Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits ea...

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Autores principales:	Staci J. Kearney, Amanda Lowe, Jochen K. Lennerz, Anil Parwani, Marilyn M. Bui, Katy Wack, Gina Giannini, Esther Abels
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	regulatory strategy clinical affairs total product life cycle in vitro diagnostics development digital pathology business strategy Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/34f8f7360ab14310a50c7eddd8b3501f
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spelling	oai:doaj.org-article:34f8f7360ab14310a50c7eddd8b3501f2021-11-17T05:35:53ZBridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software2296-858X10.3389/fmed.2021.765385https://doaj.org/article/34f8f7360ab14310a50c7eddd8b3501f2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fmed.2021.765385/fullhttps://doaj.org/toc/2296-858XManufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.Staci J. KearneyAmanda LoweJochen K. LennerzAnil ParwaniMarilyn M. BuiKaty WackGina GianniniEsther AbelsFrontiers Media S.A.articleregulatory strategyclinical affairstotal product life cyclein vitro diagnostics developmentdigital pathologybusiness strategyMedicine (General)R5-920ENFrontiers in Medicine, Vol 8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	regulatory strategy clinical affairs total product life cycle in vitro diagnostics development digital pathology business strategy Medicine (General) R5-920
spellingShingle	regulatory strategy clinical affairs total product life cycle in vitro diagnostics development digital pathology business strategy Medicine (General) R5-920 Staci J. Kearney Amanda Lowe Jochen K. Lennerz Anil Parwani Marilyn M. Bui Katy Wack Gina Giannini Esther Abels Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software
description	Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits each stage of the TPLC. RACA professionals are important contributors to product development and deployment strategies because these professionals maintain an understanding of the scientific, technical, and clinical aspects of biomedical product regulation, as well as the relevant knowledge of regulatory requirements, policies, and market trends for both local and global regulations and standards. Defining a regulatory and clinical strategy at the beginning of product design enables early evaluation of risks and provides assurance that the collected evidence supports the product's clinical claims (e.g., in a marketing application), its safe and effective use, and potential reimbursement strategies. It is recommended to involve RACA early and throughout the TPLC to assist with navigating changes in the regulatory environment and dynamic diagnostic market. Here we outline how various stakeholders can utilize RACA to navigate the nuanced landscape behind the development and use of clinical diagnostic products. Collectively, this work emphasizes the critical importance of RACA as an integral part of product development and, thereby, sustained innovation.
format	article
author	Staci J. Kearney Amanda Lowe Jochen K. Lennerz Anil Parwani Marilyn M. Bui Katy Wack Gina Giannini Esther Abels
author_facet	Staci J. Kearney Amanda Lowe Jochen K. Lennerz Anil Parwani Marilyn M. Bui Katy Wack Gina Giannini Esther Abels
author_sort	Staci J. Kearney
title	Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software
title_short	Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software
title_full	Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software
title_fullStr	Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software
title_full_unstemmed	Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software
title_sort	bridging the gap: the critical role of regulatory affairs and clinical affairs in the total product life cycle of pathology imaging devices and software
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/34f8f7360ab14310a50c7eddd8b3501f
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Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

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