Thursday, October 04, 2007

The Rise of Human Factors Principles

Ergonomics in the medical device field ...

"More device companies are incorporating human factors into their product development processes. There are a variety of reasons to do so, but also many reasons why some are still holding out.

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.

... There is plenty of evidence to show that the principle of human factors is part of the medical device design process more than ever before.

“Our customers are much more receptive than they used to be” to incorporating human factors in their designs, says Steve Guerrera, industrial design manager for Foster-Miller Inc. (Waltham, MA), a firm that assists companies with product development. “There is greater awareness of it now, and enlightened firms understand that they need it. We want industrial design and human factors principles incorporated into the process from day one, not treated ad hoc. And more of our customers are seeing the light.”

“Companies are getting in tune with trying to get it right the first time,” because they are beginning to understand how costly a redesign forced upon them by use errors can be to the bottom line, adds Bob Andrews, Foster-Miller’s medical division manager.

“A big driver is patient safety and ease of use,” says Joel Bartholomew, manager of OEM product development for B. Braun OEM Div., B. Braun Medical Inc. (Bethlehem, PA), a contract manufacturer that also helps device firms with design. “If you can make your device more intuitive to use, you will usually make it more safe."    (Continued via Medical Device Link)    [Ergonomics Resources]

Medical Device Ergonomics - Ergonomics

Medical Device Ergonomics

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