Circular Economy Through Green Additive Manufacturing in Medical Device Manufacturing

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 ...