MedCon took place April 24-26, 2024

Columbus, OH

Agenda from MedCon 2024

If you missed the conference, here’s what we covered:

April 23, 2024

9:00 am

–

4:30 pm

Pre-Conference Workshop

April 23, 2024

5:30 pm

–

6:30 pm

Welcome Reception

April 24, 2024

7:00 am

–

8:00 am

Breakfast

April 24, 2024

7:30 am

–

5:00 pm

Registration

General

April 24, 2024

8:00 am

–

8:15 am

Let’s Make a Difference!

Plenary Session

Moderator

Steven Mandernach, Executive Director, AFDO

Bill McMoil, Executive Director, RAPS

April 24, 2024

8:15 am

–

8:45 am

Patient Engagement

Moderator

Jessica Zeller, Vice President, Quality, Regulatory, Environmental, and Public Affairs Counsel, Edwards Lifesciences

Speaker

Sarah Sue Morbitzer, Edwards Lifesciences Sapien 3 and Alterra Recipient, OSU volleyball player

April 24, 2024

8:45 am

–

9:15 am

The Solutions Exchange

Plenary Session

Moderator

Shannon Hoste, Chief Scientific Officer, Pathway for Patient Health

Jessica Zeller, Vice President, Quality, Regulatory, Environmental, and Public Affairs Counsel, Edwards Lifesciences

April 24, 2024

9:15 am

–

9:35 am

Break

April 24, 2024

9:35 am

–

10:20 am

Returning to the New Normal in the Face of Evolving Challenges: Update from CDRH Director, Jeff Shuren

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

10:20 am

–

11:05 am

FDA Office of Regulatory Affairs (ORA) and Office of Medical Device and Radiological Health Key Updates

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

Anne Reid, Program Director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Rhonda Mecl, Deputy Program Director, Medical Device and Radiological Health Operations, (OMDRHO), Office of Regulatory Affairs (ORA), FDA

April 24, 2024

11:05 am

–

12:05 pm

Lunch and travel to breakouts

April 24, 2024

12:05 pm

–

1:15 pm

FDA Digital Health Center of Excellence Overview

Digital Health Track

Moderator

Kim Shoemaker, Senior Director, Global Regulatory Affairs, Johnson & Johnson MedTech

Speakers

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

Diane Johnson, Senior Director North American Policy, Global Digital Health Policy Lead, Johnson & Johnson MedTech

April 24, 2024

12:05 pm

–

1:30 pm

Harnessing the Power of Advances in Clinical Evidence

Pre Market Track

Moderator

Shannon Hoste, Chief Scientific Officer, Pathway for Patient Health

Speaker

Felipe Aguel, Deputy Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA
Daniel Canos, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA
Paul Coplan, Vice President and Global Head, Medical Device Epidemiology, Johnson & Johnson MedTech
Tom McLain, President, Renalytix
Simon Mason, President, National Evaluation System for health Technology Coordinating Center (NESTcc) part of MDIC

April 24, 2024

12:05 pm

–

1:30 pm

Best Practices for Engaging Patients and Using the Patient Perspective Over the Device Lifecycle

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, Vice President, Quality, Regulatory, Environmental, and 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

April 24, 2024

1:15 pm

–

1:30 pm

FDA Voluntary Improvement Program: Fostering Medical Device Improvement

Digital Health Track

Moderator

Kim Shoemaker, Senior Director, Global Regulatory Affairs, Johnson & Johnson MedTech

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

1:30 pm

–

1:50 pm

Break

April 24, 2024

1:50 pm

–

2:50 pm

News and Best Practices for Signals Involving Reports of Correction and Removal (806) and Adverse Events (MDRs)

Post Market Track

Moderator

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

Speakers

Mike Ryan, Deputy Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Emma Schaefer, Division Recall Coordinator Division I/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

April 24, 2024

1:50 pm

–

2:50 pm

FDA’s PCCP Draft Guidance Deep Dive

Digital Health Track

Moderator

Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Speakers

Alex Cadotte, Vice President, Digital Health, AI & Radiology, 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

1:50 pm

–

2:50 pm

International Influences on a Lifecycle Risk Management System

International Track

Moderators

Kim Trautman, Medical Device, IVD and Combo Product Expert

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

Speakers

Matt Graf, Quality Assurance & Global Quality Systems, Cook Medical

Tina Krenc, Principle Consultant, KTA Compliance Consulting

Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

2:50 pm

–

3:10 pm

Break and travel to plenary

April 24, 2024

3:10 pm

–

4:20 pm

Regulators: Global Harmonization and Convergence Initiatives

Plenary Session

Moderators

Kim Trautman, Medical Device, IVD and Combo Product Expert

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

Speakers

Augusto Geyer, General Manager – Medical Devices Office ANVISA

Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health (CDRH), FDA

April 24, 2024

4:20 pm

–

4:30 pm

Day 1 Close-Out

Moderator

Bill McMoil, Executive Director, RAPS

April 24, 2024

6:00 pm

–

8:30 pm

MedCon Annual Dinner

April 25, 2024

7:00 am

–

8:00 am

Breakfast

April 25, 2024

8:00 am

–

8:30 am

Day 2 Open: Patient Engagement Story

Moderator

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

Speaker

Heidi Dohse, Founder & President of Tour de Heart

April 25, 2024

8:30 am

–

9:45 am

FDA Provides Highlights of the Updated Compliance Program for Inspection of Medical Device Manufacturers

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

Speakers

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

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

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

9:45 am

–

10:05 am

Break and travel to breakouts

April 25, 2024

10:05 am

–

12:00 pm

Utilizing Effective Cybersecurity Risk Management as an Element of a Complete Risk Management Program

Digital Health Track

Moderator

Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

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

10:05 am

–

12:00 pm

EU MDR and IVDR State of Play

International Track

Moderators

Kim Trautman, Medical Device, IVD and Combo Product Expert

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

Speaker

Kristen Hastings, Director of Design Quality, Haemonetics
Sabina Hoekstra-van den Bosch, Global Director Regulatory Strategy, TÜV SÜD Medical Health Services

Colleen Watson, Senior Director of Regulatory Affairs, Thermo Fisher Scientific

April 25, 2024

10:05 am

–

12:00 pm

Navigating Recent Changes: An Update on Premarket Programs

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)
Josh Nipper, Director, PreMarket Operations, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
April Veoukas, Director, Regulatory Affairs, Abbott

April 25, 2024

12:00 pm

–

1:00 pm

Lunch and travel to breakouts

April 25, 2024

1:00 pm

–

2:00 pm

Incorporating PMS Risk Assessment / HHEs Into Quality and Regulatory Systems

Post Market Track

Moderators

Kim Trautman, Medical Device, IVD and Combo Product Expert

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

Speaker

Katie Furtick, Principal Quality System Engineer, Boston Scientific

Kristen Hastings, Director of Design Quality, Haemonetics

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

April 25, 2024

1:00 pm

–

2:00 pm

The Current State of Biocompatibility: Experience and Expectations

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

Toward Regulatory Reliance

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

2:00 pm

–

2:20 pm

Break and travel to plenary

April 25, 2024

2:20 pm

–

3:40 pm

Medical Device Sterilization Sustainability: EPA’s New Rule, FDA Initiatives, and Industry’s Challenges

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
Ryan Ortega, Regulatory Policy Advisor, Office of Product Evaluation and Quality (OPEQ) at the 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

3:40 pm

–

4:40 pm

FDA and Industry Panel Q&A on Hot Topics

Plenary Session

Moderator

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

Kim Trautman, Medical Device, IVD and Combo Product Expert

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

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

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

April 25, 2024

4:40 pm

–

4:50 pm

Day 2 Close-Out

Moderator

Bill McMoil, Executive Director, RAPS

April 25, 2024

5:30 pm

–

6:30 pm

Networking Reception

April 26, 2024

7:00 am

–

8:00 am

Breakfast

April 26, 2024

8:00 am

–

10:20 am

Investigator Insights

Plenary Session

Moderator

Monica Wilkins, VP Regulatory and Quality, Abbott

Speakers

Benjamin Dastoli, Consumer Safety Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Laureen Geniusz, Consumer Safety Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Thomas Peter, Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

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

April 26, 2024

10:20 am

–

10:40 am

Break

April 26, 2024

10:40 am

–

11:40 am

What You Need to Know About FDA’s Transition to the Quality Management System Regulation (QMSR)

Plenary Session

Moderators

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

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

11:40 am

–

11:45 am

Conference Close-Out

Moderator

Bill McMoil, Executive Director, RAPS

Agenda from MedCon 2024

If you missed the conference, here’s what we covered:

What makes this Conference so unique?

This conference WAs 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.