March 10, 2023

Human Factors Data from Animal Studies

First, as a general rule, my understanding is that the HF Category is intrinsically governed by the nature of the subject device and its intended use rather than the HF study method or results.  For example, HF Category 2 devices are expected by the U.S. FDA to involve no user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.

In general for assessing the usability of a subject device, there could be a variety of user interface test-usage paradigms (e.g., use on humans, use on animals, or even on the bench) that could be sufficient as long as the chosen paradigm is representative of how the user interacts with the user interface.  For example, testing a user’s interaction with an electrosurgical generator and handpiece by having the user use the devices on animal tissue could be an adequate way to assess the usability as long as the testing gives appropriate consideration to relevant human factors like user characteristics, capabilities, needs, expectations, cognition, preferences, real-world demands, etc., etc.