Human Factors Usability Studies Following ISO 62366 and FDA Guidance

This training program will examine how human factors/usability is the analysis of how people 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. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

• User error versus use error
• Use related hazards and risk analysis
• User profiles
• Use scenarios
• Step-by-step human factors program development
• Validation
• Use specification template
• User interface evaluation template
• Usability validation control matrix form

• The need for understanding and optimizing how people use and interact with technology
• Definitions: Use scenario, task, critical task
• Latest FDA Guidance on applying human factors and usability engineering to medical devices
• Usability plan
• Use specification
• Usability hazard analysis
• Use-related hazards
• User interface specification
• User interface evaluation plan
• Preliminary analysis and evaluations
• Evaluation methods
• Analytical methods
• Empirical methods
• Verification and validation
• Human factors report

The FDA will only approve devices designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term “user error” with “user error,” which means that it’s how the product is used and not a human error that is considered by the FDA to be a device nonconformity. As a result, human factors should be considered in the design process, and the burden is now on the device designer to create an “idiot-proof” product.

Human Factors Usability Testing is the analysis of how people interact with medical devices. This session will explain 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. The various types and methods of human factors analysis will also be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

• Development Engineers
• Production Management
• QA/QC Personnel
• Software Developers
• Usability engineers
• Risk managers
• Design Engineering Managers
• Engineer
• Engineer Management
• Quality assurance
• Regulatory Professionals

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.