ORTHOPEDIC IMPLANT MANUFACTURER

Orthopaedic implant manufacturer, Exactech, found the perfect package design and material to deliver a sterile, user-friendly container for porous coated (required to promote bone adhesion) medical implants. For Exactech, the choice of materials was obvious—Eastman Chemical Company’s Eastar® copolyester 6763.

Developing the packaging design was a challenge because of the porous coating on the medical implants. The medical devices required a unique packaging design not only because of the porous coating but also the different lengths and weights of the implants. Since most of the implant surface is covered with a porous coating, the product could only be captured in two spots, the areas that were free from the porous coating.

The overall objectives were to develop a package design that would protect the medical implant and not adversely affect the porous coating on the implants; minimize or eliminate the porous coating from interfering with the packaging materials during shipping and handling; minimize the number of packaging materials required to assemble the product, thereby reducing material costs; and develop one package system to accommodate a family of products consisting of different lengths. To meet these objectives, rigid medical packaging was the design of choice for porous coated medical implants.

By closely collaborating with the designer/thermoformer and materials supplier, Exactech was able to develop one packaging system that: 1) accommodated a family of implants; 2) prevented the porous coating from interfering with the packaging materials during shipping and handling; 3) reduced the packaging components to assemble the product; 4) improved package usability; and 5) reduced material costs.

“Our chief package requirement was to protect the sterile integrity of the product and maintain the sterile barrier for the shelf life of the product,” says Exactech packaging engineer, Stephanie Riley. “Eastar copolyester 6763 has a proven track record and based on past experience, I’ve never had any problems using PETG as a rigid tray material. It’s very easy to form, protects medical devices and has aesthetic appeal.” Package clarity was another important requirement in addition to the ability to withstand gamma ray sterilization.

None of the alternative materials had Eastar copolyester’s balance of purity, clarity and resistance to impact and numerous sterilization techniques, including higher dose gamma. As an added benefit, Eastar enabled a clean trim edge, free from angel hair or trim-related particulate.

This winning combination of properties was key to an ingenious package that met Exactech’s requirements for a user-friendly tray design. Designer and thermoformer, Perfecseal, developed a unique dual tray system whereby an inner tray was nestled within an outer tray. Vertical sidewall ridges on the inner tray were key to package modularity. The ridges hold sidewall inserts that allow various size products to be packaged into a single tray. Each of the two vertical sidewall inserts includes a protruding male boss, which when inserted into the ends of the product, literally suspends the implants to prevent abrading.

Perfecseal project engineer, Tad Kinyon, says, “Instead of five different package designs, we did it with one.” Plus, the two vertical sidewall inserts are made from the same tooling, which streamlined design time and reduced overall costs. Thanks to Eastar copolyester 6763, the design efficiencies translated into additional cost reductions in processing. Perfecseal’s Kinyon added that the part released well and scrap rates were reduced in comparison to PVC.

Trade named the AcuMatch® M-Series Metaphyseal, the newly designed package more than paid for itself in a 30% reduction in packaging costs. Additionally, surgical technicians and nurses found Metaphyseal easy to open and its clarity allowed them to quickly identify the contents—two vital features for a busy operating room.

The success of the new package has as much to do with the design and materials as it does with the co