Tall order, high stakes


A fast-growing medical device company aiming to be a global leader in minimally invasive spinal therapies asked Donatelle for design assistance in improving an existing device. The product, a bone cement mix and transfer system, had a high profile and projected high-volume sales. And the project would require developing new tooling, component molding, assembly, packaging and finished product sterilization.


Combining the customer’s experience and user feedback with our technical team’s expertise, we made recommendations for design improvement, along with Design for Manufacturability (DFM) direction. Once the redesign was finalized, we manufactured production tools, then moved to full process validations. Donatelle’s engineers authored the validation protocols, completing molding, packaging and sterilization validations while meeting project deadlines.


With the product design complete, we managed inventories of the new device 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. Bottom line: On-time delivery of the system improved to 100 percent and quality issues were eliminated.

“We really appreciate how the team at Donatelle kept our project on time and then ensured a seamless transition to the new design. Fantastic job every step of the way!”

– Director, Global Supply Chain for OEM

Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.

501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486