Multiparametric quality by design-fuzzy model applied in the development of a biomedical measuring system

This work presents the adaptation of the Quality by Design (QbD) approach for application in the quality assurance of a biomedical measuring system under development. First attempts in applying QbD to biomedical technologies indicated a significantly higher number of parameters than its traditional application in the pharmaceutical industry. These preliminary studies did not fulfill the QbD stage of Design Space (DS) configuration for biomedical devices, an essential step to identifying the proper operating ranges of parameters and guaranteeing quality features. Therefore, it persisted the challenge of configuring DS for health devices, overcoming dependences in the interaction of multiple process parameters and critical attributes. The present work develops a hybrid QbD-Fuzzy approach for multiparametric DS configuration. The proposed method was applied in the development phase of a low-cost and high-sensitive magnetic measuring system for locating metallic foreign bodies in patients, employing sensors based on the Giant Magnetoimpedance effect. The results provided the acceptable operating ranges of the multiple process parameters to ensure the biomedical equipment's suitability. The proposed strategy contributes to the QbD implementation in biomedical technologies and, therefore, promotes the reliability of diagnostic and therapeutic results in the clinical environment.