Involving People in Medical Device Design

An article in MD&DI (Medical Device and Diagnostic Industry) magazine discusses the rise of human factors methods among designers of medical devices.  Excerpt:

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.

Take Hospira (Lake Forest, IL). Its practices are becoming more the norm than the exception, it seems. “Human factors is an integral part of our device development process,” says Steven Pregulman, MD, medical director of device development. “We work with end users early and often before we even have working prototypes. We work with focus groups and single users.” In fact, to ensure that all user feedback is accounted for, Hospira’s policy is to document each and every comment and note whether it was heeded or disregarded, he says. “If we did not have a system like that, it would be too easy to sweep everything under the rug.”

There are a number of reasons why the human factors discipline is finally catching on in the medical device industry. Unfortunately, there are an equal number of reasons why it still hasn’t caught on in parts of the sector. 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.

Link: Catching the Human Factors Fever,

via Putting people first.

It might seem like a no-brainer that you should try out your products on real people to ensure that they work well, but many industries are just now catching on to this idea.  The field of human factors engineering is sometimes called human factors psychology or industrial psychology, and overlaps with the related fields of ergonomics, usability engineering, human-computer interaction, and cognitive psychology (among others).  Human factors has its origins in the aerospace industry.