Quantifying Patient Capabilities and Setting the Stage for Future Development: Insights from a Sensor-Augmented Simulated Use Study with Pen Injectors.

Abstract

Background: While formative and summative usability testing is essential to confirm safe and effective product use, it may not be sufficient to comprehensively understand user capabilities and limitations in device interactions. Therefore, this research aims to quantify user handling forces for different device handling steps of pen injectors through sensor-augmented simulated use studies.

Research design and methods: The study involved 46 participants who were divided into two groups: a healthy control group and a group of users with dexterity impairments. All participants were instructed to perform simulated handling steps using non-functional dummy devices equipped with force and torque sensors. Each handling step was performed twice: first at what participants considered a comfortable force level and then at their maximum force. The study then analyzed force data to investigate the impact of user characteristics and device geometry on force exertion during the different handling steps.

Results: The study demonstrates differences in the perceived comfortable and maximum force levels between the control and patient groups. These force levels decrease slightly with the user's age and level of dexterity impairment. Furthermore, the forces applied by the users are dependent on the geometry of the device and the holding pattern.

Conclusion: The results highlight the significance of sensor-augmented simulated use studies as a tool for providing quantitative insights into users' ability to exert force while handling self-injection devices. These data offer comprehensive insights that inform the definition of performance requirements and specifications for injection device design, thereby supporting the advancement of future self-injection devices.