Agenda Sessions

Agenda Sessions

DeviceFest agenda is still in the process of being finalized. Please continue to check the website for agenda updates.

August 27, 2013

7:30 a.m. - 8:30 a.m.Registration & Networking

8:30 a.m. - 9:00 a.m.Opening Remarks

9:00 a.m. - 9:45 p.m.Keynote Presentation

Over the last few years Dr. Shuren has actively engaged BIOCOM and BIOCOM members in ongoing dialogue regarding improving CDRH. At DeviceFest he will discuss the progress on this effort as well as implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.

Presenter (via webcast)
Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health , FDA

9:45 a.m. - 10:00 a.m.Refreshment Break

10:00 a.m. - 10:50 a.m.Reimbursement: A Hard Look at the Value of Medical Technology

Demonstrating the value of new health technologies has never been more critical to the commercial success of these products. The Centers for Medicare and Medicaid Services (CMS) are responsible for making sure that every dollar they invest in new medical devices is a dollar well spent, so understanding how they assess, evaluate, and reimburse these products is important for all involved in the development and commercialization of new medical devices. In addition, as many private sector payers take their cues from CMS, understanding how they adapt and adopt CMS decisions into their own reimbursement policies and procedures is a key piece of knowledge for the medical device industry. In this session, a panel of experts including Rina Wolf, Vice President of Commercialization Strategies, Consulting & Industry Affairs at Xifin, and Alex Bastian of GfK Bridgehead will discuss how CMS is addressing cost considerations in medical devices, and the challenges faced by medical device manufacturers. Moderated by MD+DI editor-in-chief, Heather Thompson.

Specific topics of discussion include:

The feasibility of a new process reimbursing for precision diagnostics.
Global considerations for reimbursement.

Frank Pokrop, Director, Reg. Affairs, CareFusion, Inc.

Confirmed Panelist:

Alex Bastian, MBA, Vice President, Market Access, Health, GfK Bridgehead, LLC

Nick Poulios, Head of MORE, Medical Outcomes - Reimbursement & Economics, Roche Molecular Systems, Inc.

Rina Wolf, Vice President of Commercialization Strategies, Consulting & Industry Affairs, Xifin

10:50 a.m. - 11:15 a.m.Networking Break

11:15 a.m. - 12:00 p.m.A Look Ahead: The Future of Connected Health

As wireless continues to enable innovative health information technologies and services it has become a key component in the delivery of health services and the provision of care in the U.S. and around the world. Don Jones will present his vision on what's next for the wireless heath industry in the next 5-10 years. Jones will discuss how the cloud is breaking down barriers and empowering communication between mobile apps, EMRs, and medical devices-literally liberating the data for better patient outcomes.

Don Jones, Vice President Global Strategy and Market Development, Qualcomm Life

12:00 p.m. - 12:45 p.m.Networking Lunch & Medtech Industry Update

John Babitt, Partner - Life Science Industry Leader for North America Transaction Advisory Services Practice, Ernst & Young

12:45 p.m. - 1:45 p.m.Medical Device Deal-Makers: Creating Value Through Strategic Partnerships

Come hear Johnson & Johnson, CareFusion, Covidien and Medtronic review payment and deal structures, the developmental barriers to deal-making strategies. The panelists will also discuss the most pressing issues facing deal makers including how industry insiders are developing their product pipeline; essential diligence to evaluate potential deals and partners; strategies to effectively approach and negotiate with key innovation contributors; what kinds of medical device deals are being made and how partnerships compare.

Benjamin Perkins, Senior Managing Director, Group Head Life Sciences M&A, Ernst & Young

Confirmed Speakers:

Dennis Crowley, Senior Vice President, Business Development, Covidien

Aileen Stockburger, Worldwide Vice President of Business Development, Johnson & Johnson

Christian Voigtlaender, Senior Vice President, Strategy & Business Development, CareFusion

Conrad Wang, Sr. Director, Corporate Development, Medtronic

1:45 p.m. - 2:15 p.m.Networking Break

2:15 p.m. - 3:15 p.m.Impact of Accountable Care Organizations on Device Industry – The Shifting Goalposts of Medical Device Marketing

Accountable Care Organizations (ACOs) will bring significant change to the structure and rewards within the U.S. healthcare system, and will have a significant impact on the reimbursement and utilization of healthcare resources. Physicians will have new incentives to save money and, where clinically appropriate, use lower-cost technologies to treat patients. Device manufacturers will need to understand these changes, their impact on customer attitudes and decision-making and how to incorporate them into product and commercialization strategies.

Stacy Taylor, Partner, DLA Piper

Confirmed Speakers:

Jeff Benabio, Physician Director of Innovation and Transformation, Kaiser Permanente
Richard Neale, Corporate VP, Ambulatory Development and Research, Scripps Health
Carlos M. Nunez, M.D., Chief Medical Officer, SVP Medical Operations, CareFusion

3:15 p.m. - 3:30 p.m.Networking Break

3:30 p.m. - 4:30 p.m.Approaching Markets Overseas

To penetrate international markets, companies must understand the dynamics in each country. Navigating regulatory requirements, government reimbursement policies, cultural behavior that drives markets and other variables can trip up companies working to enter the markets overseas. This panel will describe the trends, challenges and opportunities facing medical device and diagnostics companies entering international markets.

Stacy Taylor, Partner, DLA Piper

Confirmed Speaker:

Daniella Cramp, President of Chronic Care, Alere
Rick Doubleday, VP, Sales & Marketing, DexCom
James McLaughlin, CTO & Co-Founder, Intelesens; Director, NIBEC, Univ. of Ulster (UK)

4:30 p.m. - 6:30 p.m.Medical Device & Diagnostics Expo

Following the conference, we will kick-off BIOCOM's Medical Device and Diagnostics Expo. This is your opportunity to see the future - viewing the hottest life-saving technologies. More than 25 companies will showcase their innovative devices and diagnostic tools.