March 2015 saw Metabolomic Diagnostics accredited to ISO:13485. As head of Regulatory Affairs at Metabolomic Diagnostics, I am confident that this significant achievement will enable us to complete the process of deploying our innovative technology on the market in a timely, compliant manner. Our new staff members, equipment, and laboratory have greatly enhanced our capabilities. Our screening test will be offered by medical reference diagnostic laboratories and will greatly reduce the incidence of preeclampsia and thereby save lives and lower the cost of antenatal care. My experience in hiring and building a team of consultants to complete the accreditation of laboratories within every major hospital in Ireland has given me an invaluable insight into the workings of pathology departments which is now proving invaluable as we bring innovative technology to market. We are also in ongoing discussions with regulators and health plan providers in Europe and the US as we seek the smoothest path to market for our blockbuster test.
Open Innovation Partners has increased it’s presence among startups and recently concluded the BioApp For Health Programme which is an EU Erasmus Programme to help medical and engineering students work together to bring innovative medical technologies to market. I am also a member of ISO TC215 Technical Committee for Standardization in the field of information for health, and Health Information and Communications Technology (ICT) to promote interoperability between independent systems, to enable compatibility and consistency for health information and data, as well as to reduce duplication of effort and redundancies.
The domain of ICT for health includes but is not limited to:
Disease prevention and wellness promotion;
Public health and surveillance;
Clinical research related to health service.