DescriptionFDA validation testing states that participant training should most closely match the environment and conditions in which a user will most commonly and in worst-case scenarios be required to interact with the device (Schmettow, et al., 2017). As such, in-person studies utilizing a controlled environment have been widely utilized. However, due to the COVID-19 pandemic, laboratory research has decreased in a wide range of disciplines or in instances continued with masks and many other COVID mitigations. As a result, industries such as medical device manufacturers who need to provide human factors validation to receive U.S. Food and Drug Administration (FDA) approval were impacted. Remote usability testing, while a fairly new phenomenon, affords the ability to functionally test a product within naturalistic environments that are indistinguishable from the settings in which they would be used to fulfill their purpose. However, there is not abundant published literature to support whether remote HF testing could potentially be an acceptable approach.
As such, the objective of this study was to replicate the objectives of an original in-person study, which was conducted using migraine patients who performed one unaided simulated injection using a 2-stage autoinjector. The original methodology was modified to adapt to the remote testing. This paper presents the results obtained from the complete replication of a validation protocol. The presentation will detail the lessons learned which would be helpful to practitioners.