
Arthrex is a global medical device company headquartered in Naples, Florida. They specialize in implantable devices and their products are in several sports stars, including Drew Brees and Troy Polamalu.
NOTABLE PROJECTS
Revalidations
This project was to revalidate packaging designs that didn't have the correct documentation. The other coop and I looked into documentation from as early as 2004 comparing the bill of materials in Agile to the validation to see if it met current standards. We created excel sheets to identify which products needed to be revalidated, and chose a product family to focus on. We then moved into the testing phase of the packages to update the documentation.
Test Method Validation
This project focused on validating our test methods for effectiveness. We manufactured defects in sample set of over 1200 samples of foil/foil pouches, blister trays, and poly/tyvek pouches. We picked numbers at random and assigned defects to them to test for in the following tests: seal strength, seal integrity, peel rating, package integrity, and dye penetration.
Size Reduction
This was a project to reduce the size of a package for a bio tenodesis kit. I contacted a supplier to create a new pouch, contacted labeling for a smaller label, created and engineering change order to route the new pouches, wrote a protocol on how to validate the design, updated the packaging instruction, and ordered the parts for validation. This resulted in a 30% reduction in the outer pouch, 23% reduction in the inner pouch, 20% reduction in the carton, and 26% reduction in overall weight.