The Thermoformed Tray: More Than Just a Commodity

Thermoformers hope that design expertise and attempts to operate more efficiently will help them build and retain relationships.

 

What's blue, weighs nearly 50 lb, and contains everything necessary to save a heart patient's life?

Thermoforming deep-draw trays, like this single sterile one from Tek Packaging, requires frequent collaboration between supplier and device manufacturer.

A custom thermoformed tub, measuring 30 in. long x 22 in. wide x 10 in. deep and designed to package a complete set of devices required for heart transplant surgery. Thermoformed by Alloyd Co. (DeKalb, IL) for Jostra Bentley Inc.'s devices, the bottom of the tub is contoured to accommodate two injection-molded medical devices— a blood filter and an oxygenation module—two principal elements of the surgical kit. Individually shaped cavities for both devices are slightly elevated above the bottom plane of the tub in order to protect the medical instruments from inadvertent jarring or impact. When fully assembled, the custom tub includes surgical drapes, tubes, and other accessories that bring the total package weight to nearly 50 lb. The tub itself rests on four contoured corners, which maintain its evenly balanced orientation during shipment, storage, and use.

Thermoformed trays like this are common in the medical industry. Sometimes as intricately designed as the device itself, such packages are carefully executed to protect and deliver delicate, sterile devices at critical moments of healthcare. Because of the time, effort, and materials that go into the design and manufacture of such trays, these packages are usually the most expensive.

However, bargain hunters in the medical device industry, often those companies that have merged with others and are under pressure to reduce costs, are trying to drive tray costs down through competitive bidding. Some medical device makers are proposing long-term contracts with thermoformers in which the unit price is driven down considerably. Thermoformers agree that, while such contracts make good economic sense, they may not take into consideration other important factors like design expertise, documentation services, and added quality control procedures. "Some medical companies that look for major price reductions from suppliers may at times lose sight of the quality and skills of the thermoformer," says Dick Simmons, vice president of medical marketing for Ivex Technical Packaging (Lincolnshire, IL).

PROBLEMATIC PRICE CUTS?

Buying in bulk is a great way to reduce operating costs, so it makes sense for medical device manufacturers to seek discounts on large volumes of packaging materials and supplies. Russ Riescher, a packaging engineer for C. R. Bard (Covington, GA), reports that his company routinely tries to solicit bids from a number of suppliers for several commodities, including medical trays. "We lay out our criteria, give a sample of the devices, explain the setting and sequence of use," and wait for the bids, he explains.

However, when cost becomes the determining factor in bid acceptance, medical device manufacturers can lose sight of some important considerations. "What these approaches miss are new ideas," laments Sam Mazzola, president of Tek Packaging Group (Huntley, IL), a medical tray thermoformer. "Being able to leverage purchase and package economics is important, but you get what you pay for."

Riescher agrees that price shouldn't be the only consideration and suggests that package engineers get more involved in the bidding process. "Purchasing should consult engineering when selecting candidates for bid packages," he explains.

Hopefully, says Bill Leib, senior packaging engineer at B. Braun Medical Inc., Hospital Care Div. (Bethlehem, PA), thermoformers are realistic about their bids. "Thermoformers do charge for engineering, prototyping, and production tool manufacturing costs," he explains. "Up front, thermoformers should know what the project's cycle times are and, in order for the thermoformer to make money, they should include those costs in the bid."

The reason medical device makers shouldn't base their decision on price alone, says Mazzola, is that not all medical thermoformers are created equal. "None of the companies in the medical thermoforming industry are equally as good as one another. There are companies that are less suited to handle medical projects and production. Medical device manufacturers require high quality, on-time delivery, excellent expertise, quick response time in package development, and continuity of supply through the forming process, all done at a fair price. Some medical thermoformers fall short in delivering based on this guideline. This is the reason we cannot all be considered the same."

Simmons is confident that medical device manufacturers will ultimately make the right choice. "While price pressures are increasing, device companies are very mindful of who can actually add the value and quality required."

TAILORED EXPERTISE

Providers of medical trays must not only know how to thermoform, they must know a little physics, chemistry, and perhaps even a little medicine. For instance, if a tray thermoformer has not paid close attention to certain design requirements needed for a specific device or set of devices, the thermoformed part may fail.

"The thermoformed tray is a precision part," explains Tom Misik of Belco Packaging Systems (Monrovia, CA), a supplier of tray sealing equipment. "If there is any flaw in the sealing flange," for instance, there could be problems maintaining packaging integrity, says Misik.

Ken Sullivan, director of marketing for Alloyd, explains that Alloyd's designers "attempt to use the largest possible free-form radius in order to minimize corner sharpness. Sharp corners are susceptible to thinning and structural degradation." Other structural features such as ribs are often added to strengthen trays, he adds.

Riescher relies a lot on the proficiency of Prent Corp. (Janesville, WI), one of the thermoformers his firm uses. "I appreciate the intuitiveness of its design group and its ability to come back with ideas close to what I have envisioned. A lot of the designs we use stem from my ideas and theirs."

To produce intricate trays like this deep-draw double sterile tray set from Tek Packaging, thermoformers must carefully calculate draw angles and avoid material thinning and stress to ensure package integrity.

Leib also relies upon a thermoformer for its design expertise. "If we can, we often do a preliminary design in-house first with our products or our OEM's products to determine product placement. Then the thermoformer determines the amount of space between the parts, the angle of the material draws, and the depth of the tray."

In addition to needing expertise tailored to the production of medical trays, thermoformers must be able to work closely with medical device manufacturers, a service that is hard to quantify during bidding. In other words, if a contract is awarded to the thermoformer with the lowest bid, such a determination does not take into account the ability of the thermoformer to forge a beneficial engineering partnership.

Brian Meltzner, sales manager for Merrill's Packaging (Burlingame, CA), says that thermoformers often "become an extension of a medical device manufacturer's engineering department. A lot of companies don't even have a packaging engineer."

Donna Kilhefner, customer service manager for the plastics forming and molding company Brentwood Industries Inc. (Reading, PA), gives an example of a project in which close contact with the designers at the medical firm is essential. In this case, the weight of the device had to be kept in mind throughout package design. "A package approximately 60 in. long may have on one end a metal device that could be several pounds and [leading] from this weight might only be tubing [extending] all the way to the other end [of the package]. Therefore, if picked up by the tubing end, the weight is furthest away, resulting in a potential package failure." Kilhefner explains that communication during such a project is necessary. "The medical firms know the usage of their individual parts much better than does a thermoformer of these parts," she adds.

Vitalo Packaging's (Meulebeke, Belgium) approach is similar. To strengthen and maintain relationships, "we try to be present with the customer; we want to go for a partnership and subsequently think as our partner does," explains Steven Matthys, account manager for Vitalo. In addition to such personalized service, the firm assists clients in the validation of their packages.

And Tek Packaging has invested in the same computer-aided design equipment and software that its customers use in order to better collaborate with them for faster results, says Mazzola.

In some cases, signing long-term contracts does help to build and strengthen working relationships. Dave Rosten, global product manager for thermoforming for Perfecseal Mankato (Mankato, MN), says that his firm tries "to get yearly contracts, sometimes two- to three-year contracts. And then we try to set up engineering reviews with our key customers every quarter."

ALTERNATIVE APPROACHES TO COST-CUTTING

Medical tray thermoformers appreciate the fact that consolidating device manufacturers are being forced to reduce operating costs. Says Simmons: "In the next year or so, we expect to see further movement in the consolidation of large medical device companies. The companies that can not only make acquisitions but also effectively integrate them will stand out as the winners."

Aware of the cost pressures, many thermoformers are finding new ways to operate more efficiently and to pass savings along to medical device manufacturers. Says Mazzola, "We design and build prototypes and production tooling in less time than we ever did because our customers require it. In addition, we've put in place newer pressure-forming production equipment that gives us the advantage of forming more-complex designs in less cycle time and more efficiently. This gives our customers better package economics for a long period of time."

When designing large trays, Brentwood's engineers design the trays with features that allow for a thinner gauge, therefore making the product less expensive, says Kilhefner.

This single sterile tray with lid from Tek Packaging features a retainer kit to hold contents in place.

Locating thermoforming operations close to medical device manufacturers may also help cut costs. Ivex places low-cost manufacturing plants in locations advantageous to its customers' facilities, says Simmons. "We keep the contacts, design, and manufacturing local and consolidate other activities to support our goal to be the highest value supplier."

A global presence may also result in a savings. "Only global players will stand a chance of competing successfully in an ever-consolidating medical devices market," Matthys says.

Ivex's Simmons agrees. "By positioning our plants in strategic locations in the United States as well as in Puerto Rico and Malaysia, we are poised to be where the new larger companies need us."

As living proof of that prediction, Riescher selected Prent to thermoform a package for his firm's brachytherapy needles because the thermoformer serves Malaysia, one of C. R. Bard's markets.

In the end, though, a thermoformer's ability to provide quality, economical trays may just be the end result of a good operation. "To be a viable thermoform supplier you must manage well, apply a high degree of expertise and diligence to your process, have patience through the development period, and continue to invest in ways to make your process even better," says Mazzola.

Daphne Allen, Editor
 

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