Stephan Wegner, Jana Milenkovic, Anthony D Andre, Carson P Whitaker, Tobias Theiler
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A Human Factors Validation of a Smart Autoinjector Accessory Designed to Improve Self-Injection Outcomes and User Confidence.
Purpose: Enhancing user guidance via visual and auditory real-time feedback during subcutaneous injections-combined with automated injection-data logging-has the potential to improve self-injection outcomes and increase user confidence. To meet these objectives, a Smart Autoinjector Accessory (SAA) was developed to help patients, caregivers, and healthcare practitioners (HCPs) manage the injection process more effectively. This human factors validation study assessed whether the SAA, together with its Instructions for Use (IFU), could be operated safely and effectively with an autoinjector by the intended user population.
Methods: Seventy-five untrained participants (patients, n=45; caregivers, n= 15; HCPs, n=15) were evaluated on completion of SAA use tasks and IFU knowledge tasks in a simulated use environment.
Results: All participants (75/75, 100%) successfully delivered the full dose with the associated autoinjector. A total of 1196 out of 1200 use tasks (99.7%) delivering a simulated injection with the SAA and 2772 out of 2775 knowledge tasks (99.9%) concerning content in the IFU were completed successfully. Therefore, the overall results show near perfect success rates. All observed errors were isolated to individual participants, and no patterns of recurring use- or knowledge-task errors were found. Root cause analysis attributed these errors to inattention rather than deficiencies in the IFU clarity or device design.
Conclusion: This study shows that the intended users can operate the SAA safely and effectively. Given the strong usability outcomes, the results warrant further investigation into the SAA's potential to improve treatment adherence and persistence in longer-term studies. In post-launch use, the SAA could play a key role in facilitating the onboarding of inexperienced patients or those undergoing more complex treatment regimens. Beyond individual therapy, the SAA also holds promise in digitalizing real-world evidence collection for post-market insights and clinical drug development, supporting decentralized clinical trial designs, where patients administer injections at home rather than in clinical environments.
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