Implant Lifecycle Management© Simon Pieske
The manufacture of medical devices requires compliance with comprehensive safety and performance requirements already during the development process. In particular, this includes product documentation and monitoring and interdisciplinary networking between medical device development, patient safety requirements, certification, and quality assurance. Product Lifecycle Management solutions can support the creation of the necessary documentation by networking the various areas and coordinating the necessary work. A PLM system provides a unified data platform for managing, sorting, and processing the data associated with a product. Thus, processes such as development, quality assurance, documentation, and certification of products can be supported in a way that is unique in pre-competitive university research.
The objective of this project is to explore a comprehensive PLM system for lifecycle management and coordination of the development of a biologized medical device using the biohybrid vascular prosthesis as an example. The implant lifecycle management (ILM) system is to enable implant-specific data acquisition and data provision and thus support the legally required traceability during development of the implant.
The ILM project is embedded in the NeWTranslation project. The aim of the collaborative project is to research and establish an end-to-end translation process that enables researchers and physicians to successfully navigate the path from preclinical studies to clinical applications.
ILM will first identify opportunities to support researchers in the development and manufacture of medical devices and the technical documentation required to do so. This includes the determination of requirements for such a system, taking into account laws and standards.
Subsequently, the existing and necessary processes, materials as well as raw materials, and intermediate products are determined and transferred into a uniform semantic data model. In addition, it will be determined how the supports identified at the outset can be implemented in concrete terms. Finally, the system will be implemented concretely in the form of a software demonstration.
We would like to thank the German Federal Ministry of Education and Research for its support in the research of the Implant Lifecycle Management, within the framework of a grant (FKZ: 13GW0452A).