Abstract
An Instructions for Use (IFU) is a critical element of a drug delivery device system user interface that is frequently used as risk mitigation when the product cannot be effectively mitigated by the design of the device itself. However, format of a printout IFU is often selected without thoughtful consideration or even neglected while the IFU contents such as wordings and images are iteratively improved over the course of device development. There is a limited number of research papers that exist on the effects of the IFU printout format on task performance, especially with a drug delivery device. This study was to evaluate two different IFU formats (spiral bound vs accordion style) on task performance for use of a complex reusable electromechanical injection pen device system for preparing and administering medication. This study provides valuable insights for biotech/pharmaceutical industry for optimizing their IFU design by selecting more appropriate hardcopy IFU format for their drug delivery device. This will enable creating optimal user experience as well as more effectively reducing use related risks as part of overall device user interface for a complex drug delivery device system.
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