Barriers to medical device innovation

Jacob Bergsland, Ole Jakob Elle, Erik Fosse The Intervention Centre, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway Abstract: The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it&#39...

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Autores principales:	Bergsl, J, Elle OJ, Fosse E
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/ec5b8740f31043c2a7988c52f78297f8
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spelling	oai:doaj.org-article:ec5b8740f31043c2a7988c52f78297f82021-12-02T01:32:21ZBarriers to medical device innovation1179-1470https://doaj.org/article/ec5b8740f31043c2a7988c52f78297f82014-06-01T00:00:00Zhttp://www.dovepress.com/barriers-to-medical-device-innovation-a17200https://doaj.org/toc/1179-1470 Jacob Bergsland, Ole Jakob Elle, Erik Fosse The Intervention Centre, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway Abstract: The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it's purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. Keyword: implantable, FDA, regulation, CE-mark, innovationBergslJElle OJFosse EDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2014, Iss default, Pp 205-209 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Bergsl J Elle OJ Fosse E Barriers to medical device innovation
description	Jacob Bergsland, Ole Jakob Elle, Erik Fosse The Intervention Centre, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway Abstract: The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it's purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. Keyword: implantable, FDA, regulation, CE-mark, innovation
format	article
author	Bergsl J Elle OJ Fosse E
author_facet	Bergsl J Elle OJ Fosse E
author_sort	Bergsl
title	Barriers to medical device innovation
title_short	Barriers to medical device innovation
title_full	Barriers to medical device innovation
title_fullStr	Barriers to medical device innovation
title_full_unstemmed	Barriers to medical device innovation
title_sort	barriers to medical device innovation
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/ec5b8740f31043c2a7988c52f78297f8
work_keys_str_mv	AT bergsl barrierstomedicaldeviceinnovation AT j barrierstomedicaldeviceinnovation AT elleoj barrierstomedicaldeviceinnovation AT fossee barrierstomedicaldeviceinnovation
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Barriers to medical device innovation

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