Human Factors Usability Studies Following ISO 62366 and FDA Guidance

Human factors and usability engineering looks at how people interact with medical devices. This 60-minute human factors usability webinar explains how to run rigorous usability studies throughout the design process, following ISO 62366 and FDA guidance.

You'll learn how to tie human factors work into the device risk analysis and design process, which types and methods of analysis to use, and how to validate that the studies were effective. The session moves from definitions such as use scenario, task and critical task through the usability plan, use specification and usability hazard analysis.

It then covers the user interface specification and evaluation plan, analytical and empirical evaluation methods, verification and validation, and the human factors report.

• Explain the difference between user error and use error
• Identify use-related hazards and link them to device risk analysis
• Define user profiles and use scenarios
• Develop a human factors program step by step
• Choose analytical and empirical evaluation methods
• Validate usability and document results in a human factors report

• Why it matters to understand and optimize how people use technology
• Definitions: use scenario, task and critical task
• FDA guidance on applying human factors and usability engineering to medical devices
• User error vs use error
• User profiles and use scenarios
• Usability plan and use specification
• Usability hazard analysis and use-related hazards
• User interface specification and user interface evaluation plan
• Preliminary analysis and evaluations
• Evaluation methods: analytical and empirical
• Verification and validation
• Human factors report
• Templates: use specification, user interface evaluation and usability validation control matrix

FDA expects devices to be designed so that people can't easily harm themselves, even when they use the device incorrectly. FDA treats a use error as a device nonconformity rather than a human mistake, so the burden is on the designer to make the product hard to misuse, and human factors must be part of design.

The session suits development and design engineers and managers, software developers, usability engineers, risk managers, production management, QA and QC personnel, and regulatory professionals.

• 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.