Understanding physical limits of users
By Horacio M Pace-Bedetti, PhD, Principal Human Factors Engineer
Question this answers
Why should user physical capabilities be considered early in medical device design?
Medical device design must incorporate users' physical capabilities, such as force limits, vision, hearing, and component manipulation, especially for home-use products. Designing based solely on technical aspects risks failing user needs. Understanding these realistic physical constraints upfront ensures usability actively drives design choices rather than merely justifying decisions after the fact.
I’ve been working in the medical device industry for over a decade, across various device types and sectors. Despite years of regulatory emphasis on understanding users and their use environments, I still encounter many companies making decisions without considering the end users’ capabilities. They seem to believe that technical aspects alone can dictate product design and functionality.
This is particularly concerning for devices intended for home use by non-medical professionals. Without a thorough understanding of the users, their realistic force capabilities, visual and auditory abilities, and their ability to manipulate components under real-world conditions, it becomes impossible to design a system that truly meets their needs.
When decisions are not made with the right information upfront, usability becomes a mere tool to justify decisions rather than a driving force in creating the right design.
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