Human factors analysis studies perception, cognition, and behavior in product use, identifying foreseeable errors and designing to prevent them. Medical device regulations require usability engineering.
It informs both design and warning adequacy.
Alternative Names:
Human Factors Engineering, Usability Analysis
Why it Matters?
The discipline's core principle is that foreseeable use error is a design problem rather than user fault, which is the framing plaintiffs adopt and which manufacturers should anticipate. Designing out the error condition is preferred over warning against it in the recognized hazard control hierarchy, and that hierarchy is used against manufacturers who chose a warning over a design fix. Documented usability testing supports the defense where it addressed the error at issue.
Frequently Confused with
Related terms
Frequently asked questions
What is the hazard control hierarchy?
How does the discipline treat use error?
