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The aim of the proposed JRP is to develop chemical metrology tools for the traceable measurement and characterisation of advanced biomaterials in the medical device industry. Robust metrological tools for the rapid characterization of medical devices surfaces are needed both for patient safety and to ensure the continuing competitiveness of the European Medical Device Industries. The tools developed in JRP IND56 will improve reproducible manufacture and quality management of advanced medical device materials. JRP IND56 will develop the underpinning metrology the industry needs to improve device performance, reduce failure rates and satisfy existing and emerging regulatory requirements.

No existing chemical analytic tools are able to meet all of the industry demands. High vacuum surface analysis methods, such as XPS, Time-of-Flight Secondary-Ion Mass Spectrometry (ToF-SIMS), NEXAFS, and GIXRF, have proven valuable in the research and development of advanced biomaterials but further improvement is necessary to provide the spatial resolution and reproducibility needed to design materials and understand failure mechanisms. Furthermore, these methods are very poorly suited for in-line and on-line analysis in the manufacturing environment. They are also generally incapable of handling the complex geometry of complete medical devices. Emerging ambient techniques that employ either optical spectroscopy or mass spectrometry are far better suited to the manufacturing environment but at this time these techniques lack the reproducibility, traceability and surface specificity needed for the characterisation of advanced biomaterials. The focus of JRP IND56 is to bridge the gap between the proven high vacuum techniques and the emerging ambient methods in order to provide a robust metrology tool set for quality management in the medical device industry.

Consortium

The JRP-Consortium will also host a stakeholder workshop and a special session on the analysis of medical device surfaces at the European Society for Biomaterials and the Surfaces and Biomaterials meetings. Peer-reviewed publications and conference presentations will also disseminate the results to academic and industrial audiences.

Impact

The project will provide guides, standards and protocols for the quantitative analysis of biomaterials relevant to the needs of medical device manufacturers. This initiates a new area of activity for European National Measurement Institutes (NMIs) and addresses the needs of the large and rapidly growing medical device industry. The project will provide input to standards, protocols on the analysis and quality management of medical devices, propose VAMAS inter-laboratory studies, and contribute to meetings and relevant new work items within ISO. The JRP-Consortium will also host a stakeholder workshop and a special session on the analysis of medical device surfaces at the European Society for Biomaterials and the Surfaces and Biomaterials meetings. Peer-reviewed publications and conference presentations will also disseminate the results to academic and industrial audiences.

The research within this EURAMET joint research project receives funding from the European Community's Seventh Framework Programme, ERA-NET Plus, under Grant Agreement No. 217257.