Background The RebiSmart ® electromechanical autoinjector supports people living with relapsing multiple sclerosis (MS) with their adherence to treatment with subcutaneous interferon beta-1a (sc IFN β-1a; Rebif ® ), a well-established and effective therapy. We report on the validation of the next-generation device, RebiSmart 3.0, tailored to meet patients’ changing needs. Methods To conclude a series of formative usability studies, a final formative study of an updated prototype version of the RebiSmart electromechanical autoinjector was conducted to identify the device’s strengths, potential device-related use errors, opportunities for improvement, and to inform device safety. The findings were incorporated into the next-generation device, RebiSmart 3.0, which was then evaluated in a summative usability study involving 45 participants. The study consisted of evaluation activities – use scenarios and knowledge tasks – designed to validate mitigations to reduce the risks of not successfully completing critical tasks for successful administration of medication. During each evaluation activity, observations (including use errors, instances of moderator assistance, close calls, and difficulties) were recorded, focusing on the potential for serious harm arising from not completing critical tasks. Participants then provided their subjective assessment of RebiSmart 3.0 as part of a user needs survey that assessed device usability and design. Results Regarding critical tasks, main findings were failure to inspect/dispose of the cartridge and not washing hands or disinfecting the injection site. These issues could be readily overcome by modifying future training. In the subjective assessment, 43 out of 45 participants considered the updated device safe to use as-is. In the user needs survey, overall, the participants rated the device positively. Conclusion Findings validate the safety of use of the next-generation device, RebiSmart 3.0, through a comprehensive evaluation of use scenarios and knowledge tasks by the study participants, who provided positive ratings of the device in the user needs survey.

BACKGROUND Digital solutions targeting children’s health have become an increasingly important element in the provision of integrated health care. For the treatment of growth hormone deficiency (GHD), a unique connected device is available to facilitate the delivery of recombinant human growth hormone (r-hGH) by automating the daily injection process and collecting injection data such that accurate adherence information is available to health care professionals (HCPs), caregivers, and patients. The adoption of such digital solutions requires a good understanding of the perspectives of HCPs as key stakeholders because they leverage data collection and prescribe these solutions to their patients. OBJECTIVE This study aimed to evaluate the third generation of the easypod device (EP3) for the delivery of r-hGH treatment from the HCP perspective, with a focus on perceived usefulness and ease of use. METHODS A qualitative study was conducted, based on a participatory workshop conducted in Zaragoza, Spain, with 10 HCPs experienced in the management of pediatric GHD from 7 reference hospitals in Spain. Several activities were designed to promote discussion among participants about predefined topics based on the Technology Acceptance Model and the Unified Theory of Acceptance and Use of Technology to provide their perceptions about the new device. RESULTS Participants reported 2 key advantages of EP3 over previous easypod generations: the touch screen interface and the real-time data transmission functionality. All participants (10/10, 100%) agreed that the new device should be part of a digital health ecosystem that provides complementary functionalities including data analysis. CONCLUSIONS This study explored the perceived value of the EP3 autoinjector device for the treatment of GHD by HCPs. HCPs rated the new capabilities of the device as having substantial improvements and concluded that it was highly recommendable for clinical practice. EP3 will enhance decision-making and allow for more personalized care of patients receiving r-hGH.

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