Gregory Montalbano, MIDI Medical Product Development
Designing a medical device is not a lighthearted or straightforward task. Every design choice during the development process can influence how the device is used, whether it is effective and if it has the potential to cause its user or intended patient harm.
The vast majority of medical device failures stem from use errors. While this may lead some to believe that the blame lies on the user, the fact is that use errors are frequently the result of unintuitive device design choices.
With this in mind, the FDA and its supporting standards organ…