Clinical & Trials
Human Factors Engineering(HFE)
In one line
Engineering discipline focused on safe and effective device use by intended users.
Definition
Human Factors Engineering (also called Usability Engineering) applies knowledge of human behavior, abilities, and limitations to the design of medical devices to ensure safe and effective use by intended users in intended use environments.
FDA's 2016 guidance on applying human factors and usability engineering expects manufacturers to identify critical tasks, design out use-related hazards, and run a summative (validation) test with representative users in realistic conditions. Results feed the risk file under ISO 14971 and the usability engineering file under IEC 62366-1, and human factors data is expected in many 510(k), De Novo and PMA submissions.
Why it matters
FDA expects a Human Factors Validation Study for devices with use-related risks. Findings can drive labeling, training, and design changes.
Common pitfalls
- •Treating human factors validation as a satisfaction survey. It evaluates safe and effective performance of critical tasks, not just whether users like the device.
- •Relying on warnings or training instead of addressing avoidable interface hazards. Design changes should be considered before relying on users to remember instructions.
- •Testing only with employees or experienced clinicians in ideal conditions. Participants and conditions should represent intended users, including lay users where applicable, and intended use environments.
Sources
- FDA Human Factors Guidance · FDA
- ClinicalTrials.gov · NIH
- ICH Guidelines · ICH