The case for an academic discipline of medical device science

Anne Lübbeke; James A Smith; Daniel Prieto-Alhambra; Andrew J Carr

doi:10.1302/2058-5241.6.200094

The case for an academic discipline of medical device science

EFORT Open Rev. 2021 Mar 1;6(3):160-163. doi: 10.1302/2058-5241.6.200094. eCollection 2021 Mar.

Authors

Anne Lübbeke^{1

2}, James A Smith^{2

3}, Daniel Prieto-Alhambra², Andrew J Carr^{2

3}

Affiliations

¹ Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland.
² Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
³ National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK.

Abstract

Medical devices are a very important but largely under-recognized and fragmented component of healthcare.The limited regulation of the past and the lack of systematic rigorous evaluation of devices leading to numerous high-profile failures will now be replaced by stricter legal requirements and more transparent evaluation processes.This constitutes an unprecedented opportunity, but it also uncovers urgent needs in landscaping, methodology development, and independent comprehensive assessment of device risks and benefits for individual patients and society, especially in the context of increasingly complex devices.We argue that an academic discipline of 'medical device science' is well placed to lead and coordinate the efforts necessary to achieve much needed improvement in the medical device sector.Orthopaedics and traumatology could contribute and benefit considerably as one of the medical specialties with the highest use of medical devices. Cite this article: EFORT Open Rev 2021;6:160-163. DOI: 10.1302/2058-5241.6.200094.

Keywords: implants; medical device science; medical devices.

Publication types

Review