Delivery & Quality

The Challenge

Medtronic-owned Kyphon Inc. (Sunnyvale, CA), approached Donatelle™ with an opportunity to provide design input and assistance to improve an existing device—the Kyphon Mixer®, a bone cement mix and transfer system. Donatelle understood this was a system with projected high-volume sales; this project would require the development of new tooling, molding of components, assembly, packaging, and sterilization of the finished product.  

Course of Action

Donatelle's technical team was able to readily provide the needed design improvement and Design for Manufacturability (DFM) direction requested by Kyphon. Its technical team was also able to utilize Kyphon's experience and customer feedback with the existing first generation product to make recommendations for improvement.  

Once the design was complete, production tools were manufactured which gave way for full process validations. Donatelle's validation engineers authored the validation protocols and completed the molding, packaging, and sterilization validations in a timely manner - adhering to project deadlines.

The Result

Through a collaborative approach, Donatelle was able to successfully team with Kyphon in becoming an extension of their product development and manufacturing arm. Final device inventories were managed to allow a smooth ramp-down of the previous design and a quick ramp-up of the new and improved design without stockpiles of inventory. Ultimately, on-time delivery of the system improved to 100 percent and quality issues were reduced by 200 percent as a result of engaging Donatelle.












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