The case for an academic discipline of medical device science.

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.
Competing Interests: ICMJE Conflict of interest statement: AL declares no conflict of interest relevant to this work. JAS reports consultancy for Biolacuna Ltd, outside the submitted work. DPA reports fees for speaker services and advisory board membership. AMGEN, fees for consultancy services from UCB Biopharma, grants from Les Laboratoires Servier, all outside the submitted work; and Janssen, on behalf of IMI-funded EHDEN and EMIF consortiums, and Synapse Management Partners have supported training programmes organised by DPA's department and open for external participants. AJC reports consultancy for the Novartis musculoskeletal advisory board and patents with BioPatch, outside the submitted work.
(© 2021 The author(s).)