Pharmaceutical and Medical Packaging News Magazine
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Originally Published January 1998

MEDICAL

Thermoformed Trays: Less Is More

by Tammy Flaherty , Features Editor

In the medical industry, the theme for rigid thermoformed trays in the 1990s is simple: Less is more. Device manufacturers want packaging that is less expensive, requires decreased development time, has few sterilization limitations, and uses minimal materials.

Yet, today's thermoformed trays have to deliver more—higher performance and value, particularly in the areas of ease of use, versatility, and environmental compatibility.

Thermoformed parts manufactured in Tel Packaging Group's (Huntley, IL) Class 100,000 cleanroom are being inspected to customer specifications.

"To successfully compete, today's tray suppliers need to be continually innovative through creativity and design," says John Rottunda, president of Perfecseal Mankato (Mankato, MN). "Quality is a given."

John McNulty, director of sales for Alloyd's new DeKalb, IL, medical packaging division, agrees. "Medical device manufacturers are always looking for packaging to do more. In the medical market, the package is more than just a tray that protects sterile products and holds them securely in place. The tray may need to function as a dispensing unit that can easily pop the device out into the hands of a medical professional, or act as a receptacle for waste material from surgery. There is constant demand for innovation, but manufacturers don't want to pay a high price. Innovative solutions must be combined with cost-efficiency."

The industry's constant struggle to meet cost pressures without sacrificing performance has eased somewhat, as a result of stabilized resin prices. "The price of resins for medical trays—primarily polyester and copolyesters—has been relatively stable over the past few years," says Gene McFarlane, business unit manager/medical, Eastman Chemical Co. (Kingsport, TN).

However, in years past when resin prices were steadily rising and price fluctuations were a constant concern, device manufacturers began making longer-term contractual arrangements with thermoformers, as did thermoformers with their extruders and resin suppliers, all in an effort to gain supply and price security.

LONG-TERM PARTNERSHIPS

"Contracts of a year or two are now commonplace," says McFarlane. "This helps manufacturers make their annual forecasts because there aren't price fluctuations, and they can keep less material in inventory. These contracts also helped build stronger partnerships."

Perfecseal Mankato's Rottunda concurs. "We believe these longer-term contracts have provided a general upgrade in the supply chain. The long-term contract builds a closer working relationship with the customer, and each partner tries to add value to the business."

Eastman's McFarlane has seen numerous benefits resulting from contractual arrangements. "To minimize development time and costs, partnership with the device manufacturer, thermoformer, extruder, and resin supplier is essential," he says.

In many instances a partnership ex-tends to include the medical personnel who will use the medical device. "The input of hospital personnel is key when designing a product and its packaging," notes Gerri Chatelain, project manager for FemRx (Sunnyvale, CA), which specializes in medical devices for gynecological procedures. "In the development process we ask ourselves, 'Does this packaging make it easy for the OR staff to open and use?' We believe medical packaging needs to be intuitive or it's not effective. These people have a lot of things on their minds, and figuring out how to get a device out of the package shouldn't be one of them."

The tray for FemRx's newest product, the Diva morcellator, a noninvasive device that removes the endometric lining or fibroids from the uterus, was developed using research conducted with hospital personnel. According to Chatelain, there were two design objectives for the tray: make it easy for OR staff to open, and construct it to hold the instruments, particularly the motorized morcellator, safely and securely.

The package, produced by Plastofilm Industries (Wheaton, IL), includes a rectangular tray thermoformed from 35-mil clear Eastar PETG (Eastman Chemical). The two-piece tray features a round cavity sealed with a removable PETG lid. A laparoscope and morcellator are supported by cavities created with deep draws. To provide a double barrier, the tray is sealed with a circular lid over the round cable, and the entire tray is sealed with Tyvek lid stock.

GLOBAL MANUFACTURING

The close-knit relationship among suppliers, packagers, and medical companies is driving many tray suppliers to establish manufacturing facilities overseas. "To improve customer satisfaction and quality, you need to be close to your customers," says Alan McClure, CEO, Perfecseal, Philadelphia. To participate in the global healthcare market, Perfecseal situated facilities in Puerto Rico and Northern Ireland, and has further plans for expansion.

Eastman's McFarlane refers to this movement as "transplant business." "Packaging is specified in the United States, but due to labor and tax situations the device manufacturing moves to Puerto Rico or Ireland. To maintain a strong partnership [with manufacturers], the suppliers need to move geographically closer."

WASTE REDUCTION

Hospitals continue to strive for source reduction, and to that end are encouraging packagers to produce recyclable items. "Since the cost for a hospital to dispose of waste is so high, there is a continual quest to achieve source reduction," notes Alloyd's McNulty.

Since PETG is still the primary tray material for medical devices, most trays are recyclable. High-density polyethylene is also making inroads because of its recyclability.

However, trays cannot be recycled unless the material is clearly indicated as recyclable on the unit. "Monolayer thermoformed trays are easy to recycle because they just need to be reground," says Greg Conigliaro, president of Conigliaro Industries (Framingham, MA), a major hospital waste recycler. "The key is to ensure that the thermoformer codes the tray with the recycling number symbol."

Extruders are also taking responsibility for reducing the waste stream. Lustro Plastics (Evanston, IL) buys scrap material from tray thermoformers and extrudes it back into general-purpose PETG rolls. "Typically there is up to a 30% waste associated with tray thermoforming," says Mike Mallin, president of Lustro Plastics. "By recycling tray scrap we can help save manufacturers material cost as well as the tremendous cost of dumping."

THE FUTURE

Corporate partnerships will continue to help device manufacturers and their suppliers prosper into the next millennium. "Today's customers are looking for broader product lines and faster development time on a wider geographic basis," says Rottunda. "Only suppliers with the ability to make continuous investments in facilities and human resources will be able to compete in this global and mature market."