Lange Jakob, Nemeth Tobias
Ypsomed AG, Burgdorf, Switzerland.
Med Devices (Auckl). 2018 Apr 4;11:105-112. doi: 10.2147/MDER.S159733. eCollection 2018.
This article for the first time presents a formative usability study of a fixed-dose pen injector platform device used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a user population of both naïve and experienced users across a range of ages. The goals of the study were to evaluate whether users could use the devices safely and effectively relying on the instructions for use (IFU) for guidance, as well as to benchmark the device against another similar injector established in the market. Further objectives were to capture any usability issues and obtain participants' subjective ratings on the properties and performance of both devices.
A total of 20 participants in three groups studied the IFU and performed simulated injections into an injection pad.
All participants were able to use the device successfully. The device was well appreciated by all users with, maximum usability feedback scores reported by 90% or more on handling forces and device feedback, and by 85% or more on fit and grip of the device. The presence of clear audible and visible feedbacks upon successful loading of a dose and completion of injection was seen to be a significant improvement over the benchmark injector.
The observation that the platform device can be safely and efficiently used by all user groups provides confidence that the device and IFU in their current form will pass future summative testing in specific applications.
本文首次介绍了一种用于皮下注射生物制药的固定剂量笔式注射器平台设备的形成性可用性研究，主要供患者自行给药。该研究针对不同年龄段的新手和有经验的用户群体进行。研究目的是评估用户能否依靠使用说明书（IFU）安全有效地使用该设备，以及将该设备与市场上另一种类似注射器进行对标。进一步的目标是找出任何可用性问题，并获取参与者对两种设备的特性和性能的主观评价。
三组共20名参与者研究了IFU，并在注射垫上进行模拟注射。
所有参与者都能成功使用该设备。所有用户对该设备评价很高，90%或更多的用户在操作力和设备反馈方面给出了最高可用性反馈分数，85%或更多的用户在设备的贴合度和握持方面给出了高分。与对标注射器相比，成功装载剂量和完成注射时明显的听觉和视觉反馈被视为一项重大改进。
所有用户群体都能安全有效地使用该平台设备，这一观察结果让人相信，该设备及其当前形式的IFU将通过未来特定应用中的总结性测试。
