaced the term “user error” with “use error”. This means that user error is considered by the FDA to be a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an “idiot-proof” product.
Handouts use a specification template, user interface evaluation template, and usability validation control form.
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.