With regard to usability testing practices for medical device manufacturers seeking FDA clearance, not much will change in 2021 until the COVID-19 vaccination rates reach levels that make study participants and researchers feel confident enough to participate in human factors validation research studies. For now, most companies continue to postpone efforts to prepare pre-market submissions for FDA review because they can’t complete the face-to-face usability testing required as part of the submission package.
While most usability research companies are not conducting face-to-face usability studies, there are exceptions, my company being one. We ran a number of safe, successful formative and summative usability studies in an Atlanta-based market research company that provides a fully CDC (Centers for Disease Control and Prevention) compliant facility with all safety protocols in place. The company not only provided a safe space for researchers and participants to engage in usability studies, but it also was successful in recruiting the study participants from its panel.
They accomplished this by conducting regular surveys of their panel to inform them of their safety protocols and determine the comfort level of the panel in participating in face-to-face one-on-one research studies A trend in 2021 is that a increasing number of market research companies are putting safety protocols in place in a growing number of cities throughout the U.S. and in Europe.
Because the pandemic has gone on much longer than was originally anticipated by many companies and because research companies are likely to continue to retrofit their facilities to provide the proper safety protocols, more device manufacturers and developers are likely to proceed with usability testing studies, cautiously and under the appropriate protocols.
Another change to the way medical device usability testing has been impacted by COVID-19 and will very likely continue into 2021 is the implementation of remote training on the use of the device prior to usability testing. FDA guidelines indicate that any training required to use a medical device needs to match the actual training planned for the device. With medical device manufacturers having to switch to remote in-person training, accompanied by demonstration videos, in their current practice, the ability to match this same context of training in advance of usability testing is becoming more prevalent and is likely to continue.
UX Firm has conducted several studies in 2020 in which the client could not travel from Europe to be present to observe usability testing and also could not provide face-to-face training, as originally planned. Instead, remote observation was set up via Zoom conference software and remote training was conducted by the client via Zoom for each participant individually. This change in training delivery is likely to accelerate in 2021.