Circular economy (CE) decouples value creation from virgin resource use and waste in the medical device sector, which faces stringent patient-safety, quality, and regulatory obligations. Green Additive Manufacturing (AM) offers a precise, digitally driven route to implement CE through dematerialization, on-demand localized production, topology optimization, and material circularity. In this study, a comprehensive CE framework is tailored to medical device manufacturing that integrates eco-design, material circularity, remanufacturing, and regulatory compliance across the product life cycle. Methods include an International Organization for Standardization (ISO) 14040/44-aligned life cycle assessment, process energy metering, sterilization-compatibility studies, mechanical/biocompatibility verification to relevant standards, and a techno-economic/circularity analysis with Monte Carlo uncertainty quantification. Three case studies are explored using bio-based PA11 (selective laser sintering), recycled polyethylene terephthalate glycol (fused deposition modeling), and low-volatile organic carbon biocompatible photopolymer (stereolithography): (1) a patient-specific wrist orthosis, (2) a dental surgical guide, and (3) a single-use catheter Y-connector. Results indicate 38–68% reductions in embodied greenhouse-gas emissions, 22–54% energy savings per functional unit, and up to 80% mass recapture through in-process powder/runner reuse while maintaining clinical performance and regulatory conformity. Design-for-circularity patterns (DfC) were created for DfDisassembly, DfSter, DfTraceability, DfUpgrade, and DfPowder-Loop and provide a governance architecture combining ISO 13485 QMS, ISO 10993 biological evaluation, the European Union’s Medical Device Regulation (Regulation (EU) 2017/745), and the United States Food and Drug Administration’s guidance on Additive Manufactured (3D-printed) medical devices, guidance with unique device identification for closed-loop returns. The paper concludes with an Industry 5.0 roadmap for hospital-proximate micro-factories, materials passports, and digital product passports enabling verified circular flows at scale.
Wai Yie Leong (Fri,) studied this question.