Full_Product_Line_Keystone

Full Product Line, Tight Timeline

Challenge

Developing a new medical device, especially a long-term implant, is never easy. But bringing an entire metal implant line of over a hundred parts to market raises the difficulty factor to a whole new level. That was the challenge a growing medical device company brought to Donatelle, along with the requirement that we complete everything—design, manufacturing, packaging and sterilization processes—within nine months.

Action

The breadth and depth of our engineering resources enabled us to dedicate a program manager exclusively to the project and to assemble a multi-disciplinary engineering team that acted as an extension of the customer’s company. Because our team was involved early in the design phase, we were able to leverage our manufacturing engineering expertise to provide Design for Manufacturability analysis. This input was incorporated into the final designs, ultimately resulting in a product that was optimized for manufacturing, as well as meeting strict tolerance requirements. Parallel to finalizing designs and qualifying manufacturing and assembly processes, we brought our packaging, validation and sterilization experts in on the project. Flawless execution in these areas was critical to our customer, since the scope and timeframe of the project left no room for error. Thanks to Donatelle’s experience, the customer had complete confidence that process validation was effectively applied to ensure consistency throughout the product lifecycle.

The Result

The entire product line was completed and ready to roll out– on time, as promised. Taking full advantage of Donatelle’s vertically integrated manufacturing and engineering capabilities, our customer was able to focus on specifications, launch, marketing and building success for the product line in the marketplace.

Capabilities Used:

“We were thoroughly impressed with your ability to pull this project off on time due to its size and changing scope. We look forward to working with you on our next project.”

- VP of Engineering and Development for OEM