Recommended Agenda Regulatory - The MedTech Conference

Case for Quality: CDRH-Industry Update

2017 has been a significant year for the Case for Quality as we have seen several updates including the maturity model, the rollout of quality culture and the announcement of FDA’s pilot program. This interactive panel will incorporate the latest developments in the Case for Quality Initiative with presentations from CDRH and key industry leaders.

Moderator: Luann Pendy, PhD, Senior Vice President, Global Quality, Medtronic
Robin Newman, M.S.N., Ed.D., Director, Office of Compliance, FDA CDRH
Cisco Vicenty, Mechanical Engineer, FDA
Joe Sapiente, VP, Quality Assurance and Regulatory Affairs, Hologic, Inc.
Beth Staub, Group Compliance Officer, Global Quality and Operations, Stryker Corporation

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.

Moderator: Allison W. Shuren, Partner, Arnold & Porter Kaye Scholer LLP
Jonah Myerberg, Co-Founder and CTO, Desktop Metal
M. Scott Taylor, Ph.D., Chief Technology Officer, Poly-Med, Inc.

Preparing for the New European Medical Technology Regulations: Are You Ready?

After nine years of consultations and negotiations, the European Union adopted new regulations for medical devices and in vitro diagnostics earlier this year. While maintaining a decentralized approach using notified bodies, the new regulations will have far-reaching consequences on pre-market approval, data requirements and post-market surveillance and inspections. The number of notified bodies that are qualified to perform conformity assessments has already fallen from over 80 in 2015 to below 60 today. A new European Commission (EC) experts committee will be created to conduct “scrutiny” of certain new high risk medical devices.Will the EC be ready to implement these regulations? Will notified bodies have the expertise to test your products? Will you be ready to comply with these new regulations? How will implementation shape the requirements? The panel will represent experts from government, consultants and industry to provide the information you need to be ready.

Moderator: Erik Vollebregt, Partner, Axon Lawyers
Oliver Bisazza, Director, Industrial Policy and Regulations, MedTech Europe
Jon Lange, Principal, EY
Ibim B. Tariah, PhD, Technical Director, Healthcare Solutions, BSI Inc.
Hilde Viroux, Global EU MDR Compliance, Alcon

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

Flexible Regulatory Paradigm for Device Modifications

FDA has established a Flexible Regulatory Paradigm that can be applied across the total product lifecycle. It is a patient-centered, total product life cycle (TPLC) approach that has risk-benefit trade-offs. The regulatory paradigm is designed around the type of technology rather than pushing all types of technology down a one-size-fits-all pathway. This thinking can be easily applied to the segment of the TPLC that deals with changes to currently marketed devices. FDA will describe this approach and industry representatives will discuss how this approach could impact their regulatory strategies.

FDA Inspection Reforms

This panel session will explore FDA’s program alignment and how implementation will impact industry. It will highlight strategies moving forward as well as introduce and discuss the new legislation surrounding device establishment inspections.

Moderator: Nathan A. Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
Eric Anderson, Director of Investigations Branch, Division 3, FDA
Shari Shambaugh, Program Division Director, Division 3, FDA
Vy Tran, Senior Vice President of Regulatory Affairs and Quality Systems, Varian Medical Systems

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.

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

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.

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 & MedTech Innovator $500K Competition Finals

Keynote Speaker - Dr. Regina E. Dugan, Vice President of Engineering, Building 8, Facebook

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

Rethinking Malfunction Reports: Does Summary Reporting Work?

FDA recently concluded a pilot that permitted eligible device manufacturers to report malfunction reports in summary form and on a periodic basis. During this panel, FDA will present the findings of this pilot program and offer insights into the usefulness and viability of such a program. In addition, industry experts will discuss how the pilot can be leveraged to fulfill section 227 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and related provisions of the MDUFA IV Commitment Letter.

Success with Surrogates: A New Framework and Best Practices for Surrogate Samples to Support Diagnostic Innovators

Difficulty obtaining clinical specimens can delay and hinder the development of new and improved innovations. In the midst of tremendous advances in diagnostic technologies and the drive to personalized medicine, the use of surrogates can help support diagnostic product development and support validation when clinical specimens are difficult to obtain. Developed by the Medical Device Innovation Consortium collaboration with key stakeholders, this new framework is aimed at supporting validation studies and thereby timely patient access to safe and high-quality diagnostic technologies, and will be launched with participation from FDA and industry on this exciting panel. Key topics include: why surrogates are used; factors to consider when using surrogate samples; and surrogate sample use in diagnostic validations by study type. A can’t miss session for diagnostics developers and their partners.

Speakers:

Moderator: Carolyn Hiller, MBA, Program Director, Clinical Dx, Medical Device Innovation Consortium (MDIC)
Susan Alpert, Ph.D., M.D., Principal, SFA Consulting
Adam Berger, Senior Staff Fellow, Personalized Medicine, FDA
Patrick O’Donnell, Roche
April Veoukas, JD, Director Regulatory Affairs, Abbott

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.

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

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

Recommended Agenda

Regulatory Companies

Thank you for attending The MedTech Conference 2017! The information below is from our 2017 program, but stay tuned as we will be updating it soon for The MedTech Conference 2018 in Philadelphia, PA on September 24-26!

Monday, September 25

Tuesday, September 26