300 Global Regulators and Industry Partners Gather in Columbus for MedCon 2024

MedCon 2024 convened this week at the Hilton Columbus Downtown in Columbus, Ohio, welcoming 300 attendees from 11 countries and five continents — including 45 FDA participants — for three days of purpose-driven discussions that harmonize different perspectives to inspire collaboration, lead innovation, and make a difference in patient care. The event was hosted by the AFDO/RAPS Healthcare Products Collaborative and co- sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services.

“This event is like no other and has a long history of supporting a collaborative community focused on action,” said Gina Brackett, chair of the MedCon Strategic Committee and Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA. “It’s always exciting to see so many healthcare product experts and innovators gathered together in one place. MedCon is all about creating connections, sharing ideas, and driving change to improve public health and patient care.”

This year’s educational program consisted of 52 speakers and 14 moderators across 25 sessions, including 30 FDA expert presenters.

• Anne Reid, Program Director of the Office of Medical Devices and Radiological Health Opera]ons (OMDRHO), Office of Regulatory Affairs (ORA), FDA
• Jeff Shuren, Director, Center for Devices and Radiological Health (CDRH), FDA
• Sean Boyd, Director, Office of Regulatory Programs, Office of Product Evalua]on and Quality, Center for Devices and Radiological Health (CDRH), FDA
• Gina Brackeb, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Opera]ons (OMDRHO), Office of Regulatory Affairs (ORA), FDA
• Daniel Canos, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA
• Benjamin Dastoli, Consumer Safety Officer, Office of Medical Device and Radiological Health Opera]ons (OMDRHO), Office of Regulatory Affairs (ORA), FDA
• Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
• Laureen Geniusz, Consumer Safety Officer, Office of Medical Device and Radiological Health Opera]ons (OMDRHO), Office of Regulatory Affairs (ORA), FDA
• Karen Masley-Joseph, Senior Advisor, Office of Medical Device and Radiological Health Opera]ons (OMDRHO), Office of Regulatory Affairs (ORA), FDA
• Rhonda Mecl, Deputy Program Director, Medical Device and Radiological Health Opera]ons, (OMDRHO), Office
• of Regulatory Affairs (ORA), FDA
• Josh Nipper, Director, Pre-market Opera]ons, Office of Product Evalua]on and Quality, Center for Devices and Radiological Health (CDRH), FDA
• Thomas Peter, Medical Device Senior Opera]ons Officer, Office of Medical Device and Radiological Health Opera]ons (OMDRHO), Office of Regulatory Affairs (ORA), FDA
• Phil Pon]kos, Inves]gator, Medical Device Na]onal Expert, Division of Medical Products and Tobacco Program, Opera]ons Branch, Office of Regulatory Affairs (ORA), FDA
• Mike Ryan, Deputy Director, Office of Regulatory Programs, Office of Product Evalua]on and Quality, Center for Devices and Radiological Health (CDRH), FDA
• Keisha Thomas, Director of Compliance and Quality, Office of Product Evalua]on and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA
• Melissa Torres, Associate Director for Interna]onal Affairs, Center for Devices and Radiological Health (CDRH), FDA

The MedCon Strategic Committee curated the program with key content themes centered on updates from FDA, global harmonization, medical device sterilization sustainability, and investigator insights. Education sessions spanned four tracks, including digital health, pre-market, post-market, and international. In addition, attendees participated in an interactive Solutions Exchange Case Study, which focused on accounting for all stakeholder voices — patients, caregivers, HCPs, advocacy and patient groups, regulators, suppliers, organizational internal silos, etc. — and applying those perspectives across business and product strategies.

The event also featured a preconference workshop on Tuesday, April 23, entitled “AI/ML Enabled Medical Devices from a Quality & Regulatory Perspective: An Interactive Workshop,” featuring expert presenters from Brooke & Associates, Citingale, Ketryx, King & Spalding, and Medtronic.

This daylong workshop aligned attendees on vocabulary and concepts and included a hands-on session that took a simple AI algorithm and moved it through the training, testing, and tuning process.

“MedCon is an important forum for connecting industry with FDA for three days of open, transparent dialogues,” remarked Bill McMoil, Executive Director, RAPS. Steve Mandernach, Executive Director of AFDO added, “this event offers a most unique opportunity for critical dialogue with regulatory partners during all stages of product development as well as a forum for discussing obstacles and innovation as an industry moving forward together.”

Since 2009, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. With a distinct focus on important issues that increase speed to market and product quality through innovation, the event brings together medical device regulators and industry experts from around the world for content-rich conference sessions that include uncommon collaboration, deep dialogue, and sharing.
Sign up for information and updates on MedCon 2024 by visiting www.healthcareproducts.org/medcon.