Formative usability evaluation of a fixed-dose pen-injector platform device

Jakob Lange, Tobias Nemeth Ypsomed AG, Burgdorf, Switzerland 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 patie...

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Autores principales:	Lange J, Nemeth T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Human factors engineering pen injector handling study user error instructions for use FixPen™. Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/33de18e21414451f9c6d47baff4810d3
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spelling	oai:doaj.org-article:33de18e21414451f9c6d47baff4810d32021-12-02T06:36:02ZFormative usability evaluation of a fixed-dose pen-injector platform device1179-1470https://doaj.org/article/33de18e21414451f9c6d47baff4810d32018-04-01T00:00:00Zhttps://www.dovepress.com/formative-usability-evaluation-of-a-fixed-dose-pen-injector-platform-d-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Jakob Lange, Tobias Nemeth Ypsomed AG, Burgdorf, Switzerland 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: human-factor engineering, pen injector, handling study, user error, instructions for use, FixPenLange JNemeth TDove Medical PressarticleHuman factors engineeringpen injectorhandling studyuser errorinstructions for useFixPen™.Medical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 11, Pp 105-112 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Human factors engineering pen injector handling study user error instructions for use FixPen™. Medical technology R855-855.5
spellingShingle	Human factors engineering pen injector handling study user error instructions for use FixPen™. Medical technology R855-855.5 Lange J Nemeth T Formative usability evaluation of a fixed-dose pen-injector platform device
description	Jakob Lange, Tobias Nemeth Ypsomed AG, Burgdorf, Switzerland 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: human-factor engineering, pen injector, handling study, user error, instructions for use, FixPen
format	article
author	Lange J Nemeth T
author_facet	Lange J Nemeth T
author_sort	Lange J
title	Formative usability evaluation of a fixed-dose pen-injector platform device
title_short	Formative usability evaluation of a fixed-dose pen-injector platform device
title_full	Formative usability evaluation of a fixed-dose pen-injector platform device
title_fullStr	Formative usability evaluation of a fixed-dose pen-injector platform device
title_full_unstemmed	Formative usability evaluation of a fixed-dose pen-injector platform device
title_sort	formative usability evaluation of a fixed-dose pen-injector platform device
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/33de18e21414451f9c6d47baff4810d3
work_keys_str_mv	AT langej formativeusabilityevaluationofafixeddosepeninjectorplatformdevice AT nemetht formativeusabilityevaluationofafixeddosepeninjectorplatformdevice
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Formative usability evaluation of a fixed-dose pen-injector platform device

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