Why is there a lack of sophisticated UX, usability, and UI discipline in the current design of safety-critical apps and devices?
A friend of mine, a User Interaction (UI)/User Experience (UX) designer and a usability expert that is doing some work at a technology-based medical device client, wrote to me wondering why many medical device companies don’t have much of a UX/UI and usability focused discipline in their marketing and product design teams. The simple reason is that many device manufacturers are still following top-down monolithic processes like waterfall instead of more agile processes that allow feedback-driven requirements definition. Requirements engineering is a formal process in a safety-critical design world inhabited by device manufacturers and locking down of requirements early, which is the antithesis of usability-centered design that thrives on feedback, happens to be the norm.
My friend continued the thread and asked how we can convince device vendors that UI/UX/usability is something worth investing in and I mentioned these reasons:
- Good UI/UX discipline should create safer products with lower risk
- Good UI/UX discipline is required for next generation FDA clearances (see links below)
- Good UI/UX discipline creates more functional products that deliver on actual end user requirements instead of perceived requirements
- Good UI/UX discipline creates a more traceable set of artifacts to specific requirements
- Good UI/UX discipline creates better usability which ties to improved usage which means more products sold
Here are some good FDA presentations to reference:
- The FDA Perspective on Human Factors in Medical Device Software Development (1)
- The FDA Perspective on Human Factors in Medical Device Software Development (2)
- Join me next week for a free webinar where I answer “How do we get beyond Meaningful Use rhetoric and ‘disruption in healthcare’ bloviation and into actionable innovation?”
- Join me at the fifth annual Medical Device Connectivity Conference Nov 21-22 in DC (discount ends Monday)
- Writing safety critical software using an agile, risk-based, approach should be the norm in modern medical device development
Shahid N. Shah
Shahid Shah is an internationally recognized enterprise software guru that specializes in digital health with an emphasis on e-health, EHR/EMR, big data, iOT, data interoperability, med device connectivity, and bioinformatics.