Research & Development

TCC-CASEMIX

Medical Device Information System – Post-Market Surveillance – Open Registry Infrastructure.

Developing a Medical Device Information System [MDIS] has been a central ambition of TCC-CASEMIX since we commenced trading in January 2020. Thanks to a significant investment by UK Research & Innovation this is now a reality and already commercially deployed.  Our significant Euroean deployment has been in Szeged, Hungary, in the Department of Orthopaedics and Traumatology, led by Professor Varga.  We are currently [August 2021] managing enquiries from Netherlands, Belgium, and Austria.

The next step in the development of the MDIS, has been to establish the infrastructure for Post-Market Surveillance [PMS] of medical devices used in surgery.  This enables medical device manufacturers to demonstrate compliance with Medical Device Regulations in both UK and mainland Europe.   To achieve this major innovation, TCC-CASEMIX has developed the foundational work for an Open Registry Infrastructure.  This infrastructure is the means to receive PMS data streamed real-time data from the MDIS.

The significance of the Open Registry Infrastructure cannot be underestimated, because it enables medical device registries receiving data at hospital level to be automatically aggregated into regional registries, and then into national regsitry, thereby enabling manufacturers to ‘harvest’ performace data relating to their devices from across the registry infrastructure.  Conventional practice makes this very hard to achieve – both expensive and time-consuming for device manufacturers.

Further research and development work, is currently the subject of a UK Research & Innovation Biomedical Catalyst grant application.  Watch this space!