Abstract
Well-designed instructions for use (IFUs) reduce medical device risk and facilitate regulatory review. This study evaluated two common IFU formats (booklet and foldout) to identify benefits and drawbacks for comprehension and use. In an A/B usability test, 16 adults simulated the preparation of a dose of medicine and were asked to find critical information using instructions in each of the formats. They then compared the two formats and completed a standardized health literacy assessment. Our results showed that the foldout presented an accessible overview of the steps while the booklet showed ease-of-use benefits, particularly for those with lower health literacy scores. Our results indicate that physical design decisions impact the user experience, and that they should be carefully evaluated to provide an optimal IFU.
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