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

Jakob Lange,1 Philipp Richard,1 Nick Bradley2 1Ypsomed AG, Burgdorf, Switzerland; 2BERGO UK, Bearsden, Glasgow, UK 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, pr...

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Autores principales:	Lange J, Richard P, Bradley N
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/d4fc2543ef534e24a8874aa81e90a82d
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spelling	oai:doaj.org-article:d4fc2543ef534e24a8874aa81e90a82d2021-12-02T05:41:55ZUsability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population1179-1470https://doaj.org/article/d4fc2543ef534e24a8874aa81e90a82d2015-06-01T00:00:00Zhttp://www.dovepress.com/usability-of-a-new-disposable-autoinjector-platform-device-results-of--peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Jakob Lange,1 Philipp Richard,1 Nick Bradley2 1Ypsomed AG, Burgdorf, Switzerland; 2BERGO UK, Bearsden, Glasgow, UK 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. Keywords: human factors engineering, autoinjector, handling study, use error, instructions for use, YpsoMate™Lange JRichard PBradley NDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2015, Iss default, Pp 255-264 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Lange J Richard P Bradley N Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
description	Jakob Lange,1 Philipp Richard,1 Nick Bradley2 1Ypsomed AG, Burgdorf, Switzerland; 2BERGO UK, Bearsden, Glasgow, UK 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. Keywords: human factors engineering, autoinjector, handling study, use error, instructions for use, YpsoMate™
format	article
author	Lange J Richard P Bradley N
author_facet	Lange J Richard P Bradley N
author_sort	Lange J
title	Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
title_short	Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
title_full	Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
title_fullStr	Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
title_full_unstemmed	Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
title_sort	usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/d4fc2543ef534e24a8874aa81e90a82d
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Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population

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