The U.S. market for medical device packaging is expected to continue notable levels of growth over the next few years. Forecasts of annual growth rates have ranged from 4 to 5.5% among industry observers—growth spurred largely by increased volume rather than profit margins. In this month's article, Adapting Packaging Technology to Meet Device Industry Needs, a number of packaging professionals comment on issues that are influencing device packaging—including advances in technology, pressure to cut costs, and new testing strategies.
"Expect to see more development in film technology, combining different polymers in multilayer structures, to build in desired functional properties," says Carl D. Marotta, president, Tolas Health Care Packaging (Feasterville, PA). He adds that in addition to tear, puncture, and abrasion resistance, these properties will include selected barrier and peelability characteristics.
Industry observers have noted that some packaging concepts are overengineered. Marotta agrees that overengineering does occur at times, "particularly where a like material may be used for a wide range of product applications." He adds that "this can be somewhat lessened by selectively choosing materials that best satisfy specific package criteria, using lower-cost materials for commodity devices, and vice versa." Marotta explains that, "This may not always be most cost-effective, but will ensure that the higher-value product reaches its intended use safely, undamaged, with sterility maintained, and conveniently delivered to the patient."
Pressure to actively seek cost savings continues to exert a strong influence on many packaging decisions. Says Marotta, "Cost savings are an ever-present concern of both packaging manufacturers and device companies. However, we cannot ignore the overall value provided by high-performance, quality packaging, in terms of ease-of-use, security, shelf stability and general reliability."
Looking to the future, Marotta believes that the market "will continue to seek and respond to more-functional design and more-specialized packaging, both in flexible and rigid packaging."
In addition to new materials and production methods, package testing is also experiencing significant changes. Stephen Franks, executive vice president, T.M. Electronics Inc. (Worcester, MA), anticipates a greater reliance on nondestructive testing methods. Says Franks, "Pressure and vacuum decay testing will see an evolution into faster and more-automated forms for high-speed, in-line testing." These changes are expected to result partly from the development of more-defined requirements for physical versus microbiological testing for sterility. "In effect, sooner or later there will be an accepted standard for a leak size or leakage rate that will prove to be allowable and maintain a sterile barrier for the shelf life of the package," he adds.
The motivation for the use of nondestructive testing is fairly basic, says Franks. "I believe that, as usual, economics is the strongest force, right behind regulatory pressures. Nondestructive testing provides the opportunity to do on-line testing for high-volume manufacturers, and saves material loss and reprocessing time for lower-volume manufacturers who do sample audit testing using destructive techniques."
What are the hurdles to such testing? Franks suggests it may be that the medical package is both flexible and complex. "From a structural viewpoint, testing the medical device package is like trying to measure a rubber band. A lot depends on the state of the package when it is tested. From a materials viewpoint, there are multiple materials that will react to different measuring systems in different ways. The final hurdle is the peelable package, which puts the manufacturer of packages between the proverbial rock and a hard place. The package must simultaneously be strong and maintain its integrity for the claimed shelf life and be weak enough to open on demand. Not always an easy task."
Gregg Nighswonger is executive editor of MD&DI.