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Human FactorsPractice reflection2 min read

What is this stage of testing trying to answer?

How I distinguish early learning from later validation when planning medical-device usability work.

If usability is first discussed when a product is nearly fixed, findings may affect hardware, software, instructions, and training together. Time and room for changes are limited.

In medical-device consulting, I first ask where development stands and what can still change. That helps define what this evaluation needs to answer.

Early work exposes assumptions

Sketches or prototypes can support discussion of tasks and observation of difficulties. Records should preserve what happened, the participant’s account, and uncertain causes so the team can decide what to change and examine next.

Later work needs the full use conditions

Near final validation, planning needs to return to intended users, tasks, environments, and accompanying materials. Exploratory settings cannot simply be carried over; their representativeness needs examination.

This note describes my planning approach. The specific evaluation depends on product risk, development state, and applicable requirements.

There is a step after the report

I want each finding to have someone who will discuss it, a corresponding design question, and a next check. Making that follow-up explicit helps research enter development work.

Materials to use in your own work

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