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)