The systematic process, defined in IEC 62366-1, for analyzing, specifying, designing, verifying, and validating the usability of a medical device to minimize use-related risk.

Definition

Usability engineering, also called human factors engineering, is the process standard IEC 62366-1 defines for identifying user interface characteristics related to safety, identifying and evaluating hazard-related use scenarios, and applying verification and validation activities to ensure a device can be used safely and effectively by its intended users, uses, and use environments. The process integrates with ISO 14971 risk management: use errors that could lead to a hazardous situation are analyzed, design mitigations are applied to the user interface, and formative evaluations (iterative, exploratory testing during design) precede a final summative (validation) usability evaluation conducted under simulated or actual conditions of use before market release.

Why it matters

FDA's human factors guidance, applicable to devices FDA has flagged as needing human factors data (including many combination products, infusion pumps, and other devices where use error could cause serious harm), expects a summative usability study with a representative user population, defined critical tasks, and root-cause analysis of any use errors or close calls observed. IEC 62366-1:2015 plus its Amendment 1:2020 is the internationally recognized and FDA-recognized consensus standard; IEC/TR 62366-2 provides non-mandatory guidance on applying the process.

Common pitfalls

•Conducting only formative usability testing and skipping a rigorous summative (validation) study before submission, when the device involves tasks FDA or a notified body considers safety-critical.
•Defining critical tasks too narrowly, omitting steps where a use error, though less obviously safety-related, could still lead to a hazardous situation under IEC 62366-1's use-related risk analysis.
•Treating usability engineering as a labeling and instructions-for-use exercise rather than a design-input activity that should influence the user interface from early development.

Sources

IEC 62366-1:2015+AMD1:2020 · IEC
FDA, Applying Human Factors and Usability Engineering to Medical Devices (2016) · FDA
AAMI Standards · AAMI

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