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:


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2 thoughts on “Why is there a lack of sophisticated UX, usability, and UI discipline in the current design of safety-critical apps and devices?

  1. I think there are several problems that cause device makers and software developers to ignore usability issues. Among these are:

    o Cost. Vendors see efforts to build usability in as an add on that users aren’t demanding.

    o Closed Development. Development teams are often closed affairs that make little or no effort to incorporate knowledgeable users in or to give them a meaningful place at the table,

    o Design Fit. Corporations have spent great amounts to develop their systems, which have their own look and feel. A new device or app has to fit in, even if it continues a poor interface.

    o Requirements analysis and usability design are seen as soft skills and not on the same level with “harder” skills.

    This is not to say your friend is wrong, but to say that there are many obstacles to overcome.

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