CRN is 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 Community of Practice (COP) for CRNs to speed the development and maturity of the networks. CRN COP 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 COP ensures that each CRN focuses on broad and balanced stakeholder participation which leads to strong stakeholder engagement and sustainability. Within the community, the CRN leaders are able to leverage medical device ecosystem stakeholders currently engaged with the MDEpiNet.
COP’s 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 COP. Currently, there are fourteen CRNs operating or under development (see below).
- Robotic CRN
- Abdominal Core HealthSM CRN
- Women’s Health CRN
- VISION Vascular CRN
- Orthopedic CRN
- SPARED (prostate ablation)
- NBIR (breast implant) CRN
- DAISI Neuro CRN
- TMJ CRN
- VANGUARD CRN
- Cardiac CRN
- ESRD CRN
- GI CRN
- 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 a CRN assessment tool to evaluate CRN 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 of each CRN to help plan further development.
- Development of individual CRN-led interdisciplinary tactical teams that directly support CRNs in creating developmental plans and help CRNs track their progress.
- Development of recommendations to the NESTcc on the needs for future infrastructure and methodological development for CRNs.