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Formative Usability Evaluation of a Fixed-Dose Pen-Injector Platform Device

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Formative Usability Evaluation of a Fixed-Dose Pen-Injector Platform Device

Jakob Lange et al. Med Devices (Auckl).

Abstract

Background: 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.

Methods: A total of 20 participants in three groups studied the IFU and performed simulated injections into an injection pad.

Results: 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.

Conclusion: 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.

Keywords: FixPen; handling study; human-factor engineering; instructions for use; pen injector; user error.

Conflict of interest statement

Disclosure Both authors work for Ypsomed AG. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
The FixPen (A) and Forteo (B) disposable pen injectors used in the study. Notes: For the FixPen, a neutral label was used; for the Forteo, the product label was removed.
Figure 2
Figure 2
Tasks performed by the user during an injection.
Figure 3
Figure 3
Sequence of events during the handling tests. Abbreviations: IFU, instructions for use.
Figure 4
Figure 4
Initial injection-success rate. Notes: Success rate defined as the fraction of injections where tasks 1–5 (cap removal, needle attachment, dose loading, needle insertion, injection) were completed by the user without any involvement by the moderator. All injections were ultimately successful. Group 1, females >45 years of age; group 2A, naïve users; group 2B, experienced users.
Figure 5
Figure 5
User-feedback scores on usability questions asked at the end of the handling test. Notes: Users self-reported convenience on a scale of 1–4, where 4 represented the highest degree of convenience. Each bar provides a breakdown of the percentage of users assigning a certain agreement score to a question, with the absolute number of users per score given as a numeral.
Figure 6
Figure 6
User feedback on which pen feature indicated that the injection had been completed. Notes: Results combined for all user groups (n=20).

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