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Speakers will be added as confirmed
7:15am - 7:55am
Registration and Continental Breakfast
7:55am - 8:00am
- Mark Leahey, President & CEO, MDMA
8:00am - 8:40am
As new opportunities emerge to address clinical needs in patient populations, securing the necessary funding remains a pressing concern. Hear from some of the top med tech experts on how you and your team can increase your ability to successfully access capital, and what investors are looking for today.
- Mike Carusi, General Partner, Lightstone Ventures
- Marc Galletti, Managing Director, Longitude Capital
- Daniel Hawkins, Founder, Shockwave Medical, Inc.
- J. Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati
8:40am - 9:35am
Lessons Learned from Top Executives
Learn from some of the industry's top CEOs about how they navigated the various pitfalls and hurdles in today's landscape while growing their companies and delivering value to patients and investors. This interactive session will allow attendees to hear best-practices, and discuss with colleagues how to adapt to the shifting market dynamics.
- Christopher Chavez, Chairman, President & CEO, TriVascular Technologies, Inc.
- Scott Huennekens, Chairman, EndoChoice, former President & CEO, Volcano Corporation
- James Mazzo, Chairman & CEO, AcuFocus
- Dan Moore, President & CEO, Cyberonics, Inc.
9:35am - 10:30am
The Future of Innovation
Medical technology innovators face great opportunities and challenges with an aging population and increasing clinical needs, in addition to pricing pressures, market consolidation, reimbursement challenges, and more. Panelists will share what they believe are the "new normals" and how you and your team can succeed in today's marketplace.
10:30am - 10:35am
- Ken Drazan, M.D., Head, Johnson & Johnson Innovation
- Thomas Fogarty, M.D., Physician, Inventor & Founder of Fogarty Institute for Innovation
- K. Angela MacFarlane, President & CEO, ForSight VISION4, Inc. & Managing Member, ForSight Labs, LLC
- Joshua Makower, M.D., General Partner, NEA & Founder, ExploraMed Development, LLC
10:35am - 11:15am
CDRH Update *via video conference
Hear from the CDRH Director in light of ongoing administrative enhancements, legislative proposals and upcoming MDUFA IV negotiations and how they will each impact med tech innovation.
- Jeffrey Shuren, M.D., Director, CDRH
11:15am - 12:00pm
This panel will respond to Dr. Shuren's comments and share their insights on how present and future policies are shaping the ecosystem.
- Mike Billig, Chief Executive Officer, Experien Group LLC
- John Manthei, Partner, Latham & Watkins LLP
- Daniel Schultz, M.D., Principal, Medical Devices & Combination Products, Greenleaf Health, LLC
12:00pm - 1:00pm
Amir Dan Rubin, President and CEO of Stanford Health Care (SHC), will address attendees about how SHC is adapting to the current health care landscape, and what hospitals, payors and their leaders are looking for in today's marketplace from medical technology innovators.
- Amir Dan Rubin, President & CEO, Stanford Health Care
1:00pm - 1:45pm
As Congress and the courts continue to examine the patent system, learn how various proposals and decisions will impact your ability to protect your intellectual property, and how legislative solutions could hurt - or help - your ability to grow.
1:45pm - 2:30pm
- Eb Bright, COO and General Counsel, Nuelle
- Sabing Lee, Partner, Knobbe, Martens, Olson & Bear, LLP
Developing Evidence to Meet the Needs of all Stakeholders in the Health Care Ecosystem
Payors and providers continue to demand more clinicla data to demonstrate value before utilizing medical technologies. Learn how your team can efficiently satisfy these changing standards, and ensure that your technology gains entry into the healthcare ecosystem.
2:30pm - 2:45pm
- Vicki Anastasi, Vice President and Global Head, Medical Device & Diagnostics Research, ICON plc
- Dominic Galante, M.D., M.S., Chief Medical Officer, Medical Policy & Quality, Precision Advisors
2:45pm - 3:30pm
Developing Strategy to Navigate the CPT Process
Medical technology innovators face a convoluted path to secure fair and adequate reimbursement. Learn from the former Director of the CPT Editorial Panel about how you can obtain a favorable code, and what editorial panelists are looking for today.
3:30pm - 4:15pm
- Michael Beebe, Partner, ADVI
- Eric Meier, President & CEO, Cervel Neurotech
Med Tech executives continue to have growing concerns over compliance challenges, and how the various government agencies are enforcing regulations and adjudicating violations. A unique panel of practitioners, executives and policy makers will share how you and your team should prepare for this new landscape.
4:15pm - 5:00pm
- Phil Brewster, Brewster Law Firm, LLC
- Carolyn Bruguera, Vice President, Consulting Services & General Counsel, R-Squared Services & Solutions, Inc.
- Jackie Huber, Vice President, Compliance, MDMA
- Benjamin Wallfisch, Associate, Norton Rose Fulbright
Addressing Cyber & Other Threats: Known & Unknown
With the growth of wireless medical devices, IT integration, cyber security risks and more, hear from top experts about what you and your team should be doing today to mitigate weaknesses, and prepare for threats to product development and safety.
- Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
- Matt Cohn, Senior Vice President, Alliant Life Sciences & Medical Product Solutions
- Natasha Kohne, Partner, Akin Gump Strauss Hauer & Feld LLP
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.