Registration Opens & Continental Breakfast

Keynote Address:
The Changing Medical Device Landscape: Staying Innovative, Avoiding Pitfalls & Seizing Opportunities
Amar Sawhney, PhD, President & CEO, I-Therapeutix Inc.

While innovation in Medical Devices is not the sole purview of small companies and start-ups, the risk reward ratio and the type of people such ventures attract, predispose them to be at the forefront of innovation. As spending on healthcare spirals, new devices and therapeutics have to increasingly justify their cost effectiveness. Rapid and capital efficient execution, close contact with eventual customers, and a spirit of continual improvement are essential to creating lasting and valuable companies. Dr. Sawhney will describe a platform for enabling medical ventures, called Incept, that he and his partner Fred Khosravi, have founded.

Managing Your Regulatory & Quality System Requirements While Outsourcing Key Operational Areas
Clay Anselmo, President, Reglera, LLC

Outsourcing is a proven method of increasing efficiency, but how do you maintain control over your product with in today’s intense environment of FDA scrutiny? Device manufacturers face the challenge of ever-changing regulations, training requirements and a myriad of compliance issues. Learn how to streamline your internal processes so you can focus on your core competencies and feel confident in your outsourcing decisions.

Networking Break

Outsourcing Product Development: How it Can Positively Impact Your Business
Terence O’Hagan, Director of Business Development & Strategy, Radius Product Development

Medical device firms are leveraging the benefits of outsourced product development. As these companies continue to look for ways to maximize resources, develop a sustainable stream of innovative products, improve their speed to market and gain competitive advantage, outsourcing medical device development has come into the mainstream as an effective tool and adjunct to internal expertise.

Networking Luncheon

How Will New Medical Device Market Trends Affect Your Company?
Rick Hoole, Partner, PRTM

Competition is fierce and outsourcing trends increase the stakes. Learn how cutting-edge market data can help you strategically manage the device environment including:
• Mergers & Acquisitions
• Regulatory Changes
• Cost Constraints and More!

Medical Device Risk Management in the Post Riegal World
Kevin Quinley, President, Kevin Quinley & Associates

This session will answer pressing concerns including:
• What are the risk management implications of Riegel?
• What are the liability exposures are untouched by Riegel?
• What are the major factors shaping medical device product liability in 2008 and beyond?
• How can medical device firms use insurance and non-insurance tactics to bulletproof themselves from financial loss due to product liability?

Attend this session and learn how to financially protect your company from hemorrhaging product liability costs!

Networking Break

Tips & Tactics for a Successful OEM Outsourcing Partnership in a Matrix Organization
Scott W. Holmes, Vice President Strategy & Portfolio Management, Covidien Kendall

Working in a matrix organization is challenging. Those that operate under regulatory, quality and cost constraints are even more difficult. We will discuss some methodologies we use for effectively managing outsourcing programs.

Networking Reception  sponsored by
                                                

Registration Opens & Continental Breakfast
                                                                                        

Medical Device Manufacturing Logistics and Supply Chain Management – Imperatives Revealed
Greg Frazier, Executive Vice President, Global Supply Chain Services, Avnet, Inc.

Design for manufacturing and supply chain confidence during the concept and feasibility phase of the medical device development process is imperative. Mitigation of risk includes incorporating collaborative component supply and manufacturing strategies early in the design cycle in order to ensure long-term system sustainability and component traceability over the course of the product lifecycle. In addition, with off-shore manufacturing continuing to provide substantive ‘up front’ cost savings, trade-offs must be made with regard to the logistics and quality management of a global supply chain.

Networking Break

Strategic Sourcing Management Practices
Andrès Rochwerger, Global Sourcing Manager, Contract Manufacturing, Boston Scientific

Strategic Sourcing is a management process used to answer the critical questions - What to buy, Whom to buy from, and How to buy. In this session we will share and discuss best practices used in the Medical Product Outsourcing marketplace in order to gain maximum mutual value in Sourcing Relationships..