Phase II/III Working Group Meeting

Registry Assessment of Peripheral Interventional Devices (RAPID) Phase II/III Working Group Meeting 

BE PART OF THE LAUNCH TEAM! RAPID May 25 Agenda Final

Meeting Recording (Audio Only)

08:00-08:30 Welcome and Updates

• Welcome Mitchell Krucoff, Duke University / MDEpiNet
• National Evaluation System for Health Technology (NEST) William Maisel, US Food and Drug Administration (US FDA) – Center for Devices and Radiological Health (CDRH)
• RAPID Phase II/III Overview Jack Cronenwett, Dartmouth-Hitchcock / Society for Vascular Surgery (SVS)

08:30-9:45 Leveraging National Data Models & Terminologies for Medical Device Evaluation

              Moderator:  James Tcheng, Duke University

• BUILD, PCORnet & SENTINEL: Background, Data Model and Data Elements Jeffrey Brown, Harvard Pilgrim Healthcare Institute/Harvard School of Medicine
• RAPID Core Data Element Development in LOINC Stanley Huff, Intermountain Healthcare / Healthcare Services Platform Consortium
• Lead Discussants

Michael Nguyen, US FDA / Center for Drug Evaluation and Research (CDER) / Sentinel Program Lead / CDR, US Public Health Service

Gregory Pappas, US FDA / CDRH, Associate Director for National Devices Surveillance

• Group Discussion: Opportunities for RAPID

9:45-10:00 BREAK

10:00-11:00   Inaugural RAPID Phase II/III Research Project

              Moderator:  Robert Thatcher, 4C Medical Technologies

• SFA-Popliteal EvidencE Development (SPEED): Project Selection and Description Pablo Morales, US FDA / CDRH, Medical Officer Division of Cardiovascular Devices
• Status of RAPID CDE Implementation by Registries, EMRs, Industry

Lead Discussants:

Jens Jorgensen, Maine Medical Center, Vascular Quality Initiative (VQI)

Ralph Brindis, University of California, San Francisco / National Cardiovascular Data Registry (NCDR)

Ahmed Saad, MedStreaming LLC

Ronnie Bunshaft, Epic Systems Corporation

Patrick Wang, Medtronic

• Group Discussion

11:00-12:15 Methods for Data Capture, Integration, Exchange, & Management

Moderator: Brian McCourt, Duke Clinical Research Institute

• Core and Supplemental Clinical Data James Tcheng, Duke University
• UDI Data for Device Identification, Categorization, and Coding Behnaz Minaei, US FDA / CDRH, Informatics Analyst
• Current Experience: Successes and Challenges

Lead Discussants:

UDI Data Collection

Barry Daniels, GMDN

Kin-Wah Fung, National Library of Medicine

Registry Data Collection

Daniel Bertges, University of Vermont, VQI

Ralph Brindis, NCDR

EMR Discrete Data Element Collection:

Ronnie Bunshaft, Epic Systems Corporation

Ahmed Saad, MedStreaming LLC

Industry Implementation of UDI:

Aaron Lottes, Cook Medical

• Group Discussion

12:30-1:30    Working Lunch:  Funding RAPID Phase II/III 

Moderator: Mitchell Krucoff, Duke Clinical Research Institute

• Cost of Current Industry-Based Device Evaluation Brad Martinsen, Cardiovascular Systems, Inc.
• Cost of Current Registry-Based Device Evaluation Jack Cronenwett, Dartmouth-Hitchcock / Society for Vascular Surgery (SVS)
• NEST Coordinating Center Funding for Pilot Projects Rachael Fleurence, Executive Director, NEST Coordinating Center / Medical Device Innovation Consortium (MDIC)
• Opportunities Provided by RAPID Robert Thatcher, 4C Medical Technologies
• Group Discussion

13:30-14:30 Methods for Data Aggregation, Analysis and Sharing with Industry and FDA

Moderator: Danica Marinac-Dabic, US FDA / CDRH, Director of the Division of Epidemiology

• Registry Data from VQI Daniel Bertges, VQI
• Analyses from SENTINEL Jeffrey Brown, Harvard Pilgrim Healthcare Institute / Harvard School of Medicine
• Health Care System Data from BUILD James Tcheng, Duke University
• International Analyses and Data from ICOR, ICVR Danica Marinac-Dabic, US Food and Drug Administration
• Group Discussion

14:30 – 15:45 Multi-Stakeholder Benefits from RAPID

Moderator:  Pablo Morales, US FDA / CDRH, Medical Officer

• Perspectives

Misti Malone, US FDA / CDRH, Chief Peripheral Interventional Devices Branch

Daniel Canos, Centers for Medicare & Medicaid Services (CMS)

Mera Choi, Office for the National Coordinators for Health Information Technology (ONC)

Josh Smale, Bard Peripheral Vascular

Joni Creal, Bard Peripheral Vascular

• Group Discussion

15:45 – 16:30 Planning Next Steps

Moderators:  Mera Choi, Jack Cronenwett, Pablo Morales, Robert Thatcher

• Working Groups, Timeline & Next Meeting

16:30 Adjourn