2019 MDIC Annual Public Forum | NESTcc-Led Sessions
On September 5, 2019, the medtech community gathered for the MDIC Annual Public Forum (APF) in Washington, D.C. Industry experts, patients and other community innovators discussed a range of regulatory topics from cybersecurity and real-world evidence to patient input, quality and innovative medical device developments.
NESTcc Executive Director Dr. Rachael Fleurence and Data Network Director Dr. Robbert Zusterzeel each led panel sessions as part of the conference program. The panel descriptions, presentation slides and audio recordings are below.
Highlighting NESTcc Progress Towards Launching NEST 1.0
The National Evaluation System for health Technology Coordinating Center (NESTcc) has made strides in achieving its 2019 Strategic Priorities, including preparing for the launch of NEST 1.0 by the end of 2019.
This multi-stakeholder panel highlighted the strategic importance of programmatic advancements this year—NESTcc’s expanding role in active surveillance, the launch of the increased test-case portfolio, and the development of frameworks to support high-quality data and methods across the NESTcc Data Network. In addition, the panel discussed the importance of the upcoming launch of NEST 1.0 to accept and operationalize externally sponsored projects.
NESTcc Executive Director Dr. Rachael Fleurence introduced the panel composed of NESTcc Governing Committee members and provided an overview of NESTcc advances since last year’s Annual Public Forum and the vision for NEST 1.0.
Following Dr. Fleurence, Dr. Jeff Shuren provided the U.S. Food and Drug Administration (FDA) perspective on NESTcc’s recent milestones, and expectations for the future through NEST 1.0.
From the perspective of a NESTcc Network Collaborator, Dr. Harlan Krumholz of Yale-New Haven Hospital discussed the NESTcc Data Network, as well as his perspective as a member of the NESTcc Active Surveillance Task Force.
Finally, Diane Wurzburger of GE Healthcare discussed expectations for the launch of NEST 1.0, along with the impact of the advancements of the Data Network for industry stakeholders.
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Advancing NESTcc Real-World Evidence Test-Cases
The National Evaluation System for health Technology Coordinating Center (NESTcc) announced a new slate of twelve Real-World Evidence (RWE) Test-Cases in June 2019, bringing the full portfolio to twenty Test-Case projects. NESTcc Test-Cases have a dual purpose of answering important stakeholder questions and testing the capabilities of NESTcc’s Data Network. Now, the first test-cases are launching, preliminary results will start to be submitted this fall, and lessons are being learned.
NESTcc Data Network Director Dr. Robbert Zusterzeel provided an overview of NESTcc Test-Case projects, describing what they hope to accomplish, and the progress NESTcc has made since announcing the first set of projects in January 2018.
Dr. Fred Resnic of Lahey Health, a NESTcc Data Network Collaborator, showcased the experience of data partners participating in the Test-Cases.
Dr. Frances Thorndike of Pear Therapeutics and Dr. Ron Yustein of the FDA discussed the anticipated value of the Test-Cases to their organizations, both as submitting organizations with Test-Cases in the portfolio.