Blended Approaches to Medical Device, IVD and Combination Product Usability Testing

A good portion of this month’s TalkingPoints newsletter is focused on how to proceed with proper human factors engineering during the COVID-19 pandemic. We have made this our focus at the risk of causing fatigue among readers already saturated with information on the topic. However, we are eager to share our latest insights on how we and others in the human factors business are coping with and overcoming limitations. These are insights we also plan to share during an upcoming webinar on the subject. We encourage you to sign-up for the free event scheduled for Thursday, July 23^rd.

Our HFR&D team is presently taking a blended approach to usability testing. That is to say, we are conducting usability tests remotely (i.e., via tools like Zoom and Teams) when appropriate and have resumed running some types of in-person usability tests, albeit with extensive precautions in place. In all cases to date, in-person testing has been for human factors validation purposes, but we are moving toward conducting other types of essential, in-person research in the near future. Notably, FDA still expects manufacturers to present human factors validation data in submissions associated with medical products that call upon users to perform critical tasks (i.e., cases in which use errors could lead to significant harm or even death).

We approach our in-person testing in the US and abroad with a keen awareness that safety rests on implementing the right risk mitigations in a vigilant manner, and this is what we are committed to doing. We stand ready to adapt our approach rapidly based on our growing experience with in-person testing during these times, changes in policy within UL and the regions in which we do our work, and the general course of the pandemic. We are driven to do this work based on the knowledge that our work is essential to our customers, who themselves are working on essential products.

 Michael Wiklund, CHFP, P.E., is General Manager of Human Factors Research & Design at Emergo by UL.