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NESTcc Announces the First Round of Real-world Evidence Test-cases

Dec 19, 2018 12:00:00 PM

Logo for NESTcc, an initiative that uses real-world evidence test-cases 

This article was originally published in the December 2018 issue of AAOS Now, the American Academy of Orthopaedic Surgeons' (AAOS) monthly news magazine.

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced the first round of NESTcc test-cases that address topics of high priority from the medical device industry using real-world data and evidence.

“It’s exciting to reveal this milestone for NEST with the launch of these first test-cases… with health systems and coordinated registry networks through the NESTcc network collaborators,” said Rachael Fleurence, PhD, executive director of NESTcc.

The initial concepts were submitted in January 2018 through a public call open to medical device manufacturers. The test-cases will address two primary objectives. First, they will explore the feasibility for the medical device industry to work with real-world data sources and NESTcc’s 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, institutional review board, data-sharing agreements, publication policies).

The first round of test-cases will be executed through collaborations with industry partners Abbott, Adhesys Medical, Johnson & Johnson Medical Devices Companies, and W.L. Gore & Associates, Inc. In addition to the industry groups working through independent collaborations, AAOS is serving as a neutral convener, representing 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 part of AAOS.

“AAOS’ collaboration with NESTcc demonstrates our continued commitment to improve the safety and quality of care for orthopaedic patients,” said AAOS President David A. Halsey, MD. “AJRR is an excellent resource to help determine more accurate device performance, survivorship, and surgical outcomes for total joint arthroplasty. This effort supports standardized care and quality improvement.”

Paul Voorhorst, MS, MBA, vice president of clinical research at DePuy Synthes, said, “The funding commitment by NESTcc to support the feasibility study of linking data from the AJRR with data from private payers is a testament to multistakeholder collaborations. It is exciting to think about where these types of collaborations will lead us and how patients will ultimately benefit through enhanced surveillance methodologies.”

The industry partners and network collaborators are working together on eight projects within the first round of test-cases, which include projects along the 510(k) and premarket approval regulatory pathways and throughout the medical device total product life cycle.

“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, MD, director of the Center for Devices and Radiological Health at the Food and Drug Administration and 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 health care decisions and be assured they have access to the safest medical devices,” he added.

The test-cases will address specific disease areas and corresponding products (see Table 1 below). AJRR is assisting with the sixth Total-product Life Cycle Alignment item from the top.

 

Table 1: Disease Areas and Corresponding Products

 

For a description of each test-case, visit https://nestcc.org/test-cases.

 

Read more about this NESTcc initiative in their November 5, 2018, press release here. 

 

 

 

For information about the AAOS RegistryInsights platform, speak with a Registry Engagement Associate at (847) 292-0530 or Request A Demo today!

 

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Topics: Medical Devices

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This blog was created by the American Joint Replacement Registry (AJRR), part of the American Academy of Orthopaedic Surgeons (AAOS) Registry Program. The blog is part of our commitment to improve orthopaedic care through the collection, analysis, and reporting of actionable hip and knee arthroplasty data. Our purpose is to communicate with others in the orthopaedic field who share the same commitment. Watch for weekly news alerts, quick tips, actionable checklists, best practices, and research findings posted to this blog. It will be information you can use each week!

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This Week's Blog

  • Wednesday, December 19, 2018 - NESTcc Announces the First Round of Real-world Evidence Test-cases

 

This Week’s References

The National Evaluation System for Health Technology Coordinating Center (NESTcc)

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 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 life cycle, 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

Medical Device Innovation Consortium (MDIC)

Founded in 2012, the MDIC is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s 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.



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