Impact of regulations on innovation in the field of medical devices
Res. Biomed. Eng. (Online)
;
34(4): 356-367, Oct.-Dec. 2018. graf
Artigo
em Inglês
| LILACS
| ID: biblio-984961
ABSTRACT
Abstract Introduction The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. However, innovative products need the development of more appropriate assay methods and streamline regulatory and scientific evaluation to encourage innovation and ensure more expedite delivery of novel, safe and effective innovative medical devices to patients. The aim of this work is to review the latest focus on the conflicting issues that are involved in the evaluation of recently developed biomaterials and medical devices. Methods This paper is based on a review of the relevant academic literature regarding the field of medical devices over the last ten years (2008-2017). A systematic search was conducted in Medline data base for articles using "medical devices" + "regulations" + "innovation" in the title or abstract. Discussion There is the widespread perception that research and marketing of innovative medical devices are moving swifter, even more so than the issues concerning evaluation methods and regulations. Collaboration among all the stakeholders could contribute to overcome the existing problems in medical device innovation.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Tipo de estudo:
Fatores de risco
Idioma:
Inglês
Revista:
Res. Biomed. Eng. (Online)
Assunto da revista:
Engenharia Biomdica
Ano de publicação:
2018
Tipo de documento:
Artigo
País de afiliação:
Colômbia
/
Cuba
Instituição/País de afiliação:
Metropolitan Technological Institute/CO
/
University of Havana/CU
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