MedCon 2023 Program

Please continue to check back for additional speaker and session details.

Please note: Separate registration and fee are required to attend the workshop

APRIL 24, 2023 / WORKSHOP
8:30 a.m.

Risk Management: Practical Applications of Risk Management Throughout the Device Life Cycle

Learn effective risk management strategies from an exceptional panel of experts who are rich in industry and FDA experience. You will learn how to take a total life-cycle approach to risk management by walking through a comprehensive case study throughout the day. You will learn from your peers by being immersed in multiple exercises and engaged in group discussions. The facilitators will share industry pain points and successful practices throughout the workshop.

Facilitators
  • Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
  • Shanon Hoste, Sr. Director of Human Factors & Regulatory Strategy, Agilis Consulting Group
  • Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS

5:00 p.M. – 7:30 P.M.

Welcome Reception

Please join the MedCon Strategic Committee at the Hyatt Regency Columbus hotel for an evening welcome reception. Reconnect with colleagues and make new connections. Light hors d’oeuvres and beverages will be served.

APRIL 25, 2023 / DAY 1
7:30 a.M. – 5:05 P.M.

Registration

7:45 a.M. – 8:30 A.M.

Breakfast

8:30 a.M. – 8:40 A.M.

Let’s Make a Difference!

Welcome to the conference, welcome back, and welcome to the Cincinnati District of the FDA. This purpose-driven conference will lead you to actionable learning and implementation plans!

Facilitator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
8:40 a.m. – 9:45 a.m.

Solutions Exchange

Start your day with solutions! This fast-paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.

9:45 a.M. – 10:00 A.M.

Break

10:00 a.M. – 10:45 A.M.

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

Hear about CDRH’s strategic priorities, new initiatives, and ongoing work to return to the new normal in the wake of the COVID-19 Public Health Emergency. Jeff Shuren, CDRH Director, will provide his insight on several activities underway at CDRH to address the evolving challenges facing the medical device ecosystem, including the Medical Device User Fee Amendments (MDUFA V), the Total Product Life Cycle Advisory Program (TAP) pilot, medical device cybersecurity, the Digital Health landscape, and more. You won’t want to miss it!

Moderator
  • RADM Sean M. Boyd (Invited), Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA CDRH
Speaker
  • Jeffrey Shuren (Invited), Director of the Center for Devices and Radiological Health, FDA CDRH
10:45 a.M. – 11:30 A.M.

Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Update

ORA’s Office of Medical Products and Radiological Health houses all medical device and radiological health investigators across the country. Elizabeth Miller, Associate Commissioner of the Office of Medical Products, will provide an update on the strategic priorities for medical products. Anne Reid, Program Director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), will provide an update on OMDRHO’s key initiatives, strategic priorities, and inspectional and compliance activities.

Moderator
  • Gina Brackett (Invited), OMDRHO Division 1 Director, Compliance Branch, FDA ORA
Speakers
  • Elizabeth Miller (Invited), Associate Commissioner of the Office of Medical Products, FDA ORA – OMPTO
  • Anne Reid (Invited), Acting Program Director of the Office of Medical Devices and Radiological Health, FDA ORA – OMDRHO
11:30 a.M. – 12:30 P.M.

Networking Lunch

Day 1 – Midday Breakouts (choose one):

12:30 P.M. – 2:00 P.M.

Medical Device User Fee Amendment (MDUFA) V: How Is It Impacting FDA Staff, Industry, and Patients?

Join this session to learn about the MDUFA V commitments that are affecting FDA staff, the med tech industry, and patients, and where we are ending with MDUFA IV. Hear about the new TPLC Advisory Program (TAP), global harmonization efforts, updated performance goals, and what’s expected of FDA in unlocking additional funding for FDA in FY2026 and FY2027.

Moderators
  • Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Vice President Regulatory Affairs, MDMA
  • Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization / Global Regulatory Policy, Medtronic
Speakers
  • Barbara Zimmerman (Invited), Deputy Office Director, Office of Regulatory Programs, FDA ORP
  • Melissa Torres (Invited), Associate Director for International Affairs, FDA CDRH
  • Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)
  • Michael Pfleger, Vice President, Head of External Affairs and Regulatory Policy, Alcon
12:30 P.M. – 2:00 P.M.

Are You Assuring All Your Suppliers Are Meeting Purchasing Controls Requirements

Through interactive case studies with industry and FDA experts, gain a better understanding of actions you need to take to meet the Quality System Regulation to ensure that components and services conform to specified requirements.

Moderator
  • Monica Wilkins, Vice President Regulatory and Quality, Abbott
Speakers
  • Gina Brackett (Invited), OMDRHO Division 1 Director, Compliance Branch, FDA-ORA
  • Lauren Priest (Invited), OMDRHO Division 3, Compliance Officer, FDA-ORA
12:30 P.M. – 2:00 P.M.

The Effect and Impact of the MDR Delay – Controversies Continued

This session will take the form of a brief introduction to the latest regulatory changes in the EU MDR, followed by a moderated panel discussion. It will end with a Q&A session with the audience.

Moderators
  • Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
  • Gert Bos, Executive Director & Partner, Qserve Group
Speakers
  • TBD
2:00 p.M. – 2:15 p.M.

Break

Day 1 – Afternoon Breakouts (choose one):

2:15 P.M. – 3:15 P.M.

Finding Common Ground: Managing Device Interoperability Expectations

This session will compare and contrast current global regulatory expectations for demonstrating medical device interoperability and the complexities manufacturers must overcome. Challenges associated with integrating internally developed devices with devices from other manufacturers will be discussed from the perspective of risk management, design verification, and human factors.

Moderator
  • Francis Blacha, Senior Vice President, Quality, Eli Lilly and Company
Speakers
  • Osman Kafrawy, Advisor, Device Quality and Regulatory Compliance, Eli Lilly and Company
2:15 P.M. – 3:15 P.M.

The Dos and Don’ts of 483 and Warning Letter Responses

Hear from FDA and industry on content expectations when writing a response to a Form FDA-483 Inspectional Observations or a Warning Letter.

Moderator
  • Gina Brackett (Invited), OMDRHO Division 1 Director, Compliance Branch, FDA-ORA
Speakers
  • Monica Wilkins, Corporate Vice President, Regulatory and Quality, Abbott
  • Melissa Michurski (Invited), OMDRHO Division 2 Director, Compliance Branch, FDA-ORA
  • Gina Brackett (Invited), OMDRHO Division 1 Director, Compliance Branch, FDA-ORA
2:15 P.M. – 3:15 P.M.

Security and Privacy

This session will broadly explore security and privacy, as they impact medical device manufacturers and the healthcare delivery organizations using connected medical devices. The panel will discuss FDA’s cybersecurity guidance and collaborations, HIPAA, the FTC’s privacy enforcement activities, the E.U.’s General Data Protection Regulation (GDPR) and proposed European Health Data Space, and other elements of the evolving security and privacy landscape.

Moderator
  • Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP
Speakers
  • Igor Gorlach (Invited), Partner, Healthcare/Data, Privacy and Security, King & Spalding
  • Axel Wirth (Invited), Chief Security Strategist, Med Crypt
3:15 p.M. – 3:35 p.M.

Break

Participants are invited to use this time to return to the plenary session held in the main conference room.

3:35 P.M. – 5:05 P.M.

Situation in Europe – EU, UK, Switzerland

This session will take the form of a brief introduction on the latest regulatory changes in three European jurisdictions, followed by a moderated panel discussion and a final Q&A session with the audience.

Moderators
  • Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
  • Gert Bos, Executive Director & Partner, Qserve Group
Speakers
  • TBD
5:45 P.M. – 8:30 P.M.

Annual MedCon Dinner (off-site)

Separate Ticket Purchase Required

APRIL 26, 2022 / DAY 2
7:30 A.M. – 5:15 P.m.

Registration Hours

7:45 A.M. – 8:30 a.m.

Breakfast

Join your colleagues from around the globe as we kick off the second day of MedCon 2023 with a complimentary hot breakfast.

8:30 a.m. – 8:35 a.m.

MedCon Day 2 Welcome

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
8:35 A.M. – 9:30 a.m.

Sustainability Throughout the Supply Chain: FDA and Industry Perspectives

Attendees will hear FDA and industry insights on the evolving supply chain landscape, including challenges and solutions through partnership. Speakers will address challenges we face as a community, such as planning for shortages and supply chain disruptions and mitigating adverse impacts.

Moderators
  • RADM Sean M. Boyd (Invited), Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA CDRH
  • Monica Wilkins, Vice President Regulatory and Quality, Abbott
Speakers
  • Linda Ricci (Invited), Division of All Hazards Response, Science and Strategic Partnerships, FDA CDRH
  • Mike Hoffmann (Invited), Program Lead, Medical Device Shortages Program, FDA CDRH – OPEQ
9:30 A.M. – 9:50 A.M.

Break

Day 2 – Morning Breakouts (choose one):

9:50 A.m. – 11:00 a.M.

Biocompatibility – Where Are We Now?

Listen to FDA leaders discuss the most current expectations for medical device biocompatibility testing to be included in premarket submissions. Also hear updated trends and areas of concern from test lab experts as well as industry leaders’ experience with recent FDA submissions and preparation of technical files for EU Medical Device Regulation.

Moderator
  • Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
Speakers
  • Ed Magerrison (Invited), Director, Office of Science and Engineering, FDA CDRH
  • Kelly Coleman, Distinguished Toxicologist, Medtronic
  • Thor Rollins, Senior Director of Toxicology and E&L Consulting, Nelson Labs, LLC
9:50 A.m. – 11:00 a.M.

The Essence of EU SSCP and EU PSUR

This session will discuss in panel style the best practices developed so far for sharing relevant clinical data in a transparent way in the new documents SSCP (Summary of Safety and Clinical Performance) and PSUR (Periodic Safety Update Report).

Moderator
  • Gert Bos, Executive Director & Partner, Qserve Group
  • Kim Trautman, Managing Director and Vice President, MEDIcept, Inc.
Speakers
  • TBA
9:50 A.m. – 11:00 a.M.

Uses of Real-World Evidence Including Patient Self-Reporting

Innovations in medical devices, including mobile apps, have resulted in novel data sources, including the device itself. Real-world evidence (RWE) and real-world data (RWD) are data relating to a patient’s health status and/or the delivery of healthcare routinely collected from a variety of sources. This session will discuss the current U.S. FDA regulatory approach for use of RWE in regulatory decision-making and describe the related FDA draft guidance. Additionally, the session will review current projects that will provide insight into how RWD and RWE can play a role in supporting evaluation of the safety and effectiveness of drug and biological products.

Moderator
  • Susan Matthias (Invited), CSO Special Assistant, FDA-OMDRHO
Speakers
  • Daniel Caños, Office Director, Office of Clinical Evaluation and Analysis, FDA-OCEA
11:00 a.M. – 12:05 P.M.

Networking Lunch

Day 2 – Midday Breakouts (choose one):

12:05 P.M. – 12:50 P.M.

As FDA Emergency Use Authorization (EUA) Phases Out, How Do You Transition to Legal Marketing — Or Not?

In December 2021, the FDA issued the draft guidance document entitled “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” This session will focus on where FDA is today with the status of EUAs and expectations for industry. Join FDA officials to hear how industry should be preparing and from industry experts on how they are preparing for continued marketing – or not. Also learn how FDA enforcement could come into play after the expiration of EUA.

Moderator
  • Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Vice President Regulatory Affairs, MDMA
Speakers
  • Eli Tomar (Invited), Associate Director for Guidance, Legislation and Special Projects, Office of Policy, CDRH
  • Sue Dahlquist, Senior Director Global Strategic Regulatory & Clinical Affairs, Thermo Fisher Scientific
  • April Veoukas, Director, Regulatory Affairs, Abbott
12:05 P.M. – 1:05 P.M.

Artificial Intelligence (AI)/ Machine Learning (ML): Path to the Future

This session will cover the current U.S. FDA regulatory approach for AI/ML-based medical devices and explore opportunities for further enhancement through evolving developments in regulatory science in the areas of predetermined change control plans, labeling for transparency, and avoiding unintended bias. Additionally, the session will touch on the intersection of U.S. regulatory frameworks and the evolving global regulatory landscape for these types of products.

Moderator
  • Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP
Speakers
  • Cassie Scherer (Invited), Senior Director of Digital Health Policy and Regulatory Strategy, Medtronic
  • Brendan O’Leary (Invited), Acting Director, Digital Health Center of Excellence, FDA-DHCoE CDRH
  • Scott Thiel, Global Heal of Regulatory Policy and Intelligence, Hologic
12:05 P.M. – 1:05 P.M.

Managing Medical Device Cybersecurity Risk in the Healthcare Ecosystem

The FDA’s April 2022 Draft Premarket cybersecurity guidance emphasized the importance of a Secure Product Development Lifecycle, including the essential role of communications to properly inform HDOs (Health Delivery Organizations) of key security characteristics. This session will explore essential elements of these communications in properly securing medical device deployment and operation throughout the healthcare ecosystem. This exploration will include highlighting the newly revised Joint Security Plan (JSP) from the Healthcare Sector Coordinating Council’s Cybersecurity Working Group. In addition, IMDRF best practice resources on SBOM (Software Bill of Material) and Legacy, along with other recently released resources, will be addressed. This presentation will also highlight the importance of transparency between MDMs (Medical Device Manufacturers) and HDOs to ensure that medical device cybersecurity risk is adequately managed throughout the healthcare ecosystem.

Moderators
  • Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization/ Global Regulatory Policy, Medtronic
Speakers
  • Aftin Ross (Invited), Senior Project Manager, Staff Fellow, FDA-CDRH
  • Debra Bruemmer, Mayo Clinic
  • Chris Reed, Director, Regulatory Policy, Digital Health Digital Health and Product Security, Medtronic
1:05 p.M. – 1:25 p.M.

Break

Participants are invited to use this time to return to the plenary session held in the main conference room.

1:25 P.M. – 2:10 P.M.

FDA Transition to ISO 13485/Update on Proposed Rule Aligning QSR With 13485 (QMSR)

FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. Session participants will gain understanding of the status of the FDA’s proposed rule and implementation activities from FDA experts.

Moderator
  • Aaron Dunbar, Vice President QARA Compliance, Olympus
Speakers
  • Keisha Thomas (Invited), Associate Director for Compliance and Quality, FDA CDRH
  • Karen Masley-Joseph (Invited), Senior Advisor, Office of Medical Devices and Radiological Health Operations, FDA ORA
2:10 P.M. – 3:10 P.M.

Global Regulatory Convergence and Shaping Innovation

Do you market your devices in more than one jurisdiction? Do you seek a predictable, risk- and capacity-based regulatory framework? The global medical device regulatory landscape continues to evolve and increase in complexity. It is crucial to prioritize regulatory convergence in support of efficient pathways for patient access to medical technologies with less cost. Join this session to hear the current state of global regulatory convergence efforts and initiatives and an update on International Medical Device Regulators Forum (IMDRF) efforts to further convergence. Lastly, this session will provide industry’s perspective on the importance of globally convergent regulatory requirements.

Moderator
  • Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization / Global Regulatory Policy, Medtronic
Speakers
  • Melissa Torres (Invited), Associate Director for International Affairs, FDA OCD – CDRH
  • Tammy Steuerwald, JD, Roche
  • Augusto Benche Geyer, PharmD, MSc, ANVISA
3:10 p.M. – 3:30 p.M.

Break

3:30 P.M. – 4:15 P.M.

Innovating Submission of Premarket Applications – CDRH’s Customer Collaboration Portal and eSTAR Program

Listen to FDA Leadership describe novel technology solutions that facilitate the submission and tracking premarket applications. This session will cover CDRH’s electronic Submission Template AND Resource (eSTAR) program, which provides a dynamic, guided template for use in preparing premarket submissions and an update on the eSTAR Pilot announced in January 2023. Presenters will also share information on the Customer Collaboration Portal (CDRH Portal), which allows real-time tracking of submission status for industry members. These system improvements have been hailed by industry as some of the most impactful CDRH has made for the device program, and will give participants valuable insight into each.

Moderator
  • Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
Speakers
  • Douglas Kelly, MD (Invited), Deputy Center Director for Science, Office of the Center Director, FDA OCD
  • Nelson Anderson (Invited), CDRH Portal Platform Owner, Office of Regulatory Program, CDRHFDA
  • Patrick Axtell (Invited), Assistant Director, Lifecycle Tools and Templates Team, Office of Regulatory Programs, CDRHFDA
4:15 P.M. – 5:15 P.M.

Demonstration of FDA Databases and Publicly Available Tools

This presentation will provide an overview and demonstration of FDA publicly available databases and tools that can be used to retrieve, download, and analyze FDA data, including Total Product Life Cycle Data, Recalls, Medical Device Reports, Inspections, 483 observations, Compliance, and other information. The speaker will also highlight CDRH’s educational tool, which includes learning modules covering both premarket and postmarket topics and an introduction to CDRH’s Division of Industry and Consumer Education.

Moderator
  • Susan Matthias (Invited), CSO Special Assistant, FDA OMDRHO
Speaker
  • James Hildreth (Invited), OMDRHO Division 2 Director, Investigations Branch, FDA -ORA
TBD

Networking Reception

After the conference sessions on Wednesday, benefit from open dialogue while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with Strategic Committee members and speakers in a pleasant, informal setting.

April 27, 2023 / DAY 3
7:30 A.M. – 12:00 P.M.

Registration

7:45 A.M. – 8:30 A.M.

Breakfast

Join your colleagues from around the globe as we begin the last day of MedCon 2023 with a complimentary hot breakfast.

8:30 A.M. – 8:35 A.M.

MedCon Day 3 Welcome

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
8:35 A.M. – 10:30 A.M.

Investigator Insights

Every year at MedCon, investigators share insights on inspection trends they’ve observed. Hear from veteran FDA investigators with all three of the program’s divisions, who will “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.

Moderator
  • Monica Wilkins, Vice President Regulatory and Quality, Abbott
Speakers
  • Edward Lockwood (Invited), OMDRHO Division 2 CSO, FDA-ORA
  • Rafael Padilla (Invited), OMDRHO Division 2 Compliance Officer, FDA-ORA
  • Thomas Peter (Invited), OMDRHO Division 1 CSO, FDA-ORA
  • Phil Pontikos (Invited), OMDRHO National Expert, FDA-ORA
  • Janet Pulver (Invited), OMDRHO Division 3 CSO, FDA-ORA
10:30 A.M. – 10:45 A.M.

Break

10:45 A.M. – 11:45 A.M.

Understand the Recalls Process from Initiation to Termination!

FDA will walk through the process of a recall (Correction and Removal) including the requirements of 21 CFR Part 806 and 21 CFR Part 7. This presentation will include what is often missing or needs further clarification to ensure that notification and processing are completed efficiently and patients are notified in a timely manner. Additional information will include what is needed to terminate your recall.

Moderator
  • Gina Brackett (Invited), OMDRHO Division 1 Director, Compliance Branch, FDA ORA
Speakers
  • Meredith Andress (Invited), OMDRHO Division 2 Recall Coordinator, FDA-ORA
  • Cynthia Aycock (Invited), OMDRHO Division 1 Recall Coordinator, FDA-ORA
11:45 A.M. – 11:55 A.M.

To Your Success!

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a full action plan!

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative

RAPS Regulatory Affairs Certificate (white)

Are you a current RAC holder? 

Attend MedCon 2023 and earn 12.0 RAC recertification credits. 

In 2023, 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.