If you are not conducting human factors research as part of your medical device development, you are increasing the likelihood of use errors. And with those come the potential for patient injuries, recalls, lawsuits, and FDA enforcement action.

And make no mistake, FDA can force your product off the market if shoddy or nonexistent human factors work results in too many use errors. The agency has gotten much more serious about this in recent years. 

Don’t know what human factors research is, or how to go about doing it? Never fear. In the February issue of MD&DI, we present three articles that can help you.

FDA now requires that device companies conduct human factors research as part of the risk management process. A lot of it entails trying to predict how the device could be misused, then correcting the design to try to prevent misuse. A new standard, HE 75, is being developed to help device firms navigate this process. Experts from Battelle Medical Device Solutions discuss their experiences implementing human factors in this month's Product Development Insight column.

One critical aspect of human factors research is user research. For example, ethnographic research involves conducting interviews and observing users. The information obtained can be adapted to design devices that meet the user’s needs. Stephen Wilcox of Design Science, and of MD&DI’s Editorial Advisory Board, addresses the validity issues that designers who engage in this type of research must account for. In addition, Matthew Jordan explores how to design devices to be used in the home.

It has never been more crucial to develop a sound human factors program. The patients that are being treated by your devices deserve nothing less.

Erik Swain
erik.swain@cancom.com