Photo: Abstract image of light rays

Insights

Blog | The Latest

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The draft guidance originally issued by the U.S. Food and Drug Association (FDA) five years ago was very vague.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
Posted
October 17, 2016
Author
Battelle Insider
Estimated Read Time
1 Mins

Human Centric Design

Building Better Solutions through empathy and rigor.

Learn More
Stay In the Know

Get Battelle Insights in Your Inbox

Get Updates

BATTELLE UPDATES

Receive updates from Battelle for an all-access pass to the incredible work of Battelle researchers.


View all blog articles

Events | Upcoming

Case Studies

View All Case Studies

Press Releases


View all Press releases


Visit our youtube page

Sign Up for Battelle Updates

Follow along with the latest news, announcements and updates from our Battelle community of solvers.