2022 - Human Factors Usability Studies Following ISO 62366 and FDA Guidance

OVERVIEW
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.
WHY SHOULD YOU ATTEND?
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.
AREA COVERED
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
LEARNING OBJECTIVES
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
WHO WILL BENEFIT?
Development Engineers
Production Management
QA/QC Personnel
Software Developers
Usability engineers
Risk managers
Design Engineering Managers
Engineer
Engineer management
Quality assurance
Regulatory Professionals
SPEAKER PROFILE
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.
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