Stryker Orthopaedics among MDEA Winners

For years, Stryker Orthopaedics has been surrounding its femoral hip implants with foam wedges before packaging them. The foam was bulky and required a lot of manual labor, though, so the company was eager for a change. However, the implants’ special coatings, which are designed to work with cementless application, are tough on packaging materials. “The coatings can be very abrasive,” says Sarah Grare, director of packaging innovation.

When seeking alternative packaging formats, Stryker had been eyeing a Surlyn skin-pack format used by its facility in Limerick, Ireland, for knee implants since 2003. Machinery from Illig shrinks the skin pack around the smooth knee implants using heat. However, “the coatings on our hip implants were aggressive and would have chewed through the skin pack,” says Grare.

Sealed Air Nelipak, formerly Alga Plastics (Cranston, RI), offered Stryker another option. It presented a new urethane material, which had the properties Stryker was looking for. Stryker engineers, working closely with partners at Sealed Air, designed a sleeve using the material as a protective layer. The sleeved implant could then be placed onto a thermoformed base made from PETG and covered with the Surlyn film for heat shrinking to conform to the implant. “The entire package looks like a vacuum pack,” says Grare.

The package is a winner in the Finished Packaging category in the Medical Design Excellence Awards, organized by Canon Communications LLC, publisher of PMP News.

Stryker decided to adopt the new format and realized several benefits. “We had several hundred packaging configurations,” says Grare. “The sleeves enable us to take that down to four or five."

In addition, Stryker did not have to change its outer packaging or its labelling. The new packaging process is somewhat automated, reducing some manual labor.

Stryker also encouraged manufacturing efficiencies in the sleeve-making process at Sealed Air to allow for increasing volumes. “They were even able to develop a method to stamp part numbers for us,” said Grare.

Customers also appreciate the change, Grare says. “It is tremendous for our customers. Once packages are opened, nurses can simply pick up the implants in the sleeve, preventing premature exposure. They have also reduced bulk hospital waste. And we have had no complaints.”

The new packaging line is in place at Stryker’s Cork, Ireland, facility. It is currently being used only for its Accolade line of femoral hip implants, but the company is now in the process of moving all primary hip stems into the new packaging.

“The one challenge is that we are a device manufacturer, not a thermoformer,” says Grare. “There was a bit of a learning curve. But we have gained a tremendous amount of experience.”

Packaging engineers involved in the project are Katherine Liccardo, Delphine Patterson, and Joe Wilmot. “Our group has full R&D responsibility for packaging new products, and we provide ongoing quality support for existing products. Stryker recognizes that you cannot innovate if you leave packaging to the end,” says Grare. “So packaging engineers work very closely with device R&D, and we partner with regulatory affairs, sterility assurance, and quality.”

“We are delighted to have won this award, made possible by the excellent working relationship we enjoy with the Sealed Air team in Cranston,” concluded Grare. “Their creativity and responsiveness are exactly what we look for in our packaging suppliers and clearly it impressed the judges as well.”

Also recognized in the Finished Packaging category is Cimzia’s Packaging, manufactured by UCB Celltech. Cimzia’s packaging is designed to enable self-injection. The package promotes compliance and provides a positive user experience. Supply and design are credited to Smart Design and OXO International.

Winners will receive gold or silver recognition in ceremony at MD&M East this June. For details, visit www.mdeawards.com.