MedCon 2022 Program

Support and Drive the Speed of Innovation at this Premier Event

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. We thank them for their hard work and dedication to this important event.

Wednesday

Thursday

Friday

May 4, 2022

Early Morning Sessions

9:30 A.M. – 10 A.M.

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10:00 A.M. – 10:20 A.M.

WELCOME TO MEDCON 2022

MODERATOR

Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA-ORA

SPEAKERS

Steven Mandernach, Executive Director, Association of Food and Drug Officials (AFDO)
Brian Savoie, Vice President, Education & Professional Development, Regulatory Affairs Professionals Society (RAPS)
Marla Phillips, CEO & President,
Pathway for Patient Health
Cynthia Culmo, Principal Consultant, Culmo Compliance Consulting

10:20 A.M. – 11:05 A.M.

CDRH’S STRATEGIC DIRECTION FOR 2022

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH), will provide an update on FDA’s priorities and strategic direction for the medical device industry. The session will highlight Center activities that continue to promote device safety, efficacy, quality, access, and innovation.

MODERATOR

RADM Sean M. Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA – CDRH

SPEAKERS

Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA – CDRH

11:05 A.M. – 11:15 A.M. BREAK

Mid-Morning Sessions

11:15 A.M. – 12:15 P.M.

UPDATE FROM ORA’S OFFICE OF MEDICAL PRODUCTS AND OFFICE OF MEDICAL DEVICE AND RADIOLOGICAL HEALTH

The Office of Regulatory Affairs’ (ORA) Office of Medical Products and Radiological Health houses all medical device and radiological health investigators across the country. Dr. Elizabeth Miller, Associate Commissioner of the Office of Medical Products and Anne Reid, Acting Program Director of the Office of Medical Devices and Radiological Health will provide an update on ORA’s key initiatives, strategic priorities, and inspectional approaches to the medical device industry.

MODERATOR

Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA-ORA

SPEAKERS

Elizabeth Miller, Associate Commissioner of the Office of Medical Products, FDA-ORA
Anne Reid, Acting Program Director of the Office of Medical Devices and Radiological Health, FDA – OMDRHO

12:15 P.M. – 12:45 P.M. LUNCH

Afternoon Sessions

12:45 P.M. – 1:45 P.M.

MEDICAL DEVICE USER FEE AMENDMENTS (MDUFA) V UPDATE

Learn about the commitments that will affect every device company.

MODERATOR

Heather Rosecrans, Executive Vice President, Medical Devices and Combination Products, Greenleaf Health

SPEAKER

Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)

1:45 P.M. – 2:45 P.M.

FDA PROPOSED QMSR – UPDATING 21 CFR 820 TO HARMONIZE WITH ISO 13485:2016

On February 24, 2022, FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation” (QMSR) with comments due by May 24, 2022.

CDRH will provide an update on the proposed rule from an FDA perspective.
Hear the analysis of the proposed rule from industry and ISO TC 210 International Committee experts.
Join in open discussions on questions, concerns, and how to submit public comments.

MODERATOR/SPEAKER

Kim Trautman, Managing Director and Vice President, MEDIcept

SPEAKER

Scott Sardeson, International Regulatory Affairs and Quality Compliance Director, 3M, TC 210 Working Group Chairman
Melissa Torres, FDA – CDRH
Keisha Thomas, Associate Director for Compliance and Quality, FDA – CDRH

2:45 P.M. – 2:55 P.M. BREAK

Day 1 Tracks

Pick From Three Track Options.

Premarket TrackPostmarket TrackInnovation/Digital Health/Postmarket Track

2:55 P.M. – 3:55 P.M.

CYBERSECURITY: HOLISTIC STRATEGIES TO MITIGATE AND MANAGE RISK

Cybersecurity is a key enabler within our healthcare systems to protect the privacy and safety for patients as well as the business continuity of providers. Successful strategies for cybersecurity require a high degree of collaboration across multiple stakeholders with shared responsibility. Learn from this panel of industry experts some key areas to consider.

MODERATOR

Kim Trautman, Managing Director and Vice President, MEDIcept Inc.

SPEAKERS

Carlos Arglebe, Siemens Healthineers
Arnab Ray, Abbott
Dan Lyon, Global Director of Product Security, Boston Scientific Corporation
Arnab Ray, Abbott

3:55 P.M. – 4:00 P.M.

BREAK

GLOBAL DEVELOPMENTS IN REGULATING AI BASED MEDICAL DEVICES

4:00 P.M. – 5:00 P.M.

AI almost seems too hot to handle. Many active devices will see an AI component supporting them in the future, following the earlier steps of getting them all ‘connected’. This time the regulations are gearing up in speed with the technical development in the market. US, EU, China and more countries are adding legislation and guidance for AI in general and for medical devices in specific. This panel will bring some of the latest insights from around the world, and will support the discussion on how to best approach global regulatory approvals in this exciting field of development.

MODERATOR

Gert Bos, Executive Director and Partner, Qserve Group

SPEAKERS

Koen Cobbaert, Senior Manager – Quality, Standards & Regulations, Philips
Eric Henry, King & Spalding
Yu Zhao, Founder & President, Bridging Consulting LLC
Arnab Ray, Abbott

May 5, 2022

Early Morning Sessions

9:30 A.M. – 10 A.M.

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Day 2 Tracks

Pick From Three Track Options.

Premarket TrackInnovation/Digital Health TrackInternational Track

10:00 A.M. – 11:30 A.M.

BIOCOMPATIBILITY AND PREMARKET SUBMISSIONS

Listen to a panel of experts discuss the current challenges of addressing biocompatibility issues for premarket submissions. Hear FDA leaders discuss expectations for medical device biocompatibility testing to be included in Premarket Notifications. Test lab experts will present trends and areas of concern observed while performing tests to support submissions. Finally, join in the discussion as industry leaders share experiences with recent FDA submissions as well as best practices in the inclusion of biocompatibility in preparation of Technical Files.

MODERATOR

Bill Brodbeck, Senior Director Regulatory Affairs, STERIS

SPEAKERS

Ed Margerrison, Director, Office of Science and Engineering, FDA-CDRH
Kelly P. Coleman, Ph.D., Distinguished Toxicologist, Medtronic
Thor Rollins, Sr. Director of Toxicology and E&L Consulting, Nelson Labs LLC

11:30 A.M. – 11:40 A.M.

BREAK

11:40 A.M. – 12:40 P.M.

HOW DOES FDA REGULATE ACCESSORIES TO MEDICAL DEVICES?

Is your product’s performance supported, supplemented, and/or augmented by an accessory? Then it may be classified as an accessory that requires premarket notification or approval. Hear from CDRH and Industry on medical device accessory determination, classification, and pathways for clearance or approval.

MODERATOR

Lenore Faulhaber, Principal Scientist, Global Product Stewardship, Procter & Gamble
Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health Vice President Regulatory Affairs, MDMA

SPEAKERS

Melissa Kann, Director, Regulatory Affairs, Stryker
Josh Silverstein, Regulatory Advisor, Office of Device Evaluation, FDA-CDRH
Connie Soves, FDA

12:40 P.M. – 1:10 P.M. BREAK

Afternoon Sessions

1:10 P.M. – 2:10 P.M.

SUPPLY CHAIN AND MEDICAL DEVICE SHORTAGES – NAVIGATING A CHALLENGING SITUATION

Have you experienced challenges due to supply chain disruptions and product shortages? This session will provide FDA and industry perspective on past experience, lessons learned during the COVID public health emergency, and how government and industry can partner to identify issues before they become problems in the future.

MODERATOR

RADM Sean M. Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA-CDRH

SPEAKERS

Mike Hoffman, Lead, FDA/CDRH/OPEQ
Abby Pratt, Senior Vice President, Global Strategy & Analysis and Staff Lead, Supply Chain, AdvaMed
Jessica Johnston, Sr. Director, Global Community Affairs, BD
Linda Ricci, Director, Division of All Hazards Response, Science and Strategic Partnerships, FDA – CDRH

2:10 P.M. – 2:20 P.M. BREAK

2:20 P.M. – 3:35 P.M.

SOFTWARE BILL OF MATERIALS (SBOM): AN ESSENTIAL TOOL SUPPORTING CYBERSECURITY RISK MANAGEMENT ACROSS THE HEALTHCARE ECOSYSTEM

Cybersecurity issues such as ransomware plague the healthcare ecosystem and one major contributor to the sector’s vulnerability is failure to keep software components updated to address emerging vulnerabilities. In 2017, the WannaCry ransomware outbreak that crippled over 70,000 devices across the National Health Service hospitals in the UK and Scotland was possible due to inability to identify and patch a Microsoft Windows vulnerability (MS17-010). The problem is complex and significant risk still exists today. Executive Order 14028, issued on May 12, 2021, specifically calls out SBOM and its value in an effort to improve the Nation’s Cybersecurity and help address this specific problem. Have you wondered why Software Bill of Materials (SBOM) should be important to your company? What is the benefit of disclosing your SBOM? Why do some regulatory jurisdictions strongly recommend it? Join this session to understand the importance of SBOM for your medical device’s security and quality. Industry and FDA experts will provide an update on regulatory and market expectation, invaluable insight on best practices for implementing SBOM, and current efforts to advance international regulatory convergence on medical device cybersecurity.

MODERATOR

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

SPEAKERS

Aftin Ross, Senior Project Manager, Staff Fellow, FDA-CDRH
Ed Heierman, Informatics Software Architect, Abbott
Chris Reed, Director, Regulatory Policy, Digital Health and Product Safety, Medtronic

3:35 P.M. – 3:45 P.M.

CLOSEOUT / WRAP-UP FOR DAY

May 6, 2022

Early Morning Sessions

9:30 A.M. – 10 A.M.

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10:00 A.M. – 11:20 A.M.

EU MDR IMPLEMENTATION: FIRST LESSONS LEARNED

Join us as a panel of experts provide core elements of learning from the first phase of the EU MDR implementation. Explore what worked well, where have they surprised each other, and what is not easy to implement or review.

MODERATOR

Gert Bos, Executive Director and Partner, Qserve Group

SPEAKERS

João Martins, Associate Director, Regulatory Affairs Strategy, Abbott
Sabina Hoekstra, Regulatory Strategy, Principal, TÜV SÜD
Bassil Akra, Chief Executive Officer, Akra Team GMbH
Erik Vollebregt, Axon Lawyers

11:20 A.M. – 11:50 A.M. BREAK

Mid- Morning Sessions

11:50 A.M. – 1:50 P.M.

INVESTIGATOR INSIGHTS

Every year at MedCon, Investigators share insight on inspection trends observed. The FDA sends veteran device investigators to “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.

MODERATOR

Monica Wilkins, Corporate Vice President, Regulatory and Quality, Abbott

SPEAKERS

Phil Pontikos, Investigator, Medical Device National Expert, FDA – OMDRHO-ORA
Debara Reese, Consumer Safety Officer, FDA-OMDRHO-ORA
Michelle Glembin, Medical Device Senior Operator, FDA-OMDRHO – ORA
Karen Archdeacon, Compliance Officer, FDA-OMDRHO-ORA

1:50 P.M. – 2:00 P.M. BREAK

Afternoon Sessions

2:00 P.M. – 3:00 P.M.

UNIQUE DEVICE IDENTIFIERS – ACCESSGUDID.
ARE YOU WHERE YOU SHOULD BE?

In this session, the FDA will provide an overview of the Unique Device Identification (UDI) System, its benefits, and the latest information on implementation timelines and extensions. Insights on how UDI is covered during FDA inspections and what medical device manufacturers should expect will also be shared. Industry representatives will also share their perspectives of the FDA’s UDI System, UDI requirements from other geographies, and managing the differences in applicable requirements.

MODERATOR

Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA-ORA

SPEAKERS

Stephen Smith, FDA – OMDRHO
Dennis Black, BD
Wendy Jackson, Boston Scientific Corporation
Indira Konduri, Deputy Director, Division of Market Intelligence Office of Regulatory Programs, Office Product Evaluation & Quality, FDA – CDRH

3:00 P.M. – 3:45 P.M.

ASSESSING AND IMPROVING DEVICE SAFETY & PERFORMANCE THROUGH ADVERSE EVENT SURVEILLANCE

Adverse event information is one of several data elements that industry and FDA consider in monitoring medical device performance in the real world. This session will focus on Medical Device Reporting (MDR) and related programs, to provide updates on policy process and systems made by FDA in recent months. FDA and industry representatives will provide perspective on a variety of topics, as well as best practices and anticipated developments in this space.

MODERATOR

RADM Sean M. Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA – CDRH

FACILITATORS

Matt Graf, Director, Quality Assurance and Global Quality Systems, Cook Medical
Michael Ryan, Deputy Director, Office of Regulatory Programs, FDA CDRH-OPEQ