Legal and Health Care/Global Compliance Recommended Agenda

Official Opening and Global Ministerial Opening

The MedTech Conference will officially open with a ministerial panel. Moderated by the Economist Intelligence Unit (EIU), Healthcare, the panel will feature government officials from the U.S. and around the world who will share their visions about medical technology investment, innovation, entrepreneurship support, and other key factors driving growth and development for the benefit of patients worldwide.

Moderator:

Ivy Teh, Global Managing Director, The Economist Intelligence Unit Healthcare

Speakers:

H.E. Mokhtar Hazbellaoui, Minister of Health, Population, & Hospital Reform, Algeria

Invited:

Hon. Gaétan Barrette, Minister of Health, Government of Quebec, Canada
Prof. Piotr Czauderna, Senior Advisor to The President – Chairman of the Presidential Healthcare Council, The Chancellery of the President of Poland
Lord Prior of Brampton, Parliamentary Undersecretary of State, Department for Business, Energy and Industrial Strategy, United Kingdom
Ian Steff, Deputy Assistant Secretary for Manufacturing, Department of Commerce, United States

Location: Convention Center - Room 210 A

Tomorrow vs. Today: Envisioning the Future of Health Care Delivery

The pace of change (both policy and technological innovation) in American health care continues at an unprecedented rate. To be successful tomorrow and in the coming years, companies need to think strategically, prepare for and anticipate these changes. This panel includes some of the most influential figures in the health care industry and their dialogue will help you understand where health care and health care delivery is going and what challenges and opportunities may lie ahead.

Speakers:

Omar Ishrak, Chairman and Chief Executive Officer, Medtronic
Josh Makower, MD, General Partner, NEA

Location: Convention Center - Room 210 C

Printing the Future: 3D Printing Today, Tomorrow and Beyond

The scope of 3D printing’s impact on the medtech industry and patient care is still emerging, but innovation in this disruptive and exciting field is moving quickly. This panel will explore 3D printing in medtech and other industries today, lessons learned from those experiences, potential future applications and global regulatory considerations.

Speakers:

Moderator: Allison W. Shuren, Partner, Arnold & Porter Kaye Scholer LLP
Dennis Hahn, Director, Regulatory Policy Innovation, Ethicon & Vision Care, Johnson & Johnson
Jonah Myerberg, Co-Founder and CTO, Desktop Metal
M. Scott Taylor, Ph.D., Chief Technology Officer, Poly-Med, Inc.

Location: Convention Center - Room TBD

Welcome Reception (open to all registrants)

The San Pedro Square Market is the Downtown San Jose meetup place for foodies, music lovers, locally-made shop supporters, demanders of coffee perfection, history seekers, old-time barbershop hunters, social media trendsetters and wine and beer libation imbibers. The Market is the all-around best place to hang out, complete with an open-air plaza and sidewalk café – there is no better place to kick off the conference and welcome everyone to San Jose.

Location: San Pedro Square Market

Good Ethics is Good Business

Studies have shown that companies that implement good ethical business practices perform better than their peers that do not implement similar standards and expectations. In the medtech industry, top-performing companies have made good ethics an essential element of their business plan. Listen as industry CEOs describe why a strong ethical culture is not just about doing the right thing, it's good for the bottom line.

Speakers:

Lisa Earnhardt, President & CEO, Intersect ENT
David B. Perez, President & CEO, Terumo BCT, Inc. and Chairman of the Board, Terumo Global Blood Management Business
Jorgen B. Hansen, President and Chief Executive Officer, Cantel Medical

Location: Convention Center - Hall 1 & 2; CEOs Unplugged Stage

D.C. Download: Update from Capitol Hill

Senior leaders from AdvaMed and MDMA will share the stage to address the most pressing legislative and policy issues facing the medtech industry today. Join us for a discussion about key issues including medical device tax, MDUFA reauthorization and 21st Century Cures implementation.

Speakers:

Moderator: Scott Whitaker, President & CEO, AdvaMed
Paul LaViolette, Managing Partner and Chief Operating Officer, SV Life Sciences Advisers, LLC
Mark Leahey, President & CEO, Medical Devices Manufacturers Association
Michael R. Minogue, Chairman, President and Chief Executive Officer, ABIOMED, Inc.
JC Scott, Chief Advocacy Officer and Head of External Affairs, AdvaMed

Location: Convention Center - Hall 1 & 2; CEOs Unplugged Stage

Establishing a Culture of Cybersecurity Excellence

Responding to a medical device cybersecurity incident could be your make or break moment. In today's environment, and in light of FDA’s heightened focus on this field, it is not enough to think only about how you would respond to a threat. To ensure patient safety and protect critical infrastructure, your organization needs to have processes and procedures in place before an incident occurs. The panel will engage in a spirited and experience-based discussion about how state-of-the-art cybersecurity and information security best practices can be shared and utilized, regardless of organizational structure, to ensure patient safety. Cybersecurity experts will also offer their views on establishing internal processes to respond to potential incidents, how organizations can practice and test their systems, and who outside of the organization should be contacted in the event of an incident.

Speakers

Moderator: Russell L. Jones, National Co-Leader, Medical Device Safety and Security (MeDSS), Deloitte & Touche - Cyber Risk Services
Michelle Jump, RAC, M.S., MSRS, Principal Regulatory Affairs Specialist, Stryker

Location: Convention Center - Room TBD

Risk Contracting: Putting Your Money Where Your Value Is

Novel risk-based payment models are pushing hospitals and physicians to develop new gain sharing or risk approaches with each other and with health plans. Medtech companies are also expressing an interest in similar risk-based approaches that include the manufacturer, which can improve care and lower costs. Some companies are even moving forward with new models. This session will include a discussion of examples of risk-based arrangements between hospitals, payers, providers and industry, as well as the hurdles that maybe affecting the development of such partnerships.

Speakers:

Tom Beimers, Partner, Hogan Lovells US LLP
Elizabeth Carder-Thompson, Counsel, ReedSmith
Mary Cummins, Life Sciences and HealthCare Principal, Deloitte Consulting

Location: Convention Center - Room TBD

Bridging the Gap Between FDA Approval and CMS and Private Payer Coverage

Increasingly, health care is focused on patient access to new and innovative medical products. Many medical technologies are receiving FDA approval with less long-term data. As a result, CMS and private payers are challenged to assess new medical technologies for coverage and payment with less available evidence regarding health outcomes, and with more data collection occurring through post-market studies or registries. While CMS has employed mechanisms such as FDA-CMS parallel review, or coverage with evidence development (CED) to allow for provisional coverage while additional data are collected, many private payers have not adopted such strategies. The panel will discuss ways to streamline and improve the process from FDA approval to CMS and private payer coverage and enable patient and provider access to new and innovative technologies.

Speakers:

Moderator: Michael A. Mussallem, Chairman of the Board and Chief Executive Officer, Edwards Lifesciences
Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, FDA
Tamara Syrek Jensen, Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services (CMS)

Location: Convention Center - Room 210 C

Afternoon Plenary Session: Innovation as a Discipline

Keynote Speaker - Regina E. Dugan

The MedTech Conference is excited to welcome MedTech Innovator back to the plenary stage on the afternoon of Tuesday, September 26. Four finalist companies from the MedTech Innovator competition will present to a panel of industry-leading judges and compete for the audience vote to win $500,000 in prizes and the award of MedTech Innovator 2017!

MedTech Innovator is the industry’s nonprofit global competition and accelerator for medical device, digital health and diagnostic companies. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the health care system. In 2017, MedTech Innovator, with the support of its partners and sponsors, will give out $500,000 in cash prizes, scholarships and in-kind awards.

Location: Convention Center - Grand Ballroom

America First: Will the Trump Administration’s Policies Help Your Global Business?

President Trump has announced varying policies on trade, “Buy American, Hire American”, border taxes and corporate tax rates designed to improve the competitiveness of American industry. On trade policy, President Trump withdrew the U.S. from the Trans Pacific Partnership (TPP), while proposing bilateral free trade agreements with some of participating TPP countries, and was on the verge of withdrawing from the North American Free Trade Agreement but decided to renegotiate. On taxes, the border adjustment tax appeared to be in play earlier this year, but lowering the corporate rate seems to be the President’s focus. The President also seems intent on expanding use of “Buy American” and reducing the use of the H1-B visa program. The experts on this panel will discuss whether the President’s stated policies will accomplish his goal in putting “America First” or have the opposite impact.

Speakers:

Moderator: John K. Veroneau, Partner, Covington & Burling
Bruce H. Andrews, Managing Director, Rock Creek Global Advisors
Kristen A. Chadwick, Fierce Government Relations
Arun Venkataraman, former Director of Policy at the Department of Commerce's International Trade Administration

Location: Convention Center - Room 210 C

Talking to Your Customer: How New Requirements are Changing the Way Companies Relate to Physicians and HCPs

Global trends in transparency and direct sponsorship are changing how companies manage their relationships with physicians and other healthcare practitioners (HCPs). This panel will focus on how companies’ practices toward dealing with HCPs are shifting in reaction to government reporting requirements related to meal, consulting and other expenditures related to HCPs (“sunshine” or “transparency” regulations) as well as new code of ethics requirements, which are phasing out direct payments in support of physician education in several regions (specifically Europe & Asia) by yearend. How can companies continue to manage these relationships productively to ensure ongoing physician partnerships to spur innovation as well as training of HCPs? What practices have succeeded in the United States and what lessons can be learned for regions that are transitioning to these new norms?

Location: Convention Center - Room TBD

Key Developments in Device Advertising and Promotion: Demystifying Communications and Scientific Exchange in Today’s Health Care System

With increasing need for accurate and up-to-date information on innovations in health care, new off label legal and policy developments, growing payer demands and scientific progress at a breakneck pace, what does this all mean for today’s innovators? Join a panel of industry thought leaders to review the latest policy developments in manufacturer device communications, and learn about changes in the policy landscape; new guidance on communications consistent with labeling, health care economic information, communications with payers and similar entities and evolving regulation and First Amendment considerations with off-label communications. This session will examine what this all means for medical device manufacturers, what changes may be in store and device-specific considerations.

Speakers:

Moderator: Christina Anderson Mooney, Senior Legal Counsel, Corporate Legal Regulatory, Medtronic
Tony Blank, President/CEO, Infinity Biomedical, LLC
Jennifer L. Bragg, Partner, Health Care and Life Sciences, Skadden, Arps, Slate, Meagher & Flom LLP

Location: Convention Center - Room TBD

CDRH Town Hall

Join us for an exclusive peek into the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) during our Wednesday afternoon CDRH Town Hall. This exclusive, interactive Town Hall session is a rare opportunity to interact directly with Dr. Jeff Shuren, CDRH Director, and other senior office leaders from the FDA’s device center. After Dr. Shuren provides an update on CDRH priorities, panelists will answer specific questions from the audience. Take advantage of this session to get answers to all of your burning questions directly from CDRH.

Speakers:

Jeff Shuren, MD, JD, Director, FDA CDRH
Thomas Gross, MD, MPH, Director, Office of Surveillance and Biometrics, FDA CDRH
Robin Newman, MSN, EdD, Director, Office of Compliance, FDA CDRH (invited)

Location: Convention Center - Room 210 C

Closing Reception

Gather with your medtech colleagues one last time before leaving Silicon Valley and rock out to a Journey tribute band! We’ll be ending the conference with a closing reception at Paper Plane in downtown San Jose, a hip spot known for creative cocktails and great food. The food’s on us, but don’t forget your wallet as there will be a cash bar at this reception. See you there and be sure to brush up on the lyrics to Don't Stop Believin', Any Way You Want It and more!

Location: Paper Plane - 72 S 1st St, San Jose, CA 95113

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