Successfully Redesigning & Testing A User Friendly Patient Information Leaflet (PIL)

The challenge:
A device manufacturer with otherwise excellent human factors acumen faced a labeling roadblock in the process toward FDA clearance. The information leaflet for their device was initially intended for professional medical users and did not work for lay users. The manufacturer recognized the challenge of communicating product and medical information to lay users, as well as the added challenge of communicating to users between the ages of 7-55 years. Our goal was to help the company revise the information leaflet so that it was understood by lay users within the age range of the product users.

How we did it:
Agilis applied our proven evidence-based methods to help the company redesign and test a user friendly Patient Information Leaflet (PIL). The company was initially resistant to our methods, however this quickly faded upon testing of the PIL.

The result:
Success! The performance measures showed that 100% of adult users rated the PIL as “effective” to “very effective,” and 95 % of the pediatric population felt that the PIL provided their adult caregiver with all of the information needed to use the device. And of course, the device was cleared by the FDA.