Multi-parameter fuzzy design space for QbD approach applied in the development of biomedical devices

Velázquez, Daniel; Louzada, Daniel Ramos; Monteiro, Elisabeth Costa; Fortaleza, L. G. S.; Barbosa, Carlos Roberto Hall; Silva, E. C.; Gusmão, L. A. P.

doi:10.1088/1742-6596/1044/1/012051

Cited by 4 publications

(17 citation statements)

References 11 publications

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“…The fundamental assumption underlying QbD is that product quality can only be ensured if critical sources of variability are understood and adequately mitigated or controlled [15]. Thus, the QbD tool can be implemented by identifying a series of interdependent parameters and attributes, which, when analyzed, generate knowledge for optimization and quality assurance of the product to be fabricated [16].…”

Section: Introductionmentioning

confidence: 99%

“…In alignment with Biometrological precepts [7,8], the Laboratory of Biometrology (LaBioMet) at PUC-Rio conducts research aimed at developing low-cost, highsensitivity biomedical sensors and transducers for safe and noninvasive measurements to be incorporated into the clinical environment. Thus, to contribute to the improvement of the quality assurance of biomedical technologies under development, preliminary initiatives have been undertaken to apply QbD approach in the development of devices for use in healthcare such as assistive technologies [15] and magnetic transducers for biomedical application [16,19]. In these studies, initial steps to configure DS was achieved using Fuzzy Logic.…”

Section: Introductionmentioning

confidence: 99%

“…Despite the advances, the work evaluated a simplified DS configuration with only two pairs of CPPs associated with two CQAs, being each pair independently analyzed. The subsequent initiative has been the application of the QbD tool in the development of a low-cost magnetic transducer intended for biomedical applications [16,19]. This measurement system, under development at LaBioMet, uses magnetometers based on the Giant Magnetoimpedance (GMI) effect, specifically designed to locate non-ferromagnetic metallic objects inserted into the human body.…”

Section: Introductionmentioning

confidence: 99%

“…These preliminary studies applying the QbD approach in the development of biomedical technologies did not reach a complete analysis of the set of involved parameters [15,16,19], and a greater complexity of the QbD scenario was evidenced when applied to these technological modalities. In these cases, the QbD implementation results in a higher number of parameters (CQAs and CPPs) [15,16,19] when compared to its application in the pharmaceutical industry [ More recently, two other studies investigated the application of QbD approach in the medical field [41,42]. Martinez-Marquez [41] developed an extensive literature review on the suitability of QbD for the development process of 3D printed custom bone prosthesis and scaffolds.…”

Section: Introductionmentioning

confidence: 99%

“…However, for the proper implementation of this quality tool in the development process of devices with biomedical applications, one must overcome the challenge of QbD implementation in this field. It is necessary to develop a method that allows the configuration of DS in situations involving a significant number of CQAs and CPPs, which employ several measurement units and operating ranges [16,19].…”

Section: Introductionmentioning

confidence: 99%

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

Velázquez

Monteiro

Louzada

et al. 2020

Int. J. Metrol. Qual. Eng.

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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.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Velázquez

Monteiro

Louzada

et al. 2020

Int. J. Metrol. Qual. Eng.

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Automatic system for locating magnetic foreign bodies using GMI magnetometer

Oliveira

Louzada

Monteiro

et al. 2021

J. Phys.: Conf. Ser.

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The development of systems capable of characterizing the positioning and inclination of metallic objects inside the human body is seen with great interest by health professionals who are responsible for their extraction. A surgical procedure can be shortened from a few hours to minutes with a system that provides accurate positioning data. Thus, the present work aims at the construction of a measurement system of magnetic fields originated by ferromagnetic objects, based on magnetoimpedance (GMI) sensors. The developed system is capable of positioning a ferromagnetic object to be measured with 5 degrees of freedom, being 3 linear (X, Y, Z) and 2 angular (θ, Φ), and measure the magnetic flux density of this source in an automated way. Three tests were performed with a steel needle, varying the angles of inclination to the measurement plane (θ) and rotation angles in the same plane (Φ). The obtained results yieded records of the magnetic patterns formed by the needle, which can be later processed in order to create a localization software.

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Estratégia Híbrida Das Abordagens Quality by Design E Failure Mode and Effect Analysis Para Aplicação No Desenvolvimento De Tecnologia Biomédica

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Multi-parameter fuzzy design space for QbD approach applied in the development of biomedical devices

Cited by 4 publications

References 11 publications

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

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

Automatic system for locating magnetic foreign bodies using GMI magnetometer

Estratégia Híbrida Das Abordagens Quality by Design E Failure Mode and Effect Analysis Para Aplicação No Desenvolvimento De Tecnologia Biomédica

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