Bringing an Entire Product Line to Market

The Challenge
A growing medical device company approached Donatelle™ with an exciting challenge: help them bring a new metal dental implant line consisting of over 100 parts to market in nine months. Within this timeframe designs would need to be finalized as well as manufacturing, packaging, and sterilization processes developed and validated.

Course of Action
With our broad depth of engineering resources, Donatelle was able to assemble a multi-disciplined engineering team to act as an extension of this medical device company. Donatelle's team was led by a program manager dedicated exclusively to this project. Because Donatelle's engineering team was involved early in the design phase of the project, we were able to engage manufacturing engineering experts to provide Design for Manufacturability input. This input was incorporated into the final designs, ultimately resulting in a product that was easier to manufacture and capable of meeting strict tolerance requirements. Parallel to finalizing designs and qualifying manufacturing and assembly processes, Donatelle was able to deploy packaging, validation, and sterilization experts on the project. Partnering with a supplier that had been down the validation path before was critical to our customer, especially with such a large project on a relatively tight timeframe. Our customer was able to draw upon Donatelle experts who understand the importance of process validation and how to effectively apply it to ensure product consistency throughout the product lifecycle.

The Result
Bringing a new medical device to market, especially a long-term implant is challenging in and of itself. Bringing an entire product line to market requires significant development resources. Leveraging Donatelle's manufacturing and engineering capabilities and resources as a vertically integrated medical device manufacturer allowed our customer to focus their time and resources on product specifications, the product launch, and marketing.

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