Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
While the needs for and concepts around usability testing aren't new (see this 10-year old FDA guidance and 12-year old MDDI article which are both still very useful), the growing importance of IEC 60601 has led to a keener interest in usability testing.
Interestingly, usability testing isn't just for the physical medical device; labeling is getting more attention as well.
That's a good thing, too. Many new hardware components have resource allocated to optimize their usability but it is frustratingly common to see well-considered hardware undermined by poorly written/designed/conceptualized documentation.
A good starting point for information is the informative presentation Usability Testing on Medical Device Labeling [PDF]. By attracting more attention to the usability testing and its benefits, we can hope that device labeling will show similar improvements as did pharma labeling in Europe after the introduction of readability testing requirements for PILs.
Have a few more minutes? Good. Take a look at the following articles:
- Medical software ready to take on the world
- The human factor
- All you need to know about web usability
- Talk about "usability", not "quality"
ForeignExchange translates IFUs, software UIs, and training programs for medical device companies. For specialized medical translation services, contact us today!