Rapid Product Line Transfer for Quality | Case Study

Opportunity: 

The customer was looking for a new contract manufacturer based in North or South America after being dissatisfied with their existing supplier’s lack of quality and limited technical and engineering abilities. Customer had an EPA electromechanical device that was expected to become FDA Class 1 certified. They needed to find another contract manufacturing partner that could get started immediately. They reached out to Sanbor Medical based on our experience and global operations, offering additional manufacturing options and expertise in medical device manufacturing.

Sanbor Medical Requirements: 

1. A team from the Sanbor Medical manufacturing facility in Xiamen, China, including the lead Engineer, was en route to the other contract manufacturing facility in Shenzhen within 48 hours. The group drove 500 miles to evaluate the existing molds and arrange to move them to the Xiamen manufacturing facility within a week.
2. 14 molds were sent to the Xiamen manufacturing facility for further evaluation.
3. Ultrasonic welding was done for the SA0001 cartridge assembly, which includes CP0001/CP0003/CP0004.
   
   A leakage test is required for the SA0001. It took the previous vendor a very long time to get it done. To improve the pass rate, the vendor applied glue around the welding cones before doing the ultrasonic welding. Even so, the overall pass rate of the devices made by previous vendor was very low.
4. Resources from Sanbor Medical’s global team of experts were utilized to ensure the success of the project. From supply chain management, engineering services, project management, and customer service, the Sanbor Medical team was ready to lend support, whether in the U.S. or China.

Result: 

The customer was extremely happy with the fast turnaround time to get the molds from the previous manufacturer, evaluated, and then used to make components for them. This was an integral factor in their process to make the finished product. Sanbor Medical met the customer’s budget, quality, and time requirements. In the time since this project completed, this customer has supplied Sanbor Medical with additional projects.

Quote from Customer: 

“Thanks to all those involved for the fast action and help.”