Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population

Abstract

This article presents a late-stage formative usability study of an autoinjector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. Previous usability work on autoinjectors reported in the literature has been specific to single indications. This study was instead conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to evaluate whether users could use the devices safely and effectively, and could understand the instructions for use (IFU) as well as the accompanying training. Further objectives were to capture any usability issues and to obtain participants’ subjective ratings on the IFU and training as well as the confidence and comfort in using the device. A total of 43 participants in 5 groups received training and performed simulated injections either into an injection pad or a mannequin. All participants were able to successfully use the device. The device was well appreciated by all users, with a reported degree of confidence in using the device of 98%, of user comfort of 93%, and of comprehensibility of IFU and training of 98%. These values are higher than other comparable results reported in the literature. The presence of both audible and visible feedback during injection was seen to be a significant factor contributing to injection success. The observation that the device can be safely and efficiently used by all tested user groups provides confidence that the device and IFU in their current form will pass future summative testing in specific applications.

Toward a new age of patient centricity? The application of eye-tracking to the development of connected self-injection systems

“…The connected self-injection system consisted of the standard 2-step disposable autoinjector platform YpsoMate ('AI', Ypsomed AG, Burgdorf, Switzerland), a reusable monitoring add-on module with built-in sensor and wireless communication technology ('ADD-ON', Ypsomed AG, Burgdorf, Switzerland) and a related mobile app on a smartphone ('APP', Ypsomed AG, Burgdorf, Switzerland) for in-use patient guidance throughout the injection process. The YpsoMate autoinjector platform has been successfully tested for basic usability and ease of use across various user groups [32]. The focus of the evaluation at hand was on the ADD-ON and the companion APP, and on how the injection process can be optimally guided with such a connected self-injection system.…”

“…Formative usability studies have proven indispensable tools to advance device development [32,33]. Traditionally, new product development has advanced in cycles of optimizing the user interface of pen systems and (re-) assessing patient preferences [34].…”

Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors

“…25] for use with equally novel and easy-to -use handheld autoinjectors [e.g. 4,5,[26][27][28], foster highvolume drug administration. As a consequence, emerging dosing regimens demand the administration of a single bolus dose up to 2 mL [18,19].…”

The Pharmacokinetics and Relative Bioavailability of Mepolizumab 100 mg Liquid Formulation Administered Subcutaneously to Healthy Participants: A Randomized Trial

“…However, use of devices such as PFSs and AIs, together with appropriate patient training, should help to minimize the likelihood of this occurring. In addition, it is worth noting that the AI and PFS assessed in this study are intended for injections of a single fixed dose and have been tested in the real world by patients for self‐administration in the clinic and at home, suggesting that both devices may be ideal platforms for the delivery of mepolizumab …”

“…In addition, it is worth noting that the AI and PFS assessed in this study are intended for injections of a single fixed dose and have been tested in the real world by patients for self-administration in the clinic and at home, suggesting that both devices may be ideal platforms for the delivery of mepolizumab. 21,26,27…”