Redefining “In-Person” Research in the Midst of a Global Pandemic

Redefining “In-Person” Research in the Midst of a Global Pandemic

Learnings, Considerations, and Opportunities

By Pati Anderson

When the stay-at-home orders were first implemented in the Philadelphia region, we at Core, like many others, had a lot of questions about what our future would look like and how we could keep providing our services to the medical device community. Not long after, we got confirmation from our governor that we were considered an essential business and could continue our research efforts. Having the permission to continue our work was only the first step on a long road back to running studies at our full capacity around the world - a road we are still navigating.

At Core, our business goal is to help further medical device development and help our clients create usable Products that can come to market. We strongly believe that hitting “pause” on medical innovation is a damaging and even dangerous choice. Nevertheless, we make the safety of our participants, staff, and clients a priority that we are not willing to compromise on. This leaves the question of - how can we conduct usability research that is traditionally done face-to-face, during a pandemic, particularly when some of our studies require working with participants who may have conditions that put them at risk of developing serious complications should they contract COVID-19?

We’ve developed, tested, and implemented multiple solutions.

In-person, socially-distanced sessions (“study behind the glass”)

The most common method we are currently using involves implementing some rather extensive cleaning and social distancing measures in our usability labs.

In some ways these sessions are the same as our usability sessions have always been - a participant comes into the office, a moderator greets them and guides them through the session, the participant interacts with the study product in a simulated environment, and the moderator observes the participant complete tasks and asks them questions.

In other ways these sessions feel very different from research we have done in the past - all interactions are through a monitor with the participant in one room and the moderator in another (behind the lab’s one-way mirror), the participant does not see another person face-to-face while in our office, sessions are spaced apart to allow for cleaning and more involved set-ups between sessions, and common touch-points across participants are reduced.

At-home sessions (“study in a box”)

The second method we are using involves packing up study Product and mailing it to participant’s homes. The product is kept secure and returned to the study sponsor after the session is complete. This option is ideal for studies where the intended use environment is the user's home, but a few simple “study environment” items included in the package could open up the door to other project possibilities as well. For example, a sterile drape, some gloves, and a set of instructions for the participant to clear away an appropriate space in their home could satisfy your requirements for simulating a clinical environment.

The moderators for this type of study call the participant through a video-call, and observe all the tasks through the participant’s webcam or phone. The entire session involves “in person,” albeit virtual, interactions between the moderator and the participant where observations and data collection is done real-time and live.

Remote sessions (“study with another buddy”)

Although travel is difficult during this time, sometimes the project needs are such that another city apart from our home-office is needed. In that situation, we have experience with reserving lab space in other cities (and even countries!) and having a staff member of that facility set up the room and cameras for the study. Once the room is set up, moderators call into the session and conduct the session from afar. From the participant’s perspective, it feels no different than “study behind the glass,” but from our perspective there are more logistics required. No one said this was supposed to be easy!

Mobile office sessions (“study in a van”)

What happens if the user group involves particularly at-risk populations? Or if for other reasons participants are uncomfortable with coming into our office? The mobile office option involves a Core-owned vehicle that is outfitted as a usability lab. We drive the vehicle to participants, park it in their driveway, have them step into the back (which is set up as a simulated environment appropriate for the study product we’re working on), complete the session, and then we drive away. It’s like a taco truck but better!

Non- “in person” study options

It would be remiss for me to not mention the multitude of other research opportunities that do not involve in-person interactions. These options were available before the pandemic, but perhaps now is a perfect time to consider whether your project could benefit from these types of studies in the coming months. A lot can be assessed online through surveys - preference between two products, preference between design concepts of one product, user perspectives on adoptability of products or acceptability of new features. You can test training materials online or through phone interviews by sending participants a video ahead of time and collecting feedback afterwards. Consider taking this opportunity to design and develop your IFUs. And of course analytical research (e.g., risk analysis, expert reviews, cognitive walk-throughs) is a huge part of the design process and much of it can be done during work-from-home situations.

Core is committed to continuing to provide high quality human factors research for the medical device community. By developing safe study designs and working to customize research to fit our clients needs, we stand by our mission “to apply a human touch to all aspects of user research.” We are excited to continue working on novel solutions to meet the needs of our clients and participants in these uncertain times. Contact us on our website to discuss our research options.