Transforming Innovation & Policy

Agenda

Friday, September 16, 2011

8:00 - 9:00 am

Registration & Continental Breakfast

9:00 - 9:10 am

Welcoming Remarks

• Mark Leahey, President & CEO, MDMA
  

9:10 - 9:45 am

Opening Address

• The Honorable Anna G. Eshoo, Congresswoman, 14th District, CA
  

9:45 - 10:30 am

Attracting Funding & Deal Design

Panelists will discuss the current investment environment for start-up medical technology companies and what strategies companies should consider as they seek funding.

• Casey McGlynn, Chairman, Life Sciences Group, Wilson Sonsini Goodrich & Rosati
• Allan May, Managing Director, Emergent Medical Partners, LLP
• Brad Vale, Vice President, Head of Venture Invesments, Johnson & Johnson Development Corporation
• Kevin Wasserstein, Managing Director, Versant Ventures

10:30 - 10:45 am

Networking Break

10:45 - 11:15 am

Impact of Patent Reform for MedTech Companies

Learn about new legislation Congress is debating and how it will affect medical technology innovation, and most importantly, how it could impact your growth.

• Stephen Jensen, Partner, Knobbe Martens Olsen & Bear, LLP

11:15 - 12:00 pm

Planning for the New Era of Comparative Effectiveness for Device Manufacturers

With comparative effectiveness research becoming more important in obtaining appropriate coverage and payment for your technology, understanding how and when to develop evidence-based studies will be critical. This session will provide you with the guidance necessary to prepare impactful evidence-based studies to achieve succesful coverage for your medical technology.

• Randel Richner, President, Neocure Group, LLC

12:00 - 1:00 pm

Networking Luncheon

1:00 - 1:30 pm

CDRH Update

Hear from the Deputy Director of CDRH on the 510(k) and New Science Reform as well as the recent Guidance documents that have been released

• William Maisel, MD, MPH, Deputy CDRH Director, FDA (via teleconference)

1:30- 2:30 pm

Update on Potential FDA Changes

As FDA and others prepare their final recommendations to reform the regulatory process for medical devices, hear from former senior administrators and industry experts on what the proposals could mean to you.

• Joshua Makower, MD, Founder & CEO, ExploraMed
• Heather Rosecrans, Vice President of Regulatory Affairs, MDMA
• Daniel Schultz, Senior Vice President, Greenleaf Health LLC

2:30 - 2:45 pm

Networking Break

2:45 - 3:45 pm

Launching Overseas

As emerging markets in Asia, Latin America and elsewhere continue to grow, learn from those who have successfully navigated the challenges and know what it takes to build out medical technology innovations.

• Michael Carusi, General Partner, ATV Capital
• Eitan Konstantino, President & CEO, Trireme Medical
  
• Thomas Novelli, Vice President of Government Relations, MDMA
• Ferolyn Powell, Divisional Vice President & General Manager, Abbott Vascular

3:45 - 4:30 pm

Objectively Assessing the Market Opportunity: Implications for Company Valuation and Product Strategy

A medtech executive's job is to be a strong proponent of the company's product and technology but unrealistic market expectations and imprecise views of the value proposition across stakeholders can lead to investors discrediting a solid market opportunity and set the company up for a suboptimal commercialization strategy.  Join Susan Posner of Health Advances, seasoned investors, and commercialization experts as we discuss how to accurately assess a product's value across decision-makers and size the market opportunity to both effectively position a product for market success and/or a rewarding exit.

• Wende Hutton, General Partner, Canaan Partners
• Mike Kleine, President & CEO, EndoGastric Solutions
• Susan Posner, Vice President, Health Advances, LLC
• David Stoffel, MD, Senior Director, New Busines Development, Intuitive Surgical, Inc.

4:30 - 5:00 pm

Implementation of the Health Care Law

With numerous provisions of the nation's new health care law being implemented, learn about what these policies will mean to your company and the future of the medical technology industry.

• Mark Leahey, President & CEO, MDMA

(agenda will be updated periodically, speakers and titles are subject to change)