9:15 – 10:00 am
Breaking the Barriers of Organizational Silos

“Goal-focused cross-functional facilitation in support of a well-defined business deliverable breaks down organizational silos and achieves milestones”

The typical functional organization can create silos that make cross-functional collaboration difficult, or at least slows down the process. Want to get things done? Make a project organization chart that reflects roles and responsibilities, not titles and position. Many organizations flounder as different functional groups do their best to deliver in a program lacking a system-wide approach to achieving the overall goals required by the business. This creates confusion, missed milestones, and real financial impacts to the business because products are stuck, delayed, or abandoned as the market window closes.  Learn why the status quo organizational structure doesn’t work and how to structure a unified team focused on shared big picture goals resulting in clarity that gets everyone rowing in the same direction.

10:00 – 10:45 am
How Experts Evaluate Supplier Quality During Outsourcing Decision-Making

Traditionally in many organizations supplier quality has not been a conscious consideration in the outsourcing decision making process, with only traditional supplier selection techniques being employed such as standard quality system supplier questionnaires and checklists being used, possibly supported by a first article inspection process later on.  
 
This presentation considers a different more proactive approach, where active planning for the specific opportunity ahead of the actual supplier quality evaluation takes place.  This process determines the traits the outsource company must have to be successful, driven from the outsourcing companies true business, technical and quality needs for the product or products to be outsourced.  This results in a tailored approach or assessment based on those needs.  This technique is based on and fully supports the requirements of the Global Harmonization Task Force guidance on Supplier Controls which also expects the outsourcing company to consider not only this but also controls to maintain product quality through time.  In this presentation new tools and techniques for doing this are introduced and explained.

11:15 am – 12:00 pm
Strategies for Managing IP

Medical device innovations can have positive impact on patient care and can also be tremendously lucrative.  Critical issues come into play with ownership, especially when developments are made in an academic setting. Learn how to effectively navigate in both the academic and legal world.  This session will cover strategies to help your organization cultivate progressive innovation that is not stymied by an IP tug-of-war.

1:30 – 2:15 pm
Top Five Metrics to Assessing Vendor Health

How to choose the correct vendor and ensure that the vendor is in compliance with quality and regulatory requirements is a huge challenge. This session will address what to look for in assessing companies on knowledge of product and material specifications, quality control, change specifications, delivery conditions, sub-contracting, etc. As well as risk mitigating points to consider in the contracting process.

2:15 – 3:00 pm
Risk Mitigation in Offshore Sourcing: Is Your Company Truly Achieving Lowest Total Cost?

Medical device OEMs have outsourced manufacturing for decades. Typically it is a choice driven by either the improved financial performance that outsourcing can drive or the ability to access technical and manufacturing expertise not resident in an OEM’s internal resources. However, as cost pressure grows OEMs are seeking lower cost labor markets. This presentation looks at the results of interviews with OEMs and suppliers on sourcing practices in several emerging, established and mature labor markets.
 
 Areas of focus include:
  · Risks in outsourcing
  · Key medical OEM concerns and strategies
  · The hidden cost equation
  · Changing medical industry dynamics
  · The low cost labor market evolution process and advantages/disadvantages of each stage
  · Advantages and disadvantages of India, Vietnam, Singapore and Eastern Europe

3:30 – 4:15 pm
The Open-book Pricing Debate: An Interactive Panel Discussion

The debate continues on whether an open-book partnering process is integral to a successful outsourcing relationship. A panel of OEMs and contract manufacturers will discuss this issue addressing the following questions:
 
  · Can total transparency help to communicate the cost intricacies of the work being performed?
  · Does it force companies to be the lowest-cost provider at the sacrifice of quality service delivery?
  · Do clients feel comfortable when they understand easily how costs are being aligned with the necessary resources?
  · Does Open-Book pricing help to forge long lasting strategic partnerships?

9:15 – 10:00 am
The New Productivity Paradigm: Where Do Lean Six Sigma Fit Into Your Operations?

Many medical device manufacturers question the effectiveness of lean because its rapid-change capability appears to be in direct conflict with the requirement for rigorous process validation in such a heavily regulated environment.  In fact, lean is providing the consistency and stability required to support critical business initiatives such as rapid product development and quality assurance.  Mike Serena will discuss the application and benefit of lean for both OEM contract manufacturers and for companies who source contract manufacturing engagements.  He will discuss the primary reasons for deploying lean in a medical device manufacturing environment and will highlight examples of companies applying lean to drive growth and profitability.

10:00 – 10:45 am
Key Elements to Negotiating Outsourcing Agreements—Pitfalls and Strategies

This panel of OEMs and CMs will focus on the central points of negotiation in a typical outsourcing agreement, and related strategy, including: the central role of cost and quality assurance, regulatory issues, risk sharing, inventory management, documentation, intellectual property, inspection and relocation rights amongst others. This will be a moderated panel of experienced CM and OEM personnel who will have a dynamic discussion about  what works and what doesn't in contract negotiations.

11:15 am – 12:15 pm
Medical Device & Diagnostic (MDD) Industry
Direct Material Sourcing Benchmark Study Results

MDD Direct Material Sourcing Survey provides MDD executives with insights for setting and achieving best-in-class cost reduction in direct materials. The study focuses on direct material cost reduction performance, levers and constraints among MDD manufacturers. Survey participants represented over 20 small, mid-size, and large MDD companies, including 8 of the 12 largest MDD companies in the world. This presentation of the survey results will cover:

    • Direct material sourcing data to the MDD industry;
    • Benchmarks for sustainable cost reduction performance and targets; and
    • Other benchmarks that MDD operations executives can use when establishing annual cost reduction targets.