J&J MedTech Instructions For Use (IFU)

Jan 4

Written By Katie Z

Summary

Ethicon Endo-Surgery, Inc. (EES), a Johnson & Johnson company, designs and manufactures medical devices. As the technical writing intern for EES’ Global Packaging and Labeling Solutions (GPLS) team, I was tasked with creating an Instructions For Use (IFU) for a new medical device, the Enseal G2 Articulating Tissue Sealer. I collaborated with members of the Quality Assurance, Preclinical, R&D, Regulatory, Packaging, and Marketing departments to develop new content for the IFU that was submitted to the FDA.

In addition to creating content, I was challenged to develop and propose a user-friendly alternative to the standard Steps 4 Use (S4U) that is depicted in the Tissue Sealer IFU. Market trends and feedback from the field indicated the need for a more usable design. I began researching eye tracking data and user-centered design methods for medical device instructions and developed four versions, varying in size and design, that could significantly increase the usability for EES’ end users.

Other projects include: developing a legibility study for a Cost Improvement Project (CIP), editing and updating the GPLS guidelines (175 pages and 4 years old), constructing and analyzing a regulatory gap assessment, and more. After my summer internship, I was asked to stay on as a part-time technical writing intern for fall semester. During that time, I created task-based IFUs for device return kits for J&J’s medical device companies: EES, Ethicon Inc., and Biosense Webster.