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When conducting simulated use human factors validation testing, the U.S. FDA requires that test conditions are sufficiently realistic to represent actual conditions of use. As part of this realistic simulation, a simulated patient, also called a “study model,” may be developed or acquired specifically for human factors validation testing of the device. The authors present a recommended process for choosing or developing a study model, using examples from past surgical device studies, and they provide a sample of study model design requirements as well as a summary of study model development considerations. This paper is meant to encourage discussion amongst medical device developers, human factors practitioners, and regulatory agencies regarding the development of study models that are sufficiently realistic for human factors validation testing.

Surgical Simulation: Simulating Realistic Use in Human Factors Validation Testing Using Study Models