by Carollyn Goldenberg, Engineering Supervisor at Wolcott, CT site
As inter-site collaboration becomes increasingly essential in the medical device manufacturing industry, Nissha Medical has been leveraging its growing network of facilities to bring innovative products to life. A recent example of this is the successful release of a navigable drill system designed for spinal surgery. This single-use, sterile medical device required input and effort from multiple sites to bring it from concept to manufacturing readiness.
Collaborative Design and Development
Although the product was originally designed by the customer, Nissha Medical’s Wolcott, CT, team took the lead in getting the device ready for production. The Design and Development Engineering team in Wolcott, working closely with Operations, spearheaded the process development and validation. This collaboration ensured that the device met the rigorous standards required for safe and effective use in spinal surgeries.
Harnessing Vertical Integration
To streamline production and fully utilize Nissha Medical’s vertical integration, components were sourced from several global locations. The Kunshan, China, facility manufactured injection mold tools, achieving near-perfect precision on the first attempt. These tools were then sent to Colorado Springs, CO, where the team molded key components, consistently meeting tight tolerances with glass fiber-filled parts. The Norwalk, OH, facility contributed by producing the stainless-steel thumbscrew, a critical component ensuring precise attachment of the device during surgeries.
Ensuring Precision Through Testing
Given the high-risk nature of spinal surgery, 100% of the devices required testing for electrical functionality. The Sandpoint, ID, team developed an automated test system to ensure that the device’s Duty Cycle, Frequency, and RMS Current Draw were within specification. Sandpoint is now in the process of developing a new automated tester for use in further production by the PCBA manufacturer.
A Blueprint for Future Success
The cross-site collaboration resulted in the successful release of the navigable spinal drill system at the Wolcott facility in June 2024. This project showcases Nissha Medical’s ability to harness vertical integration across multiple locations to bring innovative medical solutions to market. It sets a strong precedent for future initiatives, demonstrating how the company’s global collaboration and integrated capabilities drive efficiency and high-quality outcomes.
