MedCon 2024, co-sponsored by the FDA

2024 MedCon Agenda

April 24, 2024

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7:00 am

8:00 am

April 24, 2024

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8:00 am

8:15 am

Plenary Session

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

April 24, 2024

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8:15 am

8:45 am

Moderator

Jessica Zeller, VP Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences

Speaker

Sarah Sue Morbitzer, OSU volleyball player

April 24, 2024

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8:45 am

9:15 am

Plenary Session

Moderator

TBA

April 24, 2024

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9:15 am

9:35 am

April 24, 2024

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9:35 am

10:20 am

Plenary Session

Moderator

Sean Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Speaker

Jeff Shuren, Director, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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10:20 am

11:05 am

Plenary Session

Moderator

Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Speakers

Elizabeth Miller, Assistant Commissioner of the Office of Medical Products, Office of Regulatory Affairs (ORA), FDA (Invited)
Anne Reid, Program Director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA (Invited)

April 24, 2024

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11:05 am

12:05 pm

April 24, 2024

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12:05 pm

1:15 pm

Digital Health Track

Moderator

Kim Shoemaker, Senior Director, Global Regulatory Affairs, Ethicon

Speakers

Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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12:05 pm

1:30 pm

Pre Market Track

Moderator

Shannon Hoste, Vice President, Human Factors Engineering, Agilis by Kymanox

Speaker

Daniel Canos, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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12:05 pm

1:30 pm

Post Market Track

Moderators

Sean Boyd, Director, Office of Regulatory Programs Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Jessica Zeller, VP Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences

Speakers

Kathryn Capanna, Associate Director for Strategic Development, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH), FDA
Alissa Hanna, Director of Patient Engagement, Edwards Lifesciences
Jodi Smith, Director, Strategic Alliances, WomenHeart

April 24, 2024

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1:15 pm

1:30 pm

Digital Health Track

Moderator

Kim Shoemaker, Sr. Director, Global Regulatory Affairs, Ethicon

Speaker

Erin Keith, Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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1:30 pm

1:50 pm

April 24, 2024

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1:50 pm

2:50 pm

Post Market Track

Moderator

Susan Matthias, Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Speakers

Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Mike Ryan, Deputy Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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1:50 pm

2:50 pm

Digital Health Track

Moderator

Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP

Speakers

Alex Cadotte, Senior Director, Digital Health and Imaging, MCRA
Jessica Paulsen, Digital Health Associate Director, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic

April 24, 2024

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1:50 pm

2:50 pm

International Track

Moderators

Kim Trautman, Managing Director and VP, MedIcept, Inc.

Aaron Dunbar, Vice President of Quality Systems & Post Market, Boston Scientific

Speakers

Matt Graf, Quality Assurance & Global Quality Systems, Cook Medical
Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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2:50 pm

3:10 pm

April 24, 2024

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3:10 pm

4:20 pm

Plenary Session

Moderators

Kim Trautman, Managing Director and VP, MedIcept, Inc.

Gert Bos, Executive Director & Partner, CSO, CEO Qserve China, Qserve Group

Speakers

Augusto Geyer, MSc, General Manager – Medical Devices Office ANVISA
Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

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4:20 pm

4:30 pm

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

April 24, 2024

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6:00 pm

8:30 pm

April 25, 2024

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7:00 am

8:00 am

April 25, 2024

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8:00 am

8:30 am

Moderator

Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific

Speaker

Heidi Dohse, Founder & President of Tour de Heart

April 25, 2024

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8:30 am

9:45 am

Plenary Session

Moderator

Susan Matthias, Consumer Safety Officer Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA (Invited)

Speakers

Gina Brackett, Director, Compliance Branch Division 1/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Kristina Donohue, Policy Analyst for Case Quality, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA (Invited)
Jake Dyer, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Lauren Priest, Medical Device Compliance Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA (Invited)
Brian Putz, Commander, Public Health Service Supervisory Investigator, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

April 25, 2024

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9:45 am

10:05 am

April 25, 2024

@

10:05 am

12:00 pm

Digital Health Track

Moderator

Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP

Speakers

Edison Alvarez, Senior Director, Regulatory Strategic Planning for Cybersecurity, BD
Matt Hazelett, Cybersecurity Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

April 25, 2024

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10:05 am

12:00 pm

International Track

Moderators

Kim Trautman, Managing Director and VP, MedIcept, Inc.

Gert Bos, Executive Director & Partner, CSO, CEO Qserve China, Qserve Group

April 25, 2024

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10:05 am

12:00 pm

Pre Market Track

Moderator

Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Inc
Vice President Regulatory Affairs, MDMA
Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic

Speakers

Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)
Toby Lowe, Associate Director for Regulatory Programs, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH), FDA (Invited)
Josh Nipper, Director, PreMarket Operations, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Mary Wen, Regulatory Advisor, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA

April 25, 2024

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12:00 pm

1:00 pm

April 25, 2024

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1:00 pm

2:00 pm

Post Market Track

Moderators

Kim Trautman, Managing Director and VP, MedIcept, Inc.

Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific

Speaker

Phil Pontikos, Investigator, Medical Device National Expert, Office of Regulatory Affairs/OO/OMPTO, Division of Medical Products and Tobacco Program Operations Branch, FDA (Invited)

April 25, 2024

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1:00 pm

2:00 pm

Pre Market Track

Moderator

Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS Corporation

Speakers

Jennifer Goode, Biomedical Engineer, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Jim Kleinedler, Director, Regulatory Strategy, Medtronic
Thor Rollins, Vice President, Global Market Segment Leader—Medical Device, Nelson Labs

April 25, 2024

@

1:00 pm

2:00 pm

International Track

Moderator

Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic

Speakers

Augusto Geyer, General Manager, Medical Devices, ANVISA
Tammy Steuerwald, Global Head of Regulatory Policy, Foundational Principles and Supranational Organizations, Roche
Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH), FDA

April 25, 2024

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2:00 pm

2:20 pm

April 25, 2024

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2:20 pm

3:40 pm

Plenary Session

Moderator

Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS Corporation

Speakers

Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)
Brian McEvoy, Senior Director Global Technologies, Steris
Clarence Murray III, Deputy Director, Division of Infection Control and Plastic and Reconstructive Surgery Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Suzanne Schwartz – Director, Office of Strategic Partnerships & Technology Innovation, Center for Devices and Radiological Health (CDRH), FDA

April 25, 2024

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3:40 pm

4:40 pm

Plenary Session

Moderator

Kim Trautman, Managing Director and VP, MedIcept, Inc.

Speakers

Sean Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific
Phil Pontikos, Investigator, Medical Device National Expert, Office of Regulatory Affairs/OO/OMPTO, Division of Medical Products and Tobacco Program Operations Branch, FDA (Invited)
Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Inc | Vice President Regulatory Affairs, MDMA
Monica Wilkins, VP Regulatory and Quality, Abbott
Jessica Zeller, VP Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences

April 25, 2024

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4:40 pm

4:50 pm

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

April 26, 2024

@

7:00 am

8:00 am

April 26, 2024

@

8:00 am

8:20 am

Moderator

TBA

April 26, 2024

@

8:20 am

10:20 am

Plenary Session

Moderator

Monica Wilkins, VP Regulatory and Quality, Abbott

April 26, 2024

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10:20 am

10:40 am

April 26, 2024

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10:40 am

11:40 am

Plenary Session

Moderators

Susan Matthias, Consumer Safety Officer Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Sean Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Speakers

Karen Masley-Joseph, Senior Advisor, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Keisha Thomas, Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA

April 26, 2024

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11:40 am

11:45 am

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

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.