ArticleMedical devices (Auckland, N.Z.)2018
Formative usability evaluation of a fixed-dose pen-injector platform device.
Article in Medical devices (Auckland, N.Z.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Seeking a common human factors language for the development and testing of injection devices.Drug delivery · 2025Article
- Smart Textile Sock System for Athletes' Self-Correction during Functional Tasks: Formative Usability Evaluation.Sensors (Basel, Switzerland) · 2022Article
- Evaluating the usability and safety of the semaglutide single-dose pen-injectors through summative (human factors) usability testing.Journal of diabetes investigation · 2021Article
- DropSafe safety pen needle helps to prevent accidental needlesticks after injections: results of a simulated clinical study.Journal of infection prevention · 2021Article
- Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.Medical devices (Auckland, N.Z.) · 2021Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis 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.
methodsA total of 20 participants in three groups studied the IFU and performed simulated injections into an injection pad.
resultsAll 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.
conclusionThe 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.
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