MedCon Agenda: Day 2
Thursday, May 3, 2018

 

7:45 AM - 8:30 AM

Breakfast

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


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8:30 AM - 8:40 AM

Day 2 Opening

Participants will feel the Xavier Difference at MedCon, a purpose-driven, action-oriented conference. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process with a focus on “action.

Moderator:

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices

Speaker: 

  • Dennis Hahn

8:40 AM - 9:40 AM

EU Regulations: Beyond the Unknown

The European Regulations for Medical Devices and In Vitro Diagnostic Devices have been published for more than a year. Now that there are fewer unknowns, we can dive deep into understanding the “how to” and the impact of these regulations.  During this session participants will understand the implementation progress related to NB designation, Governance of the MDR/IVDR (MDCG), defining the “Implementing and Delegated” acts and the EUDAMED database. Participants will also walk away with insight on what is known about the impact of Brexit on medical technologies. Don’t miss this opportunity to ensure your organization is aligned with your colleagues across the industry.

Moderator:

  • Gert Bos, Executive Director & PartnerQserve Group

Speakers:

  • Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy, Abbott
  • Bassil Akra, Vice President, TÜV SÜD Product Service

9:40 AM - 10:00 AM

Break


10:00 AM - 10:45 AM

Align Your Organization with the FDA PreMarket Priorities

Product approval is vital to your organization and to the patients and customers you serve. Learn directly from FDA on how they are working to increase speed to market for some products that are proven to be safe, and how you can work to have your products on that fast-track list. Don’t miss this opportunity to stay abreast of the priorities FDA has for premarket submissions.

Moderator:

  • Steve Binion, Ph.D., M.B.A., Sr. Director, Regulatory Policy Corporate Regulatory Affairs, BD

Speaker:

  • Dr. William Maisel, Deputy Center Director for Science, Acting Director for ODE, Acting Director for the Office of Compliance, FDA-CDRH

10:45 AM - 11:30 AM

FDA PostMarket Update and Strategic Priorities

CDRH is working internally and with industry to collectively advance how “quality” can be leveraged for the benefit of your patients. CDRH is taking a Total Product Lifecycle approach to decisions they make about your product, folding in real-world evidence to PreMarket and PostMarket approvals, and working to assess the maturity of your company. Learn firsthand what is on the horizon and how to position your company for patient success.

Moderator: 

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

Speaker:

  • CAPT Sean M. Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA-CDRH

11:30 AM - 11:35 AM

Focus on Learning

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Participants will assess their key learnings through the Act-Change-Transfer process with a focus on “change.”

Moderator: 

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices

Speaker:

  • Dennis Hahn

11:35 PM - 12:35 PM

Lunch 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 these topics:

  • International Regulatory Convergence
  • 510(k) Guidance Expectations
  • Benefit & Risk

12:35 PM - 2:40 PM


DAY 2 TRACKS

1a. PreMarket Track (12:35pm - 1:35pm)

How to Effectively Implement the New 510(k) Guidance Expectations:  Join Marjorie Shulman, CDRH (invited), as she explains what CDRH expects from industry based on the Final Guidance on 510(k) Modifications. She will share what the CDRH 510(k) staff is seeing from industry, especially what is working well and what isn’t. Since the medical device innovation cycle results in continuous changes to medical devices as technology evolves and new uses for existing devices are evaluated, don't miss this opportunity to better understand when a new 510(k) submission is required for modifications made to an existing device or software.  

Moderator:

  • Susan Rolih, Executive Vice President, Regulatory and Quality Systems, Meridian Bioscience, Inc.

Speakers: 

  • Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, FDA-CDRH (remote)
  • April Veoukas, Director, Regulatory Affairs, Abbott

1b. PreMarket Track (1:35pm - 2:40pm)

The CDRH 510(k) Review Template: A Demo of the 510(k) Smart Template Used by CDRH Reviewers to Review 510(k)s: This demo will begin with a brief description on how the Smart Templates were developed and are presently maintained, followed by a demo of the main characteristics and parts of the 510(k) Smart Template. The demo will include a brief look inside the automated guides used by reviewers to review cross-cutting disciplines (e.g., Biocompatibility, Sterilization, Cybersecurity). By the end of the demo you will understand how the template is used, how a single template can be used to review multiple device types, and what the components of the template are.

Moderator: 

  • Bill Brodbeck, Director, Regulatory Affairs, STERIS

Speaker: 

  • Patrick Axtell, Program Operations Staff, Office of Device Evaluation, FDA-CDRH

2. PostMarket Track (12:35pm - 2:40pm)

Understanding and Applying Critical to Quality Principles in Device Design:   Through interactive case studies, gain a better understanding of critical to quality attributes that focus around principles of product risk, and their resulting impact on the design of your finished device. Learn about the importance of establishing the criticality of the cTQs and linking it to the acceptance activities and/or design verification/validation activities for your device.

Moderator:

  • Gina Brackett, Director Compliance Branch, FDA

Speakers:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA-ORA
  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding
  • Phil Pontikos, National Device Expert, FDA
  • Bleta Vuniqi, Quality System Specialist, Division of Manufacturing and Quality, Office of Compliance, FDA


3a. International (12:35pm - 1:35pm)

Regulatory Convergence Strategies (ISO 13485).  Convergence is upon us.  It is critical that medical device manufacturers supplying the global marketplace understand the compounded effect of these converging changes across multiple regulatory jurisdictions.  Come away with a deeper understanding of these changes, how the will impact your organization and tools to plan and fine-tune your approach to compliance with ISO 13485:2016, MDSAP, EU MDR, EU IVDR and Brexit.

Moderator:

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

Speakers:

  • Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF International
  • Scott Sardeson, International Regulatory Affairs and Quality Compliance Leader, 3M

 

3b. International Track (1:35pm - 2:40pm)

China - Land of Opportunity and Challenges: Perhaps the most dynamic market in the world, China's rapidly expanding economy and continuously evolving regulatory landscape represents opportunities and challenges to medical device innovators. This session will provide an overview of the evolving regulatory landscape in China and present case studies on successful practices.

Moderator: 

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices

Speaker:

  • Gert Bos, Executive Director & Partner, Qserve Group
  • Effie Lin, Ph.D., Director Regulatory Affairs, Abbott Vascular


    2:40 pm - 3:00 pm

    Break


    3:00 pm - 4:00 pm

    The Balance of Benefit and Risk – FDA Insight

    Benefit-risk evaluations are at the center of everything we do as medical device professionals, striving to provide safe and effective devices for patients and providers. When problems are encountered, decisions concerning device availability, regulatory actions, and enforcement options need to consider the balance between benefit and risk. FDA has prioritized developing uniform, transparent, and harmonized methods and tools for use throughout the postmarket space. In this session, you will learn about these new tools, how and when they are employed, how they drive decision making, and how you might integrate them into your processes. 

    Moderator: 

    • James O'Reilly, Professor, University of Cincinnati

    Speakers:

    • Adam Saltman, Medical Officer, Office of Compliance FDA-CDRH
    • Randall Brockman, M.D., Acting Deputy Director, Clinical, Office of Medical Products and Tobacco, Office of Device Evaluation, FDA-CDRH (remote)
    • Pat Baird, Regulatory Head of Global Software Standards, Philips

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    4:00 pm - 5:00 pm

    How Medical Device Firms are Gearing Up for Compliance with Europe’s New Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)

    The session will poll the attendees and members of the industry on the progress they have made to meet the requirements of the new European MDR and IVDR. Following a discussion of the poll results, representatives from medical device and IVD companies will provide examples of ways they are addressing the requirements.

    Moderator: 

    • Nancy Singer, Founder, Compliance-Alliance

    Speakers: 

    • Gert Bos, Executive Director & PartnerQserve Group
    • Frank Fucile, Senior Director, Regulatory Affairs, STERIS
    • Susan Rolih, Executive Vice President, Regulatory and Quality Systems, Meridian Bioscience, Inc.
    • Michael Viscido, Sr. Director, Quality & Technical Services, Mallinckrodt, Inc.
    • Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott

    5:00 PM - 7:00 PM

    Networking Reception

    After the conference sessions on Thursday, benefit from open dialog 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.