April 14, 2008 - The performance of many large, global EMS companies such as Jabil Circuit, Flextronics, Celestica, to name a few, is surely not ...

Typically, what many OEMs are presented with from their contract manufacturing partners, with regards to supply chain contract scheduling and schedule changes, allows for schedule changes to occur but there is a limit to the degree of change in manufactured product volumes delivered.

The following is what a typical medical product design outsourcing contract agreement being presented by a contract manufacturer offering medical product design and manufacturing services.

Contract manufacturers in this space should have extensive knowledge in, and be able to provide valuable guidance with, product regulatory requirements such as Pre-Market Notification (PMA or 510(k)) as well as Notified Body submissions for CE Mark compliance.

Startup executives can refer to this plan to help them review internal depth and scope capabilities against anticipated company capability requirements so they may then determine at what point it may make sense to consider evaluating and engaging a contract product design partner or contract manufacturing partner.

Typically, contract manufacturers will purchase specified quantities of long lead time material and OEM customer-unique materials only when the OEM customer authorizes such in advance and in writing.

In short, the coming generation of advanced IT-based medical devices creates a whole new driving force for outsourcing electronics manufacturing. The sophisticated requirements for producing such devices raises questions about how well prepared manufacturers are to build their own products. And it reopens the question of whether EMS providers can offer a cost-effective alternative for producing devices that meet the requirements of the heavily regulated medtech marketplace.