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A Note To Our Clients: Medical Device Usability Testing In The Age of COVID-19


Dear Research Colleague: We sincerely hope you and your family are safe and secure. Even though we have temporarily closed our offices in NYC, we remain fully productive in a remote capacity through our cloud-based mirror capability covering all projects and related research. This note is focused on helping our clients and professional colleagues navigate this complex and challenging time of COVID-19.

Clients Are Not Canceling Studies, But Reconfiguring To Meet New Risk Factors: Based on our direct experience and feedback from corporate research colleagues and clients, at this time, development teams are not canceling lab-based user testing studies, but are working to reconfigure studies into 3 primary categories (below is a link to our article that describes how to segment into 3 categories) based on product development priorities. Notably, today our firm has more requests for proposals (RFPs) for testing programs than prior to the onset of COVID-19 in the United States. We have also recently executed a complex lab-based usability study within the time of COVID-19 in NYC. Times have changed, but critical user testing will continue under a new set of risk mitigation standard operating procedures (SOPs) and utilization of only the most experienced user research teams. The following is a shortlist of 4 key steps we recommend for starting the process of dealing with user testing in the age of COVID-19.

Step 1: Segment Your User Study Pipeline Into 3 Categories: Your team should immediately review all planned user studies and segment them into 1 of 3 categories. We recently published an article describing how to proceed with such segmentation. The article describes segmentation and user testing reconfiguration in the context of medical device user testing; however, the same approaches can be applied to user testing for products, websites, or systems of any kind. Please feel free to send us questions based on that publication.

Step 2: Begin Updating Your User Testing SOPs Immediately: We highly recommend that all product development teams immediately update their SOPs to accommodate user testing in the age of COVID-19. There is no future for user testing without improved planning and risk mitigation processes. It is also important to generate a robust vendor selection criteria checklist to confirm that your user testing partners have in place updated risk mitigation SOPs as well. For those teams undertaking this process remotely, our team has found SLACK to be especially helpful in combination with the Google Docs collaboration framework. We also utilize an online database created using FileMaker Pro. Please feel free to send us questions based on this recommendation.

Step 3: Move Formative Studies to Professional HFE Heuristics Analysis: Today, we are working with our clients to help them replace lab-based formative research with professional heuristics analysis, a service for which we are well known. Professional heuristics analysis involves highly experienced human factors engineering (HFE) experts auditing a physical product, website, system, etc., for usability issues based on a validated HFE audit structure. Early and aggressive use of professional HFE heuristics analysis can identify HFE problems prior to user testing, which can significantly reduce HFE formative testing costs. We are also helping our colleagues and clients reconfigure lab-based user testing studies already in the pipeline based on the application of our SOPs for risk mitigation. This work includes collaboration with our IRB sites and testing facility vendors, who are also undertaking major updates of their SOPs. There are many moving parts to proceeding with lab-based HFE research in the age of COVID-19. Please feel free to send us questions based on this recommendation.

Step 4: Rethink How HFE Science Is Integrated Into Development Programs: Our clients tell us that this is a time to analyze how studies are executed and to determine if other methods, such as HFE heuristics and/or robust online data capture, can supplant early formative studies. It is clear, based on the execution of hundreds of usability testing studies over the past 30 years, that MANY usability problems with products, websites, systems, etc. uncovered in formative studies could have been identified and eliminated through early and aggressive use of HFE heuristics analysis. In a surprising way, a benefit of this very difficult time may be an improvement in how HFE science is utilized to improve usability AND reduce development costs. Please feel free to send us questions based on this recommendation.

Be safe and secure. We are all hoping for the best, but planning for less.

Charles L. Mauro CHFP


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