Banca de QUALIFICAÇÃO: Vladimir França Nogueira

Uma banca de QUALIFICAÇÃO de DOUTORADO foi cadastrada pelo programa.
STUDENT : Vladimir França Nogueira
DATE: 27/04/2023
TIME: 09:30
LOCAL: Sala de Seminários (Espaço Sérgio Barroso)
TITLE:

Dimensões Éticas e Regulatórias do Processo de Desenvolvimento Tecnológico do Dispositivo Médico Portátil para Tratamento de Doenças dos Pés no Diabetes: da Bancada à Fabricação em Escala

KEY WORDS:

Translational medical research, Diabetic Foot, Rapha® Equipment, Unified Health System, Health Policy.

PAGES: 116
BIG AREA: Engenharias
AREA: Engenharia Elétrica
SUBÁREA: Eletrônica Industrial, Sistemas e Controles Eletrônicos
SPECIALTY: Controle de Processos Eletrônicos, Retroalimentação
SUMMARY:

The development of new technologies applied to health is complex, due to this the academy, the government, society and companies have been committed in order to accelerate the achievement of basic research and the availability of new products for the population. It is known that the Brazilian regulatory system for medical equipment involves ethical, technical, regulatory, economic and social issues in order to guarantee safety and minimum technical conditions to meet the proposed solution according to the indication of use effectively. In this sense, translational medical research (TMS) emerged as a set of actions and activities with the aim of transferring the results found from basic research to the approval of the technology to be made available to users/patients through the translation steps in which was considered the Brazilian regulatory processes. Objective: To develop a theoretical framework in relation to the TMS process in the research, development and innovation ecosystem of the Public University of Brazil and the ethical and regulatory environment associated with the development of new medical products for the Brazilian health system according to the case study of Rapha® equipment. Method: The approach is composed of strategies that initially carried out a survey of public policies encouraging the technological development of medical equipment by the Public University in order to identify the ecosystem with the capacity for social inclusion and benefits for society. In this context, it was necessary to characterize the steps, markers, entities and policies of translational research related to new health technologies in Brazil for medical products and the ethical and regulatory aspects based on the single case study of the Rapha® equipment, in addition to their degree of technological maturity. Results: The transformation of research carried out within universities into products that can be assimilated in health care generated patents, technological transfers that are linked to the innovation process. Thus, the TMS configures as a non-linear research process as determined by the analysis of the case study of the Rapha® equipment. Among the difficulties encountered were the regulatory and production process for the transition from phase T3 to T4 in order to make the technology available to the Brazilian market. In this way, the time steps T0, T1, T2, T3 were identified as results of the translation of the Rapha® equipment over time. Conclusion: The TMS presents the scientific development carried out in order to enable access to health by the population through the research, development and innovation environment of the Public University of Brazil and the ethical and regulatory environment associated with the development of new medical products for the system of Brazilian health.

BANKING MEMBERS:
Presidente - 404943 - ADSON FERREIRA DA ROCHA
Externa ao Programa - 2293952 - FLAVIA MARIA GUERRA DE SOUSA ARANHA OLIVEIRA
Externa ao Programa - 2506617 - SUELIA DE SIQUEIRA RODRIGUES FLEURY ROSA
Externo à Instituição - TALÍA SIMÕES DOS SANTOS XIMENES - UNICAMP
Externa à Instituição - FÁTIMA MRUÉ - UFG