2017 MDMA Medical Technology Executive Forum Agenda


*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

Friday, September 15, 2017

7:15am - 7:55am - Registration and Continental Breakfast

7:55am - 8:00am - Welcoming Remarks

  • Mark Leahey, President & CEO, MDMA

8:00am - 8:45am - CDRH Update (via video conferencing)

MDUFA reauthorization is making its way through Congress, while the new FDA Commissioner has promised to increase transparency and predictability at the agency. Hear from the CDRH Director on what steps they are taking to enact these policies and reforms, and to have your questions answered on the new priorities for the agency.

  • Jeffrey Shuren, MD, Director, CDRH, FDA

8:45am - 9:30am - Industry Perspective on FDA Today and in the Future

Hear from former leaders of CDRH who implemented many of the reforms that now constitute the regulatory pathways.  They will share best practices and what you and your team should be doing to help maximize a favorable outcome for your technology.

  • Michael Billig, Chief Executive Officer, Experien Group
  • Heather Rosecrans, Vice President, Regulatory Affairs, MDMA
  • Daniel Schultz, Principal, Medical Devices and Combination Products, Greenleaf Health, LLC
  • Yarmela Pavlovic, Partner, Hogan Lovells (moderator)

9:30am - 10:15am - Raising Capital

As Washington continues to debate tax and regulatory reforms, the capital markets are adapting to this changing landscape.  Hear from some of the leading venture capitalists and strategists on what it takes today to successfully raise funding, and how to maximize your chances of success.

  • Mike Carusi, General Partner, Lightstone Ventures
  • Marc Galetti, Managing Director & Founder, Longitude Capital
  • Renee' Ryan, Vice President, Venture Investments, Johnson & Johnson Development Corporation
  • Philip Oettinger, Partner, Wilson Sonsini Goodrich & Rosati (moderator)

10:15am - 10:30am - Networking Break

10:30am - 11:30am - Lessons Learned from Industry Leaders

Legendary med tech innovators will discuss where they see the industry moving in the 21st century, and how today’s entrepreneurs can overcome the headwinds we all face, and address the increasing challenges in the health care field.

  • Thomas Fogarty, MD, Founder, Fogarty Institute for Innovation
  • Mir Imran, Founder, InCube Labs

11:30am - 12:45pm - Buffet Lunch

12:45pm - 1:30pm - Future of Medtech Innovation: Where Do We Go from Here?

Personalized medicine, big data, value based models and countless other developments are playing an increasing role in the development of medical technology. Learn from some of industry’s leading minds on how innovators can succeed in our rapidly changing ecosystem.

  • Vic Gundotra, Chief Executive Officer, AliveCor
  • Paul Yock, MD, Weiland Professor Bioengineering & Medicine Director Program in Biodesign

1:30pm - 2:15pm - CEO Perspective: "Do's and Don'ts" for Successful Leaders

Some of the industry’s top CEOs will share their strategies on how they grew their businesses and spurred innovation, while remaining nimble to address shifts in the marketplace.  This panel will include lessons learned from over the years, and what they think every executive in today’s environment should be prepared for.

  • Andrew Cleeland, Chief Executive Officer, Fogarty Institute for Innovation
  • Lisa Earnhardt, President & CEO, Intersect ENT
  • James Reinstein, Chief Executive Officer, Cutera, Inc. 

2:15pm - 2:30pm - Networking Break

2:30pm - 3:15pm - Developing a Reimbursement Strategy and Demonstrating Value

With ongoing challenges in securing fair and adequate reimbursement from both public and private payors, learn the latest approaches to maximize the value of your technology.  CEOs and reimbursement experts will detail best-practices that achieved favorable outcomes, as well as what they recommend in dealing with payors in today’s environment.

  • Jeff Dunn, President & CEO, Si-Bone, Inc.
  • Mark Leahey, President & CEO, MDMA

3:15pm - 4:00pm - Compliance

As the compliance arena grows in complexity, it has never been more critical that medical technology leaders know how to address the pitfalls confronting our industry.  Learn the latest insights on what you need to prepare for and how to educate your team.

  • Carolyn Bruguera, Vice President & General Counsel, MDMA
  • Margaret Tough, Partner, Latham & Watkins LLP

4:00pm - 4:45pm - International

The EU Parliament is adopting new rules for medical devices and other regions are making major changes to their reimbursement and regulatory systems.  From Europe, India, Japan and more, the international marketplace continues to shift rapidly, and this panel will make sure you learn how to maximize your OUS growth.

  • Edward Rozynski, Senior International Advisor, MDMA


Sessions and speakers are subject to change without notice. MDMA reserves the right to cancel or reschedule any program, whereupon full registration fees will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of canceled programs, MDMA assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.