AGENDA SESSION DESCRIPTIONS
Keynote Presentation
Supply Management in Medical Devices Under Economic Challenging Times
As today's economy becomes more challenging and more volatile, the ability for a medical device company's supply chain to respond to such an environment becomes critical. In this presentation, we will discuss key elements of supply management framework to drive speed, flexibility, and performance. We may touch on IT related tools, sourcing examples, supplier development initiatives, and organizational alignment.
Creating and Sustaining a Compliant Quality Management System
for Multiple Regulatory Environments
The medical device industry is continually challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. It is made more complex in globalizing economies in which companies operate in multiple jurisdictions. Learn to develop an effective Quality Systems Matrix to facilitate a more comprehensive plan, which will enable you to ensure compliance in a global environment.
Case Study
Part 1: Building the Bridge Between OEM Design and Outsourced Manufacturing
OEMs and Contract Manufactures must work together to ensure that manufacturing goals are incorporated into the design process. This case study will examine key attributes of the outsource partner relationship. Sharing views on:
- Creating a healthy business relationship
- Working together during the development/prototype stages
- Value of communication through all stages of the project
Panel Discussion
Part 2: Building the Bridge Between OEM Design and Outsourced Manufacturing
OEMs of all sizes are strategically moving away from device manufacturing and are focusing resources on core competency—designing products. To aid companies with this transition, we crafted a session that will help them successfully bridge the gap between design and design transfer, including:
- Getting the Contract Manufacturer Involved Early in the Process
- Staying Flexible by Planning Time for Design Changes
- Planning for Validation
Hear from our panel of OEMs and contract manufacturers and gain tips to success.
Panel Discussion
Qualification Across the Supply Chain:
Working With Your Supplier and Your Supplier Suppliers
As outsourcing increases, manufacturers are ever more dependent on their suppliers to ensure customer success. As multiple business functions such as design engineering, supplier engineering, quality, manufacturing and environmental compliance work with each other and with their counterparts at supplier organizations, companies face significant challenges in managing the process. Learn about effective and efficient supplier evaluation programs to assure adherence to quality specifications.
The Future of Testing and Validation: The Role of Modeling and Simulation
Testing is becoming more challenging given stricter FDA regulations. Like everywhere else in their supply chains, medical device manufacturers want more from their testing partners—good documentation practices for test results, protocols, and other records have never been more important. Learn how best to leverage outsourced partners in the development and manufacturing process.
When Outsourcing Isn't Forever: Making the Right Decision at the Right Time
When does near-sourcing or in-house production makes strategic and economic sense? The changing market landscape demands due-diligence. With global economic changes, erratic fuel costs and additional risks such as supply chain disruptions, medical device companies are actively examining ways to increase competitive advantage and mitigate risk.
Future of Sourcing: Trends & Technologies in Logistics, Supply Chain, and Manufacturing
There are the big trends that are gaining momentum which will change how and where we do sourcing. The Chinese Middle Class will soon be twice as big as the whole US and will have money to spend. Who will make the foreign goods that they will want to import? Both the US and Chinese populations are aging. Currency exchange rates will weaken the dollar and strengthen the Yuan. The Green revolution is underway and will weigh against long distant outsourcing. Global labor costs are evening out. Supply chain risk managers are targeting the suppliers to your suppliers. Where will new technologies such as nano-materials be manufactured? Some of these trends will favor moving sourcing to other regions including back to the Americas. Will it be North America?
The speakers will describe the major global demographic, financial, social, and financial trends and their likely impacts on the supply chain. Combining the impacts of these trends will create a view into the future impacts on sourcing.
Materials Qualification Mission Critical- The Why and How of Materials Qualification!
Materials qualification is an important aspect in the design and manufacturing of critical components and should be considered early on in the process. Generally thought of as a necessary evil, it is better to practice due diligence on the front end and build materials qualification and validation into your system, versus performing it as an afterthought, or worse yet as the result of a catastrophic field failure. Product recalls and field failures can not only cost your company large sums of money, but they can also cause a loss of your reputation and are factors that should always be considered when designing any critical component or device.
To view speakers and specific topics, please visit the conference agenda.
