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Optimal Usability Test Procedure Generation for Medical Devices

Medical device usability testing offers many benefits, including finding medical device usage errors and providing safety to users. As usability testing becomes mandatory for medical devices, manufacturers are increasing the cost burden. In order to perform a high-quality usability test, it is impor...

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Detalles Bibliográficos
Autores principales: Shin, Jeehoon, Lee, Hyuk
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9914048/
https://www.ncbi.nlm.nih.gov/pubmed/36766871
http://dx.doi.org/10.3390/healthcare11030296
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author Shin, Jeehoon
Lee, Hyuk
author_facet Shin, Jeehoon
Lee, Hyuk
author_sort Shin, Jeehoon
collection PubMed
description Medical device usability testing offers many benefits, including finding medical device usage errors and providing safety to users. As usability testing becomes mandatory for medical devices, manufacturers are increasing the cost burden. In order to perform a high-quality usability test, it is important to implement a usability test procedure, but guidelines for this are lacking. In this paper, we propose a method to systematically design and implement a usability test procedure. We propose methods to reduce test time-costs and apply them to implement the final procedure. Next, by applying the proposed method to sinus surgical navigation system, it is shown that the total time was reduced by 21% compared to the usability summative test procedure previously used in the same system.
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spelling pubmed-99140482023-02-11 Optimal Usability Test Procedure Generation for Medical Devices Shin, Jeehoon Lee, Hyuk Healthcare (Basel) Article Medical device usability testing offers many benefits, including finding medical device usage errors and providing safety to users. As usability testing becomes mandatory for medical devices, manufacturers are increasing the cost burden. In order to perform a high-quality usability test, it is important to implement a usability test procedure, but guidelines for this are lacking. In this paper, we propose a method to systematically design and implement a usability test procedure. We propose methods to reduce test time-costs and apply them to implement the final procedure. Next, by applying the proposed method to sinus surgical navigation system, it is shown that the total time was reduced by 21% compared to the usability summative test procedure previously used in the same system. MDPI 2023-01-18 /pmc/articles/PMC9914048/ /pubmed/36766871 http://dx.doi.org/10.3390/healthcare11030296 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Shin, Jeehoon
Lee, Hyuk
Optimal Usability Test Procedure Generation for Medical Devices
title Optimal Usability Test Procedure Generation for Medical Devices
title_full Optimal Usability Test Procedure Generation for Medical Devices
title_fullStr Optimal Usability Test Procedure Generation for Medical Devices
title_full_unstemmed Optimal Usability Test Procedure Generation for Medical Devices
title_short Optimal Usability Test Procedure Generation for Medical Devices
title_sort optimal usability test procedure generation for medical devices
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9914048/
https://www.ncbi.nlm.nih.gov/pubmed/36766871
http://dx.doi.org/10.3390/healthcare11030296
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