A multidisciplinary approach to online support for device research translation : regulatory change and clinical engagement
© 2020 Published by Elsevier Ltd on behalf of Fellowship of Postgraduate Medicine..
OBJECTIVES: To promote medical device EU regulatory understanding in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials.
METHODS: An interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources.
RESULTS: A multimedia based self-paced e-Learning course focusing on the 'Fundamentals of Medical Device Design and Regulation' was produced in tandem with an interactive online web portal: Medtech Translate.
CONCLUSIONS: Health research translation relies on both clinical input and regulation to drive progress and to ensure quality and safety standards from concept development to clinical investigation. A lack of regulatory awareness and access to clinical expertise has the potential to significantly impact on health research translation and ambition for market. Our interdisciplinary academic-regulator-clinical-industry led approach meets the need for a coordinated stakeholder response to support innovation and promote growth in the medical technology sector.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2020 |
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| Enthalten in: |
Health policy and technology - (2020) vom: 15. Okt. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Miller, Anne-Marie [VerfasserIn] |
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| Links: |
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| Themen: |
Biomedical research |
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| Anmerkungen: |
Date Revised 22.02.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1016/j.hlpt.2020.10.005 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM316524484 |
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| 100 | 1 | |a Miller, Anne-Marie |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A multidisciplinary approach to online support for device research translation |b regulatory change and clinical engagement |
| 264 | 1 | |c 2020 | |
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| 500 | |a Date Revised 22.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2020 Published by Elsevier Ltd on behalf of Fellowship of Postgraduate Medicine. | ||
| 520 | |a OBJECTIVES: To promote medical device EU regulatory understanding in the biomedical research community and encourage greater levels of clinical engagement to further medical device research innovation, translation and effective clinical trials | ||
| 520 | |a METHODS: An interdisciplinary, iterative, needs-based design approach was used to develop medical device regulatory training, information and clinical expertise resources | ||
| 520 | |a RESULTS: A multimedia based self-paced e-Learning course focusing on the 'Fundamentals of Medical Device Design and Regulation' was produced in tandem with an interactive online web portal: Medtech Translate | ||
| 520 | |a CONCLUSIONS: Health research translation relies on both clinical input and regulation to drive progress and to ensure quality and safety standards from concept development to clinical investigation. A lack of regulatory awareness and access to clinical expertise has the potential to significantly impact on health research translation and ambition for market. Our interdisciplinary academic-regulator-clinical-industry led approach meets the need for a coordinated stakeholder response to support innovation and promote growth in the medical technology sector | ||
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| 650 | 4 | |a translation | |
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| 700 | 1 | |a Smith, Ian |e verfasserin |4 aut | |
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| 700 | 1 | |a Keane, Fionnuala |e verfasserin |4 aut | |
| 700 | 1 | |a Langan, James |e verfasserin |4 aut | |
| 700 | 1 | |a O'Rourke, Colm |e verfasserin |4 aut | |
| 700 | 1 | |a McAleenan, Niall |e verfasserin |4 aut | |
| 700 | 1 | |a Pandit, Abhay |e verfasserin |4 aut | |
| 700 | 1 | |a Watson, Mark |e verfasserin |4 aut | |
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