Procedimentos para seleção de materiais para uso em protótipos de dispositivos médicos

Abstract

Technological innovation in Brazil faces significant challenges due to issues such as the lack of integration between design and manufacturing, especially in the local production process of high-value-added products. This study explored the Product Development Process (PDP) in two Science and Technology Institutions (STIs) focused on technological innovation for health. It was observed that effective integration between the initial stages of product design and manufacturing processes can result in reduced rework and shorter development time. The objective of this study was to develop a model that integrated the procedures for material selection and prototyping processes into the design of medical devices, aligning them with regulatory requirements to promote product feasibility and validation through effective prototyping and testing. The methodology adopted included an exploratory case study with a qualitative approach, based on bibliographic research to identify essential practices for product development and define the specifics of the medical device lifecycle. The proposal was evaluated with a group of medical device developers to verify if the proposed development process mapping had a positive impact on the team's understanding and planning of the process. The results showed that presenting the proposal improved the team's understanding of issues affecting medical device development and identified useful tools to assist in this process. The application of the procedures in a previous project demonstrated that regulatory risk analysis is essential for planning development, resulting in a prototype plan to be constructed for testing execution. This planning facilitates the preliminary analysis of necessary materials and production processes, which aids in the feasibility of the prototyping process to meet the project demands, even with limited resources.