When COVID-19 hit and the lockdown occurred, there was an almost immediate economic recession triggered in our industry that trickled down from hospitals to medical device suppliers. While our primary work at Medi-Vantage is to help medical device, diagnostics, digital health, and drug-delivery companies with strategy research, we also heard from several clients about human factors research they had planned with us. One client had been planning to start summative usability testing two weeks after the lockdown. He called to explore options since he was due to submit his 510(k) package to FDA.

Medical Device Usability Testing Still Needs to Be Done During the Pandemic

In the COVID-19 age, medical device development teams must continue to use robust processes to maintain their product development deadlines and this includes human factors usability testing. Most usability testing will ultimately continue, but under a different set of processes, unless your device falls into the category that can utilize online usability testing.

Below, we share our process for human factors usability testing in the era of COVID-19. If it is unclear which category fits your medical device, call us to discuss the specifics. At Medi-Vantage, we have performed human factors usability testing for a variety of medical devices and understand that not all products can fit into an online process.

Healthcare Providers Want an Alternative to F2F Usability Testing

Healthcare providers, one of the most important resources we have in medical device usability testing, have seen the agony caused by COVID-19, and most will not risk further exposure by participation in face-to-face testing at usability testing facilities. No one, including me, wants to go to a usability testing facility in person and risk being infected. In the early days of COVID-19, Medi-Vantage didn’t want to stop innovating and delay getting new products to the patients that need them. The way I saw it, in March 2020, we had three options for continuing human factors usability testing. 

After some creative thinking about how usability testing is done, Medi-Vantage developed Option 3.  One of the fundamental requirements of medical device usability testing is the ability to video the end-user using the product, without showing that end-user’s face or other distinguishing characteristics. We knew we could get the technology to work for us, and we decided to pivot to online usability testing.

While researching options for our client, we performed multiple online searches to see how other usability testing companies were coping with the restrictions of the pandemic. We learned that many were not doing usability testing online, since the audio and video recording requirement could not be met appropriately. Audio and video recording is an absolute requirement to see and consistently monitor the errors and successes of end-users, to complete the entire human factors process.  We needed to come up with a pivoting strategy, so that we could make clients happy to move forward with their timelines, make end-users happy so they didn’t have to come in person to  a usability testing facility and risk infection, and, importantly, ensure that FDA would get the results it needed and the high quality of work expected.

New Intellectual Property

Medi-Vantage created a new IP to address all the concerns about the testing requirements needed and the logistical challenges that we found along the way. We use web tools to make it work.

There Are Two Categories of Medical Devices When Considering Online Usability Testing

Not all medical devices fit the online usability testing methodology.  As a company with extensive, demonstrated experience in human factors usability testing, Medi-Vantage has developed a robust process to identify which products to recommend for online testing in the age of COVID-19.  Our goal is risk mitigation, in terms of study execution.

Many types of medical device and non-medical device studies can migrate to online usability testing. These methods can provide the insights needed to accurately link critical use errors to their root causes. Online usability testing enables end-users to assess products from their homes, while communicating with researchers. When using the Medi-Vantage methodology, usability researchers can see exactly what end-users are doing with full video capture of their interactions with the device. Examples are:

This methodology provides an opportunity for medical device development teams to develop a deeper awareness of testing methods outside of usability lab-based testing. Many human factors challenges encountered in contextual inquiry, formative, and summative studies can be mitigated early in device development by researching early-stage medical device concepts currently in progress and work with human factors professionals to adopt from a tool kit of  new testing methodologies. This reduces your company product development cycles and reduce expenditures that can often occur with late-stage user testing.

The Brave New World of Medical Device Human Factors Usability Testing

We have all had to change our lifestyles and strategies in the face of the pandemic. In human factors, this can only happen with significant expertise to increase medical device safety, avoid product development delays, and reduce user testing costs.