by Erik Swain, Senior Editor
Suppliers will have to work hard to capitalize on the growth opportunities in medical device packaging. Not only are medical device manufacturers demanding stronger packages at lower costs, but they are also asking suppliers to perform more services. Producing a better package in some cases is no longer where the suppliers' job ends. Now suppliers may have to help the device manufacturer in the qualification and validation processes as well.
In the United States, demand for sterile medical packaging—which covers mostly medical devices and supplies and diagnostics—is expected to increase 5.3% per year to $1.4 billion in 2002, according to a study by The Freedonia Group Inc. (Cleveland), an industrial marketing firm. A two-year-old Freedonia study covering sterile and nonsterile packaging for medical devices and supplies projected that market to reach $3.8 billion by 2000, growing 5.8% annually.
According to Freedonia, the biggest drivers of growth in sterile medical packaging will be more stringent infection control standards and an aging population who needs more hospital care. The increasing trend of using disposable packaging instead of reusable packaging also creates more demand. But efforts to contain medical costs will put pressure on device manufacturers to keep prices down, and manufacturers in turn will look to packaging as a source of cost savings. If resin prices spike up, as they did this year, suppliers often are forced to absorb the costs.
Figure 1. Sterile medical packaging demand by product, 1997 ($1.1 billion).
Thermoformed trays will continue to be the largest segment of the sterile medical packaging market (see Figure 1). Trays are projected to grow 6% per year to $395 million in 2002. This growth is caused by increasing demand for surgical and diagnostic test kits, especially custom surgical trays. Pouches will grow 5.7% to $336 million, and bags 5.7% to $153 million, helped by their ability to be used as primary or secondary packaging and the fact that they cost less than trays. Blister packs and clamshells will grow 7% to $115 million, plastic IV containers, 3.7% to $132 million, and vials 2.3% to $121 million. The remaining kinds of packaging, including prefillable syringes, plastic bottles, glass containers, and ampules, will grow 5.2% to $173 million.
FEWER TO BENEFIT
This growth is likely to be spread among fewer and fewer suppliers. Medical device manufacturers are consolidating, and they are streamlining their bidding processes and cutting down the number of suppliers they use. Companies that are consolidating are also asking their suppliers to do much more than offer a variety of packages. They are looking for price breaks, just-in-time delivery, and warehousing services. They are also looking for help with meeting FDA's requirements for documentation. Some suppliers are finding they need to diversify in order to win contracts, and others are acquiring compatible companies to meet that goal. There will be more acquisitions like the recently announced purchase of KenPak Inc. (Asheville, NC, and Los Angeles) by American National Can Co. (Norwalk, CT).
FlexForm P film from Rollprint Packaging Products Inc. (Addison, IL) allows medical device manufacturers to reduce overall costs while producing a high-quality peelable package.
The suppliers that remain will need to expand their services. For example, says Jerry Bennish, global marketing director, Rexam Medical Packaging (Mundelein, IL): "A higher percentage of customers are asking suppliers to provide shelf-life and stability data, as tied to the ISO 11607 guidelines. If they have the data on the front end, that allows improved speed to market."
These additional services are becoming necessary in order to entice a device maker to accept a supplier's new package or material. Wary of FDA's complex validation requirements, device manufacturers don't want to spend time and money on material qualification and process validation tests unless they know they will get a significantly better package than the one they have.
"A lot of new technology can bring the customer big savings, but because of difficulty on the regulatory end, it's not always easy to get it to the customer," explains Bill Singer, vice president of marketing, Perfecseal (Philadelphia). "So we've started a program called RADICEL (Rapid Development Centers of Excellence) to assist customers in the myriad of tests to validate a new material. We can do physical property tests, accelerated aging studies, material analysis, and prototype packaging."
Anyone who can provide services that can assist in validation might be poised for success, says Donald Barcan, president of DBI Inc. (Donbar Industries Inc.), a medical device package engineering consulting firm in Long Valley, NJ. "The regulations have always required, even from a packaging perspective, that processes and material choices be validated," he says. "With the inclusion of ISO 11607 as a consensus standard (by FDA), more and more companies are recognizing that they don't have the proper validation done and that they are potentially at risk if there is an audit or a problem in the field."
Machinery manufacturers will have greater responsibilities in that climate, Barcan says. "There is going to be more of an industry demand requiring that machinery manufacturers provide them with validation information concerning process control and process stability," he says. "I see a change in the way machinery manufacturers do business."
While FDA does have a guidance document, some in industry find it vague, and it is not easy to predict how it will be enforced.
Another area experiencing a lot of activity is package testing, both for seal strength and overall integrity. The introduction of nondestructive tests in recent years has made testing more efficient and, in some cases, more cost-effective. "You have to be sensible about the cost of destructive testing. It can be extremely costly," says Jackelyn Rodriguez, quality assurance manager at BioEnterics Corp. (Carpinteria, CA). The company recently purchased nondestructive seal-integrity test equipment from True Technology Inc. (Newton, MA) and will be seeing a "huge return on investment," according to Rodriguez. "We no longer destroy packages during integrity testing, and we will also be eliminating 100% visual inspection, which means we will save an approximate 48% cycle time with a more scientific testing method rather than the visual type of inspection. Once the new system's results are proven and are validated at an AQL level, we will see a greater benefit. Therefore, the cycle time will be reduced by approximately 97.5%."
She feels the medical device packaging industry will readily accept nondestructive test methods for both integrity and strength as soon as the technology becomes available. "You would have to if you want to be more efficient," Rodriguez says. "In today's environment, we as managers need to look for ways to help our company's bottom line by improving our inspection techniques and cycle time."
But no one method, whether destructive or nondestructive, has emerged as the industry standard. Whether anything will emerge is something to watch for.
NEW IN MATERIALS
Several innovations in materials came to the forefront last year, and they are expected to be factors in future years. One is DuPont Medical Packaging Systems's (Wilmington, DE) introduction of Tyvek 2FS, the first new Tyvek for medical packaging in more than 15 years. It has a lower-basis weight than its predecessors and is designed for form-fill-seal applications. "We currently have qualification under way at many device companies. Our expectations are that it will compete quite nicely with high-basis-weight coated papers in the form-fill-seal market," says Michael H. Scholla, president of DuPont Medical Packaging Systems. Tyvek 2FS, compared with other forms of Tyvek, seals at higher temperatures without transparentizing, runs at faster speeds, and provides higher breathability and better printability.
Another innovation is the advent of films that can seal to uncoated lidding, thus removing the coating step of the packaging process, adding breathability to the package, and providing a cost savings as well.
THE REGULATORY FRONT
The many U.S. suppliers that also sell to Europe will need to monitor the progress of the European Union's Packaging and Packaging Waste Directive. The standard has been in place for a few years, but now it may start to be enforced in some countries.
"Some compliance bodies in Europe may start asking for technical dossiers to show whether you are meeting the minimum requirements for the material and whether it is recoverable or reusable," says Harold Miller, director of packaging technology, Johnson & Johnson (New Brunswick, NJ). "Other than in design control, you may not have had to do that before. Suppliers will have to be able to provide manufacturers with a lot more detailed information, potentially about the composition of materials, particularly how combustible they are."
A side benefit, he says, is that "reducing the amount of materials will provide you with cost advantages."
Transport packaging for medical devices will be getting some long-deserved guidelines in the near future. ISTA is working on a medical device distribution test procedure that will offer some standardized, measurement-driven tests designed to ensure that a medical device will be protected by its packaging during shipping and storage. Leading the effort is Dennis E. Young, senior consultant for Dennis Young and Associates Inc. (Grand Rapids, MI) and an authority on transportation testing.
Also on the standards front, ASTM is trying to come up with a new method to determine seal strength continuity involving peel adhesion.
ADAPTING FOR SUCCESS
As the medical device market grows so will the device packaging market. But only by adapting to the divergent needs of customers, and by keeping abreast of FDA and overseas regulations will packaging suppliers be able to capitalize on this trend. Quality and innovation have never been more essential to success.
Opening photo by Roni Ramos