“Only a few years ago, human factors was a discipline virtually ignored in the medical device world. Device design was a field dominated by engineers, and their main concern was whether the device functioned properly or not. How easy it was to use, how well it fit into a caregiver’s workflow, and whether the design contained the potential to prompt use errors were factors considered secondarily, if at all.
But that is changing. More device companies are incorporating principles of human factors and ergonomics into their designs. Some are hiring human factors experts for their staffs, while others are using consultants. More devices go through some form of usability testing before hitting the market. And FDA has begun refusing to accept “it was a user error, not a design problem” as an excuse for problems in the field. [...]
What follows is a look at some of the trends that are forcing medical device manufacturers to change their design practices, and should force those who haven’t to reconsider.”