1. Abstract
Rivero, Alejandro Martínez ; 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 Pós-Graduação
emMetrologia (Área de concentração: Metrologia para Qualidade e
Inovação), Pontifícia Universidade Católica 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