Human Factors Engineering
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.What this means in practice
FDA expects a Human Factors Validation Study for devices with use-related risks. Findings can drive labeling, training, and design changes.Use cases
1 scenarioAuto-injector for at-home use
Human factors engineerThe team performs formative studies with caregivers and patients, identifies confusion around the safety cap, redesigns it, then runs a validation study with 15 users per use group per IEC 62366-1 and FDA HF guidance.
Cross-references
See also
Related terms
Shared paths + categoryApplication of usability engineering to medical devices.
User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.
International standard for the application of risk management to medical devices.
Defined description of intended users, uses, use environments, and patient populations for a device.
All written, printed, or graphic matter on or accompanying a device.
Pre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk.
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Primary references
3 sources- 1FDA Human Factors GuidanceVerifiedFDAfda.gov
- 2ClinicalTrials.govVerifiedNIHclinicaltrials.gov
- 3ICH GuidelinesVerifiedICHich.org
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