A Human Factors Validation of a Smart Autoinjector Accessory Designed to Improve Self-Injection Outcomes and User Confidence

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.