Clinical Translation, Trials & Regulation

Human Factors & Usability

The discipline and regulatory requirement of designing and validating a device around the real capabilities, limits, and environment of its actual users, so it can be operated safely and effectively without the research team present. For BCIs this spans the setup burden (donning, calibration time), who operates it (a person with severe paralysis, a fatiguing caregiver, or an aide), error tolerance, and the consequences of use errors. Regulators require human-factors and usability engineering, often including a validation study showing that representative users perform critical tasks safely.

Usability, not raw decoding accuracy, frequently decides real-world adoption and abandonment. A system that needs daily expert recalibration, lengthy setup, or constant supervision will be abandoned regardless of its peak performance, and designing for independent, unsupervised home use is far harder than a supervised laboratory demonstration.

Also called
usability engineeringhuman factors engineering人因工程