2018 MDMA Medical Technology Executive Forum Agenda


                    

*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

Friday, September 21, 2018

7:30am - 8:00am
Registration and Continental Breakfast

8:00am - 8:05am
Welcoming Remarks

  • Mark Leahey, President & CEO, MDMA

8:05am - 8:20am
Trends and Predictions in The Venture MedTech Landscape

Learn about the latest funding trends and active investors in the medical technology sector. Get a deep dive into venture M&A activity, with an acquirer analysis and predictions on what to expect in the coming years.

  • Jonathan Norris, Managing Director, Silicon Valley Bank (SVB)

8:20am - 9:05am

The Future of MedTech Innovation

From artificial intelligence, robotics and digital health, our industry is entering a new generation of innovation and opportunity. Learn from innovators who are on the front lines and working with cutting-edge technologies on how your company can prepare for this bold future. 

  • Scott Huennekens, President & CEO, Verb Surgical
  • Joshua Makower, General Partner, New Enterprise Associates (NEA)

9:05am - 9:45am
CDRH Update

Dr. Maisel will discuss the recent developments at CDRH, the ongoing implementation of MDUFA IV and answer questions from the audience.  He will also discuss regulatory trends and real-world examples of how med tech innovators can expedite the approval or clearance of their products.

  • William Maisel, MD, MPH, Director, Office of Compliance (Acting), Director, Office of Device Evaluation (Acting), Chief Scientist, CDRH, FDA

9:45am - 10:00am

Networking Break

10:00am - 10:30am
Industry Response from Top Experts

Some of the industry’s leading experts on the regulatory pathways will respond to Dr. Maisel’s presentation, and share what they think the future holds and how your team can be well positioned to confront it.

  • Michael Billig, Chief Executive Officer, Experien Group
  • Heather Rosecrans, VP, Regulatory Affairs, MDMA
  • Daniel Schultz, MD, FACS, Principal, Medical Devices & Combination Products, Greenleaf Health

10:30am - 11:20am

CEO Perspective: "Do's and Don'ts" for Successful Leaders

With more expectations and hurdles facing medical technology executives, it is more important than ever to learn how your peers have navigated the waters.  CEOs will share how they mobilized their teams to successfully overcome obstacles and grow despite the headwinds.

  • Mark Foley, former CEO, Zeltiq
  • Keith Grossman, Former CEO, Thoratec

11:20am - 12:00pm
Raising Capital in the New Economy

Hear from some of our industry’s top leaders in what you and your team need to do to raise capital, and maximize growth in today’s marketplace.

  • Marc Galletti, Managing Director & Founder, Longitude Capital
  • J. Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati (WSGR)
  • Jim Momtazee, Head of Health Care Industry Team, Kohlberg Kravis Roberts, Co. (KKR)
  • Brad Vale, General Partner, Strategic Healthcare Investment Partners

12:00pm - 1:00pm

Buffet Lunch

 

1:00pm - 1:15pm

Election Update

Learn the latest predictions on how the 2018 election outcomes might shift the policy agenda, and what it will mean for our industry.

  • Mark Leahey, President & CEO, MDMA

1:15pm - 2:00pm

Securing Reimbursement in Challenging Times

Reimbursement continues to be one of the greatest hurdles for med tech executives, and some of the nation’s top experts in coding, coverage and payment will share the latest strategies to improve your chances for a positive outcome.

  • Bernice Hecker, MD, MBA, FACS, Healthcare Consultant
  • Jo Carol Hiatt, MD, MBA, FACS, Chair, National Product Council for Kaiser Permanente
  • Michael Beebe, Vice President, ADVI (moderator)

2:00pm - 2:45pm

The NEW EU Medical Device Regulations (MDR) Transition Period is Rapidly Coming to an End. Are you Prepared?

The EU Medical Device Regulation Does Not Take Affect Until May 2020. Time is Already Growing Short to Work with the New Notified Bodies that Won't Be Named Until This Fall that Can Help You to Affix the New CE Mark to Your Medical Devices under the MDR. Hear from One or Two Notified Bodies that Are Expected to Be Certified in the Coming Few Months to Review your Products to the New EU Regulations.

  • Ed Rozynski, Senior International Advisor, MDMA
  • Royth von Hahn, Senior Vice President, Global Head of Medical & Health Services, TUV SUD Product Service Division

2:45pm - 3:00pm
Networking Break

3:00pm - 3:45pm
What Would You Do? A Day in the Life of a Chief Compliance Officer?
                        In this session, experienced compliance officers and attorneys will examine real-life scenarios and best practices for minimizing risk and improving ethics in your organization.

  • Carolyn Bruguera, VP & General Counsel, MDMA
  • Jim Garrett, Chief Compliance Officer, Leader Risk Management, NuVasive, Inc.
  • Michael Pisetsky, General Counsel & Chief Compliance Officer, SI-BONE, Inc.
  • John Richter, Partner, King & Spalding

 3:45pm - 4:30pm
MedTech Potpourri: Digital, Cyber and IP Best Practices
                                           With the ongoing integration of the healthcare marketplace come new challenges for companies as well.  Learn how other executives have navigated these thorny issues from protecting your IP, confronting cyber threats and digital opportunities.

  • Hussein Akhavannik, Partner, BakerHostetler
  • Matt Cohn, Vice President & Senior Program Manager, Life Sciences & Medical Products Solutions, Alliant

         

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.