May 4 – 6 — VIRTUAL 


MedCon 2022 Sessions

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Are you a current RAC holder? 

Attend MedCon 2022 and earn 12.0 RAC recertification credits. 

All sessions will be held virtually in the Eastern Time Zone. 

Early Morning Sessions

9:30 a.m. – 10 a.m.

CONNECT in early

Take this time to log in early and check your connection.

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.
2:55 p.m. – 3:55 p.m.

IMDRF Good Regulatory Review Practices: How to Make Single Review a Reality

Do you market your products in more than one jurisdiction? Do you seek globally harmonized regulatory requirements that reduce regulatory redundancy and support patient access to medical devices? The Medical Device Single Review Program (MDSRP), once implemented, will support earlier patient access to devices by enabling a single regulatory premarket review across multiple regulatory jurisdictions. Hear from CDRH on what they have been doing in collaboration with other regulators participating in the International Medical Device Regulators Forum (IMDRF) to help move international device regulatory submissions into a “single review” process. This session also provides industry’s perspective on the importance of a globally harmonized regulatory requirements, including potential challenges.

Moderator
  • Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization / Global Regulatory Policy, Medtronic
speakers
  • Patrick Axtell, Senior Tools & Templates Engineer, Office of Regulatory Products, FDA-CDRH
  • Nicole Taylor-Smith, Vice President, Global Regulatory Policy, Medtronic
  • Melissa Torres, Associate Director for International Affairs, FDA-CDRH
3:55 p.m. – 4:00 p.m.

break

4:00 p.m. – 5:00 p.m.

CDRH Premarket Program Updates

Listen to FDA Leadership from the Office of Product Evaluation and Quality provide updates to current ongoing novel programs at FDA including: eSTAR, transitioning from Emergency Use Authorizations, SteP, the submissions progress tracker, and the Breakthrough Device Program. Also, get up-to-date information on recent trends of Premarket Submissions data and information regarding premarket submission appeals and the least burdensome flag.

moderator
  • Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS
speaker
  • Joshua Nipper, Director, Division 1: Division of Submission Support, Office of Regulatory Programs, FDA-CDRH
2:55 p.m. – 3:55 p.m.

Current Perspectives on Lifecycle Risk Management

Explore, with this panel of experts, the current landscape of Risk Management and ISO 14971 implementation, including EN harmonization. This discussion will also traverse lifecycle management of use-related risks and discuss considerations and best practices for the transition of risk management activities from pre-market to post market.

Moderator/speaker
  • Shannon Hoste, Senior Director of Human Factors and Regulatory Strategy, Agilis Consulting Group
speakers
  • Taylor Dieringer, MEDIcept
  • Ed Bills, Edwin Bills, Consultant
3:55 p.m. – 4:00 p.m.

break

4:00 p.m. – 5:00 p.m.

The Connected Journey of Data, Metrics, KPIs and CAPA

Does your firm use metrics and Key Performance Indicators (KPIs) to make CAPA decisions? Learn how data sources, metrics and KPIs interrelate and their relationship to CAPA. Using examples, the speakers will demonstrate the importance of setting triggers based on risk data to incorporate into CAPA decision making to achieve consistency in escalation to the improvement process.

  • Discuss data sources and how to determine triggers.
  • Explore utilizing risk data and other quantitative historical data to establish triggers.
  • Reiterate the importance of communication within the organization and up to management.
Moderator
  • Aaron Dunbar, Director of Corporate Quality Systems, Boston Scientific Corporation
speakers
  • Amanda Rucker, Cook Medical
  • Katie Crawford, Boston Scientific Corporation
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
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
9:30 a.m. – 10 a.m.

COnnect in early

Take this time to log in early and check your connection.


Day 2 Tracks

Pick from three track options.
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
10:00 a.m. – 11:00 a.m.

FDA Digital Health Software Precertification (Pre-Cert) Pilot

The Software Precertification (Pre-Cert) Pilot, as outlined in the FDA’s Digital Health Innovation Action Plan, will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market. Brendan O’Leary, Acting Director, FDA / CDRH Digital Health Center of Excellence will provide an overview of the pilot and its continued development. Industry representatives will also share their perspectives of the pilot.

Moderator
  • Aaron Dunbar, Director of Corporate Quality Systems, Boston Scientific Corporation
speakers
  • Brendan O’Leary, Acting Director, Digital Health Center of Excellence, FDA DHCoE CDRH
  • Damien McPhillips, Director, Quality, Global Software & Digital Health, Boston Scientific Corporation
  • Szymon Perkowski, Head of Quality, BetterOmics
11:00 a.m. – 11:40 a.m.

What Cloud Computing Teaches Us About the Future of the Validated State

The cloud endows software with incredible speed, flexibility and power. How can we harness that power for our medical device software while remaining compliant? And how can we apply best practices from the cloud to our broader interoperable MedTech world? Orthgonal’s Randy Horton and Philips’ Pat Baird co-chaired a team to create the groundbreaking consensus report on operating medical device software on cloud computing, AAMI CR510:2021. That consensus report has set the stage for AAMI TIR #115, currently in the works, that will provide more detailed guidance on how we can use cloud computing in the operation of medical devices.

Moderator
  • Francis Blacha, Global Quality Leader – Drug Delivery System Development, Eli Lilly
speakers
  • Pat Baird, Philips
  • Randy Horton, Orthogonal
11:40 a.m. – 12:40 p.m.

break

10:00 a.m. – 11:00 a.m.

UK MHRA and Swiss Medic Medical Device Registrations – Are you in compliance?

As of May 2021, with the effectiveness of the EU MDR, the CE mark will no longer be extending to three countries: United Kingdom, Switzerland, and Turkey. To market in these countries, medical device manufacturers must have new Authorized Representatives, registrations, and additional requirements. This session will cover deadlines for registration and appointment of Authorized Representatives as well as up-to-date information on specific requirements for the UK and Switzerland. Recognize the need to stay tuned to upcoming UK MHRA publications of new medical device regulations that will not be the same as the EU MDR or EU IVDR scheduled for the UK in 2023. Learn about the nuances of Northern Ireland and the Republic of Ireland. Understand what you need to know about marketing your products in Switzerland.

Moderator
  • Kim Trautman, Managing Director and Vice President, MEDIcept Inc.
speakers
  • Natalie McRoberts, Magnetosphere Ltd
  • Michael Maier, Medidee
11:00 a.m. – 11:1o a.m.

break

11:10 a.m. – 12:4o p.m.

EU MDR and EU IVDR: Latest Guidance and Developments

Notified body, industry and service provider will come together to bring an overview of current developments in the field of EU MDR and EU IVDR. New guidance will be explained, and general updates will be provided. The audience will be engaged in discussion centering around several examples of core regulatory issues.

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
12:40 p.m. – 1:10 p.m.

Lunch 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

Early Morning Sessions

9:30 a.m. – 10 a.m.

CONNECT in early

Take this time to log in early and check your connection.

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.

Lunch 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
3:45 P.m. – 4:00 P.m.

CLOSE OUT / EVENT WRAP-UP

In 2022, 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.