Towards Non-Destructive Quality Testing of Complex Biomedical Devices—A Generalized Closed-Loop System Approach Utilizing Real-Time In-Line Process Analytical Technology

Abstract

This study addresses the critical issue of cardiovascular diseases (CVDs) 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. This research addresses this challenge by proposing a novel approach: a closed-loop cyber-physical production system (CPPS) employing non-destructive process analytical technology (PAT). Through a mixed-method approach combining a comprehensive literature review and the development of a CPPS prototype, the study demonstrates the potential for real-time quality control, reduced production costs, and increased manufacturing efficiency. Initial findings showcase the system’s effectiveness in streamlining production, enhancing stability, and minimizing defects, translating to substantial financial savings and improved product quality. This work extends the author’s previous research by comparing the validated system’s performance to that of pre-implementation manual workflows and inspections, highlighting tangible and intangible improvements brought by the new system. This paves the way for advanced control strategies to revolutionize medical device manufacturing. Furthermore, the study proposes a generalized CPPS framework applicable across diverse regulated environments, ensuring optimal processing conditions and adherence to stringent 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.