Veranex partnered with Rapid Acceleration of Diagnostics (RADx®) and the National Institute of Health (NIH) to help support the creation of a Best Practices guidance document for manufacturers in the design of at home diagnostic (Dx) testing. We achieved an inclusive design or universal design approach for no vision, low vision, advanced age and low dexterity users. During the development of the Best Practices, we uncovered the following learnings:
1. Engage End User Advocates
Research what you can about these populations with End User Advocacy Groups starting with their Websites, they frequently include super useful information and tools.
3. Enlist Subject Matter Experts
Learn about your end user directly from experts (aka SMEs) (these can either be people with conditions you are trying to understand (ideally) or advocates for these groups) they will teach you things you likely won’t find in secondary research.
5. Test, Test, Test
Test internally amongst the development team. For example, check your UI with accessibility tools such as screen readers to assess compatibility, check the flow and logic and content to ensure you are not relying on vision to proceed through an app. Test externally with actual every day end users who are not SMEs. Your SMEs are great but they are also experts. You want to get a sense for what will really happen when people use your device at home. Recruit 5-8 end users from each user group and have them work with your prototypes. Remember to document all your testing activities to chronicle your development usability journey. Include findings both written and pictorial, implications and how they fueled new iterations. This is key to your preparation for FDA submission.
2. Identify Challenging Steps
Look at predicate devices and create a Task Analysis to identify which steps of your design may pose a challenge for some populations / what parts are more likely to be less inclusive ( e.g. do current versions rely only on vision for feedback to communicate results?)
4. Use Empathetic Tools
Conduct your own assessment using empathetic tools like vision obscuring glasses or low dexterity gloves . These tools are not a substitute for actual user testing but they do provide some context around the use experience.
Document Summary
This document includes recommendations for manufacturers who are working to design more accessible at-home diagnostic kits. The target audience is aging populations and/or users with visual/motor disabilities, however many of the recommendations will improve the overall kit usability and likely result in universal access to the test kit.
This is an abridged version of ‘Best Practices for the Design of Accessible COVID-19 Home Tests’ and covers topics prioritized for early release. A more complete version is expected to be posted in 2023. This project has been funded in part by the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92022C00027.