MATERIALS AND PROCESSES SELECTION FOR MEDICAL DEVICE PROTOTYPING FOR CLINICAL TRIALS

MATERIALS AND PROCESSES SELECTION FOR MEDICAL DEVICE PROTOTYPING FOR CLINICAL TRIALS

MARQUES, AMANDA DA COSTA; BEAL, Valter Estevão

Full article:

In developing countries like Brazil, technological innovation is crucial for advancing healthcare systems, but it faces challenges due to socio-economic and cultural specificities influenced by inequality. The local manufacturing of medical devices is impacted by regional technological capabilities and limitations, placing regions with restricted access to necessary resources at a disadvantage. Therefore, adaptations to processes, materials, and workforce are often necessary for successful local production. This article aims to explore approaches that aid in adapting healthcare technological innovation projects, considering materials and processes available in pre-industrial stages. The methodology involves bibliographic research on material and process selection, followed by an analysis of the life cycle of technological medical products, taking into account the incidence of regulation in this process. As a result, the study proposes a flowchart of stages for research and selection of materials and processes that enable small-scale production of medical device prototypes intended for clinical trials conducted in low complexity healthcare settings.

In developing countries like Brazil, technological innovation is crucial for advancing healthcare systems, but it faces challenges due to socio-economic and cultural specificities influenced by inequality. The local manufacturing of medical devices is impacted by regional technological capabilities and limitations, placing regions with restricted access to necessary resources at a disadvantage. Therefore, adaptations to processes, materials, and workforce are often necessary for successful local production. This article aims to explore approaches that aid in adapting healthcare technological innovation projects, considering materials and processes available in pre-industrial stages. The methodology involves bibliographic research on material and process selection, followed by an analysis of the life cycle of technological medical products, taking into account the incidence of regulation in this process. As a result, the study proposes a flowchart of stages for research and selection of materials and processes that enable small-scale production of medical device prototypes intended for clinical trials conducted in low complexity healthcare settings.

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DOI: 10.5151/siintec2023-305333

Referências bibliográficas

• [1] ASHBY, Michael. Materials selection in mechanical design. Oxford: Elsevier, 3 ed., 2005. ANDERSSON, Martin et al. Regional innovation systems in small & medium-sized regions a critical review & assessment. Working Paper Series in Economics and Institutions of Innovation, n. 10, 2004. BRASIL. Agência Nacional de Vigilância Sanitária. Manual de tecnovigilância: uma abordagem sob ótica da vigilância sanitária [recurso eletrônico] / Agência Nacional de Vigilância Sanitária, Gerência-Geral de Monitoramento de Produtos Sujeitos à Vigilância Sanitária, Gerência de Tecnovigilância. – Brasília: Agência Nacional de Vigilância Sanitária, 2021. 1046 p. : il. Acesso em: 20 jun. 2023. GIL, Antonio Carlos et al. Como elaborar projetos de pesquisa. São Paulo: Atlas, 2002. ASHBY, M.; JOHNSON, K. Materiais e Design: Arte e Ciência de Materiais no Design de Produto. Rio de Janeiro: Elsevier, 2011. BOOTHROYD, G.; DEWHURST, P.; KNIGHT, W. Product Design for Manufacture and Assembly (DfMA). Wakefield, Boothroyd Dewhurst Inc, 2002. RAMALINGAM, Ben; PRABHU, Jaideep. Innovation, development and COVID-19: Challenges, opportunities and ways forward. Paper: OECD, v. 1, 2020. THOMPSON, Rob. Prototyping and low-volume production. (No Title), 2011. PAHL, G.; BEITZ, W. Engineering Design. Londres/Berlim: The Design Council/Springer-Verlag, 2 e.d, 1997.

Como citar:

MARQUES, AMANDA DA COSTA ; BEAL, Valter Estevão; "MATERIALS AND PROCESSES SELECTION FOR MEDICAL DEVICE PROTOTYPING FOR CLINICAL TRIALS", p-92-99. In: . São Paulo: Blucher, 2023.
ISSN 23577592, DOI 10.5151/siintec2023-305333