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Towards Non-destructive Quality Testing of Complex Biomedical Devices – a Generalized Closed Loop System Approach Utilizing Real-Time in Line Process Analytical Technology
Guha, B.; Moore, S.; Huyghe, J. Towards Non-Destructive Quality Testing of Complex Biomedical Devices—A Generalized Closed-Loop System Approach Utilizing Real-Time In-Line Process Analytical Technology. NDT2024, 2, 270-285.
Guha, B.; Moore, S.; Huyghe, J. Towards Non-Destructive Quality Testing of Complex Biomedical Devices—A Generalized Closed-Loop System Approach Utilizing Real-Time In-Line Process Analytical Technology. NDT 2024, 2, 270-285.
Guha, B.; Moore, S.; Huyghe, J. Towards Non-Destructive Quality Testing of Complex Biomedical Devices—A Generalized Closed-Loop System Approach Utilizing Real-Time In-Line Process Analytical Technology. NDT2024, 2, 270-285.
Guha, B.; Moore, S.; Huyghe, J. Towards Non-Destructive Quality Testing of Complex Biomedical Devices—A Generalized Closed-Loop System Approach Utilizing Real-Time In-Line Process Analytical Technology. NDT 2024, 2, 270-285.
Abstract
This study addresses the critical issue of cardiovascular diseases (CVD) as the leading cause of death globally, emphasizing the importance of stent delivery catheter manufacturing. Traditional manufacturing processes, reliant on destructive end-of-batch sampling, present significant financial and quality challenges. The research highlights the need for non-destructive Process Analytical Technologies (PAT) to meet the increasing demand for these life-saving devices. The study employs a mixed-method approach, combining qualitative literature review and quantitative artefact development, to propose a closed-loop Cyber Physical Production System (CPPS). The proposed system aims to enhance real-time quality control, minimize costs, and improve manufacturing efficiency. Initial results demonstrate the system's effectiveness in reducing cycle times, improving stability, and significantly decreasing production misses. The findings suggest substantial financial savings and quality improvements, underscoring the potential of advanced control strategies in regulated medical device manufacturing. This study proposes a generalized CPPS framework to be applicable across diverse regulated manufacturing environments, ensuring optimal processing conditions and adherence to regulatory standards. The research concludes with the successful demonstration of innovative approaches and technologies, leading to improved product quality, patient safety, and operational efficiency in the medical device industry.
Keywords
Cyber Physical Systems; Process Analytical Technology; Stent Delivery Catheters
Subject
Engineering, Industrial and Manufacturing Engineering
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
