GTI Medical began working with a start-up that developed a surgical tool to treat meniscus tears, back when the company was still in a technology incubator. In the initial stages of the collaboration, GTI focused on producing prototypes and defining manufacturing processes. These processes included precise laser cutting, complex laser welding, electropolishing, clean-room assembly, and packaging. The development work and manufacturing characterization included preparing the product for clinical trials, a process that took several years. Upon completion, the product received FDA approval, and the company began producing substantial quantities through serial manufacturing.
In preparing for serial production, GTI guided the development company by defining the parameters required to produce the various parts that made up the product. This included validating manufacturing processes so that when the developer submitted a comprehensive product dossier to the FDA, all the information was accessible. Throughout the process, a GTI representative maintained close, consistent contact with the company’s development engineers, assisting them in writing protocols and manufacturing specifications through the product’s design freeze.
To this day, GTI remains a significant supplier of parts for this medical product.