Tuesday, October 27

Main Conference: Day One

8:15 AM – 9:15 AM

Registration & Continental Breakfast

9:15 AM – 10:00 AM

Keynote Address
Exploring a Start-up Model: Maximizing Benefits and Minimizing Risks
Maggie Pax, Vice President Business Development,MicroCHIPS, Inc.

Ms. Pax will describe how MicroCHIPS has created value and reduced risk by leveraging key assets – intellectual property and platform breadth – into milestone-driven programs and into the creation of strategically partnered relationships. She will also contrast the business models, product development paths and risk-reduction strategies used by emerging companies to those pursued by medical device giants to achieve success in the marketplace.

10:00 AM – 10:45 AM

Managing the Total Product Life Cycle: Lowering Costs While Increasing Quality
Dan Matlis, Founder & President, Axendia

To determine the industry’s adoption of the Total Product Life Cycle (TPLC) approach advocated CDRH, Axendia in cooperation with Cambashi and FDANews recently conducted a major research project on this subject. A total of 212 industry insiders from a wide range of medical device and diagnostic companies participated in this research. This session will cover key findings analysis and recommendations from this research study.

10:45 AM – 11:15 AM

Networking Break

11:15 AM – 12:00 PM

Supplier Relationship Management: Building Better Partnerships Through Transparency
Joe Kelly, Director,Tefen, USA
Shawn Ryan, Director, Tefen, USA

This presentation will focus on how organizations can improve their supplier relationships and performance while building greater transparency throughout their supply base. Supplier Management techniques including the following will be discussed.

12:00 PM – 1:30 PM

Networking Luncheon with Roundtable Discussions:

Entrepreneurship, Risk Mitigation and Partnerships in Medical Device Manufacturing
Maggie Pax, Vice President Business Development, MicroCHIPS, Inc.

Venture Capital and M&A Trends in Medical Devices
Benjamin Dunn, Managing Director, Covington Associates

Sponsored by:

1:30 PM – 2:15 PM

Managing Your Risks Has Its Rewards
Glenn McCarty, CEO, EtQ, Inc.

In this session we will examine the different methodologies for implementing risk-based quality technologies, look at some leading trends in the industry regarding risk assessment and risk mitigation, and show some example how other companies are utilizing risk assessment in their compliance initiatives today.

2:15 PM – 3:00 PM

Valuable Tools To Minimize Early Stage Development Risks:
From Feasibility Analysis to Design Considerations
Ken Fine, President & Co-founder, ProvenProcess Medical Devices

This session will explore the processes and best practices in the initial phases of a new product development that quickly mitigate the technical risks and allow for a smoother development process. We will discuss the following:

• Requirements definition, with tools and methods to understand the need
• Risk management planning and initial hazard analysis
• Iterative feasibility development and analysis with modeling, simulation and rapid prototype

3:00 PM – 3:30 PM

Networking Break

3:30 PM – 4:15 PM

OEM & Supplier Panel: Top Ten Metrics Used for Sourcing Decisions
Moderator:
Christopher Oleksy, President, ATEK Medical

Panelists:
Tom Black, Vice President, OEM Sales & Marketing,
B. Braun OEM Division
Tom Burns, Vice President, Sales & Marketing, Tegra Medical
Rick Desmarais, Worldwide Supply Chain Director, DePuy Mitek, a Johnson & Johnson Company
John Purlee, Director, Global Sourcing, Abbott Diabetes Care
Andrés Rochwerger, Global Sourcing Manager, Boston Scientific Corporation
Carl Resteghini, Vice President-Global Direct Materials & Finished Goods, Covidien

Various factors influence how OEMs and suppliers do business. Here you will learn straight from key players some of the most important criteria for successful outsourcing strategies. Ask your most pressing questions to the panel – their expertise will provide real-world answers and experiences for you to learn from.

4:15 PM – 5:30 PM

Cocktail Reception

Sponsored by:

Wednesday, October 28

Main Conference: Day Two

8:30 AM – 9:15 AM

Registration & Continental Breakfast

9:15 AM – 10:00 AM

Medical Device Manufacturing Markets Update in an Economic Downturn
Benjamin Dunn, Managing Director, Covington Associates

It is commonly assumed that medical device markets are recession proof. A more accurate description for these markets would be “recession resistant”. This session will examine the significant market variances between different sectors of the medical device industry during the recent downturn and the impact of these variances on medical device manufacturers.

10:00 AM – 10:45 AM

Improving Enterprise Profitability Through Outsourcing —
Making It a Reality
Philip Borden, General Partner, Riverside Partners
Dave Busch, Senior Director Outsourcing Services, SVTC Technologies

As markets have gone global and demand variability increases, companies are required to have a flexible global supply-chain and the ability to aggregate spend in the most efficient supply-bases. This session will uncover the current realities of outsourcing and provide directional guidance on EBITDA impact.

10:45 AM – 11:15 AM

Networking Break

11:15 AM – 12:00 PM

Finding Ways to Accelerate Time to Market and Minimize Risk
Aidan Petrie, Co-founder & CIO, Ximedica

A seasoned medical device expert will lead a thought-provoking discussion that explores best practices both within and outside the industry, addresses the complexities introduced in outsourcing relationships, and challenges both suppliers and buyers to think more innovative about product development in today’s economic reality.

12:00 PM – 1:30 PM

Networking Luncheon with Roundtable Discussions:

Improving Enterprise Profitability in a Tough Economic Environment
Dave Busch, Senior Director Outsourcing Services, SVTC Technologies

Staying Competitive in the Global Marketplace
John Shields, National Sales & Marketing Manager, Judson A. Smith Company

Sponsored by:

1:30 PM – 4:30 PM

Interactive Workshop:
Reimbursement Strategies for Devices to Succeed in the Ever-Changing Medicare and Private Pay Markets
Stephanie Mensh, MPA, Vice President, Health Policy & Advocacy, The Neocure Group, LLC

Sponsored by:

Medicare and private reimbursement is a growing concern in the success of new medical devices and technologies. This interactive session will cover the basics of reimbursement and how to develop strategies to cope with the current landscape, trends, and expected changes. Topics will include:

• Economic stimulus Recovery Act’s
• Differences between coverage, coding, payment, and value
• Determining if an application for coverage or a new code is needed
• Medicare hospital and physician payment systems, how devices fit in
• Reimbursement trends for 2010 and beyond

*agenda and schedule subject to change without notice