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Health technology assessment of medical devices: current landscape, challenges, and a way forward

BACKGROUND: Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical devices differ from that of drug therapies, and what innovations can be adopted t...

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Autores principales: Ming, Jian, He, Yunzhen, Yang, Yi, Hu, Min, Zhao, Xinran, Liu, Jun, Xie, Yang, Wei, Yan, Chen, Yingyao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9533595/
https://www.ncbi.nlm.nih.gov/pubmed/36199144
http://dx.doi.org/10.1186/s12962-022-00389-6
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author Ming, Jian
He, Yunzhen
Yang, Yi
Hu, Min
Zhao, Xinran
Liu, Jun
Xie, Yang
Wei, Yan
Chen, Yingyao
author_facet Ming, Jian
He, Yunzhen
Yang, Yi
Hu, Min
Zhao, Xinran
Liu, Jun
Xie, Yang
Wei, Yan
Chen, Yingyao
author_sort Ming, Jian
collection PubMed
description BACKGROUND: Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical devices differ from that of drug therapies, and what innovations can be adopted to overcome the inherent challenges in medical device HTA? METHOD: HTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA bodies, and a literature search was conducted to understand the growth trend of relevant HTA publications in four case studies. Another literature review was conducted for a narrative synthesis of the characteristic differences and challenges of HTA in medical devices. We further conducted a focused Internet search of guidelines and a narrative review of methodologies specific to the HTA of medical devices. MAIN BODY: The evidence of HTA reports and journal publications on medical devices around the world has been growing. The challenges in assessing medical devices include scarcity of well-designed randomized controlled trials, inconsistent real-world evidence data sources and methods, device-user interaction, short product lifecycles, inexplicit target population, and a lack of direct medical outcomes. Practical solutions in terms of methodological advancement of HTA for medical devices were also discussed in some HTA guidelines and literature. CONCLUSION: To better conduct HTA on medical devices, we recommend considering multi-source evidence such as real-world evidence; standardizing HTA processes, methodologies, and criteria; and integrating HTA into decision-making. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12962-022-00389-6.
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spelling pubmed-95335952022-10-06 Health technology assessment of medical devices: current landscape, challenges, and a way forward Ming, Jian He, Yunzhen Yang, Yi Hu, Min Zhao, Xinran Liu, Jun Xie, Yang Wei, Yan Chen, Yingyao Cost Eff Resour Alloc Review BACKGROUND: Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical devices differ from that of drug therapies, and what innovations can be adopted to overcome the inherent challenges in medical device HTA? METHOD: HTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA bodies, and a literature search was conducted to understand the growth trend of relevant HTA publications in four case studies. Another literature review was conducted for a narrative synthesis of the characteristic differences and challenges of HTA in medical devices. We further conducted a focused Internet search of guidelines and a narrative review of methodologies specific to the HTA of medical devices. MAIN BODY: The evidence of HTA reports and journal publications on medical devices around the world has been growing. The challenges in assessing medical devices include scarcity of well-designed randomized controlled trials, inconsistent real-world evidence data sources and methods, device-user interaction, short product lifecycles, inexplicit target population, and a lack of direct medical outcomes. Practical solutions in terms of methodological advancement of HTA for medical devices were also discussed in some HTA guidelines and literature. CONCLUSION: To better conduct HTA on medical devices, we recommend considering multi-source evidence such as real-world evidence; standardizing HTA processes, methodologies, and criteria; and integrating HTA into decision-making. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12962-022-00389-6. BioMed Central 2022-10-05 /pmc/articles/PMC9533595/ /pubmed/36199144 http://dx.doi.org/10.1186/s12962-022-00389-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Review
Ming, Jian
He, Yunzhen
Yang, Yi
Hu, Min
Zhao, Xinran
Liu, Jun
Xie, Yang
Wei, Yan
Chen, Yingyao
Health technology assessment of medical devices: current landscape, challenges, and a way forward
title Health technology assessment of medical devices: current landscape, challenges, and a way forward
title_full Health technology assessment of medical devices: current landscape, challenges, and a way forward
title_fullStr Health technology assessment of medical devices: current landscape, challenges, and a way forward
title_full_unstemmed Health technology assessment of medical devices: current landscape, challenges, and a way forward
title_short Health technology assessment of medical devices: current landscape, challenges, and a way forward
title_sort health technology assessment of medical devices: current landscape, challenges, and a way forward
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9533595/
https://www.ncbi.nlm.nih.gov/pubmed/36199144
http://dx.doi.org/10.1186/s12962-022-00389-6
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