* Describe the differences between needs identification and defining commercial equivalents and discuss why it is preferable to separate into two stages.

* Interpret the value to the organization when early supplier involvement (ESI) is implemented effectively.
Outside suppliers play a crucial role in virtually every medical OEM’s manufacturing process. Smart ones treat their suppliers more like partners and less like vendors; by working closely with key suppliers early in the process, they can create more value, improve quality, and reduce overall time to market for even the most difficult or critical components.
Early supplier involvement (ESI) in the development cycle is the best way to contain costs while maximizing the benefits that come from utilizing suppliers’ specialized skills. By engaging key suppliers early in the process and focusing on the desired results, an OEM can quickly address any potentially sticky issues, drive out unnecessary costs early on, encourage innovation, and improve project organization. Without ESI, a manufacturer runs the risk of unnecessarily lengthening the overall development cycle, increasing the number of design revisions later in the process, and ultimately ending up with a device that is too complex, too expensive, or too difficult to manufacture.
When assembling a project team, be sure all disciplines needed to bring the product to completion are represented on the team and are included in the each design review to ensure that the product can, in fact, be manufactured effectively, efficiently, and reliably as designed. It’s a good idea is recommended to have a single program manager from the plastic supplier appointed early to the project; this , creates assuring a single point of contact for all internal disciplines internally as with someone who well as understandsding the specifications, can help interpreting