Lifecycle of individualised 3D printed orthopaedic and prosthetic devices

This study proposes a holistic lifecycle for anatomically customised, 3D-printed orthopaedic and prosthetic devices based on the development of the AutoMedPrint system to Technology Readiness Level 9. The lifecycle was developed by comparative analysis of the engineering product LC according to Regulation (EU) 2017/745 requirements and empirical experience of the AutoMedPrint system. It contains eleven stages, from diagnosis to recycling, with defined participants and information flows. Validation in a case study of over 50 patients showed all cases handled within the defined stages, delivery within 72 hours of production start, and typically one to two fitting iterations. Limitations include validation within a single system and product family and the absence of a certified quality management system. The lifecycle is universal and applicable to other customised medical devices. It provides a foundation for constructing new systems tailored to specific product needs, patient groups, or regional requirements.