A provider of medical devices for pelvic health switches to single-barrier systems with downgauged materials for two of its most popular products
Packager:
American Medical Systems (AMS), a Minnetonka, MN-based provider of medical devices and therapies that help restore pelvic health. This story refers to two different trays from Perfecseal that hold different needle devices used during the implants of female stress urinary incontinence systems. The trays and DuPont Tyvek lids are shipped to AMS where the devices are hand-loaded and the trays are sealed using a Belco Packaging Systems sealer. At the point of kitting, the trays containing the needles are married with the implants, which are packaged in a foil pouch. The company produces just over 100,000 units a year for both devices.
Goals: AMS had three goals in its effort to redesign the trays: increase shelf space, reduce waste, and facilitate handling.
Problems:
1. The original trays for the Sparc Sling System and Monarc Subfascial Hammock were bulky and difficult to handle, says Brent Binkowski, operations engineering manager for AMS. "They also took up a lot of shelf space and created packaging waste at the hospital," he adds.
2. The original packaging consisted of an inner tray, an outer tray, and an insert that held the needles in place. Besides addressing these issues, AMS wanted to switch from a double-barrier to a single-barrier tray configuration to further reduce packaging costs.
3. The initial trays were made of uncoated PETG, which required tissue interleaving for denesting. The trays required a polyethylene tissue interleave between each one to prevent them from sticking together. That added to the expense of the tray, and to labor and handling. [AMS] had to contend with each individual sheet once the product entered the cleanroom.
Challenges:
1. Although the new tray was narrower than its predecessor, it was also deeper, making it more difficult to thermoform, "especially in the handle area where the cavity had to conform closely to the actual product handle,"says Steve Olson, Perfecseal's design team project engineer. The thermoformer overcame the draw-ratio issue by experimenting with different plug-assist configurations. "We were able to get adequate thickness and still provide the tray with sufficient impact resistance to protect the product," Olson says.
2. AMS's sealing validation was done using uncoated PETG, so switching to a silicone-coated material would have led to a revalidation of all its seal parameters. Perfecseal suggested using C0025 internal denest PETG from Pacur Inc., thereby eliminating the need for the tissue interleaf.
Solutions and benefits:
About a year ago, AMS introduced trays redesigned and thermoformed by Perfecseal. The new design eliminated the need for an outer tray, with products rearranged in the inner tray to take up less space. Previously, the needles pointed in the same direction, forcing the handles to be spread further apart to accommodate the needles' side-by-side helical loops.
By orienting the needles in opposite directions, the needles could be placed closer together. The new orientation resulted in tray volume reductions of 68% for the sling system and 54% for the subfascial hammock.
Based on the mass of the product and design enhancements, Perfecseal was also able to downgauge the materials for both trays. Although the thickness of the inner tray for the Monarc system remained 40 mils, the insert tray was downgauged from 40 to 30 mils, a 25% reduction in material thickness. Both trays for the Sparc system were also downgauged from 40 to 30 mils.
Switching to a single-barrier system using the downgauged materials has saved AMS approximately $1 million a year and another $500,000 in labor due to the elimination of the interleaving tissue. Feedback from the field has been very positive, says Binkowski. Doctors and nurses that use the product have commented on the waste reduction and increased shelf space. The reduction in materials also allows healthcare workers to open the package quickly and easily. Binkowski describes the package as "the shining star of our product portfolio." In 2005, the redesigned Monarc tray won an award from the Society of Plastics Engineers.
--By Kassandra Kania
