Rapid Launch of New Product | Case Study

Opportunity:

The customer, a privately funded medical device startup, was in late stage design of a new single use disposable surgical product and required a rapid conversion from design to volume production in order to meet investor deadlines for product release.  The product needed to be fully assembled in a Cleanroom environment, with First Articles deliverable within 7 weeks of the initial purchase order, and initial production volumes 4 weeks later manufactured in the Cleanroom.

This product was larger than anything Sanbor Medical had previously produced and required additional capital equipment to mold a part that was 19” x 14” in size.  Also, Sanbor Medical was required to install a Class 100,000 Cleanroom to meet the final assembly requirement.

Sanbor Medical Requirements: 

1. Source and install a Class 100,000 Cleanroom
2. Source and install a 320 ton molding line
3. Transfer and install a custom piece of assembly equipment that the customer had developed for their product
4. Validate the new equipment and the Cleanroom

Solution: 

1. Working from the late stage drawings, Sanbor Medical provided significant input into the material selections for plastic resins and electronic components, yielding a variety of savings for the customer. 
   • 4 weeks were saved in development of the final drawings using pre-qualified raw materials from our established supply chain.
   • All materials were sourced from the most readily available supply, cutting 5 weeks lead time from the First Article plan.
   • Working with our suppliers we expedited all plastics and PCB related tooling to produce first plastic shots and first PCBA samples in 5 weeks.
2. Our global sourcing team was assembled to locate, evaluate, and purchase the required molding line and Cleanroom.  Following initial identification of sources, factory personnel audited the pre-qualified list of suppliers and purchase orders were placed with the chosen sources.  The molding line was installed and validated 6 weeks from the customer commit date in time to mold the First Article parts following customer approval of first shot samples made by the tooling vendor.  The Cleanroom was installed and validated 8 weeks from the customer PO date.
3. The U.S. based Project Manager assigned to the program traveled to the customer site to review the custom assembly equipment, documented work instructions for its operation, and packaged the equipment for shipment to the factory.  He then traveled to Asia, having coordinated his arrival with that of the initial set of raw materials, and oversaw installation and validation of the customer supplied equipment, assembly of the First Article products, and development of the work instructions for volume assembly.
4. In order to meet the rapid transition from First Article to production volumes, raw materials for the full scale production run were purchased at the time the initial PO was placed.  These materials were purchased from the best cost sources in our supply chain, allowing us to achieve a 20% reduction in material costs for the customer. 

Result: 

Sanbor Medical met the 7 week target of First Article production and the 4 week follow-on requirement for initial production volumes. The customer commented that Sanbor Medical was the only supplier in their selected sources that met the timeline commitments as specified.