Will Your IFU
By Joely Gardner, PHD
February 29, 2016
Well-written and usable instructions are critical for all users.
Usability testing of instructions for use (IFUs) and labels is a requirement for medical devices and pharmaceuticals. You will not receive approval from the FDA or other governing bodies without objective evidence of usability. This article discusses what you need to know about usability testing requirements.
Why is the FDA focusing on the readability and usability of IFUs and labels?
You and I, and most of the people we know, live in an educated bubble. And for many, it is a bubble of advanced education and significant professional expertise. We deal with the highest level of professionals in our respective fields. Outside of our bubble, 45 million people in this country are functionally illiterate and read below a fifth grade level. And according to the National Assessment of Adult Literacy, approximately 50% of Americans read so poorly that they cannot read a prescription drug label .
However, educated laypeople and healthcare professionals also use IFUs and labels. Does that mean that readability and usability are unnecessary concerns for these groups? The answer, of course, is that well-written and usable instructions are critical for all users.
For example, the formative testing of the IFU for a device for OR anesthesiologists identified some needed changes. The reading level of the document was not a problem, but the results showed that edits needed to be made to improve the description of the device, increase the font size, improve images, clarify procedure instructions, and add instructions on the use of a stimulation clip.
Scientists involved in the formative testing of an in vitro diagnostic device had to remove a strip of foil covering a well that contained reagents. Every one of them asked what they were supposed to do with the strip: “Do I throw this away? Do I need it later to cover the well again?” These are perfectly reasonable questions and obviously, they needed to be addressed in the IFU.
The ability to read something quickly and immediately understand it has very little to do with IQ or educational level, as can be seen in the two previous examples. The more the reader has to think about what is being said, the more an opportunity for error is introduced into the process. I’ve never yet had a user say, “I really hate those instructions because they are much too easy to understand.”
Usability testing expert, FDA regulatory consultant
San Diego, California
© 2016.Joely Gardner. All Rights Reserved
Photo: morgueFile /
Joely Gardner, PHD | Usability testing expert, FDA regulatory consultant
Results-oriented consultant with international expertise in usability testing, medical device testing, customer experience research, and early-stage product development. Passionate about the customer experience as a market differentiator. Equally passionate about the rigor required to effectively combine qualitative and quantitative methodologies to provide reliable and valid data for management decisions. R&D experience with medical devices, home entertainment and wireless technologies. Change leadership consulting experience across a wide range of industries including e-commerce, banking, medical devices, biotech, and consumer products.
Usability validation for 62366
Voice of the Customer research
Survey design and statistical analysis
Customer experience research, management, and strategies
Quantitative and qualitative research
In-house training seminars for usability research and research strategy
New product/service R&D