Background: Increasing interest in digitally enhanced drug delivery tools urges both industry and academia to rethink current approaches to product usability testing. This article introduces mobile eyetracking, generating detailed contextual data about user engagement with connected self-injection systems as a new methodological approach to formative usability assessment. Methods: A longitudinal case study with a total of 35 injection-naĂŻve participants was conducted. In three consecutive experiments, eye-tracking was applied to formative usability testing of a novel connected self-injection device. Three eye-tracking derived usability indicators were established to assess product effectiveness, efficiency, and ease of use. Results: Analysis of the data revealed events of user hesitation, process interruption and unintended action, and these occurrences could either be completely eliminated or significantly reduced throughout the process (product effectiveness). At the same time, the overall use duration decreased from 86.1 to 58.7 sec (product efficiency). Analysis revealed that product modifications successfully guided user attention to those interface elements most relevant during each task, thereby improving product easeof-use. Conclusions: The step-wise improvement in the usability indicators demonstrates that iteratively applying eye-tracking methods effectively supports the user-centered design of connected selfinjection systems. The results highlight how eye-tracking can be employed to gain an in-depth understanding of patient engagement with novel healthcare technologies.
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