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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.

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.

Palavras-chave: Technological Innovation; Healthcare Systems; Developing Countries;,

Palavras-chave: Technological Innovation; Healthcare Systems; Developing Countries;,

DOI: 10.5151/siintec2023-305333

Referências bibliográficas
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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 2357-7592, DOI 10.5151/siintec2023-305333

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