For your convenience, the FDA/Xavier MedCon 2019 presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Heather Harwood, Director, Art & Communications. Note: Presentations are listed in alphabetical order by title.


Ask the Notified Body: EU MDR Insights

Presenters:

  • Bassil Akra, Vice President, TÜV SÜD Product Service

  • Klaus-Dieter Ziel, Managing Director, MEDCERT


Beyond MDSAP and ISO 13485: Multi-Purpose Global Regulatory Audits

Presenters: 

  • Kimberly Soter, VP Quality, Olympus Surgical

  • Philip M. Steele, Ph.D., Director Johnson & Johnson Regulatory Compliance, Johnson & Johnson

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


Beyond MDSAP and ISO 13485: The Impact of the New EU Regulations on Audits

Presenters

  • Rania Gerges, Quality Assurance Consultant , Qserve Group

  • Laila Gurney, Head of Global Regulatory Affairs, GE Healthcare

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


The Business of Innovation

Presenters: 

  • Vanessa Barth, Chief Scientific Officer, BioCrossroads (on-loan executive from Eli Lilly)

  • Matthew Diamond, MD, Ph.D., Medical Officer, Digital Health, Office of Strategic Partnerships and Technology Innovation, FDA-CDRH

  • Barbara Fant, President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.

  • Jason Heikenfeld, Vice President for Commercialization, University of Cincinnati (also founder and CTO for Eccrine Systems)

  • Hylton Kalvaria, Vice President of Strategic Partnerships, Verana Health

  • Bernhard Kappe, Founder and CEO, Orthogonal

  • Jim Prodafikas, Worldwide Director Market Access and Reimbursement - Diabetes Care, BD

  • Harikrishnan Ramaraju, Regional Lead - Medical Devices & Life Sciences, L&T Technology Services


Center Director Corner: Strategic Priorities for 2019 and Beyond

Presenter:

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


Changes to Marketed Product: Keeping Pace With Your Product Lifecycle

Speakers:

  • Brad Hauser, Vice President, R&D and General Manager, CoolSculpting

  • Ruth James, Senior Program Lead, Regulatory Affairs, Ethicon Endo-Surgery


Chief Quality Officers - Redesigning the Field of Quality for the 21st Century

Presenters: 

  • Georges France, VP LOCs & Global Quality Lead, GSK

  • Corlis Murray, Senior Vice President, Quality Assurance, Regulatory and Engineering Services, Abbott

  • Brian Schultz, Vice President of Quality and Regulatory Affairs, Fisher & Paykel

  • Peter Shearstone, Vice President, Global Quality Assurance and Regulatory Affairs, Thermo Fisher Scientific


Digital Health Innovation

Presenter:

  • Bakul Patel, M.S.E.E., M.B.A., Director, Division of Digital Health, Office of Science of Technology, FDA-CDRH


EU MDR: Successful Practices for Procedural Hurdles

Presenters: 

  • Phil Desjardins, VP, Global Regulatory Policy & Intelligence, Johnson & Johnson

  • Mindy McCann, US VP Regulatory Compliance, Qserve Group


EU MDR: Successful Practices for Technical Hurdles

Presenters:

  • Robyn Meurant, Executive Director, Regulatory Team, IVDs and Medical Devices, NSF International

  • Reynaldo R. Rodriguez, Jr., Director, Quality Systems and Business Support, Abbott Quality and Regulatory, Abbott Laboratories

  • Hugo Xi, M.D., M.B.A., Director, Medical Affairs, Abbott Quality & Regulatory, Abbott Laboratories


FDA Inspections: Demystifying the Process of What Happens Before and After Your Inspection

Presenters:

  • Gina Brackett, OMDRHO Division 1 Director, Compliance Branch, FDA

  • Arduino Frankovic, OMDRHO Division 1 Director, Investigations Branch, FDA

  • Melissa Michurski, OMDRHO Division 2 Director, Compliance Branch, FDA

  • CDR Cesar A. Perez, Director, Division of International Compliance Operations, Office of Compliance, FDA-CDRH


FDA Mock Inspection: Knock Knock! Guess Who’s at Your Door?

Presenters:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA-ORA

  • Laureen Geniusz, Investigator, Medical Device Specialist, FDA-ORA

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Phil Pontikos, National Device Expert, FDA-ORA

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


FDA Pre and PostMarket Update

Presenters:

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

  • Joshua Nipper, Director, PMA & HDE Programs Program Operations Staff Office of Device Evaluation, FDA-CDRH


FDARA Impacts You!

Presenters: 

  • Gina Brackett, Director Compliance Branch, FDA-ORA

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

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


Follow the Defect: Case of the Missing Cavity

Presenters:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA-ORA

  • David Elder, Executive Vice President, Regulatory Compliance, Greenleaf Health

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Phil Pontikos, National Device Expert, FDA-ORA

  • Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH


Getting Your Product on the Market: Premarket Approval is Only the Beginning

Presenters:

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

  • Jim Prodafikas, Worldwide Director Market Access and Reimbursement - Diabetes Care, BD

  • Ken Skodacek, Deputy Ombudsman, FDA-CDRH

  • Chuck Stemple, Vice President, Health Guidance Organization, Humana


Improve Your Pre-Market Review, Know What’s New!

Presenters:

  • Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS

  • Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, FDA-CDRH


Investigator Insights 

Presenters:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA

  • Laureen Geniusz, Investigator, Medical Device Specialist, FDA-ORA

  • Thomas Peter, Investigator, Medical Device Specialist, FDA-ORA

  • Timothy Philips, Compliance Officer / Biomedical Engineer, FDA

  • Phil Pontikos, National Device Expert, FDA


Navigating the Challenges of Digital Health Innovation

Presenters:

  • Matthew Diamond, MD, Ph.D., Medical Officer, Digital Health, Office of Strategic Partnerships and Technology Innovation, FDA-CDRH

  • Barbara Fant, President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.

  • Hylton Kalvaria, Vice President, Strategic Partnerships, Verana Health

  • Bernhard Kappe, Founder and CEO, Orthogonal

  • Rama K. Pidaparti, AVP, QARA - Medical Devices & Life Sciences, L&T Technology Services


Successfully Navigate the Medical Device Recalls Process: An Interactive Case Study

Presenters:

  • Shumaya Ali, Assistant Director in the Division of Restorative, Repair and Trauma Devices, Office of Health Technology 6 (Orthopedic Devices), Office of Product Evaluation and Quality, FDA-CDRH

  • Meredith Andress, OMDRHO Division 2 Recall Coordinator, FDA

  • Cynthia Aycock, OMDRHO Division 1 Recall Coordinator, FDA

  • Andrew Lang, OMDRHO Division 1 Recall Coordinator, FDA

  • Melinda Ruiz, OMDRHO Division 1 Recall Coordinator, FDA