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Master's Dissertation
DOI
https://doi.org/10.11606/D.85.2011.tde-04082011-082834
Document
Author
Full name
Vanessa Borelli
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2011
Supervisor
Committee
Higa, Olga Zazuco (President)
Aquino, Afonso Rodrigues de
Blasques, Márcia Aparecida Silva
Title in Portuguese
Pesquisa e desenvolvimento de biomateriais: estudo das inter-relações científicas, tecnológicas e normativas
Keywords in Portuguese
biomateriais
comunicação
interdisciplinaridade
normalização
regulamentação
Abstract in Portuguese
A história da pesquisa e desenvolvimento dos biomateriais e dispositivos médicos mostra a inserção de produtos não seguros no mercado, os quais foram causa de mortes e seqüelas nos pacientes. Diante de tal quadro, pode-se dizer que diversos setores da indústria, representantes da academia, assim como órgãos governamentais de regulamentação e controle da qualidade de produtos, estão sob crescente pressão para educação e integração do setor. Sob esta perspectiva, a pesquisa passou a ser um diagnóstico das interrelações inseridas em tal cenário. Este trabalho foi realizado por meio de pesquisa etnográfica entre agosto de 2008 e agosto de 2010 com o intuito de reconhecer e analisar as inter-relações científicas, tecnológicas e normativas na pesquisa dos biomaterias. Neste percurso utilizamos a Norma ISO 10.993, que trata das avaliações biológicas dos biomateriais, para aproximação com os grupos de pesquisa. A pesquisa de campo envolveu: 1. Observação das práticas laboratoriais e acompanhamento de duas disciplinas de pós-graduação oferecidas no IPEN/SP: Introdução aos Biomateriais (TNM5782) e Biomateriais Propriedades e Avaliação (TNM 5783); 2. Participação nos Congressos Latino Americano de Órgãos Artificiais e Biomateriais (COLAOB) e nos eventos promovidos pelo Instituto Nacional de Ciência e Tecnologia (INCT) Biofabris; e, 3. Organização de um Debate com os grupos de pesquisa em biomateriais do IPEN. O debate e as aulas foram filmados, transcritos e analisados. Os resultados apontaram os grandes avanços dos programas acadêmicos de biomaterais e da integração entre as diversas 18 formações que trabalham nesta linha de pesquisa. Em termos de aplicação tecnológica, o envolvimento dos pesquisadores com os aspectos industriais e regulatórios tornou-se presente no cotidiano acadêmico. Assim, foi ressaltada a importância das aproximações entre a pesquisa e ensino e estas outras esferas e discutida as possibilidades de inserção de assuntos políticos, sociais, culturais e organizacionais neste contexto.
Title in English
Research and development of biomaterials: study of scientific, tecnological and regulatory inter relationship
Keywords in English
biocompatibility
biomaterials
communications
medical supplies
qulity control
standardization
Abstract in English
The history of research and development of biomaterials and medical device has been shown the application of unsafe products on the market, which were the cause of deaths and injuries in patients. For that reason, it can be said that various sectors of industry, academic representatives, government regulation and quality control of products, are under increasing pressure for integration and education of the participants. With these in mind, this research has become a diagnosis of the interrelationships that are present in this scenario. This diagnosis was conducted through ethnographic research between August 2008 and August 2010 in order to recognize and analyze the scientific, technological and regulatory relationships in the field of biomaterial. In this course it was used use the standard ISO 10.993, which deals with biological assessments of biomaterials, for approximation to the studied groups. The research involved: 1. Observation of laboratory practice and two graduate courses offered at IPEN / SP: "Introduction to Biomaterials" (TNM5782) and "Biomaterial - Properties and Evaluation" (TNM 5783), 2. Participation in the Latin American Congress of Biomaterials and Artificial Organs (COLAOB) and events sponsored by the National Institutes of Science and Technology (INCT) Biofabris, and 3. Organization of a meeting biomaterial research groups at IPEN. The meeting and lectures were videotaped, transcribed and analyzed. The results showed the great achievements of the biomaterials academic programs and the integration of the various professionals backgrounds who work in this field. In terms of technological application, the implication of researchers with industrial and regulatory aspects becomes present in academic daily work. Therefore, it was pointed out the importance of the interactions between researchers with the others spheres and discussed the possibilities of integration of political, social, organizational and cultural subjects in this context.
 
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Publishing Date
2012-05-30
 
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