January 7, 2025 — The AFDO/RAPS Healthcare Products Collaborative has opened registration for the MedCon 2025 Conference. The event, which is co-sponsored by the Food and Drug Administration (FDA), will convene April 23-25, 2025, at the Hyatt Regency Columbus in Columbus, Ohio. On Tuesday, April 22, there will be a full-day workshop called “The Device Design Change Life Cycle Experience,” which is available for an additional fee. 

Since 2009, MedCon has united the healthcare products community for unparalleled regulatory and industry collaboration. The conference facilitates a neutral setting for information sharing to drive a common understanding of key regulatory and quality concepts. MedCon also delivers an in-depth, interactive program that examines complexities and opportunities for actionable innovation to advance patient care.

“It’s the ‘we’ that makes MedCon so special. This premier medical device event combines a patient-centric focus with a solutions-oriented approach and creates a space where participants can engage in candid discussions that focus on developing action plans while fostering meaningful participant engagement,” said Kimberly Belsky, MedCon Strategic Facilitator. “The networking opportunities also create lasting connections across industry and regulators, driving innovation and collaboration in medical devices.”

The MedCon 2025 Conference agenda is focused on current global medical device compliance and regulatory topics through delivery of dynamic plenaries and in-depth breakouts. Knowledgeable speakers from both industry and the FDA design the presentations with a panel approach and focus on facilitating collaboration, leading innovation, and making a difference. Engagement includes a Solutions Exchange and a mock inspection exercise. Session topics will cover the artificial intelligence and cybersecurity regulatory landscapes, preparing for the Quality Management System Regulation change, supply chain resiliency, correctly assessing quality system activities, risk management from a systems perspective, due diligence, and much more. To view the current session and speaker lineup, visit https://healthcareproducts.org/medcon.

The MedCon Conference program is carefully curated by experts across the healthcare products industry to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. The MedCon 2025 Strategic Committee includes:

• Gert Bos, Executive Director & Partner, Qserve Group
• RADM Sean M. Boyd, Director for the Office of Regulatory Programs, FDA Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ)
• Gina Brackett, Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA
• Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
• Aaron Dunbar, VP, Quality Systems & Post Market, Boston Scientific 
• Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
• Shannon Hoste, Senior Director of Human Factors & Regulatory Strategy, Agilis Consulting Group
• John Krug, Executive Director and Site Quality Leader of Indianapolis Device Manufacturing, Eli Lilly and Company
• Susan Matthias, Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII), FDA
• Phil Pontikos, Medical Device National Expert, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII), FDA
• Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic
• Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, ELIQUENT Life Sciences
• Kim Shoemaker, RAC, Senior Director, Global Regulatory Affairs, Ethicon
• Kim Trautman, Global Medical Device, IVD, and Combination Product Regulatory & Quality Expert
• Monica Wilkins, Vice President Regulatory and Quality, Abbott
• Jessica Zeller, Vice President, Quality, Regulatory, Environmental, and Public Affairs Counsel, Edwards Lifesciences

Early registration is encouraged, and discounted rates are available until March 12, 2025. Complete event information can be reviewed at https://healthcareproducts.org/medcon.

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The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS). The Collaborative supports idea sharing, innovation, and action across the global healthcare products community by fostering purpose-driven discussions among regulators, industry, academia, and thought leaders about the most pressing issues facing the industry. Our distinct events portfolio, which includes the MedCon Conference and Combination Products Summit, highlights just one of the ways we inspire collaboration. This unique blend of mission and values guides purpose-driven community building and innovative solutions to make a difference in patients’ lives. www.healthcareproducts.org