5. Establishing governance and ensuring sustainability: MDEpiNet emphasises strong governance and sustainability as essential issues for the CRNs. even if a CRN is mature in many domains, any registry that is solely funded as a pilot study or by a standalone manufacturer will cease to exist once the organisation has achieved its short-term goals. sustainability requires multiple stakeholders to buy into the value that is generated by the CRN. CRNs that are hosted by a professional society or health system, with multiple funding sources and transparent leadership and governance, are most likely to be sustainable in the long-term. MDEpiNet promotes creating a ‘steering committee’ as well as ‘research and publication’ and ‘sustainability’ subcommittees to engage stakeholders and to create multiple leadership opportunities for dedicated and enthusiastic experts. holding annual think-tanks or meetings with stakeholders helps to achieve alignment and priority setting for infrastructure and research. creating an atmosphere of collaboration and developing trust will enrich a CRN and is key to establish and sustain the continuous dialogue in supporting a learning (healthcare) system of medical device evaluation.
Governance and Sustainability domain describes the governance structure focusing on participation of major stakeholders enabling generalizable (regionally, nationally or health system wide) data collection and transparent governance*. The hosting organisations include professional societies, integrated health systems, payers, and various states. In addition, the ability for the registry to obtain major and diverse sources of funding is critical for sustainability. Registries and CRNs built by manufacturers for their own purposes are special instances that are not in scope of this domain.Level 1
Early Learner
Absence of professional society/major health system/state endorsement, mostly pilot and project level governance.
Level 2
Making Progress
Absence of professional society/major health system/state endorsement. Reasonable funding is available (eg, support for a specific project at NIH R01 level or industry sponsorship at the same level).
Level 3
Defined Path to Success
Hosted by a professional society/major health system/state. Reasonable funding is available (eg, support for a specific project at NIH R01 level or industry sponsorship at the same level), establishing transparency in governance.
Level 4
Well Managed
Hosted by a professional society/major health system/state. Robust funding is available (eg, multi-year large scope projects funding in place at NIH centre grant level or multiple industry sponsorship at the same level), and governance is transparent.
Level 5
Optimised
Hosted by a major professional society/major health system, commitment to funding indefinitely (eg, renewable NIH centre grant level or multiple industry sponsorship at the same level), and governance is transparent.
*Transparent governance metrics include but are not limited to participation of major stakeholders and clear organisational structure with steering committee, subcommittees, and data access policies.