Updates to device packages are often slow in coming, but they may increase due to new multiple-benefit materials and a potential ease in making material changes.
Erik Swain, Senior Editor
In recent years in the medical packaging industry, a battle has been waged between cost and quality. Device manufacturers, facing pressure from hospitals to contain costs, have in turn mandated that their packaging suppliers hold prices down. Some packagers, in turn, citing that packaging usually comprises a very small portion of a device's total cost, have warned that a single-minded focus on cost cutting could compromise a package's integrity or sterility, which could make the device worthless.
A slew of new materials and downgauged versions of existing materials emerged in the late 1990s to address these concerns. While most of these products were very successful, some in the medical packaging industry believe the downgauging trend has gone about as far as it can go.
With little left to squeeze out of materials, new ways of thinking about medical packaging have emerged. While the current range of products may not seem a whole lot different from the offerings of a few years ago, there are several products that have recently emerged, or that are still in development, that purport to represent significant steps forward. In many cases, they claim to be solutions that can reduce total costs or make the overall packaging process more efficient.
"The new materials available may be more expensive, but you can't just look at the material costs," says John Spitzley, associate fellow—packaging for Medtronic (Minneapolis). "You have to look at the impact on the whole entity. That may end up saving you money or helping you avoid a quality issue."
"There is continuing cost reduction," notes Michael H. Scholla, PhD, global business manager for DuPont Medical Packaging (Wilmington, DE), which markets Tyvek brand protective material. "But one trend that is heartening is that you see more people looking at system costs, as opposed to purchase costs."
The market for sterile medical packaging (including that for devices and diagnostics) in the United States is expected to grow 5.4% per year to reach $1.7 billion in 2005, according to a study called "Sterile Packaging" by The Freedonia Group Inc. (Cleveland). A significant driver for growth is the aging population. As the baby-boom generation continues to get older, more surgeries and more hospital stays will be needed. Other major factors include higher standards for infection control and the increasing convenience of sterile packaging configurations.
Thermoformed trays are expected to make major gains, thanks to more use of surgical and diagnostic test kits, growing 5.9% per year to reach $460 million by 2005, according to the report. Blister packs and clamshells will see the highest growth rate of any form of medical packaging, up 6.5% annually to $122 million, because of their strength and high visibility. Pouches, owing to their low cost and versatility, are projected to jump 5.7% per year to $391 million.
Plastic IV containers, the study states, will increase 3.8% per year to $147 million; vials, 3.2% to $138 million; bags, 5.4% to $117 million; and other forms of packaging, 5.6% to $345 million. Polyvinyl chloride (PVC) will remain a dominant resin used in sterile medical packaging, but thermoplastic polyesters will see faster growth. Nylon should also see a surge in popularity because of its toughness and puncture resistance, and it is becoming a preferred material for the packaging of large, bulky procedural kits.
"Stronger films are becoming more popular, as are die-cut insert cards, so that device companies can still use pouches instead of having to go to trays for larger or heavier objects," says Kathleen Daly Mascolo, vice president and director of sales and marketing for Beacon Converters Inc. (Saddle Brook, NJ). "Fancier barrier structures are also on the rise."
INNOVATIONS AND CONSOLIDATIONS
The medical packaging market is viewed as a mature one, not a dynamic one where existing packages are concerned, because of the effort required to requalify materials and revalidate processes when changes are made.
"If you have no quality concerns or issues reported by your customers, you might be resistant to making a change to a material with a slightly better attribute," notes Martin Golden, senior packaging engineer for Datascope's Collagen Products Div. (Mahwah, NJ).
The Sterilization Packaging Manufacturers Council (SPMC) of the Flexible Packaging Association (FPA; Washington, DC) is trying to change that. Its executive council has formed a task force to look into ways new materials can be approved for many applications at once.
"All SPMC member companies have new technologies and new products that are superior in performance and in many cases offer cost efficiencies, but our customers stick with products from years ago due to the cost and time to validate new packaging materials," says SPMC Chairman Robert Dodrill, who is also president of Rollprint Packaging Products Inc. (Addison, IL). "We are working with the manufacturers of the base materials to get them approvable as a universe, rather than as a single application, so everybody doesn't have to reinvent the wheel every time they think about changing their package."
Even though the medical packaging market is mature, it should not be mistaken for a stagnant market. The shifts in the device industry itself ensure that the medical packaging industry will continue to restructure and evolve.
|Supplier partnerships, like that between Rollprint and Pactiv, whose offerings are shown here, allow device makers to develop a global presence.|
"The most important development is the continuing consolidation of the device companies," Scholla says. "At any given moment, large amounts of business have the capability of changing hands. This means big shifts in business for the converter network. And there is a push within device manufacturers to insist on more global suppliers. An example is Rollprint and Pactiv Corp. (Halle, Westfalen, Germany) joining forces. Rollprint is strong in the United States, and Pactiv is strong in Europe. When they are together, they satisfy the device manufacturers that are in both markets. Neither could do that before."
Improving services is one way the top medical packagers are getting the attention of the device companies. Another way is to develop a product that has a truly significant impact on cost or quality or both. Following are a few items identified by packaging engineers and consultants for device companies as having that kind of potential:
- PETG is one of the most common materials used in rigid trays, but its drawback is its potential to cause trays to stick together when they are stacked. The usual remedy is to use a silicone coating, but that isn't always a perfect solution. "I've always been uncomfortable with putting silicone coating on a part that you want to adhere a lid to," Spitzley says. "Silicone lubricates and enhances separation. A lot of converters have devised adhesives that are compatible with silicone, but there is still the potential for problems. And device manufacturers do not like the idea of silicone all over their product."
However, Goex (Janesville, WI) has come up with a PETG material called Glidex that may put those concerns to rest. "It has a proprietary surface treatment that allows you to nest PETG trays very tightly and negates the need to go to silicone coating," Spitzley says. "I've seen samples and it looks really promising. Obviously, it will be more expensive than PETG, so its popularity may depend on the cost differential. But if you factor in that you won't have to use slip sheets or experience handling problems, it may end up being a cost benefit."
- The proper way for a circulating nurse to safely and conveniently introduce products directly into the sterile field in the operating room has been debated for years. SafePASS LLC (Point Richmond, CA) claims its SafePASS Packaging and Sterile Delivery System will solve the problem. It utilizes a proprietary "locking fold" that creates a protective tortuous path. When the package opens, it inverts over the hand and up the forearm of the nurse, allowing assured placement of the device into the sterile field. Percival Banks, president of SafePASS, claims the system will eliminate "the loss from contamination during the sterile transfer [that currently] is considered a routine cost of doing business."
"Up to this point, everything that claims to provide aseptic presentation of the device into the operating room has had issues of some sort," says consultant Donald Barcan, principal of Donbar Industries Inc. (DBI; Long Valley, NJ). "But this concept really does it."
- Several companies are making strides in automated nondestructive package testing, says Hal Miller, director of packaging technology for Johnson & Johnson (New Brunswick, NJ). "We've pretty much exhausted the list of destructive package-integrity testing," he says. "There seems to be a whole new generation of test instruments looking to do nondestructive tests for package integrity, for porous and nonporous packages. FDA asked us what would we do about better detecting pinholes in paper and Tyvek, and we are getting close to being able to do that."
"When True Technology went under, it appeared to be a major setback for the nondestructive, scientific approach to integrity testing, but others have picked up the ball and fed off that baseline technology," says Spitzley. "Mocon Inc. (Minneapolis) and PTI (Packaging Technologies & Inspection LLC; Tuckahoe, NY) seem to have come up with systems that are much less expensive, and easy to operate. They are bringing cost and test time down. It will be interesting as to how they come to the marketplace."
Another development on the package-testing front, says Scholla, is that a study is being conducted in Europe to develop a physical test that correlates to microbial testing of porous packaging material. It should be published within the next year. "This could be very significant," he says. "A microbial test takes days, whereas a physical test takes less than 20 minutes."
On the regulatory front, the chief development is the upcoming sessions to discuss harmonizing the international standard ANSI/AAMI/ISO 11607: 1997, "Packaging for Terminally Sterilized Medical Devices," with the European standard EN 868 Part 1, "Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized: General Requirements and Test Methods." Formal discussions will begin in October at a meeting in Kyoto, Japan.
An important point, says Scholla, is that "the CEN standard excludes hospitals, while ISO includes healthcare facilities. I believe that the scope will probably end up more toward CEN. By that, I mean a typical hospital with a central sterilization facility to reprocess multiple-use devices will probably be excluded, but those that reprocess for a fee or for other hospitals would probably remain covered by it."
Miller notes that the documents have some key differences on microbial barrier testing. "Europe is focused on whole-package testing, while ISO is focused on materials and seals," he says.
Barcan notes, however, that not all firms are in compliance with the original ISO document. "I have come across a surprisingly high number of companies that still have a long way to go on compliance with 11607," he says. "A lot of recordkeeping is amiss in many organizations, usually relating to obtaining all the documentation to assist with the validation process. In many cases, there are little or no data to substantiate proper package or process validation."
There is also anticipation on how the new FDA guidelines on the reprocessing of single-use devices will be enforced. (For more information on these guidelines, see the Regulatory Focus column in the July 2001 issue of PMP News.) "This has caused many hospitals that do this as a common practice to rethink it," Scholla says. "That's because by the time they revalidate everything, they will not have the manpower to keep up with it. However, for the companies that reprocess single-use devices as a business, the validation of what they're doing is a key part of their expertise."
Despite the maturity of the medical packaging market and the ongoing consolidation of the industry it serves, there are still plenty of developments, whether technological, process related, regulatory, or economic, that present opportunities for changes and breakthroughs. Firms that devote themselves to original thinking could stand to benefit significantly.