Is Remote Human Factors Testing an Acceptable Approach for Human Factors Validation

Human factors (HF) validation of medical devices is vital for approval use by the Food and Drug Administration (FDA). Historically, testing has taken place within laboratory-controlled environments where conditions are controlled, executed in accordance with similar circumstance. Due to COVID-19 pandemic, laboratory research decreased a wide range disciplines or instances continued masks many other COVID mitigations. As result, device manufacturers who need provide human receive U.S. (FDA) were impacted. Remote usability testing, while fairly new phenomenon physical devices, affords ability functionally test product naturalistic that indistinguishable from settings which they would be used (e.g. user’s home). However, published literature support whether remote HF could potentially an acceptable approach rare. The objective this study replicate objectives structure original in-person study, was conducted using migraine patients performed one unaided simulated injection 2-step autoinjector. methodology been modified adapt testing. This paper reports procedures developed ongoing endeavor.