The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces the first round of NESTcc test-cases that address topics of high-priority from the medical device industry using Real-World Data (RWD) and Real-World Evidence (RWE).
Its exciting to reveal this milestone for NEST with the launch of these first test-cases that will explore the feasibility of generating Real-World Evidence with health systems and coordinated registry networks through the NESTcc Network Collaborators, said Rachael Fleurence, PhD, executive director of NESTcc. These test-cases will show proof-of-concept for the use of Real-World Evidence for medical devices in preparation for regulatory submissions, such as label expansions, and to meet post-market surveillance requirements.
The initial concepts were submitted in January 2018 through a public call open to medical device manufacturers. These test-cases will address two primary objectives. First, they will explore the feasibility for the medical device industry to work with RWD sources and NESTccs initial set of Network Collaborators. Second, the test-cases will help identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies).
The first round of test-cases will be executed through collaborations with Abbott, Adhesys Medical, Johnson & Johnson Medical Devices Companies, and W.L. Gore & Associates, Inc. as industry partners. In addition to the industry groups working through independent collaborations, the American Academy of Orthopaedic Surgeons (AAOS) is serving as a neutral convener, bringing together DJO Global, DePuy Synthes, Smith & Nephew, Stryker, and Zimmer Biomet for a test-case that will bring together NESTcc Network Collaborators with the American Joint Replacement Registry (AJRR) which is housed at AAOS.
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The industry partners and the Network Collaborators are working together on eight projects within the first round of test-cases that include projects along the 510(k) and premarket approval regulatory pathways and throughout the medical device total product lifecycle.
This is an important step to show the potential for NEST to efficiently generate evidence for both medical device evaluation and post-market safety information, said Jeff Shuren, M.D., Director of the FDAs Center for Devices and Radiological Health who is a board member of MDIC. Our goal with NEST is to improve access to, value, use, and efficiency of real-world evidence to meet the needs of the medical device ecosystem stakeholders. With more robust, informative, and timely evidence, health care providers and patients can make better informed healthcare decisions, and be assured they have access to the safest medical devices.
The test-cases will address the following disease areas and corresponding products:
TOTAL-PRODUCT LIFE CYCLE (TPLC) ALIGNMENT
TECHNOLOGY OF INTEREST
|Pre-market Submission||Comparative Effectiveness of Alternative Approaches for Wound Closure||510(k)||Wound Closure||Dermatology|
|Label Expansion||Testing the Use of Real-World Data from Three Unique Sources to Expand Indications||PMA||Endovascular Therapies||Vascular|
|Label Expansion||The Feasibility of Using Real- World Data in the Evaluation of Cardiac Ablation Catheters||PMA||Ablation Catheters||Cardiology|
|Label Expansion||Real-World Clinical Outcomes in Patients with Mechanical Heart Valve Replacement and Anticoagulation Variability||PMA||Mechanical Aortic Heart Valves||Cardiology|
|Label from General to Specific Indication||Feasibility of Using Real-World Data to Evaluate Thermal Ablation of Liver Tumors||510(k)||Ablation Device||Surgery|
|Postmarket Surveillance||Testing the Feasibility of Registry and Claims Data Linkages||510(k)||Total Joint Arthroplasty (TJA), Primary Total Knee Arthroplasty||Orthopedics|
|Postmarket Surveillance||Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data||510(k)||Craniomaxillofacial Distractors||Orthopedics|
|Postmarket Surveillance||Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data||510(k)||Intervertebral Body Fusion Devices||Orthopedics|
For a description of each test-case, please visit: https://nestcc.org/test-cases/
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) $3 million in seed 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 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. For more information, visit http://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 the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to 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 (1 U01 FD 006292-01). 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.
Medical Device Innovation Consortium
Leah McConnell, +1