Dartmouth Device Development Symposium

12:05

Welcome

Jeff Shuren, MD JD

Director, Center for Devices and Radiological Health

FDA

12:10

Framing Comments

Aaron V. Kaplan, MD

Dartmouth Device Development Symposium

Dartmouth-Hitchcock Medical Center

12:20

Interview - What Makes EFS Different?

Clinical Site Perspective

Jaimie Walkowiak, JD

InstilBio

Baylor Scott & White Research Institute

12:35

 What Makes EFS Different - Key Issues/Stumbling Blocks

Indemnification, Reimbursement, Patient Recruitment

Moderator:  Chip Hance / Regatta Medical

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Presenter:  Examining the Metrics

                  Jon Hunt / MDIC

Panel:

Steven A. Farmer, MD, PhD / Center for Medicare Services

Lynne Goodreau / Northwestern Memorial

Jill Treckell / Edwards Lifesciences

Tamim Nazif, MD / Columbia University

Michael Zapien / Ancora Heart

1:15

Interview - What Makes EFS Different?

A Large Company & Investigator Perspective

Ian Meredith, MD, PhD

Global Chief Medical Officer

Boston Scientific

1:30

EFS Case Study  - Large Company

Interview with

Jeffrey J. Popma, MD
Chief Medical Officer (Coronary & Structural Heart)

Medtronic

1:45

 Expanding EFS Beyond Structural Heart - Learnings for other Disciplines

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Moderator:  

Andrew Farb, MD
Centers for Devices and Radiological Health, FDA

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Panel

Lauren Baker, PhD / Insight Medical Consulting

Katherine Kumar, PhD / 4C Medical Technologies

Paul Sorajja, MD / Minneapolis Heart

Vivek Reddy, MD / Mt. Sinai Medical Center

2:25

Interview - What Makes EFS Different?

A CDRH/FDA Perspective

Andrew Farb, MD

Chief Medical Officer/Cardiovascular Devices

Centers for Devices and Radiological Health, FDA

2:40

EFS/EU MDD to MDR Transition Implications

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Moderator:  Rick Geoffrion / Cyrano Therapeutics

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Panel

Olivier Delporte / MiraCor

Hansen Gifford / Lightstone Ventures

Daniel O'Mahoney / Seroba Lifesciences

Nitin Mehta / TUV-Sud

Neil Moat, MD / Abbot Vascular

3:10

Closing Remarks

David Holmes, Jr., MD

Scripps Professor in Cardiovascular Medicine
Mayo Clinic

3:30

ADJOURN