About National evaluation system for health technology coordinating center (nestcc)
National Evaluation System for Health Technology Coordinating Center (NESTcc) is a non-profit organization that aims to revolutionize the way medical device technologies are tested, approved, and monitored. The organization collaborates with leading health organizations to curate high-quality, real-world data that can be used to inform regulatory decisions and improve patient outcomes.
NESTcc was established in 2016 as part of the Medical Device User Fee Amendments (MDUFA) IV commitment by the U.S. Food and Drug Administration (FDA). The center is funded through a combination of FDA grants and industry contributions. NESTcc operates under the auspices of the Reagan-Udall Foundation for the FDA.
The mission of NESTcc is to accelerate access to high-quality, real-world evidence by catalyzing development of a national evaluation system that enables timely, reliable, and cost-effective generation of evidence throughout the total product life cycle of medical devices. This includes pre-market testing, post-market surveillance, and ongoing monitoring.
NESTcc works closely with stakeholders across the healthcare ecosystem including patients, providers, payers, regulators, manufacturers and researchers. By bringing together diverse perspectives on medical device evaluation from across this ecosystem NESTcc aims to create an inclusive environment where all voices are heard.
One key aspect of NESTcc's work is its focus on developing methods for using real-world data (RWD) in regulatory decision-making related to medical devices. RWD refers to data collected outside traditional clinical trials such as electronic health records (EHRs), claims data or patient-generated data from wearables or other digital health tools.
By leveraging RWD sources in combination with traditional clinical trial data NESTcc aims to provide more comprehensive insights into how medical devices perform in real-world settings over time. This approach has significant potential benefits including faster time-to-market for new products; reduced costs associated with clinical trials; improved safety monitoring; better understanding of device performance in diverse patient populations; and more efficient post-market surveillance.
NESTcc's work is organized around a series of strategic priorities that include developing a governance structure for the national evaluation system, building partnerships with stakeholders across the healthcare ecosystem, developing methods for using RWD in regulatory decision-making, and creating tools and resources to support medical device evaluation.
One key initiative currently underway at NESTcc is the development of a Data Quality Framework (DQF) to guide the use of RWD in medical device evaluation. The DQF will provide guidance on data quality standards, data management practices, and analytical methods for using RWD in regulatory decision-making. This framework will be developed through collaboration with stakeholders across the healthcare ecosystem including patients, providers, payers, regulators and manufacturers.
Another important area of focus for NESTcc is its efforts to build partnerships with leading health organizations. These partnerships are critical to ensuring that NESTcc has access to high-quality real-world data sources that can be used to inform regulatory decisions related to medical devices. Some of these partners include academic research institutions such as Duke University; health systems such as Kaiser Permanente; patient advocacy groups such as PatientsLikeMe; and industry associations such as AdvaMed.
In conclusion, National Evaluation System for Health Technology Coordinating Center (NESTcc) is an innovative non-profit organization that aims to transform how medical device technologies are tested approved and monitored by leveraging real-world data sources. Through its collaborative approach involving diverse stakeholders from across the healthcare ecosystem NESTcc has significant potential benefits including faster time-to-market for new products reduced costs associated with clinical trials improved safety monitoring better understanding of device performance in diverse patient populations and more efficient post-market surveillance.