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This isn’t necessarily our fault; in fact the FDA doesn’t require great user experience, and IEC 62366 requires only “reasonable usability” which means that the regulatory requirement to systematically minimise use errors can quite easily dominate our focus. Furthermore, condensed and unrealistic project timelines can also impair our ability to create great user and patient experiences. The unfortunate result of such imposing dominance is that we design medical devices that are extremely safe but unfriendly to use, and in crowded markets this can deleteriously impact commercial success.
Stephen B. Wilcox picked up on this theme during the 2013 Human Factors and Ergonomics Society (HFES) Symposium on Healthcare and posted about how, David Barash, of GE Healthcare, pointed out the irony that all the device alarm systems in an Intensive Care Unit (ICU) have been granted FDA approval and CE Marks, but they are still just awful; the vast majority of alarms are false, the alarms are unrelated to each other, so multiple alarms can quickly create chaos, and users are given poor information about what to do. In other words, we are meeting all the regulatory rules, but the result is still terrible usability and an unpleasant environment. To read the full article go here.
Re-addressing the balance between the regulated and unregulated components of medical device usability engineering is important, especially as medical devices move out of the controlled hospital environment, where they’re used by professional caregivers; to the uncontrolled home environment, where they’re used by patients and lay caregivers. After all, poor user and patient experiences can add to users’ workloads, leading to frustration and increasing the probability of potentially harmful use errors occurring. Therefore, creating great user and patient experiences and meeting the regulatory requirement are intertwined and should go hand-in-hand. Considering both components equally calls for a process-driven approach that is inherently human-centred and has an emphasis on risk management. This will achieve a level of intrinsic device usability that not only minimises the potential for harmful use errors but establishes appeal and ease-of-use, naturally leading to successful submissions and commercial success.