MDEpiNet has been championing international collaborations since our launch in 2010. The International Registry Consortia is one of the founding pillars of the MDEpiNet infrastructure with major successes of the International Consortium of Orthopedic Registries and International Consortium of Vascular Registries initiatives. In the past two years, MDEpiNet’s multi-stakeholder focused international chapters have developed as a driving and unifying force for building the device research discipline.
This chapter of MDEpiNet was founded at the University of New South Wales Big Data Centre in January 2018. In December 2018, the Chapter hosted a major stakeholder meeting in Sydney. The focus of this meeting was engaging regulators, major payers and manufacturers to develop data infrastructure and implement unique device identifiers. Another objective was to highlight the role of real world evidence in active surveillance of health technologies. Specific examples from registries and a growing number of administrative databases worldwide were discussed. The meeting also included leaders from the International Medical Device Regulators Forum that focus on big data to start a dialogue about potential maturity models and their application in the claims environment.
Developing Japan Chapter:
In January 2019, MDEpiNet organized a real world evidence workshop and summit in Japan for clinicians and regulators. There were advanced conversations with clinicians and regulators to launch a Chapter at the National Center for Global Health and Medicine, which is one of three major clinical and research centers in Japan that receives government funding for research. The Chapter will have access to insurance claims data in Japan to develop its data model. The national surgical registry of Japan is also interested in collaborative infrastructure development through a novel partnership. Major meetings are planned for fall 2019 to kick start the developmental work for chapter creation.
Developing German Chapter:
The German Chapter of MDEpiNet will be founded at the University Medical Center Hamburg-Eppendorf Research Group GermanVasc at the University of Hamburg, Germany. A nationwide Summit on Real-World-Evidence in cardiovascular medicine is planned for November 1, 2019 to kick start the developmental work for chapter creation. The GermanVasc group is well-experienced in the scientific utilization of health insurance claims and registry data and deeply involved in various national and international collaborations in cardiovascular medicine. Beginning with the development in Hamburg, Germany, public and private stakeholders as well as representatives from different medical specialties are currently invited to join the multidisciplinary task force developing the German Chapter of MDEpiNet.