Open AccessThe case for an academic discipline of medical device science
Author(s) -
Anne Lübbeke,
James Smith,
Daniel PrietoAlhambra,
Andrew Carr
Publication year - 2021
Publication title -
efort open reviews
Language(s) - English
Resource type - Journals
ISSN - 2396-7544
DOI - 10.1302/2058-5241.6.200094
Subject(s) - context (archaeology) , traumatology , discipline , engineering ethics , medical device , health care , medicine , risk analysis (engineering) , engineering management , business , engineering , political science , surgery , orthopedic surgery , biomedical engineering , law , paleontology , biology
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