Thesis summary
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This document is a 96-page MSc dissertation that explores adapting Quality by Design (QbD) principles to the development of biomedical technologies. It presents efforts to implement QbD in developing an assistive robotic device for elderly locomotion. It establishes the device's Target Product Profile through a questionnaire given to elderly care experts. Using this and literature, it identifies critical quality attributes and critical process parameters for the device. As conventional QbD statistical methods are not feasible, it configures the device's design space through an adaptation of fuzzy logic modeling.
Thesis summary
- 1. Abstract Rivero, Alejandro Mart鱈nez ; Monteiro, Elisabeth Costa (Advisor); Leite, Karla Tereza Figueiredo (Co-Advisors). New Quality by Design Fuzzy Method Applied in the Development of Biomedical Technology. Rio de Janeiro, 2015. 96p. MSc. Dissertation Programa de P坦s-Gradua巽達o emMetrologia (rea de concentra巽達o: Metrologia para Qualidade e Inova巽達o), Pontif鱈cia Universidade Cat坦lica do Rio de Janeiro. Quality by Design (QbD) has been used in the pharmaceutical and biotechnology industry since 2004, contributing to meet the pre-defined aspects of safety and efficacy. In this work are presented the preliminary efforts to adapt and implement the QbD approach to guarantee the reliability of biomedical technologies, particularly in the development phase of an assistive robotic device for elderly locomotion. For setting the Target Product Profile (TPP) associated with the device features, questionnaire was elaborated and applied to a multidisciplinary team for elderly care. Through statistical analysis of the results and literature data, clinical difficulties to be met by the device features have been identified. With this information, literature data and risk analysis techniques, the Critical Quality Atributes were specified (CQA), characteristics of technology that need to be tracked throughout the development. The CQA data and risk analysis through brainstorming were used to determine the Critical Process Parameters (CPP), including metrological aspects, which are not considered in the conventional application of QbD . Being not feasible the use of conventional QbD statistical methods applied in pharmaceutical industry, Design Space has been configured by means of adaptation of fuzzy logic, establishing the CPP associated with the optimum performance of the device; and, for reduction of system complexity, was proposed a model by applying a hierarchical fuzzy system. Keywords Metrology; Quality by Design; Assistive technology; Robotics; Biomedical Device