Framework for Component Prioritization in Medical Device Remanufacturing : A Case Study on a Powered Prosthetic Device

Sammanfattning

Transitioning toward more sustainable medical device systems requires approaches that reduce environmental impact without compromising safety, performance, or regulatory compliance. One way to support this transition is through remanufacturing, which can extend product life cycles while reducing the need for new material production. However, decisions about what can be remanufactured and to what extent remain complex. Such decisions must account not only for sustainability potential but also for technical feasibility, traceability, and regulatory considerations. This thesis develops and evaluates the usability of a decision framework to support the identification and assessment of components with high remanufacturing potential in regulated systems. The framework combines multi-criteria decision-making with a feasibility assessment to support early-stage remanufacturing decisions, helping navigate the trade-offs between sustainability goals and strict compliance constraints. Through this approach, which incorporates economic, environmental, social, technical, and regulatory considerations, the framework enables a transition from isolated sustainability assessments toward the evaluation of remanufacturing opportunities in relation to practical implementation constraints. The framework is demonstrated through a case study of a prosthetic foot using internal service data, technical documentation, disassembly observations, and expert input. To assess its usability, the framework was evaluated by a manufacturing engineer, who iteratively reviewed its usability and decision-making logic through weekly collaborative sessions. The results show that components with higher remanufacturing potential may require additional feasibility evidence before implementation, while the usability evaluation indicated that the framework effectively structures complex decision-making. Therefore, this thesis highlights the importance of combining prioritization with feasibility assessment to support the development of sustainable, practical, and implementable remanufacturing systems for regulated products.