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How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development.

Lookup NU author(s): Dr Sara Graziadio, Amanda Winter, Dr Clare LendremORCiD, Dr Jana SuklanORCiD, Dr Will Jones, Dr Sam Urwin, Rachel O'Leary, Anna Halstead, Kasia Kurowska, Dr Kile GreenORCiD, Dr Andrew SimsORCiD, Professor John SimpsonORCiD, Dr Michael Power, Dr Joy AllenORCiD



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Bringing a diagnostic point of care test (POCT) to a healthcare market can be a painful experience as it requires the manufacturer to meet considerable technical, financial, managerial, and regulatory challenges. In this opinion article we propose a framework for developing the evidence needed to support product development, marketing, and adoption. We discuss each step in the evidence development pathway from the invention phase to the implementation of a new POCT in the healthcare system. We highlight the importance of articulating the value propositions and documenting the care pathway. We provide guidance on how to conduct care pathway analysis as little has been published on this. We summarize the clinical, economic and qualitative studies to be considered for developing evidence, and provide useful links to relevant software, on-line applications, websites, and give practical advice. We also provide advice on patient and public involvement and engagement (PPIE), and on product management. Our aim is to help device manufacturers to understand the concepts and terminology used in evaluation of in vitro diagnostics (IVDs) so that they can communicate effectively with evaluation methodologists, statisticians, and health economists. Manufacturers of medical tests and devices can use the proposed framework to plan their evidence development strategy in alignment with device development, applications for regulatory approval, and publication.

Publication metadata

Author(s): Graziadio S, Winter A, Lendrem BC, Suklan J, Jones WS, Urwin SG, O'Leary RA, Dickinson R, Halstead A, Kurowska K, Green K, Sims A, Simpson AJ, Power HM, Allen AJ

Publication type: Article

Publication status: Published

Journal: Micromachines

Year: 2020

Volume: 11

Issue: 3

Print publication date: 01/03/2020

Online publication date: 10/03/2020

Acceptance date: 07/03/2020

Date deposited: 08/04/2020

ISSN (electronic): 2072-666X

Publisher: MDPI AG


DOI: 10.3390/mi11030291


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Funder referenceFunder name
National Institute for Health Research (NIHR) Newcastle In Vitro Diagnostics Co-operative
NIHR MedTech In Vitro Diagnostic Co-operatives scheme (refMIC-2016-014)