Ferramenta (calculadora) para mitigação de riscos associados ao processo de inovação e identificação do grau de maturidade tecnológica para dispositivos médicos

Abstract

This paper presents a tool (calculator) for measuring the technological maturity level of medical devices. The metrics of the TRL, MRL, PRL indicators were made compatible and harmonized, the Brazilian Health Sector Legislation converted into metrics and the DMRL indicator was developed for medical devices at nine levels of technological maturity, as a function of TRL, MRL, PRL and Legislation. Health Sector. The tool (calculator) converts the metrics in the nine levels of the DMRL indicator to evaluate the degree of maturity of medical device technology. In addition to the level of maturity the tool presents the results in 10 dimensions of the manufacturing process divided as follows: Technology; Design; Cost; Materials; Process; Quality; Team; Installation; Manufacturing and Medical Device. In the presentation of the results, the tool makes it possible to visualize at what stage of maturity (1 to 9) each dimension is located and the DMRL indicator.