Concept for the development of a methodology for the implementation of remanufacturing of medical devices

Anthropogenic environmental impacts increase the need for medical care as pollution and climate change put human health at risk. Unfortunately, the medical sector contributes significantly to resource depletion and climate change itself, being responsible for about 5% of global greenhouse gas emissions. One possibility to reduce the sector’s environmental impact is remanufacturing medical devices, thereby reducing waste, resource consumption, and associated emissions. The implementation of remanufacturing in the medical industry is, however, impeded by strict regulatory requirements. In response to these challenges, this paper presents a research concept for the development of a methodology for the regulatory-compliant, economically and environmentally sustainable implementation of remanufacturing of medical devices. Based on a summary of the state of the art, the approach is divided into three modules and covers the analysis of regulatory requirements in module 1, the product suitability for remanufacturing in module 2, and the overall implementation methodology in module 3. Research questions to be considered in the methodology development and an outlook of how the approach will be implemented are discussed. This research aims to bridge the gap between environmental sustainability and regulatory compliance, providing a new standard for manufacturing practices within the medical sector.