Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
5 Reasons IFU’s Need to Be Integrated at the Start of the Design & Development Effort
By Jeff Morang, Sr. Human Factors Engineer
So many times I’ve witnessed the same mistake; when nearing the end of a project someone on the Core Team says,“When will we review the Instructions for Use?”. This is usually followed by anawkward silence and frantic gazes in search of reassurance. Surely someone is tucked away in a room diligently typing out a Pulitzer Prize-worthy IFU that will dovetail beautifully into the project’s timeline. Sadly, that’s not usually the case.
Instructions for Use, Quick Reference Guides, and labels need to be an integrated part of the design and development effort. It’s no secret that the FDA considers IFU’s and labeling as important as the device itself! (see the FDA’s Guidance on Medical Device Patient Labeling) Moreover, the instructional material should reflect the same quality and design language as the device they are supporting. After all, they are all part of the product experience you are delivering and they all reflect your brand.
Contrary to popular belief, creating IFU’s and labels is not an activity best done in a quiet room in some remote corner of the office! Those days are where they belong…in the rearview mirror. The best way to avoid the last-minute “fire drill” is to include your Technical Writer(s) and Graphic Designers early in the project. How early? A good and valid question. In my experience with the extensive IFU work done at Ximedica, including the Tech Writers and Graphic Designers in the initial concept generation phase allows them to acquire the holistic knowledge required to develop instructional material necessary, not only for the final product, but also for the formative and summative usability testing.
Including the writers and designers early allows them the time needed to:
1) Understand nuances of the device, or system, so they can better explain it to your customers/users
2) Create an IFU design plan that fits the device/system development and usability testing schedules
3) Prioritize work efforts to match those of the program
4) Discover and investigate opportunities for improvements and
5) Verify the accuracy of their work.
Taking a proactive approach to the development of all the instructional materials will dramatically increase your likelihood for success!