Strategic collaboration designed to advance real-world evaluation of medical devices
Redmond, Wash. – The Medical Device Epidemiology Network (MDEpiNet) and Medstreaming/M2S have established a strategic collaboration to advance real-world evaluation of medical devices. This collaboration combines the registry development and support expertise of Medstreaming/M2S with the deep analytic capabilities of MDEpiNet. Currently, Medstreaming/M2S provides registry infrastructure for the Vascular Quality Initiative (VQI) and the NeuroVascular Quality Initiative – Quality Outcomes Database (NVQI-QOD), both of which collect extensive clinical data about procedures using vascular devices. Data from such registries can greatly benefit device manufacturers for research and regulatory purposes, but often requires application of sophisticated analysis and data linkages with other data sources such as claims data to enhance long-term outcome assessment. MDEpiNet is a public-private partnership that is dedicated to creating the science of medical device research and evaluation, and able to provide data linkages and powerful analytic tools.
“We recognize the established ability of Medstreaming/M2S to provide registry services to societies and create valuable datasets for industry that are derived from these registries, including the ability to add custom elements for specific research projects.” said Art Sedrakyan, MD, PhD, Director, MDEpiNet Coordinating and Science Infrastructure Center. “For example, Medstreaming/M2S accumulated important knowledge in unique device identifier implementation in registries leveraging the FDA/NLM Access GUDID system, which is valuable experience for MDEpiNet. Our experience to date indicates that Medstreaming/M2S is a key partner for large scale registry development and related work with major stakeholders. We have developed a strategic collaboration with Medstreaming/M2S to optimize the long-term goals of MDEpiNet.”
“MDEpiNet can provide valuable analytic support to enhance device evaluation using registries that we support,” said Wael Elseaidy, PhD, CEO of Medstreaming/M2S. “For example, by incorporating deep analytics and claims data matching within our registry platform offerings, we can greatly increase registry value for societies and related device research stakeholders. MDEpiNet is the ideal partner to help us offer more sophisticated analysis and long-term follow-up to accelerate quality improvement.”
This collaboration envisions joint contracts to develop device evaluation projects with interested funders, with strategic planning and shared resources to optimize the support of total product life cycle device evaluation using real-world evidence.
MDEpiNet is a global Public-Private Partnership that brings together leadership, expertise, and resources from health care professionals, industry, patient groups, payers, academia, and government to advance a national patient-centered medical device evaluation and surveillance system. Its mission is to develop and test novel methods, infrastructure, and partnerships for the creation of re-useable real-world data resources and support device evaluation by multiple stakeholders. Since its establishment in 2010, MDEpiNet has worked to build a global real-world evidence collaborative for health technologies. The MDEpiNet Coordinating Center at Weill Cornell Medicine supports MDEpiNet operations under a cooperative agreement with the US Food and Drug Administration, and the Center for Devices and Radiological Health. For more information, visit www.mdepinet.net.
September 18, 2020