Iteratively design medical device IFU

A pharmaceutical company needed to evaluate the effectiveness of their instructions for use for a new product.


A pharmaceutical company needed to evaluate the instructions for use of a new product that healthcare providers would administer to their patients. We were asked to assess if HCPs would be able to effectively use the instructional materials as intended and ensure that the instructional materials adhered to the best practices in user-centered design.


Before one-on-one interviews with potential users, our team conducted a heuristic evaluation of the instructions for use. We then completed a simulated-environment usability study to collect data that guided revisions and updates to the instructional materials. We then conducted a post-iterative study where we collected further feedback on the product and redesigned instructional materials.


The changes made to the IFU following the pre-iterative portion of our study successfully alleviated user confusion and improved overall usability of the instructions.




Documentation, Expert Review, Formative / Evaluative