New flexible packaging options are being explored and developed to meet the demands of device manufacturers.
While the demand for medical packaging has been slowly but steadily increasing for the past several years, that demand is expected to increase much more rapidly with the onset of combination products and other developing technologies. Such products, which combine drugs with medical devices, could also create more symmetry between the pharmaceutical and medical packaging industries, according to several industry experts. That symmetry could include the sharing of anticounterfeiting technologies and FDA regulations. Rising Demand Predicted The latest research shows that the medical packaging industry continues to experience slow, steady growth. A recent study by The Freedonia Group Inc. (Cleveland), “High Visibility Packaging to 2008,” projects a 5.1% annual expansion in U.S. demand for high-visibility packaging, to $7.2 billion in 2008 (see Table 1 above). According to the study, that growth will be driven partly by trends driving greater product security requirements and by packaging choices designed to deter theft. Clamshell demand is expected to rise 6.4% to 2.5 billion in 2008. The medical device and pharmaceutical markets in general represent the strongest growth opportunities for high-visibility packaging, the study adds. Gains should also be propelled by the advantages of compliance and security features as well as distribution efficiency for institutional users.
Table 1. High-visibility packaging demand by type ($ millions) (click to enlarge).
The Freedonia Group also released a report in 2003 that projected the U.S. demand for sterile medical packaging to climb 5.2% annually, reaching 1.8 billion in 2006. The fastest growth was predicted from custom surgical trays, prefillable syringes, and plastic bottles. Sterile-tray demand was projected to grow 6% per year to reach $476 million in 2006, prefillable-syringe demand was projected to increase 5.6% to hit $215 million in 2006, and plastic bottles were expected to grow 6.5% and reach $130 million in 2006. In addition, the report says that plastic resins, including high-density polyethylene, thermoplastic polyester, and polyvinyl chloride, will account for more than 70% of the materials used in sterile medical packaging by 2006. The studyï¿½s authors pointed to the aging population, more-rigorous infection-control standards, and the convenience of sterile packaging formats as major growth factors. Another 2003 report, conducted by Alexander Watson Associates BV (AWA), an international market research and marketing consultancy, suggests that ongoing changes in medical and hospital practice, such as the drive for cost reduction, shorter hospital stays, and less-invasive surgical procedures, have been at the root of the recent slow growth of the medical packaging market. The report also noted that pouches, tubing, and thermoformed trays are experiencing the highest level of growth as applications using bags and wrappings are replaced. Simultaneously, current trends are moving toward film or paper-film laminates and away from standard paper packaging. The study also reported that both disposable and single-use medical devices will help increase future de-mand. Disposable devices, such as electrode terminals and other diagnostics, are already on the rise, along with transdermal patches for drug delivery that use hypoallergenic adhesives and high-performance release liners. Their popularity has extended into the realm of over-the-counter (OTC) personal care products, like facial pore strips and antiwrinkle pads, the study says. Additionally, single-use devices are quickly replacing multiple-use applications in the United States and Europe. The total U.S. market for medical devices currently exceeds $55 billion and continues to grow, according to a 2002 Frost & Sullivan report on R&D and future growth of the medical device market. Like the other reports, the study points to the aging population and technological advances that help improve health and lengthen life-spans as driving forces in that growth. Much of the next wave of growth could come from overseas, leading to a whole new level of competition and cost considerations for medical packagers. According to the AWA report, the medical packaging market is currently growing at the fastest rate in Africa, Asia, and the Middle East. Those regions are warmly embracing the developments and advances in the traditional medical packaging markets in their wars against infection. At the current rate of growth, that combined market is expected to equal that of North America and Europe by 2007, according to the study. Drug/Device Products Lead The Way The Frost & Sullivan report also summed up what will likely be the primary catalyst for medical packagingï¿½s future growth: line-blurring products that combine a medical device with a pharmaceutical formulation, such as drug-coated stents. “Combination products are expected to drive future market growth and be the key to bringing in revolutionary therapies,” write the reportï¿½s authors. Most industry observers agree with that assessment. “Complexity is in-creasing on all fronts,” says Laura Bix, assistant professor, Michigan State University School of Packaging (East Lansing, MI). “The growth of drug/device combinations is one major indicator of that.ï¿½ ï¿½Thereï¿½s no question that more drug/device combination products will be entering the marketplace in the near future,” agrees Hal Miller, president of PACE Solutions (Warren, NJ). Miray Pereira, global business manager, medical packaging, DuPont (Wilmington, DE), is equally certain of that fact. “The medical device/pharmaceutical overlap is the biggest trend right now, and it will only get bigger,” she says. “These kinds of products are just in their infancy right now.ï¿½ According to Bix, this evolving landscape of medical products will definitely change how some packagers operate. “This is going to force medical packaging companies to become more familiar with pharmaceutical packaging regulations,” she says. “That could be challenging.ï¿½ Hal Miller concurs. “Products such as drug-eluting stents, orthopedic implants with genetically engineered human protein, and antibiotic bone cement often do not fit neatly into traditional categories of FDA-regulated items,” he says. “One of the key issues that will arise is how to terminally sterilize these products effectively without deteriorating the drug or killing live cells or proteins. New applications or cycles of traditional terminal sterili-zation methods may be what are required.ï¿½ Medical packagers will also likely have to consider investing in anticounterfeiting technologies. “Counterfeit products and packaging were prevalent in 2003ï¿½2004 not only for pharmaceuticals but also medical devices as well,” says Miller. “Overt and covert anticounterfeit methods will continue to evolve for medical packaging going forward.ï¿½
Total Medical Device Market: Revenue
Forecasts (U.S.) (click to enlarge).
ï¿½If FDA finds tremendous gains and advantages from track-and-trace technologies in the pharmaceutical world, they will probably develop similar initiatives for medical device packaging,” predicts Bix. “That is already a rapidly emerging trend,” says consultant Douglas Stockdale, president of Stockdale Associates Inc. (Rancho Santa Margarita, CA). “I know of medical packaging companies that are already using RFID internally to help them track products at the manufacturing and distribution levels. That will evolve and expand.ï¿½ Stockdale considers RFID implementation a sure thing. “If you can add electronics to a package thatï¿½s gamma sterilized, using new technology, it will be successful,” he says. “Using RFID tags might change the processing parameters, but it would be effective.” He also predicts that bar coding will find its way into the medical packaging arena. “If itï¿½s successful in pharmaceuticals, FDA will probably look at transferring that mandate to devices,” he says. Cost Considerations Even with increased demand for their services, packagers will still have to maintain a focus on controlling costs, always at the top of the list of biggest concerns. “The supply chain pressures are always going to be there, and also the margins in medical packaging are not high compared with other industries,” points out Pereira of DuPont. Thatï¿½s something that Don Barcan, president of Donbar Industries Inc. (Long Valley, NJ), says “hasnï¿½t changed in the past few years. Companies are still looking for new packaging concepts and ways to significantly reduce costs.ï¿½ The potential of adding more security packaging into the mix suggests obviously higher manufacturing costs. Pharmaceutical packaging has other implications for medical packagers as well. “One issue worth pondering is what will happen to medical devices if the purchase of non-U.S. pharmaceuticals is allowed,” says Hal Miller. “Will hospitals be permitted to buy cheaper, non-FDA-approved medical devices to keep their costs and managed care costs down?” Stockdale predicts that packagers will respond to cost challenges with smaller, yet sturdier, package designs. “It just makes sense to reduce the package size,” he says. “You can then ship more product at once and save money in freight, which offsets the material costs.” He also says theyï¿½ll continue the trend of analyzing the “entire life cycle of the product,” instead of focusing solely on materials. “Take distribution costs, for example,” he says. “If you can reduce the package size, you can then switch from a size to weight focus when weighing it.ï¿½ Another potential cost-cutting move that medical packagers will likely continue exploring is moving business off-shore. And that brings a whole new set of challenges. “As manufacturing continues to move offshore, todayï¿½s multinational packager must be careful in the selection of suppliers,” says John P. Merritt, speaking on behalf of Universal Protective Packaging (Mechanicsburg, PA). “Suppliers may work locally, according to local cultures and practices, but goods must meet the standards of quality dictated by the consuming market. The effectiveness of the liaison between parent company and satellite is also critical.ï¿½ Test Methods Package integrity testing will continue to be an integral part of the picture in the near future. “Two of the big challenges ahead for packagers are to develop a whole-package integrity test for those packages using porous ma-terials such as Tyvek and paper, and to scientifically determine how small a hole or seal channel needs to be to be considered acceptable for sterility maintenance,” says Miller. He adds that testing, documentation, and validation are critical factors in the effort to eliminate packaging errors. With that in mind, some anticipate the development of new test methods. “There are already some in the works that will cut some of the typical capital equipment costs,” says Barcan. Again, combination products will more than likely lead to testing changes. “How to deal with coated stents is going to become a testing issue,” says Pereira of DuPont. “The dynamics of the product and package will be different, for example. Also, in the last few years weï¿½ve seen more procedure packs on the market and more recycling of products.ï¿½ Sterilization methods might also change. “Iï¿½m seeing more interest in packages that are amenable to greater flexibility in sterilization methods,” says Pereira. ï¿½Different sterilization processes are definitely being explored,” adds Stockdale. “Right now, Iï¿½d say itï¿½s 45% radiation, 45% ethylene oxide, and 10% steam sterilization and other methods. Those “other methods” will get to be a bigger piece of the pie. Vaporized hydrogen peroxide, for example, is gaining popularity.ï¿½ Steam sterilization is a “huge challenge,” according to Barcan. “You have to develop materials and designs that can put up with the extreme conditions of the format,” he says. Vacuum packaging is also growing. “It gives you added protection,” says Barcan. “Companies are also developing new sealing equipment to be used with these systems. Regulatory Picture Device manufacturers and packagers will also be paying careful attention to regulatory developments in the coming months. “Weï¿½re anxiously waiting to see what FDA will do with its decision to hold third-party reviews and audits,” says Pereira. But FDA isnï¿½t expected to announce any new decrees. “Theyï¿½re still wanting compliance and wanting companies to do a better job protecting device users and the devices themselves,” says Stockdale. Pereira says companies are also starting to look to their converters and suppliers to provide FDA-mandated information regarding materials. “For example, theyï¿½re asking converters to provide biocompatibility data and information on accelerated aging of seal structures,” she says. Higher on the radar screen is the ongoing set of revisions to ISO 11607, “Packaging for Terminally Sterilized Medical Devices.” The newest version recently became harmonized with the European Committee for Standardizationï¿½s (CEN) EN 868-1, which is followed by most European device manufacturers. CEN still has not decided whether to update the standard to expand it to include processing and validation. “These are living documents. They should be allowed to be reviewed and changed, as should test methods,” says Barcan. ISO 13485, which covers quality systems for devices, is also in the process of being revised. Conclusion No matter what transpires over the course of the next few years, medical packagers will be dealing with new challenges. “Itï¿½s a very interesting time for medical packaging,” says Laura Bix from Michigan State. “There are increasing demands from consumers, and those voices will become louder as they age. Theyï¿½re going to need to take devices home with them more and more, and as a result, packagers will need to design with ease-of-use in mind.ï¿½ Yet with those challenges will surely come growth in demand. “It shows no signs of slowing down,” says Bix. “I would expect that growth will stay very healthy as we move ahead.”