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Speakers will be added as confirmed
7:30am - 8:30am
Registration and Continental Breakfast
8:25am - 8:30am
- Mark Leahey, President & CEO, MDMA
8:30am - 9:15am
Raising Capital: The Changing Needs of Technology
With continuing challenges facing medical technology development, hear about the latest expectations and opportunities that today's innovators need to know to obtain funding.
- David Anderson, Managing Director-Medical Technology, GE Capital Healthcare Financial Services
- Mike Carusi, General Partner, Lightstone Ventures
- J. Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati
- Brad H. Vale, Head of Johnson & Johnson Development Corporation
9:15am - 9:45am
Patents: New Challenges -- and Threats -- to Your IP
Protecting one's IP is becoming increasingly complex. Learn from experts what you and your team need to know in an aggressive legal environment, and as Congress examines changing patent legislation once again.
- James Heslin, Partner, Wilson Sonsini Goodrich & Rosati
- Bernard Shay, Vice President Law & General Counsel, Miramar Labs
9:45am - 10:00am
10:00am - 10:45am
CDRH Update *via video conference
CDRH Director Dr. Jeffrey Shuren will discuss with attendees about the agency's priorities and latest developments as it continues to implement MDUFA III.
- Jeffrey Shuren, M.D., Director, CDRH
10:45am - 11:15am
Top FDA Priorities for Innovators
What are the top FDA priorities that all medtech executives and innovators need to know? Hear from CDRH's Associate Director for Technology and Innovation on the collective efforts to accelerate patient access to safe and effective products.
- Murray Sheldon, M.D., Associate director for Technology and Innovations, CDRH
11:15am - 12:15pm
The Future of Innovation - Hear from Leading Innovators of Med Tech Development
While still one of the most dynamic industries in the world, the medical device field remains at a crossroads. This panel brings together a distinguished group of inventors/innovators to discuss the future of our industry.
- Thomas Fogarty, M.D., Inventor/Innovator
- Fred Khosravi, Managing Director, Incept LLC
- Paul Yock, M.D., Weiland Professor Bioengineering & Medicine, Director Program in Biodesign
12:15pm - 1:15pm
Find out what is happening in your nation's capital. Mark Leahey will give an overview on what your company needs to know and issues affecting the medtech industry.
1:15pm - 2:15pm
Key Considerations in Developing an Effective Reimbursement Strategy
Former Director of CPT at AMA will address key considerations in development of your company's reimbursement strategies.
- Michael Beebe, Senior Vice President, ADVI, former Director of CPT at AMA
- Bill Mangold, MD, JD, Counsellor, ADVI, former Noridian Chief Medical Officer
- Alan Sokolow, MD, Senior Vice President, ADVI, former Blue Shield of CA Chief Medical Officer
2:15pm - 3:15pm
Succeeding in Asia from Regulatory to Reimbursement
Lessons that can help in Japan and China
Learn from some of the industry's leading experts on how to do business in Asia -- from structuring your business to regulatory affairs to reimbursement. The speakers have a combined 65 years in the medical device arena in Japan and on a host of regulations and success stories. See how this knowledge can help you in Japan, China and more.
- Yoshio Mitsumori, Executive Advisor, Alphamed, Inc.
- Ed Rozynski, Vice President, Government Affairs, Intuitive Surgical
- Roy Zou, Partner, Hogan Lovells
3:15pm - 4:00pm
Compliance - Common Pitfalls, How to Prevent Them, and the Latest Best Practices
Medical device manufacturers are subject to a variety of compliance regulations. Learn the issues and new regulations that will affect your company's compliance program.
- Carolyn Bruguera, Vice President, Consulting Services & General Counsel, R-Squared Services & Solutions, Inc.
- Jackie Huber, Vice President, Compliance, MDMA
- Adam Jones, Divisional General Counsel, Smiths Medical
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.