How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development
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 su...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-03-01
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| Series: | Micromachines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2072-666X/11/3/291 |
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Article |
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DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Sara Graziadio Amanda Winter B. Clare Lendrem Jana Suklan William S. Jones Samuel G. Urwin Rachel A. O’Leary Rachel Dickinson Anna Halstead Kasia Kurowska Kile Green Andrew Sims A. John Simpson H. Michael Power A. Joy Allen |
| spellingShingle |
Sara Graziadio Amanda Winter B. Clare Lendrem Jana Suklan William S. Jones Samuel G. Urwin Rachel A. O’Leary Rachel Dickinson Anna Halstead Kasia Kurowska Kile Green Andrew Sims A. John Simpson H. Michael Power A. Joy Allen How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development Micromachines point of care medical device diagnostic care pathway analysis value proposition evidence generation preparation for marketing adoption implementation |
| author_facet |
Sara Graziadio Amanda Winter B. Clare Lendrem Jana Suklan William S. Jones Samuel G. Urwin Rachel A. O’Leary Rachel Dickinson Anna Halstead Kasia Kurowska Kile Green Andrew Sims A. John Simpson H. Michael Power A. Joy Allen |
| author_sort |
Sara Graziadio |
| title |
How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development |
| title_short |
How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development |
| title_full |
How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development |
| title_fullStr |
How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development |
| title_full_unstemmed |
How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development |
| title_sort |
how to ease the pain of taking a diagnostic point of care test to the market: a framework for evidence development |
| publisher |
MDPI AG |
| series |
Micromachines |
| issn |
2072-666X |
| publishDate |
2020-03-01 |
| description |
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 <i>in vitro</i> 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. |
| topic |
point of care medical device diagnostic care pathway analysis value proposition evidence generation preparation for marketing adoption implementation |
| url |
https://www.mdpi.com/2072-666X/11/3/291 |
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doaj-6f2da531a61c4d9280189716af6ed74d2020-11-25T02:28:41ZengMDPI AGMicromachines2072-666X2020-03-0111329110.3390/mi11030291mi11030291How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence DevelopmentSara Graziadio0Amanda Winter1B. Clare Lendrem2Jana Suklan3William S. Jones4Samuel G. Urwin5Rachel A. O’Leary6Rachel Dickinson7Anna Halstead8Kasia Kurowska9Kile Green10Andrew Sims11A. John Simpson12H. Michael Power13A. Joy Allen14NIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UKNIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UKNIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UKNIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKNIHR Newcastle In Vitro Diagnostics Co-operative, Room M2.088, Translational and Clinical Research Institute, William Leech Building, Medical School, Newcastle University, Newcastle NE2 4HH, UKBringing 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 <i>in vitro</i> 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.https://www.mdpi.com/2072-666X/11/3/291point of caremedical devicediagnosticcare pathway analysisvalue propositionevidence generationpreparation for marketingadoptionimplementation |