Successfully Meeting Standards for Labeling and User Guides

The challenge:
After the introduction of new FDA human factors regulations, a well-established, multi-national company realized it was not meeting standards for labeling and user guides. Two redesigns of the product user guides by another firm yielded poor results – failed human factors testing, users were unable to understand the user guides, and users had difficulty using the product while referencing the user guides. Our goal was to help the company create user guides that met the FDA human factors guidelines and successfully facilitated correct use of their product by the end users.

How we did it:
We worked with the company’s internal team to redesign the labeling and user guides. We utilized our proprietary, evidence-based methods to create a guide that both met the required human factors standards and also kept with the look and feel of the company’s brand image.

The result:
Success! After working with Agilis for less than a month, the company performed a third customer test and the results improved over 90%.