MedCon Agenda: Day 3
Friday, May 4, 2018


7:45 AM - 8:30 AM


Join your colleagues from around the country as we begin the last day of MedCon with a complimentary warm breakfast.

8:30 AM - 8:40 AM    

Day 3 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 2 through the Act-Change-Transfer process that will lead to the development of action plans for your key learnings. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process with a focus on “transfer.”


  • Dennis Hahn, Johnson & Johnson


  • Dennis Hahn

8:40 AM - 9:25 AM    

FDA Office of Regulatory Affairs Update and Strategic Priorities

The Office of Regulatory Affairs (ORA) houses all investigators across the country, and has launched an extensive realignment of its operations in response to the growing sophistication and complexity of industry technological advances and globalization. ORA partners with CDRH on inspection and harmonization initiatives, and works with industry to ensure safe and effective medical products are available and accessible for the patients you serve. Understand the key ORA initiatives that are on the horizon, and the expectations FDA has of your organization to reduce the risk of your product quality.


  • Gina Brackett, FDA-ORA (invited)


  • Jan Welch, FDA-CDRH (invited)

9:25AM -9:45AM


9:45 AM - 10:45 AM

Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today

The future is here. It is time for our industry to move from reactive to predictive!  AI enables our industry to go beyond metrics, and to identify signals that predict the conditions that will lead to product failure. FDA and industry work teams from the Xavier AI Summit 2017 will present real pathways to the power of AI for your operations. Work teams have been established to address:

  1. Validation of Continuously Learning Systems
    (Team Leaders: FDA’s Berkman Sahiner and Abbott’s Mohammed Wahab),
  2. Continuous Product Quality Assurance
    (Team Leaders: Shire’s Charlene Banard and Lachman’s David Lonza).

Participants will be engaged in table discussions for input on application development and progress, and will walk away with practical strategies to implement in their organization today…with or without AI!


  • Monica Wilkins, Abbott


  • David Lonza, Lachman (Continuous Product Quality Assurance Team)
  • Mohammed Wahab, Abbott and Mac McKeen, Boston Scientific (Continuously Learning Systems Team)

10:45 am - 12:15 pm

Investigator Insights and Breaking News

Every year at MedCon, FDA announces the enforcement data from the previous year and shares 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.


  • Monica Wilkins, Abbott


  • Phil Pontikos, FDA-ORA (invited)
  • Ben Dastoli, FDA-ORA (invited)
  • Laureen Geniusz, FDA-ORA (invited)
  • Gina Brackett, FDA-ORA (invited)


12:15 AM - 12:35 PM

To Your Success!

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a full action plan.


  • Dennis Hahn, Johnson & Johnson
  • Marla Phillips, Xavier University


  • Dennis Hahn