A workaround is often a design requirement that has not been recognized yet.
By Horacio M Pace-Bedetti, PhD, Principal Human Factors Engineer
Question this answers
What do repeated user workarounds indicate in medical device design?
Repeated user workarounds signal unrecognised design requirements rather than mere non-compliance or poor training. They reveal system limitations where workflows clash with clinical reality, interfaces demand excessive effort, or information is mistimed. Human factors methods, including observation and task analysis, help identify where a medical device design inappropriately shifts the operational burden to the user.
A workaround is often a design requirement that has not been recognized yet.
I recently read an article on Medical Product Outsourcing about Human Factors and I kept thinking about a point it made about clinician workarounds. This comes up a lot in medical device development. When users invent their own method, it is easy to call it non-compliance or a training issue. But repeated workarounds signal more than just stubborn habits or poor instruction.
The better question is, what limitation is the system forcing users to overcome? The workflow might be too slow for real conditions. The interface might need too much force or coordination. Information might come at the wrong time, or the “ideal” sequence might not match how the real clinical process plays out.
That is why early access to actual use is essential. It is not enough to just review procedures or simulate steps. Direct observation and user feedback often uncover where the intended process breaks down, especially under pressure. Not every workaround reveals a design defect. Sometimes there are regulatory, safety, or technical reasons why a process cannot change. But when you see the same workaround show up across users or sites, it becomes hard evidence that needs review.
Human factors offers methods to trace the root cause. Contextual inquiry, observation, interviews, and detailed task analysis can separate individual quirks from recurring mismatches between user, task, environment, and interface.
The objective is not to eliminate variability in human behavior. Users will always vary. The engineering question is which variability the design should accommodate, and which variability the design itself is creating.
Sometimes a workaround is harmless improvisation. Sometimes it is an early warning that the design has shifted the burden to the user.