This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate

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... the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.