The National Evaluation System for health Technology Coordinating Center (NESTcc) seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using Real-World Data (RWD) that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making.
The current fragmented health care ecosystem does not support the seamless, near real-time, cost-effective use of health data to generate high-quality evidence for medical devices needed for regulatory decision-making in both the pre- and post-market spaces.
Stakeholders across the medical device ecosystem stand to benefit from improved use of RWE and RWD generated in the routine course of care. Opportunities include increased patient awareness of device safety issues, low-cost efficient evidence generation for regulatory review, and improved patient and provider ability to make care decisions based on robust data.
NESTcc’s goal is to apply an inclusive, patient-centered approach to increase the responsible use of RWE across the total product life cycle (TPLC) for a diverse set of stakeholders in a cost-effective and sustainable manner by pursuing the following objectives:
Data and Analytics Solutions and Partnerships: Collaborate with experienced data partners to identify and implement data and analytics solutions to advance the evaluation and use of high-quality RWD
Key Functions and Sustainability: Define a strategy for responsible data-sharing and analysis, a privacy-preserving structure for efficient collection and dissemination of data between different stakeholder constituencies, and a system of standards to facilitate data reporting and auditing in a decentralized and federated environment
Communicate Results and Engage the Ecosystem: Build awareness and facilitate understanding among stakeholders across the medical device ecosystem of the potential of RWE to inform medical device innovation, regulatory decisions, and surveillance
Governance: Establish and convene a Governing Committee of key stakeholders charged with inaugurating a Coordinating Center that is inclusive, patient-focused, and anchored in accountability and transparency
A Planning Board convened by the Duke-Margolis Center for Health Policy in late 2015 envisioned NEST as a voluntary network of data partners able to efficiently consolidate RWE to inform medical device evaluation and support regulatory decision-making throughout the total product life cycle (TPLC).
In September 2016, FDA awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC). MDIC is a 501(c)(3) public-private partnership with the objective of advancing regulatory science of medical devices for patient benefit. The selection of a third-party entity was important given the need for NESTcc to establish relationships and agreements between partners in a neutral, objective manner and to solicit a balanced representation from stakeholders.