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Tue, Mar 29


FDA White Oak Bldg 32

National Coordinated Registry Network (CRN) Think-Tank

Creating Strategically Coordinated Registry Networks (CRNs) for orthopedic and vascular medical devices as a demonstration of the National Evaluation System for Medical Devices (NESMD)

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Time & Location

Mar 29, 2016, 7:00 AM – Mar 30, 2016, 5:00 AM

FDA White Oak Bldg 32, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

About the Event


Creating Strategically Coordinated Registry Networks (CRNs) for orthopedic and vascular medical devices as a demonstration of the National Evaluation System for Medical Devices (NESMD)

Agenda March 29

Agenda March 30


The FDA’s new vision for the National Evaluation System for Medical Devices highlights the importance of national registries and linkages with administrative claims data including Medicare, All payer data sources, electronic health records (EHRs), and with the Patient-Centered Outcomes Research Institute’s (PCORI) Clinical Data Research Networks (CDRN) to create national basis for national  evaluation system,

Orthopedic and vascular implants are particularly important areas of focus. Osteoarthritis and vascular disease are common, progressively debilitating diseases with a high prevalence in older Americans. During the past 20 years, device-based surgeries became the main treatment options for advanced disease, leading to the use of orthopedic and vascular devices in millions of Americans annually: most commonly used implants worldwide.

Major evidence gaps in device performance exist, however, prompting international surveillance efforts jointly by the FDA and the MDEpiNet Science and Infrastructure at Weill Cornell Medical College. These include International Consortium of Orthopedic Registries (ICOR) and International Consortium of Vascular Registries (ICVR) that are established as distributed research and surveillance networks focusing on questions related to understanding device safety, and effectiveness.

While these consortia provide enormous value, within each consortia US national systems need to be developed/strengthened. For Americans, devices used internationally are often not similar to those used in the U.S., creating a critical knowledge gap about device benefits and risks. Moreover, U.S. registries are not always efficient; few capitalizing on data linkages and taking advantage of growing national investments in claims and EHRs that could result in costs savings, gains in efficiency, and quality improvement.


This meeting serves as major planning step to advance our proposal of capitalizing on a novel partnership within the FDA’s Medical Device Epidemiology Network (MDEpiNet) to build national infrastructure. Through this initiative, we propose leveraging national investments in variety of data assets to create innovative, scalable models for the national device evaluation system that are sustainable and dynamic

 Specific Objectives
  • We will discuss linking registries with Medicare, commercial, and all payer state discharge billing claims, and CDRN data to develop an innovative infrastructure enabling evidence evaluation in orthopedic and vascular devices.
  • We will also discuss development, implementation, and distribution of new methodological approaches that address key data issues emerging from the large scale effort of linked databases. While the networks we are creating are clinically separate, centralized knowledge sharing will support cross-specialty and technology learning.

We will hear from major stakeholders and data partners about their interest in the CRN to advance device lifecycle evaluation and meet their needs.

MARCH 29, 2016 Chairs

Art Sedrakyan and Greg Daniel


TimeTopicPresenterWebcast Link8:30-8:45Registration and Badge pick up8:45-9:00Opening Remarks from ASPEScott Smith9:00-9:15IntroductionsArt Sedrakyan Context of the CRN9:15-9:45CRNs as foundational blocks of the National Medical Device Evaluation System: A Call to Action Danica Marinac-Dabic(Begins at 22:13)9:45-10:00Planning Board tasks and Update: CRN focusGreg Daniel(Begins at 57:06)10:00-10:30Q & A and moderated discussion (Greg Pappas) Moderated by Greg Papas10:30-10:40Coffee Break10:40-12:15Orthopedic CRN participants and plans PermanenteLiz Paxton (Begins at 3:28)11:00-11:20FORCE-TJRPat Franklin (Begins at 21:22)11:20-11-40AJRR Jeff Knezovich (Begins at 41:37)11:40-12:15CRN Creation (Art Sedrakyan) and moderated discussion (Mark Melkerson)             Begins (1:01:34)12:15-1:00Lunch1:00-3:20Data Partners and Stakeholder collaboration and CDRNsJoe Selby/

Adrian Hernandez

 (AH Begins at 11:43)1:20-1:30AHRQ data setsClaudia Steiner (Begins 20:55)1:30-1:40HealthCoreMarcus Wilson (Begins 32:38)1:40-1:50OptumNancy D. Lin (Begins 41:55)1:50-2:00HumanaVinit Nair (not presented)2:00-2:10PremierBimal Shah (Begins 52:18)2:10-3:20Moderated discussion on enabling data linkages (Greg Daniel and Art Sedrakyan)               (Begins 1:02:55)Discuss organizational/business barriers, and what the collaborations would need to look like in order to make them enticing enough for data partners to participate3:20-3:30Audience Q & A 3:30-3:45Coffee Break 3:45-4:45Manufacturer Perspective: value and use of CRN 3:45-4:00ManufacturersJesse Berlin & Sharon Starowicz Kuntz (Begins 08:55)4:20-4:45Moderated discussion on leveraging CRN for lifecycle needs/nesting clinical studies

(Owen Faris & Mark Melkerson)

4:45-5:30UDI implementation4:45-5:00UDI, GUDID needsTerrie Reed (Begins 54:55)5:00-5:05Premier perspectiveBimal Shah (Begins 1:11:45)5:05-5:10Pew perspectiveJosh Rising (Begins 1:20:45)5:10-5:30Moderated discussion (Terrie Reed)   (Begins 1:27:15)5:30-5:45Final Comments: Art Sedrakyan and Greg Daniel 

MARCH 30, 2016 Chairs

Art Sedrakyan and Danica Marinac-Dabic


TimeTopicPresenterWebcast Link8:30-8:45Update from Day 1Art Sedrakyan

(Begins 04:40)

8:45-9:00Opening RemarksMurray Sheldon(Begins 23:10)9:00-10:15Vascular CRN participants and plans9:00-9:20Vascular Quality InitiativePhil Goodney/Jack Cronenwett(Begins 37:38)9:20-9:35VQI linkage with PCORI CDRN- NYC plansAndrew Meltzer(Begins 55:35)9:35-10:15CRN Creation (Art Sedrakyan) and Moderated Discussion (Bram Zuckerman)  (Begins 1:13:50)10:15-10:25Coffee Break10:25-12:30Data Partners and Stakeholder collaboration: Group Discussion – specific aspects of linking, enabling linkages, and overcoming hurdles: technical challenges to data linkages similarities and differences between orthopedic and vascular CRNs10:45-11:05PCORI linkage opportunities Joe Selby/Rachael Fleurence11:05-11:20AHRQ-HCUP discussionClaudia Steiner11:20-11:50Sentinel, HealthCore, Optum, Humana linkage opportunitiesRichard Platt11:50-12:30Moderated discussion by Sharon-Lise Normand12:30-1:15Lunch1:15-2:15Continued Discussion on enabling linkages of data near real time and next steps Break2:30-3:45Stakeholder discussion on leveraging CRN for regulatory needs2:45-3:15Studies for labeling changes/nesting clinical trialsPablo Morales(Begins 09:50)2:30-2:45MDRsIsaac Chang(Begins 52:30)3:15-3:45Moderated Discussion by Danica Marinac-Dabic3:45-4:00Final Comments and Next Steps: Art Sedrakyan and Danica Marinac-Dabic 

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