Using Digital Instructions to Address on-Market Product Complaints and Improve User Experiences.

Manufacturers of medical devices are legally required to carry out post-market surveillance and respond to any on-market complaints they receive about their device. When it comes to addressing use issues experienced on market, manufacturers often focus on revising the instructions for use (IFU) and labeling. One of the challenges with this approach is the potential need to re-validate via a human factors validation study, without knowing whether the changes made will be effective in addressing the identified issues. With populations becoming increasingly technically literate, there is now great potential to rethink the way we can support self-injection through digital and web-based tools. This paper introduces the potential of digital instructions to improve the user experience of self-injection and address known use issues, as well as the challenges of incorporating them in medical device design.