Medicine

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Level 1
Trinity Biomedical Sciences Institute
Trinity College
152-160 Pearse Street
Dublin 2

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Professor Tom Melvin

Professor Tom Melvin

Associate Professor, Medical Gerontology


Biography

Tom Melvin is Associate Professor of Medical Device Regulatory Affairs in Trinity College Dublin. Prior to this, Tom worked as a senior medical officer in medical devices at the Health Products Regulatory Authority, where he served for 7 years. Tom Co-chaired the Clinical Investigation and Evaluation Working Group of the European Commission for 5 years. Tom has led various taskforces, work packages and projects at national and international level on regulatory and scientific topics related to medical device regulation. Tom is a member of the International Rare Disease Research Consortium (IRDiRC) working group on MedTech for rare diseases, and a member of the National Research Ethics Committee for Medical Devices in Ireland. Before working in medical devices, Tom worked as a medical doctor for a number of years.

Publications and Further Research Outputs

  • Melvin T, Torre M, New medical device regulations: the regulator's view., EFORT open reviews, 2019Journal Article, 2019, DOI
  • Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szyma"ski P, Melvin T, Piscoi P, CORE"MD Investigators (see Appendix), Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)., EFORT open reviews, 2021Journal Article, 2021, DOI
  • Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szyma"ski P, Melvin T, Piscoi P, CORE-MD Investigators, Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)., European heart journal. Quality of care & clinical outcomes, 2022, pdoi: 10.1093/ehjqcco/qcab059Journal Article, 2022, DOI
  • Tom Melvin, The European Medical Device Regulation - what biomedical engineers need to know, IEEE Journal of Translational Engineering in Health and Medicine, 2022, p10.1109/JTEHM.2022.3194415Journal Article, 2022, DOI
  • Melvin T, Kenny D, Gewellig M, Fraser AGF, Orphan Medical Devices and Pediatric Cardiology " What Interventionists in Europe Need to Know, and What Needs to be Done, Pediatric Cardiology, 2022Journal Article, 2022
  • Olamide Sadare; Tom Melvin; Hugh Harvey; Erik Vollebregt; Stephen Gilbert, Can Apple and Google continue as health app gatekeepers as well as distributors and developers?, npj Digital Medicine, 6, (8), 2023Journal Article, 2023, URL
  • Gilbert S, Anderson S, Daumer M, Li P, Melvin T, Williams R, Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies, Journal of internet medical research, 25, 2023, pe43682-Journal Article, 2023, URL
  • Stephen Gilbert, Andreia Pimenta, Ashley Stratton-Powell, Cindy Welzel, Tom Melvin, Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?, Mayo Clinic Proceedings: Digital Health, 1, (3), 2023, p276 - 287Journal Article, 2023
  • Gilbert S, Harvey H, Melvin T, Vollebregt E, Wicks P, Large language model AI chatbots require approval as medical devices, Nature Medicine, 2023Journal Article, 2023, DOI
  • Kathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, Ulrich Baumann, Andreas Eicken, Alan G. Fraser, Dariusz Gruszfeld, Nikolaus A. Haas, Anneliene H. Jonker, Michael Kammermeier, Damien Kenny, Sanja Kola"ek, Risto Lapatto, Ian Maconochie, Silke Mader, Gearóid McGauran, Tom Melvin, Oliver Muensterer, Paul Piscoi, Alberto Romano, Amulya K. Saxena, Dominik T. Schneider, Mark A. Turner, Johan Vande Walle, Berthold Koletzko, the European Academy of Paediatrics, European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children, Acta Paediatrica, 2023, p1 - 9Journal Article, 2023, URL
  • Siontis GC, Coles B, Häner JD, McGovern L, Bartkowiak J, Coughlan JJ, Spirito A, Galea R, Haeberlin A, Praz F, Tomii D, Melvin T, Frenk A, Byrne RA, Fraser AG, Windecker S, CORE-MD investigators. Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD Consortium, European Heart Journal, 2023Journal Article, 2023, URL
  • Kathrin Guerlich, Bernadeta Patro-Golab, Paulina Dworakowski, Alan G. Fraser, Michael Kammermeier, Tom Melvin & Berthold Koletzko, Evidence from clinical trials on high-risk medical devices in children: a scoping review, Pediatric ResearchJournal Article, URL
  • Regulatory Assessment of Medical Devices in the European Union in, Translational Pathways for Cardiovascular Devices, 2016, [ Alan G. Fraser, MD; Robert A. Byrne, PhD; Tom Melvin, MD; Niall MacAleenan, MD; Olga Tkachenko, PhD; Paul Piscoi, MD]Book Chapter, URL
  • Global Health, New Challenges in, editor(s)Michal Cenker, Louiza Hadjivasiliou, Patrick Marren and Niamh Rooney , Development Education in Theory and Practice: An educator's resource, 2015, [Tom Melvin]Book Chapter, URL

Research Expertise

Medical devices, medical device regulation, clinical research

Recognition

  • Irish Intercollegiate Global Health Competition - James Deeny Medal, The Lancet Student, Dublin, Ireland 01-JAN-2010
  • Global Health Young Leaders Award, Royal Society of Medicine, London, United Kingdom 01-JAN-2011
  • National Research Ethics Committee for Medical Devices, National Research Ethics Committee , Dublin, IE
  • European Union Representative at the Working Group on Medical Device Clinical Evaluation, International Medical Device Regulators Forum (IMDRF)