Abstract
Currently digital instructions for medical devices are primarily developed for digital products or as promotional instructional labeling and tend to be available in addition to the paper-based Instructions for Use (IFU). In many markets, digital instructions are limited to Healthcare Professional (HCP) use only and the potential benefits to patients are not being realized. This narrative review discusses some of the realities of patient onboarding and the potential to offer additional support to patients learning to inject through the provision of digital instructions. The review explores the current regulatory landscape for digital instructions across different markets and discusses some of the key differences between regulatory required labeling and promotional labeling. The review concludes with a range of digital instructional concepts to illustrate how evidence-based design principles can be incorporated into digital instructions to create meaningful, engaging content that could enhance the patient experience of instructional content.
