Medical Device Leaders Certificate – Xcelerate Your Career

MDLC Accelerates Your Career

Developed and taught by industry leaders and FDA officials, the Medical Device Leaders Certificate (MDLC) program is for high performers like you. We accelerate wisdom that may otherwise take years to acquire. As an MDLC student, you:

  • Are immersed in a deep understanding of business success, which is foundationally rooted in, grown by, and driven by patient success.
  • Learn directly from FDA faculty.
  • Receive 3 hours of personalized, one-on-one professional leadership coaching with action plans.
  • Deep-dive into a Total Product Lifecycle (TPLC) case study, gaining technical competency across the TPLC.
  • Conduct an internal and external stakeholder impact analysis.
  • Master leadership in balance, which allows you to respond to situations with agility and effectiveness.
  • Earn three credit hours toward a Xavier University MBA and a certificate for 5.0 CEUs from Xavier Health.
  • Have the flexibility to study, learn, and prepare when it’s convenient for you with our specialized 11-month course.

What’s Involved in the MDLC Program

  • Over 11 months, you will receive 50 contact hours of content, including two on-campus events with three hours of one-on-one professional coaching sessions.
  • You will collaborate on interactive assignments with cross-functional peers, current and former FDA, and industry executives.
  • You will present a complex capstone project with a partner to an outside industry panel.
  • You may choose to have access to a comprehensive 35-part webinar toolbox
  • Throughout the 11 months, you will expand your network of contacts, increase your confidence, and receive invaluable coaching to expand your experience and wisdom

View full syllabus here.
Discover all the benefits of MDLC through our Roadmap to Leadership.

Meet the MDLC Board and Faculty Who Will Guide You

  • Lisa Allgood, Executive Director, Medpace
  • Jason Barkeloo, Founder and Executive Chairman of the Board, Open Therapeutics
  • Gina Brackett, Compliance Officer, FDA
  • Bill Brodbeck, Director, STERIS
  • Tricia Cregger, Manager, Regulatory Affairs, STERIS
  • Barbara Fant, President, Compliance and Regulatory Consultants
  • Donna Godward, Strategic Advisor, Your Enocore
  • Linda Gravett, Senior Partner, Gravett and Associates (co-author of Leadership in Balance)
  • Sheryl Helsinger, Director Clinical Trial Management, Medpace
  • Michael Jodon, Senior Regulatory Specialist, STERIS
  • Jack Kraeutler, CEO Meridian Bioscience
  • John Kucia, Vice President, Xavier University (co-author of Leadership in Balance)
  • Bill MacFarland, Director of the Division of Enforcement B, FDA
  • Michael Morton, Vice President, Corporate Regulatory Affairs, Medtronic
  • Robin Newman, Director Office of Compliance, FDA CDRH
  • Steve Niedelman, Lead Quality Systems and Compliance, King & Spalding
  • Jim O’Reilly, Professor, University of Cincinnati
  • Geeta Pamidimukkala, Biomedical Engineer, Office of Device Evaluation, FDA
  • Tony Piotrkowski, Manager, Regulatory Affairs, STERIS
  • Susan Rolih, Executive Vice President, Meridian Bioscience
  • Rainer Voelksen, Vice President Regulatory Affairs/Quality Management, Occlutech Group
  • Monica Wilkins, Divisional Vice President, Abbott

Enrollment for Class of 2017


  • Industry tuition:  $8,000
  • Small Business tuition:  $6,400*
  • Government Official tuition: Free (two free government officials per cohort)

*Small Business (less than 100 employees)

Enroll today: Next Cohort starts June 2017

Reference Material

Alumni Benefits

After you receive your Medical Device Leaders Certificate, you will continue to reap benefits from the program:

  • Annual refresher at the Medical Device Leaders Forum
  • Alumni lunch at the FDA/Xavier MedCon Conference, our annual Medical Device Conference held every May, where you will have an opportunity to meet and talk with some of the biggest names in the industry and FDA.
  • Increased network of mentors and peers


For More Information
For more information and any questions about the Medical Device Leaders Certificate program, please contact Stacie Ball at or 513-745-3483.