Recommended Agenda

Building a Healthy NEST Egg: Exploring the Opportunities and Benefits of the National Evaluation System for Health Technology

Leveraging real world evidence has the potential to transform medical device surveillance. FDA recently issued guidance on the release of emerging signal communications and use of real world evidence in regulatory decision-making, and also awarded a grant to the Coordinating Center for the National Evaluation System for Health Technology (NEST). Leveraging multiple data sources, the NEST promises to transform the use of disparate data sources for pre- and post-market activities. Panelists will discuss current developments and future opportunities of NEST.

Moderator: Ginger Glaser, Vice President of Engineering, Monteris Medical
Rachael L. Fleurence, PhD, Executive Director, NESTcc
Michelle McMurry-Heath, MD, PhD, WW Vice President and Global Head, Regulatory Affairs, Medical Device Companies, Johnson & Johnson
William V. Murray, President & CEO, Medical Device Innovation Consortium
Pat Shrader, Vice President, Global Regulatory Affairs, Medtronic

Location: Convention Center - Room TBD

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
Dennis Hahn, Director, Regulatory Policy Innovation, Ethicon & Vision Care, Johnson & JohnsonJonah 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

The Point of Person Laboratory

Wearable and in vivo diagnostics could transform diagnostics and health care delivery. Innovators and business leaders will discuss the emerging technologies that will drive this market and the implications for patient care.

Speakers:

Jeffrey Brewer, President & Chief Executive Officer, Bigfoot Biomedical
Phil Charron, User Experience Design, Basil Leaf Technologies
Carlos Milla, MD, Professor of Pediatrics (Pulmonary Medicine), Lucile Salter Packard Children's Hospital
Bill Rader, President & CEO, Efferent Labs, Inc.

Location: Convention Center - Room TBD

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 state-of-the-art cybersecurity and information security best practices, 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

Location: Convention Center - Room TBD

The Rise of the Consumer: How Can MedTech Leverage the Best of Customer Centricity from other Industries?

Patients and clinicians now expect more from the medtech industry. It is no longer enough to delight surgeons in the operating room or laboratory professionals with high functioning assays. Health care innovations must deliver a customer-centric experience that involves education, optimized user experience, patient services and data feedback loops. While pharma companies are beginning to make strides with customer-centric, “beyond the pill” offerings, it is the vanguards within the consumer products industries that can teach us what good really looks like. We invite you to join our panel of experts from consumer-driven organizations as they share how they plan for and deliver optimal customer experiences, as well as leading medtech executives who will discuss how some of these best practices can be incorporated within our industry.

Location: Convention Center - Room TBD

They Call Me Big Data: Applications for Cognitive Learning in Health Care

New data streams, sophisticated analytics and cutting-edge cognitive computing technologies are enhancing health care decision-making at a rapid pace. This panel will explore the potential of big data analytics and cognitive learning technologies to enhance and forever change the landscape of health care delivery.

John Daley, Vice President Regulatory Affairs and Quality Assurance, IBM Watson Health

Location: Convention Center - Room TBD

Afternoon Plenary Session: Innovation as a Discipline

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

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!

About Dr. Regina Dugan:

Dr. Regina Dugan is Vice President of Engineering at Facebook, where she leads Building 8, the team responsible for developing breakthrough products that advance Facebook’s mission of opening the world to everyone. Building 8 focuses on combining ambitious R&D with rapid product development, technologies that blend physical and digital worlds and aggressive, fixed timelines to deliver consumer hardware products at scale.

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

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

Digital Health

Monday, September 25

Tuesday, September 26

Wednesday, September 27

Recommended Agenda

Digital Health

Monday, September 25

Tuesday, September 26

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Wednesday, September 27