2018 MDMA Annual Meeting Agenda


*Speakers will be added as confirmed

Click Here for a PDF of the Agenda

Wednesday, May 2, 2018

5:30pm - 7:00pm

Opening Reception - Capitol Room

Enjoy networking with medical technology executives and other industry leaders while hearing from a leading health expert about what to expect for the rest of 2018 in Congress and policymaking.

Thursday, May 3, 2018

7:00am - 7:50am

Registration and Networking Continental Breakfast - Grand Ballroom C

7:50am - 8:00am

Welcome Address - Grand Ballroom AB

MDMA's Chairman of the Board and MDMA's President and CEO will provide a review of Administration and Congressional activities, as well as the ongoing work to serve patients and to promote America's global leadership position in medical technology innovation.

  • Paul LaViolette, Chairman, MDMA Board of Directors, Executive Chairman, CardioFocus
  • Mark Leahey, President & CEO, MDMA

8:00am - 8:30am

Keynote - Opening Address - Grand Ballroom AB

The FDA Commissioner will share his vision on how to improve the environment for medical technology innovation, and what all stakeholders can do to help transform the health care ecosystem.

  • Scott Gottlieb, MD, Commissioner, FDA

8:30am - 9:15am

Intersection of Med Tech & High Tech - Grand Ballroom AB

As the use of digital platforms and data-driven health care increases, hear from some of the industry's cutting-edge leaders on how they are working to maximize the convergence of med tech and high tech.

  • Scott Huennekens, President & CEO, Verb Surgical, Inc.
  • Josh Makower, General Partner, New Enterprise Associates

9:15am - 10:00am

Impact of Med Tech on Patient Care - Grand Ballroom AB

It is more important than ever to share the stories of how medical technology impacts the lives of patients and their loved ones. Innovation continues to provide amazing cures and therapies that improve the quality of life, and address the pressing needs of the health care ecosystem. Hear some of the powerful examples of how our industry is rising to the challenges that patients and providers are facing, and how we can all work together to continue providing hope and improving outcomes.

  • Joe Kiani, Chairman & CEO, Masimo Corporation
  • Walter Koroshetz, MD, Director of the National Institute of Neurological Disorders and Stroke, National Institutes of Health
  • Justin Minyard, Executive Director, Operation Shifing Gears, LLC

10:00 - 10:15am

Networking Break

10:15am - 11:15am

CDRH Town Hall - Grand Ballroom AB

The Director of the CDRH will hold an interactive discussion with attendees and provide the latest insights and updates on what the agency is focusing on in 2018 and beyond, including MDUFA IV implementation and other reforms. the town hall is a unique opportunity to engage in a Q&A session with the Center Director and leading executives of the medical technology industry.

  • Jeffrey Shuren, MD, Director, CDRH, FDA

11:15am - 12:00pm

Leveraging Real World Evidence for the Purpose of Regulatory & Reimbursement - Grand Ballroom AB

The increasing use of real world evidence (RWE) has the potential to establish a more efficient regulatory process, lower the cost of development, and maximize reimbursement outcomes. It can also serve to inform patients and providers information about the clinical use of medical technologies. Hear from medical technology executives how their teams are leveraging RWE and how it allows them to improve outcomes while making for a more efficient development lifecycle.

  • Rachael Fleurence, PhD, Executive Director, NESTcc, MDIC
  • Jennifer Kerr, President, Cook Research, Inc.
  • Peter Shearstone, Vice President, RA/QA/Clinical and Medical Affairs, Sysmex America, Inc.

12:00pm - 1:00pm

Networking Lunch - Grand Ballroom C

MDMA honors and thanks the men and women who have served in the armed services both past and present, and attendees will hear about the powerful work being done by the Mentoring Veterans Program (MVPVets) and the Code of Support Foundation. These MDMA-supported programs respectively assist & prepare transitioning military veterans for meaningful employment in the life sciences, and coordinate donation of devices to qualified veterans and their families who have a documented need or inability to pay for those devices.

  • Kristina Kaufmann, Executive Director, Code of Support Foundation
  • Juliana Mercer, Managing Director, MVPVets

1:00pm - 1:45pm

CMS Update - Grand Ballroom AB

CMS is currently examining numerous initiatives to improve outcomes and promote value-based health care. Learn from the newly appointed Centers for Medicare and Medicaid Innovation (CMMI) Director about his vision to improve the delivery of health care and payment systems.

Adam Boehler, Director, Centers for Medicare and Medicaid Innovation (CMMI)

1:45pm - 2:25pm

Political Panel/Election Preview - Grand Ballroom AB

With control of Congress in the balance, hear from two leading strategists and veterans of numerous campaigns on what to expect in 2018, and how the various outcomes could impact your business.

  • Josh Holmes, President & Founding Partner, Cavalry, LLC
  • Andy Rosenberg, Partner, Thorn Run Partners

2:25pm - 3:20pm

EU Medical Device Regulation, BREXIT and Trade: Opportunities, Questions and Advice on How to Proceed - Grand Ballroom AB

What is the current UK political environment and atmosphere, industry expectations of the future with the EU, BREXIT and the United States? How could the environment, policies and political leadership changes in the coming months and year affect your business as key BREXIT, UD MDR and US Trade threats and deadlines approach? Hear some of the initiatives the UK has in place to leverage the potential of the National Health Service to be a test bed for innovation in health technology.

  • Richard Phillips, Director, Healthcare Policy, Association of British Healthcare Industries (ABHI)
  • Edward Rozynski, Senior International Advisor, MDMA

3:20pm - 3:35pm

Networking Break

3:35pm - 4:25pm

Perspectives from the C-Suite - Grand Ballroom AB

This popular panel will include several med tech CEOs who will discuss key issues facing the industry, how they continue to motivate their workforce, and what keeps them up at night as they look to the future of innovation.

  • Paul LaViolette, Chairman, MDMA Board of Directors, Executive Chairman, CardioFocus
  • Eric Major, Chairman, CEO & President (Co-Founder), K2M, Inc.
  • Jason Richey, President, North America, LivaNova, PLC

4:25pm - 5:15pm

What Would You Do? A Day in the Life of a Chief Compliance Officer - Grand Ballroom AB

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, Vice President & General Counsel, MDMA
  • Sean Flynn, Associate General Counsel & Chief Compliance Office, ABIOMED, Inc.
  • John Richter, Partner, King & Spalding
  • Sandra Sedo, Chief Compliance Officer, Cardiovascular Systems, Inc.

5:15pm - 6:30pm

Chairman's Reception - Capitol Room

Enjoy networking with medical technology executives and other industry leaders while honoring a public official who is a strong voice in Congress to restore predictability and transparency in the regulatory process and to permanently repeal the onerous medical device tax.

Friday, May 4, 2018

8:00am - 9:00am

Networking Continental Breakfast - Grand Ballroom C

9:00am - 10:00am

Accelerating Patient Access to Technology - Grand Ballroom AB

Hear from current and past senior CMS policy makers on what the agency is doing to ensure timely access for patients and providers, and on some upcoming proposals that are designed to accelerate patient access to the cures and therapies your teams are working on.

  • Laurence Clark, MD FACP, National Government Services, Jurisdiction K
  • Tamara Syrek Jensen, Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services
  • Louis Jacques, Senior Vice President & Chief Clinical Officer, ADVI

10:00am - 11:00am

Demonstrating Value to Key Stakeholders - Grand Ballroom AB

As private payers continue to grapple with changes to the Affordable Care Act, state-by-state reforms and more, it is important for medical technology innovators to know what they are looking for in new therapies and cures. hear from industry leaders on what you and your team need to provide in order to succeed in today's "new normal".

  • Maria Lopes, Chief Medical Officer, Magellan
  • Richard Snyder, SVP & Chief Medical Officer, Independence Blue Cross

11:00am - 11:45am

Patents - Grand Ballroom AB

Recent court decisions continue to reshape the patent landscape. Learn from leading experts on how these cases, PTO administrative actions and legislation are impacting the ability of innovators to protect their intellectual property.

  • Eb Bright, President & General Counsel, Exploramed Development (moderator)
  • Raja Salba, Partner, Sughrue Mion, PLLC
  • Robert Shaffer, Partner, Finnegan Henderson Farabow Garrett & Dunner, LLP

11:45am - 1:00pm

Lunch - Grand Ballroom C


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.