A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement

Anne-Marie Miller; Robert Behan; Ian Smith; Matthew Griffin; Fionnuala Keane; James Langan; Colm O'Rourke; Niall McAleenan; Abhay Pandit; Mark Watson

doi:10.1016/j.hlpt.2020.10.005

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement

Anne-Marie Miller
, Robert Behan
, Ian Smith
, Matthew Griffin
, Fionnuala Keane
, James Langan
, Colm O'Rourke
, Niall McAleenan
, Abhay Pandit
, Mark Watson

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

Abstract

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.

Original language	English
Journal	Health Policy and Technology
DOIs	https://doi.org/10.1016/j.hlpt.2020.10.005
Publication status	E-pub ahead of print - 15 Oct 2020

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10.1016/j.hlpt.2020.10.005

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@article{e980e1c4c580458a9f5a62a6fcd7898b,

title = "A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement",

abstract = "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.",

author = "Anne-Marie Miller and Robert Behan and Ian Smith and Matthew Griffin and Fionnuala Keane and James Langan and Colm O'Rourke and Niall McAleenan and Abhay Pandit and Mark Watson",

note = "{\textcopyright} 2020 Published by Elsevier Ltd on behalf of Fellowship of Postgraduate Medicine.",

year = "2020",

month = oct,

day = "15",

doi = "10.1016/j.hlpt.2020.10.005",

language = "English",

journal = "Health Policy and Technology",

issn = "2211-8837",

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TY - JOUR

T1 - A multidisciplinary approach to online support for device research translation

T2 - regulatory change and clinical engagement

AU - Miller, Anne-Marie

AU - Behan, Robert

AU - Smith, Ian

AU - Griffin, Matthew

AU - Keane, Fionnuala

AU - Langan, James

AU - O'Rourke, Colm

AU - McAleenan, Niall

AU - Pandit, Abhay

AU - Watson, Mark

PY - 2020/10/15

Y1 - 2020/10/15

N2 - 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.

AB - 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.

U2 - 10.1016/j.hlpt.2020.10.005

DO - 10.1016/j.hlpt.2020.10.005

M3 - Article

C2 - 33083213

SN - 2211-8837

JO - Health Policy and Technology

JF - Health Policy and Technology

ER -

A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement

Abstract

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