Award-Winning Package Increases Protection, Reduces Assembly

Anspach, a medical device manufacturer of bone-dissection tools used in neurosurgical, otology, and orthopedic procedures, previously packaged its devices in cellulose acetate propionate (CAP) tubes with LDPE caps. Although the packaging system was adequate, Anspach identified areas for improvement, such as minimizing device movement inside the enclosure, offering a more-consistent withdrawal procedure, and allowing for an easier assembly process.

Anspach enlisted Plastic Ingenuity, a medical packaging designer and manufacturer, to find a material and design solution for a new packaging system. Plastic Ingenuity guided Anspach through the design process to determine the package’s functional needs, develop prototypes, and tweak designs based on product integrity and biocompatibility tests.

Plastic Ingenuity developed new packaging using Eastman Chemical Eastar 6763 for Anspach's bone dissection tools.

Plastic Ingenuity’s design process began with initial meetings to help determine the current packaging system’s drawbacks and the desired design features for the new system. The packaging designers realized that a one-piece packaging system would provide several advantages over the previous tube-and-cap design.

As a result, Plastic Ingenuity developed a single-component, hinged clamshell package that securely holds each end of the sharp dissection tool while leaving space in the center for extraction by operating room staff. The design also accommodates 70% of Anspach’s various sizes. It was important for the new package to provide a tight fit around the device to minimize movement and keep the device from contacting the packaging enclosure, while also requiring little extraction force. This challenge was addressed by a two-phase snap system, in which the device snaps into the base of the clamshell and is held tightly while still allowing for easy removal by a gloved healthcare professional. The lid of the clamshell, when snapped shut over the base, increases the gripping force of the base snaps holding the device, thus locking the device securely in place.

Throughout the design process, Plastic Ingenuity worked closely with the material supplier, Eastman Chemical, to determine the right material for the packaging system. Eastman Eastar copolyester 6763 was selected for its clarity, design freedom, chemical resistance, and ability to be sterilized. By using Eastar,

Plastic Ingenuity developed an enclosure that allows operating room staff to determine whether the packaged device is uncompromised and sterile. Eastar also remains clear, maintains integrity through gamma sterilization, and meets shelf-life requirements.

Although it was an innovative packaging solution, the hinged design presented challenges. Normally, formed hinges used in such packaging are sharp and can cause damage to surrounding pouch packaging. As a result, Plastic Ingenuity reconfigured the clamshell’s hinge several times, engineering a nontraditional clamshell hinge. This new design created a natural, smooth hinge when snapped closed. Plastic Ingenuity tested the clamshell prototypes to ensure that the final design wouldn’t puncture the pouch, even during sterilization, shipping, and storage. The design versatility of Eastman Eastar copolyester 6763 also offered the freedom to contour and soften the clamshell’s edges while maintaining enough rigidity for users to effectively grip and open the package.

Opening procedures also were tested to ensure the bone dissection tool was easily accessible while in the operating room setting. Tests calculated the force needed to open the clamshell itself, as well as the effort to remove the bone dissection tool from the package—targeted at 1 to 2 lb of force. After several tests, Plastic Ingenuity perfected the clamshell design to allow operating-room staff to open the clamshell while the device was still securely held in place and then fully remove the device.

The one-piece clamshell is stackable during shipment and storage, and the dissection tool can be loaded into the clamshell in one easy step. During the last stages of development, Plastic Ingenuity provided on-site assistance to Anspach during fulfillment and packaging to ensure the package’s design was suitable for every step of the process. Anspach has realized a 50% increase in fulfillment productivity and has reduced product damage owing to a more streamlined assembly process.

Additionally, as a result of Plastic Ingenuity’s quality control testing of the opening procedures, operating room staff members have offered positive feedback regarding the new packaging and are confident the clamshell will open consistently every time.