The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced that it has officially opened for the management of sponsor-funded research projects to advance the use of real-world data (RWD) in medical device evaluation.
The public launch of NEST 1.0 is a key inflection point in the maturity of NESTcc, signifying both the demonstrated capabilities of its Research Network and the strategic value of NESTcc in ensuring real-world evidence (RWE) is reliable, relevant, and timely. To date, NESTcc has been leading Test-Case projects funded through an FDA grant to accelerate its progress and provide proof of concept for generating high-quality RWE for medical devices across the total product life cycle.
In this new phase, NESTcc is catalyzing the use of RWE in the medical device ecosystem, said NESTcc senior vice president Sandra Siami, MPH. We will continue to innovate using novel methods to inform clinical, regulatory, and reimbursement decision-making, empowering medical device stakeholders with evidence that is vital to improving patient health outcomes.
NESTcc brings scientific rigor to research by building in quality by design. With its Data Quality and Methods Frameworks, NESTcc guides the capture and effective use of clinical information as well as methodological constructs for study execution. Through its Research Network of health systems, registries, and consortia, NESTcc connects stakeholders with expert investigators and diverse sets of traditionally disparate RWD to evaluate medical technologies across device types, disease areas, and stages of the total product lifecycle. NESTcc further guides research through strategic consulting to ensure project milestones and evidentiary requirements are met.
High-quality evidence is needed to inform clinical decision-making and keep patients safe, said Adrian Hernandez, M.D., MHS, professor of Medicine at Duke School of Medicine, vice dean and executive director of the Duke Clinical Research Institute, and chair of the NESTcc Governing Committee. NESTcc is at the forefront driving transformative and scientifically sound research, and the ecosystem stands to benefit from the evidence resulting from NESTccs growth.
NESTcc enables the generation of evidence that characterizes the safety and efficacy of devices through the structured collection and analysis of EHR, claims, registry and patient-generated data, among other sources. Core offerings for medical device manufacturers include label expansion studies, post-market safety studies, historical or synthetic control groups for one-arm clinical studies, and objective performance criteria and goals. Stakeholders including patient groups, regulators, and health systems can conduct patient safety assessments and academic research studies, and payers can work with NESTcc to create and validate quality and outcome measures. In the near future, NESTcc will also be able to more rapidly conduct active surveillance projects that could help fulfill post-market reporting requirements with the use of a cloud platform that is currently being developed.
NEST will advance the creation of a true learning system that allows for the ongoing evaluation of technology across the total product life cycle, said Jeff Shuren, M.D., J.D., director of the U.S. Food and Drug Administrations Center for Devices and Radiological Health, and NESTcc Governing Committee member. As we move to a digitized world for device evaluation and surveillance, NEST can serve as a vehicle to drive evidence generation and enable new models of oversight to better meet the needs of patients.
Today marks an important step for NESTcc as a resource for accelerating access to quality data, and I look forward to the impact it can have on expanding patient access to innovative technologies, said Diane Wurzburger, J.D., executive of regulatory affairs, Developed Markets & Global Strategic Policy at GE Healthcare, and vice chair of the NESTcc Governing Committee.
About the National Evaluation System for health Technology Coordinating Center
In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The Coordinating Center seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using high-quality Real-World Data (RWD) that meets robust methodological standards for the purpose of enhancing regulatory and clinical decision-making. For more information, visit http://www.nestcc.org.
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDICs mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.
Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (3 U01 FD006292-03S1). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.