Innovation in medical devices for the SUS: a translational pathway to support Brazilian researchers

Abstract Purpose The performance of health innovation in Brazil directly impacts both population access to healthcare services and the sustainability of the Brazilian National Health System (SUS). Recognizing that innovation follows a multidimensional pathway, this study seeks to answer the following research question: “How can key competencies in the research translation process be integrated to support Brazilian researchers in developing innovative medical devices for the national health system?” The objective was to propose a structured pathway enabling Brazilian researchers to anticipate requirements and accelerate the development of safe, effective, and affordable technologies aimed at improving equitable access to healthcare within the SUS. Methods This study was based on an exploratory review of the scientific literature, Brazilian legislation, applicable technical standards, and official systems involved in research, development, and innovation processes, as well as in the requirements and studies demanded for the incorporation of technologies into the SUS. Results The incorporation of medical devices into the SUS follows a formalized process grounded in the best available scientific evidence and in the comparative economic assessment of relative benefits and costs. The translational route for innovative medical devices (TRIMD) is anchored in the alignment between regulatory processes, research phases, and health technology assessment (HTA) studies. Conclusion The TRIMD is embedded within a normative and institutional environment and provides an adaptable framework to guide research groups. It contributes to the design of institutional strategies and interinstitutional arrangements that enhance innovation performance in Brazil’s medical device sector.