MedCon 2024, co-sponsored by the FDA

2024 MedCon Speakers & Moderators

MedCon speakers are hand-selected by the MedCon Strategic Committee to deliver purpose-driven content that dives below the surface, challenges status quo, engages attendees in collaborative dialogue, and provides practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussions.

Edison Alverez

BD

Senior Director of Regulatory Strategic Planning for Cybersecurity at BD

Gert Bos

Qserve Group

Executive Director & Partner at Qserve Group

Sean Boyd

FDA

Director for the Office of Regulatory Programs Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Gina Brackett

FDA

Director for the Compliance Branch Division 1/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration

Bill Brodbeck

STERIS

Senior Director of Regulatory Affairs at STERIS Corporation

Alex Cadotte

MCRA

Senior Director of Digital Health and Imaging at MCRA

Daniel Canos

FDA

Director for the Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Kathryn Capanna

FDA

Associate Director of Strategic Development, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Heidi Dohse

Tour de Heart

Founder and President at Tour de Heart

Kristina Donohue

FDA (INVITED)

Policy Analyst for Case Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Aaron Dunbar

Boston Scientific

Vice President Quality Systems & Post Market at Boston Scientific

Jake Dyer

FDA

Regulatory Officer for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Sonja Fulmer

FDA

Deputy Director for the Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

AUGUSTO GEYER

ANVISA

General Manager of Medical Devices at Anvisa

Matt Gaf

Cook Medical

Quality Assurance & Global Quality Systems at Cook Medical

JENNIFER GOODE

FDA

Biomedical Engineer for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Alissa Hanna

Edwards Lifesciences

Director of Patient Engagement at Edwards Lifesciences

Matt Hazelett

FDA

Cybersecurity Policy Analyst, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Eric Henry

King & Spalding

Senior Quality & Regulatory Compliance Advisor at King & Spalding LLP

Shannon Hoste

Agilis Consulting Group

President at Agilis Consulting Group

Timothy Hsu

Healthcare Products Collaborative

Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative

Erin Keith

FDA

Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Jim Kleinedler

Medtronic

Director, Regulatory Strategy at Medtronic

Mark Leahey

MDMA

President & CEO at Medical Device Manufacturers Association (MDMA)

Toby Lowe

FDA (Invited)

Associate Director for Regulatory Programs, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Karen Masley-Joseph

FDA

Senior Advisor for Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration

Susan Matthias

FDA (Invited)

CSO Special Assistant for Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration

BRian McEvoy

Steris

Senior Director of Global Technologies at Steris Group

Elizabeth Miller

FDA (Invited)

Associate Commissioner for the Office of Medical Products, Office of Regulatory Affairs (ORA) at the Food and Drug Administration

Sarah Sue Morbitzer

Ohio State University

Volleyball Player at Ohio State University

Clarence Murray III

FDA

Deputy Director for Division of Infection Control and Plastic and Reconstructive Surgery Devices, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Josh Nipper

FDA

Director of Premarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Jessica Paulsen

FDA

Digital Health Associate Director for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Phil Pontikos

FDA (Invited)

Investigator for the Medical Device National Expert Office of Regulatory Affairs at the Food and Drug Administration

Lauren Priest

FDA (Invited)

Medical Device Compliance Officer for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration

Brian Putz

FDA

Public Health Service Supervisory Investigator for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration

Fatemeh Razjouyan

Medtronic

Director of Regulatory Policy, International and Harmonization, Global Regulatory Policy at Medtronic

Anne Reid

FDA (Invited)

Program Director for the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the Food and Drug Administration

Thor Rollins

Nelson Labs

Vice President of Global Market Segment Leader-Medical Device at Nelson Labs

Heather Rosecrans

Greenleaf Health

Executive Vice President of Medical Devices & Combination Products at Greenleaf Health

Mike Ryan

FDA

Deputy Director for the Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Cassie Scherer

Medtronic

Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic

Kim Shoemaker

Ethicon

Sr. Director of Global Regulatory Affairs at Ethicon

Jeff Shuren

FDA

Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Suzanne Schwartz

FDA

Director for the Office of Strategic Partnerships & Technology Innovation, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Jodi Smith

WomenHeart

Director of Strategic Alliances at WomenHeart

Tammy Steuerwald

Roche

Global Head of Regulatory Policy, Foundational Principles, and Supranational Organizations at Roche

Keisha Thomas

FDA

Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Kim Trautman

MEDIcept Inc

Managing Director and VP at MEDIcept

Melissa Torres

FDA

Associate Director of International Affairs, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Mary Wen

FDA

Regulatory Advisor for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration

Monica Wilkins

Abbott

VP of Regulatory and Quality at Abbott

Jessica Zeller

Edwards Lifesciences

Vice President of Quality, Regulatory, Environmental, and Public Affairs Counsel at Edwards Lifesciences

Because of the generosity of our supporters, we can continue our work to improve the healthcare products industry.

Abbott, sponsor

Diamond Sponsor

Zimmer Biomet, sponsor

Platinum Sponsor

Steris, Sponsor

Platinum Sponsor

Eli Lilly, sponsor

Gold Sponsor

Johnson Johnson, sponsor

Gold Sponsor

Learn more about supporting MedCon 2024 through sponsorship by contacting Patrick Flynn at +1-301-770-2920, ext. 246, or pflynn@raps.org.

This conference is co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.