Main Conference Sessions Agenda: Day 1

WEDNESDAY, MAY 6, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the globe as we kick off MedCon with a complimentary warm breakfast.


8:30 AM  -  9:15 AM

Let's Make a Difference!

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

Moderator:

  • Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University

Speakers:

  • Gina Brackett (Co-Chair), OMDRHO Division 1 Director, Compliance Branch, FDA-ORA (invited)

  • Joe Matrisciano, Divisional Director, Office of Medical Device and Radiological Health Operations, Division 1, FDA-ORA (invited)

  • Marla Phillips, Director, Xavier Health, Xavier University


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9:15 AM - 9:45 AM

The Solution Xchange

Early audience engagement. Table involvement/team building element was great.
— MedCon 2019 Attendee

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.

Moderator:

  • Dennis Hahn, Principal Regulatory Consultant, Clinical Research Consultants, Inc.

Speaker:

  • Dennis Hahn, Principal Regulatory Consultant, Clinical Research Consultants, Inc.


9:45 AM - 10:05 AM

Break


10:05 AM - 10:50 AM

From the Office of Jan Welch: Initiatives to Advance Public Health

The Office of Medical Device and Radiological Health Operations (OMDRHO) houses all medical device and radiological health investigators across the country. Understand the key OMDRHO initiatives and strategic priorities related to our commitment to public health.

Moderator:

  • Gina Brackett (Co-Chair), OMDRHO Division 1 Director, Compliance Branch, FDA-ORA (invited)

Speaker:

  • Jan Welch, Director, Office of Medical Device and Radiological Health Operations, FDA-ORA (invited)


10:50 AM - 11:35 AM

From the Office of Jeff Shuren: Strategic Priorities for 2020 and Beyond

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) will provide insight on progress and direction of the 2020-2021 strategic priorities related to protecting public health, including collaborative activities shared with industry on the balance of safety, efficacy, quality, access, and innovation.

Moderator:

  • CAPT Sean M. Boyd, Director, Office of Regulatory Programs, OPEQ, FDA-CDRH (invited)

Speakers:

  • Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH), FDA-CDRH


11:35 AM - 12:50 PM

Lunch Options:

  1. Lunch and Learn: Where are we in the MDUFA V Negotiations?

    The Medical Device User Fee Amendments V (MDUFA V) negotiations are underway and affect all medical device companies. Hear the latest from one of the negotiators who has participated in every MDUFA and FDA. Learn how you can participate!

    Moderator:

    • Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products (and Vice President Regulatory Affairs, MDMA), Greenleaf Health

    Speakers:

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

  2. Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion on three different topics.


12:50 PM - 2:15 PM — TRACKS

Innovation Track

Innovation Track

Factory of the Future: 3D Printing, Mobile Manufacturing and Beyond

Join FDA and industry experts for a panel discussion and case study where you will learn about additive manufacturing (3D printing) equipment used for medical devices and mobile manufacturing technologies and their implementation. You will also learn industry standards and get insight into FDA's inspection approach.

Moderator: Phil Pontikos, National Device Expert, FDA-ORA (invited)

Speakers: LCDR James Coburn, Senior Researcher and Research Program Coordinator FDA-CDRH (invited); Matthew Di Prima, Materials Scientist, Office of Science and Engineering Laboratories, FDA-CDRH (invited); Phil Pontikos, National Device Expert, FDA-ORA (invited)

PreMarket Track

PreMarket Track

Cybersecurity: A Shared Responsibility

Medical device cybersecurity is a critical responsibility shared across internal and external entities. Cybersecurity should be a part of product design, development, and maintenance. This session will address issues that need to be top of mind for device companies, such as cybersecurity vulnerabilities, data protection requirements, and adoption of better cybersecurity practices such as the Joint Security Plan (JSP). How will your company address cybersecurity challenges and achieve Quality integration? Hear FDA, Industry, and the researcher community’s perspective.

Moderator: Fatemeh Razjouyan, Director, Regulatory Policy, Corporate Regulatory Affairs, BD

Speakers: Seth Carmody, Cybersecurity Program Manager, FDA-CDRH (invited); Tyrone Heggins, Senior Manager Quality - Product Security, BD; Beau Woods, Cyber Safety Advocate, I Am The Cavalry

 
Postmarket Track

PostMarket Track

Recalls Happen! Walk Through a Case Study on How to Handle Them Properly

Do you have questions around how to detect, address and follow up on product defects requiring a recall? This session will provide insight into 1) data elements, triggers and trending analyses that should be considered in identifying potential recalls, 2) how to ensure root cause is identified, health hazards are appropriately assessed, and corrective actions are systematically and effectively implemented across the quality system, 3) and ensuring actions effectively address problems to prevent recurrence. The session will include speakers from industry and FDA, where participants will engage in a case study involving real and complex product problems.

Moderator: Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA-ORA (invited)

Speakers: Andrew Lang, OMDRHO Division 1 Recall Coordinator, FDA-ORA (invited); Nick Walker, FDA-CDRH (invited); Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott

International Track

International Track

Lessons Learned from EU MDR That Will Prepare You for IVDR

This interactive session will enhance your ability to plan for and manage the many uncertainties and unclarities in the EU MDR/IVDR. Although the basics are clear, interpretation of the intent and how to meet the intended expectations are not clear. Join this session to understand the evolving landscape and be confident that you know what is required to be in compliance. With the implementing tools continuing to be released, we will explore how to successfully address the challenges of interpreting the details.

Moderator: Gert Bos, Executive Director & Partner, Qserve Group

Speakers: Bassil Akra, Vice President, TÜV SÜD Product Service; Sue Spencer, Head of IVD, Qserve Group


2:15 PM - 2:35 PM

Break


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2:35 PM - 3:35 PM — TRACKS

Innovation Track

Innovation Track

Factory of the Future: Emerging Technologies

Learn what technologies are emerging and how they are being used in manufacturing and quality control. Hear from a panel of FDA and industry experts to learn best practices for emerging technologies through an interactive discussion.

Moderator: Phil Pontikos, National Device Expert, FDA-ORA (invited)

Speakers: LCDR James Coburn, Senior Researcher and Research Program Coordinator, FDA-CDRH (invited); Matthew Di Prima, Materials Scientist, Office of Science and Engineering Laboratories, FDA-CDRH (invited); Phil Pontikos, National Device Expert, FDA-ORA (invited);

PreMarket Track

PreMarket Track

STeP Up and Breakthrough!

Are you leveraging the pathways offered to you? The Breakthrough Device Program allows manufacturers to interact with FDA experts in the premarket review of qualifying devices. Recently, the Safer Technologies Program (STeP) was added for devices that do not fit the breakthrough designation but still offer safety and other improvements over current technology. What are the regulatory requirements for these programs? How does FDA assess potential clinical requirements for novel devices, and how does the Agency work with manufacturers to design appropriate clinical protocols when needed? Are manufacturers effectively taking advantage of these new pathways and if not, how can they? Join this session to learn directly from FDA on how these innovative regulatory pathways can help you.

Moderator: Steve Binion, Ph.D., MBA, Principal, SB RegConsult LLC

Speakers: Owen Faris, Principal Deputy Director, Office of Product Evaluation and Quality, FDA-CDRH; Doug Jeffery, Ph.D., Acting Deputy Division Director, Division of Immunology and Hematology Devices (DIHD), Office of In Vitro Diagnostics and Radiological Health (OIR), FDA-CDRH (invited)

 
Postmarket Track

PostMarket Track

FDARA: New and Changing Processes that Impact You!

More changes are coming as a result of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. Are you aware of what they are and how they’ll impact your company? This session will discuss FDARA provisions related to the inspection planning process, where you will hear perspective from both ORA and CDRH FDA panelists. Specifically, FDA is required to provide additional visibility on the type, nature and expected duration of the inspection; there is a new process for seeking non-binding feedback for certain inspectional observations; and changes to the process for issuing certificates for foreign government.

Moderator: Amanda Klingler, Partner, FDA and Life Sciences Practice, King & Spalding

Speakers: Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA-ORA (invited); Arduino Frankovic, OMDRHO Division 1 Director, Investigations Branch, FDA (invited); Leila Lawrence, Export Policy Specialist, FDA (invited)

International Track

International Track

The New World Order After BREXIT

After exit day, all medical devices, active implantable medical devices, in vitro diagnostic medical devices and custom-made devices will need to be registered with MHRA prior to being placed on the UK market. Gain insight directly from MHRA and a leading industry expert regarding the grace period for the different classes of devices, activities of the UK Responsible Person, import licensing, Manufacturer’s License for all importers, and the impact on clinical trials conducted in the UK.

Moderator: Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

Speakers: Graeme Turnbridge, Group Manager – Devices Regulatory Affairs, MHRA, UK (invited)


3:35 PM - 3:50 PM

Relocation Break

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


3:50 PM - 5:00 PM

From the Field: Preparing for Tomorrow Utilizing FDA Investigator Insights

Every year at MedCon, investigators share insight on the most current inspection trends. FDA sends veteran device investigators to “tell it like it is.” Use this friendly forum to prepare today for tomorrow.

Moderator:

  • Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott

Speakers:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA-ORA (invited)

  • Laureen Geniusz, Investigator, Medical Device Specialist, Cincinnati District, FDA-ORA (invited)

  • Phil Pontikos, National Device Expert, FDA-ORA (invited)

  • Thomas Peter, Medical Device Specialist, FDA-ORA (invited)

  • Timothy Philips, Compliance Officer/Biomedical Engineer, FDA-CDRH (invited)


Cincinnati Museum Center

5:45 PM - 8:30 PM

Annual MedCon Dinner at Cincinnati Museum Center

Cincinnati Museum Center is a one-of-a-kind, multi-museum complex housed in Union Terminal, a historic Art Deco train station and National Historic Landmark. Museum Center's major offerings at Union Terminal include the Cincinnati History Museum, the Cincinnati History Library and Archives, the Duke Energy Children's Museum, the Museum of Natural History & Science and the Robert D. Lindner Family OMNIMAX® Theater. Museum Center is the largest cultural institution in the city of Cincinnati, with more than 1.4 million visitors per year and its collection encompass more than 1.8 million artifacts, art works, and archives. The evening will be capped with a dinner.