The global medical device industry is estimated at over €200 billion annually and European manufacturers currently hold 35% of the market. Although implantable medical devices improve quality of life for millions of people, the rates of complications and failures due to incompatibility of the devices with human tissues and device related infections are unacceptably high. A number of promising strategies are being implemented to reduce these complications and failures including thin film coatings, surface grafted biomolecules, nano-particle coatings, and drug eluting materials.
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Manufacture and certification of devices that employ these advanced biomaterials will require traceable, reliable metrology tools that are able to measure surface layers, surface contaminants, defects and the 3-D distribution of chemical constituents in the near-surface region. The US Food and Drug Administration (FDA) have targeted better quality management of device surface chemistry as an area of growing and concern and new regulations in this area are expected in the near future. We have identified four key needs within the European Medical Device industry:
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.
For more information, please contact the project coordinator, firstname.lastname@example.org from NPL.
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