GTI Medical started working with a start-up who developed surgical tool for treat meniscus tears, from its early days, back when they were in a technology incubator. In the initial stages of our collaboration, we focused on prototype production and defining manufacturing processes. These processes included precise laser cutting, complex laser welding, electro-polishing, assembly in a cleanroom and packaging. The development work and manufacturing characterization included preparing the products 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 the process of preparing for serial production, we guide development companies by defining the necessary parameters for producing various parts that make up the developed product. This includes performing validations for manufacturing processes so that when the time comes for the developer to submit a comprehensive product dossier to the FDA, all the information will be accessible. Throughout the process, a GTI representative maintains close and consistent contact with the company’s development engineers, assisting them in writing protocols and manufacturing specifications—all the way to the design freeze of the developed product.
To this day, GTI remains a significant supplier in the manufacturing of parts of this medical product.