For your convenience, the FDA/Xavier MedCon 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, at harwoodh@xavier.edu.
2018 MedCon Presentations
Align Your Organization with the FDA PreMarket Priorities
Presenter: Dr. William Maisel, Deputy Center Director for Science, Acting Director for ODE, Acting Director for the Office of Compliance, FDA-CDRH
The Balance of Benefit and Risk – FDA Insight
Presenters: Pat Baird, Regulatory Head of Global Software Standards, Philips; Randall Brockman, M.D., Acting Deputy Director, Clinical, Office of Medical Products and Tobacco, Office of Device Evaluation, FDA-CDRH; Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH
Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today
Presenters: Xavier AI Initiative - CPQA Team: David Lonza, Head of EU, Lachman Consultant Services; Xavier AI Initiative - CLS Team: Mac McKeen, Fellow, Regulatory Science Boston Scientific; Mohammed Wahab, Quality Head, Professional Services - Informatics & Analytics, Abbott Laboratories, Diagnostic Division
The CDRH 510(k) Review Template: A Demo of the 510(k) Smart Template Used by CDRH Reviewers to Review 510(k)s
Presenter: Patrick Axtell, Program Operations Staff, Office of Device Evaluation, FDA-CDRH
Center Director Corner: Strategic Priorities for 2018 and Beyond
Presenter: Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA
China - Land of Opportunity and Challenges
Presenter: Gert Bos, Executive Director & Partner, Qserve Group; Effie Lin, Ph.D., Director Regulatory Affairs, Abbott Vascular
Digital Health Innovation...The Future is Now
Presenters: Carl Kraenzel, Vice President & Distinguished Engineer, Chief Information Security Officer, IBM Watson Health; Joshua Lloyd, Director of Operations, OptoQuest; Murali Mani, Director of Compliance, IBM Watson Health; Bakul Patel, Associate Center Director for Digital Health, FDA-CDRH
EU Regulations: Beyond the Unknown
Presenters: Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy, Abbott; Bassil Akra, Vice President, TÜV SÜD Product Service
FDA Office of Regulatory Affairs Update and Strategic Priorities
Presenters: Blake Bevill, Program Division Director, OMDRHO, Division 2 Central, FDA; Joe Matrisciano, Divisional Director, Office of Medical Device and Radiological Health Operations, Division 1, FDA; Anne Reid, Southeast Region, Acting Regional Food and Drug Director, FDA
FDA PostMarket Update and Strategic Priorities
Presenter: CAPT Sean M. Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA-CDRH
FDA Rethinks Handling of Corrections & Removals, Allegations, and 483 Responses
Presenters: Pat Baird, Regulatory Head of Global Software Standards, Philips; Gina Brackett, Director Compliance Branch, FDA; Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH
How Best to Interact with CDRH—Premarket and Postmarket
Presenters: Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding; Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products (Vice President Regulatory Affairs, MDMA), Greenleaf Health
How to Effectively Implement the New 510(k) Guidance Expectations
Presenters: Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, FDA-CDRH; April Veoukas, Director, Regulatory Affairs, Abbott
How to Leverage the Pre-Submission Program
Presenters: Maureen Dreher, Ph.D., Biomedical Engineer, FDA (remote); Vineet Erasala, Chief Operations Officer, Genetesis; Audrey Munnerlyn, Senior Director, Regulatory Affairs, Johnson & Johnson Vision; Caroline Rhim, Ph.D., Executive Director, NSF International
How Medical Device Firms are Gearing Up for Compliance with Europe’s New Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)
Presenters: Gert Bos, Executive Director & Partner, Qserve 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
IMDRF, Regulatory Convergence, and Practical Implementation
Presenters: Jackie Elkin, Global Process Owner Standard Product Identification, Medtronic; Nancy Shadeed, Special Advisor, International Programs Division, Health Canada; Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health, FDA-CDRH
Investigator Insights and Breaking News
Presenters: Gina Brackett, Compliance Officer, FDA; Ben Dastoli, Investigator, Medical Device Specialist, FDA; Laureen Geniusz, Medical Device Specialist, Cincinnati District, FDA; Phil Pontikos, National Device Expert, FDA
Leverage Real World Evidence for a Streamlined PreMarket Submission Process
Presenters: Paul Coplan, ScD, MBA, FISPE, Vice President, Head of Medical Device Epidemiology, Johnson & Johnson; Rachel Rath, Deputy Director, National Evaluation System for Health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC)
New Laws That Can Shut You Down if You Are Not Prepared
Presenters: Amanda Klingler, Partner, FDA and Life Sciences Practice, King & Spalding; Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding; James O’Reilly, Professor, University of Cincinnati, College of Law
Regulatory Convergence Strategies (ISO 13485)
Presenters: Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF International; Scott Sardeson, International Regulatory Affairs and Quality Compliance Leader, 3M; Kim Trautman, Executive Vice President, Medical Device International Services, NSF International
Streamlining the PMA Process
Presenters: Barbara S. Fant, Pharm.D., President, Clinical Research Consultants, Inc.; Joshua Nipper, Chief of Premarket Approval Staff, Office of Device Evaluation, FDA-CDRH; Steve Silverman, J.D., Vice President, Technology and Regulatory Affairs, AdvaMed
Understanding and Applying Critical to Quality Principles in Device Design
Presenters: 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