7
Forum
Sessions
21
Test-Case
Overviews
5
Test-Case
Deep Dives
20+
Leading
Speakers
2
New NESTcc
Initiatives
Session Recordings
Delivering on the Vision of NEST for the Medical Device Ecosystem
Speakers
- Pamela Goldberg, MBA, President and CEO, Medical Device Innovation Consortium (Welcome)
- Sandra Siami, MPH, NESTcc Senior Vice President, MDIC (Moderator)
- Adrian Hernandez, M.D., MHS, Professor of Medicine at Duke School of Medicine, Vice Dean and Executive Director of the Duke Clinical Research Institute (DCRI); NESTcc Governing Committee Chair
- Jennifer Kerr, MS, CCRA, RAC, President, Cook Research Incorporated; NESTcc Governing Committee Member
- Danelle Miller, BS, MA, J.D., Vice President of Global Regulatory Policy and Intelligence, Roche Diagnostics; NESTcc Governing Committee Member
- Diane Wurzburger, J.D., Regulatory Affairs Executive, GE Healthcare; NESTcc Governing Committee Vice Chair
Session Recap
Read the session recap here.
The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters
Speakers
- Keondae Ervin, MS, NESTcc Project Manager, MDIC (Moderator)
- Paul Coplan, ScD, MBA, MPH, Vice President and Global Head of Medical Device Epidemiology and Real-World Data Sciences, Johnson and Johnson
- Joseph Drozda, Jr., M.D., M.A.C.C., Director of Outcomes Research, Mercy
- Mark Fellman, Assistant Director, Cardiac Ablation, Mapping and Imaging Devices Team, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)
- Shumin Zhang, M.D., ScD, Director of Regulatory RWE & Epidemiology, Medical Devices, Johnson & Johnson
Session Recap
Read the session recap here.
Creation of a Patient-facing Mobile App for a Stress Urinary Incontinence Surgery Registry
Speakers
- Keondae Ervin, MS, NESTcc Project Manager, MDIC (Moderator)
- Bilal Chughtai, M.D., Associate Professor of Urology and an Associate Professor of Urology in Obstetrics and Gynecology, Weill Cornell Medicine
- Anne Hammer, Network of Experts Coordinator, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
- Art Sedrakyan, M.D., Ph.D., Professor of Population Health Sciences, Weill Cornell Medicine, and Director, Institute for Health Technologies and Interventions and Medical Device Epidemiology Network’s Coordinating, Science & Infrastructure Center (MDEpiNet); NESTcc Governing Committee Member
- Vahan Simonyan, MS, Ph.D., Lead Instructor, MDEpiNet-HIVE
Session Recap
Read the session recap here.
Testing the Use of Real-World Data from Three Unique Sources to Expand Indications
Speakers
- Dure Kim, PharmD, NESTcc Project Manager, MDIC (Moderator)
- Carmen Gacchina Johnson, Ph.D., Assistant Director, Vascular and Endovascular Devices, CDRH, FDA
- Philip Goodney, M.D., MS, Vice Chair of Research in the Department of Surgery, Director of the Center for the Evaluation of Surgical Care (CESC), Dartmouth
- Kayla Moore, Research Project Director, The Dartmouth Institute for Health Policy & Clinical Practice
- James Williams, Clinical Strategy Developer – Clinical Affairs, W. L. Gore & Associates, Inc.
Session Recap
Read the session recap here.
Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using EHR Data
Speakers
- Keondae Ervin, MS, NESTcc Project Manager, MDIC (Moderator)
- Paul Coplan, ScD, MBA, MPH, Vice President and Global Head of Medical Device Epidemiology and Real-World Data Sciences, Johnson and Johnson
- Ronald Jean, Ph.D., Acting Director, Division of Spinal Devices, CDRH, FDA
- Frederic S. Resnic, M.D., MSc, Chairman, Division of Cardiovascular Medicine, Lahey Hospital & Medical Center, Professor, Tufts University School of Medicine
- Shumin Zhang, M.D., ScD, Director of Regulatory RWE & Epidemiology, Medical Devices, Johnson & Johnson
Developing Objective Performance Criteria (OPC) for Outcomes after Hip and Knee Replacement
Speakers
- Dure Kim, PharmD, NESTcc Project Manager, MDIC (Moderator)
- William Jung, Ph.D., Acting Director, Division of Joint Arthroplasty Devices, CDRH, FDA
- Elizabeth Paxton, Ph.D., Director of Surgical Outcomes and Analysis, Kaiser Permanente
- Art Sedrakyan, M.D., Ph.D., Professor of Population Health Sciences, Weill Cornell Medicine, and Director, Institute for Health Technologies and Interventions and MDEpiNet; NESTcc Governing Committee Member
- Paul Voorhorst, MBA, MS, Vice President, Worldwide Clinical Research, DePuy Synthes Companies
Session Recap
Read the session recap here.
Real-World Evidence: Current Perspectives and Future Innovation
Speakers
- Sandra Siami, MPH, NESTcc Senior Vice President, MDIC (Moderator)
- Naomi Aronson, Ph.D., Executive Director, Clinical Evaluation, Innovation, and Policy, Blue Cross Blue Shield Association (BCBSA); NESTcc Governing Committee Member
- Kathleen Blake, M.D., MPH, Vice President of Health Care Quality, American Medical Association, NESTcc Governing Committee Treasurer
- Diane Pickles, BA, Program Director, One Brave Idea, American Heart Association; NESTcc Governing Committee Member
- Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA); NESTcc Governing Committee Member
*Funding for this forum 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.