Coordinated Registry Networks
Coordinated Registry Networks (CRNs) are a key MDEpiNet strategy to bring together real-world data from a variety of sources to address the needs of device evaluation for multiple stakeholders. The CRN approach circumvents the limitations of traditional registries and data repositories by building linked data systems from multiple sources.
MDEpiNet broadly defines CRNs based on the International Medical Device Regulators’ Forum (IMDRF) definition of registry system as follows: ‘Registries are organized systems with a primary aim to increase the knowledge of medical devices contributing to improve the quality of patient care that continuously collect relevant data, evaluate meaningful outcomes, and comprehensively cover the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g. international, national, regional, and health system)’. CRNs leverage national investments in various real-world data sources to create robust medical device ecosystems in multiple clinical areas.
Since 2017, MDEpiNet has been developing learning communities (LC) for CRNs to speed the development and maturity of the networks. It is facilitated and supported by the MDEpiNet Coordinating Center at Weill Cornell Medicine, which is establishing working groups charged with advancing multiple maturity domains through developmental work and implementation. The LC ensures that each CRN focuses on broad and balanced stakeholder participation which leads to strong stakeholder engagement and sustainability. Within the community, the leaders are able to leverage medical device ecosystem stakeholders currently engaged with the MDEpiNet.
The main goal is to promote CRN development as a robust source of evidence for device evaluation and serve as a foundational component of NEST. The NESTcc and MDEpiNet communities recognize the value that CRNs contribute as a real-world data source, and thus, endorse MDEpiNet in its efforts to create a LC. Currently, there are seventeen CRNs operating or under development (see links below).
Development of a repository of materials, tools, and best practices to support the maturity of the CRNs in Device Identification, Quality Improvement/Beneficial Change, Total Product Life Cycle (TPLC), Efficiency, Data Quality, and Governance.
Development of an assessment tool to evaluate maturity, determine the specific needs of each CRN, and guide the curation of resources to best meet needs – such as a maturity model that can be useful to understand the level of development to help plan further development.
Development of interdisciplinary tactical teams that directly support CRNs in creating developmental plans and help track their progress.
Development of recommendations to the NESTcc on the needs for future infrastructure and methodological development for CRNs.