Project Overview
The client, a leading medical device manufacturer, was facing significant challenges ensuring the dimensional accuracy of their complex titanium spinal implants. The intricate internal geometries of the implants were proving difficult to inspect with traditional CMMs and manual tools, leading to high rejection rates and production delays. To maintain compliance and accelerate time-to-market, they required a precision metrology solution that could provide a detailed, accurate first-article inspection.
Approach
Our team developed a custom inspection strategy tailored to the unique geometry of the implants. Using the Pearl-700 Desktop 3D Scanner, we digitized the parts to create a high-resolution point cloud. The data was then imported into our proprietary Spec.Check software, which performed a full dimensional analysis, comparing the scanned part to the original CAD model. We worked in close collaboration with the client’s quality assurance team to set critical inspection points and ensure the final report was actionable and ready for regulatory submission.
Outcome
As a result of implementing CGI Inspection’s solution, the client achieved a 99.9% first-article inspection accuracy on their surgical implants. The streamlined inspection process drastically reduced rework and rejection rates, saving the company significant time and resources. This not only accelerated their product’s path to market but also provided them with the confidence to meet and exceed strict regulatory requirements.