2020 was a challenging year for so many around the world, and medical device and pharmaceutical companies were no exception. The needs these companies fill aren’t going away just because COVID-19 showed up. In fact, if the pandemic has taught us anything, it’s that the life-altering and life-saving therapies and products they develop are needed more than ever. In 2020, we all found ourselves trying to figure out how to develop user-centered products when the very act of talking with users and observing their work, so foundational to human factors programs, became unsafe. This is definitely not covered in any guidance or textbook.
To start the new year, we thought we’d share some of the things we learned about how to conduct rich, rigorous, and valuable human factors programs in the midst of a worldwide pandemic.
Having Your Own Lab is a Blessing
We are lucky enough to have our own usability research facility, and it’s served our clients so well over the years. In fact, we recently moved to a larger one! However, when we were designing it, none of us could have foreseen how important it would end up being for safely continuing user research activities during a pandemic. Because we had our own lab, we were able to rapidly implement a rigorous protocol to keep our staff and participants safe during study sessions, and our ability to simulate many types of complex healthcare environments remained intact. Phew!
Remote Testing is an Option
While having our own facility is a big plus, sometimes it was just not feasible to conduct user research in person during the pandemic. Maybe the user population was vulnerable, or maybe they were located in a geographic location that was difficult to access due to local travel restrictions. No matter the reason, we discovered that all was not lost in some cases. FDA has been open to “remote” studies in some cases where it makes sense, and we leveraged our previous experiences to convert some in-person user research to remote, without compromising the study objectives. We’ve even conducted simulated-use studies remotely! Nobody had to leave the safety of their home, and valuable input from users could still be obtained. A win-win!
Simulated-Use Can Get Even More Real
Traditionally, in-person user research has usually meant the moderator was in the same room as the study participants to observe. Implementing our own COVID-19 protocols for studies meant that we developed new ways to collect data in-person with the moderator observing from another room. While this approach was intended to reduce everyone’s exposure, it also revealed that participants felt less pressure from someone watching them work and led to more realistic simulations (something prized and encouraged by FDA). The end result? Better data collected and far fewer common colds amongst our moderators this year!
We at Human Factors MD feel so fortunate that we’ve been able to help our clients navigate these unprecedented and completely uncharted waters over the past ten months. The silver lining is that many of these things will continue to be relevant long after this pandemic has gone – and it can’t leave fast enough! We wish you and yours a safe, healthy, and prosperous 2021!