Deciphering New Guidance for Human Factors Requirements

It doesn’t matter how potent your medication is if the device delivering it is ineffective.

There are many factors (human factors) that are considered when creating a medical device. Some of those factors focus on how the device is used. A person with limited dexterity (perhaps a person with arthritis) won’t be able to use a device in the same manner as person with full movement.

Device manufacturers often conduct human factors studies and usability testing during development to make sure people understand how to use the device effectively. But until recently, companies like Battelle who conduct these tests didn’t always have clear direction when it came to federal requirements.

The draft guidance originally issued by the U.S. Food and Drug Association (FDA) five years ago was very vague. Organizations were operating under their own interpretations of it.

The FDA issued new guidance on human factors requirements for medical device manufacturers earlier this year. This final guidance will help to make sure manufacturers are building products that are safe and effective.

Battelle’s T. Grant Leffingwell, a certified usability analyst, recently addressed the new guidance in a Med Device Online article