Industry Outlook: Medical Device Packaging
by Erik Swain, Senior Editor
When it comes to medical device packaging, things are changing, and mostly for the better. In the past few years, device manufacturers have begun to place a greater emphasis on packaging, especially as a means to help reduce costs. Recent regulations now focus on environmental, material, and process issues that all relate to packaging. This means packagers are being scrutinized like never before, and they are responding with innovations and improvements in many areas.
"Medical packaging is a very lively place to be right now," says Steve Franks, executive vice president, T.M. Electronics (Worcester, MA). "Packaging has become a very significant part of the product development and process control cycle in the last few years."
And demand for medical packaging is increasing. According to research firm The Freedonia Group (Cleveland), U.S. demand for medical supply and device packaging will expand 5.8% annually to $3.8 billion in 2000. Manufacturers will be seeking packaging components and materials with superior clarity, static-control, and infection-resistance properties. Demand for blister packs will grow the fastest. Disposable medical supplies will continue to account for more than half of medical supply and device packaging demand in 2000.
The challenge for device manufacturers is to keep costs down while increasing production capacity and maintaining the same quality standards. William Daly, president and CEO of Beacon Converters (Saddle Brook, NJ), says that because of managed healthcare, device manufacturers are looking for ways to reduce packaging costs. They often turn to their packaging suppliers for assistance, not only with requests for more economical materials and components, but for help with package development and ongoing technical support.
In many cases, manufacturers have consolidated or formed buying groups, and are looking for suppliers to fill large orders at low costs. Packaging suppliers are following suit, either by consolidating themselves or moving to larger economies of scale. "If you're not changing along with them, you will be left out of the ball game," says Dick Simmons, vice president, medical marketing, at Plastofilm Industries (Wheaton, IL). "Margins will always be under attack. You have to be more efficient in order to attain profitability."
This can be frustrating. "Manufacturers think they can milk a lot of money from a medical device by changing the packaging," says Curt Larsen, principal packaging engineer, SIMS Deltec (St. Paul, MN). "That may be true some of the time, but packaging affects a small part of the price, so sometimes they're missing the boat."
End-users say, however, that innovations in packaging can affect other costs, such as storage and shipping, and a successful supplier who meets demands for speed, quality, and service can benefit in the end. For instance, speakers at this year's Medical Packaging Symposium (MPS), held in New York City in June, addressed the importance of designing device packaging to withstand shipping, handling, and storage. Dennis Young of Dennis Young & Associates Inc. (Grand Rapids, MI) explained that any product damage sustained during such conditions because of inadequate packaging ends up costing much more than the price of replacing the product. "Transportation packaging failure is an impediment to new product introduction," he said.
But, just because device makers are looking for more economical packaging materials, that doesn't mean that suppliers are responding with lower-quality materials. Many companies, for example, are developing materials that have the same or more strength but less weight than current materials. Suppliers such as Perfecseal (Philadelphia) and Rollprint Packaging Products (Addison, IL) have developed packaging materials that are thinner yet stronger than previous ones. Even DuPont Nonwovens (Wilmington, DE) has reformulated its Tyvek brand spunbonded olefin to meet industry demands for economical options.
Packagers may be reevaluating their processes now that two new sets of standards, ISO 11607 and EN 868-1, have been developed. The regulations affect materials selection, sterilization, seal-strength and integrity testing, and process validation, among other things.
One thing is certain—regulators are paying close attention to medical device packaging. At MPS, Denis Dyke, vice president of quality and regulatory affairs at Rexam Medical Packaging (Mundelein, IL), said that in 1997 FDA's Center for Devices and Radiological Health cited process validation in 51.2% of all warning letters dealing with quality system regulation violations, 10.8% of which were related to packaging and sealing operations.
Past and projected U.S. demand for medical device packaging in billions of dollars.
Device packagers must therefore develop an adequate system for designing and assembling packaging and be able to monitor it. Thanks to ISO 11607, "Packaging for Terminally Sterilized Medical Devices," packagers are no longer without a guide. Even though the standard is not a step-by-step guide to packaging, it does explain a manufacturer's responsibilities and the processes that need to be validated. According to John Spitzley, associate fellow, packaging, at Medtronic (Minneapolis), who helped develop ISO 11607, FDA has "pretty much bought into the standard." Device packagers should therefore review the document carefully to ensure compliance with both international and domestic regulations.
EN 868-1, written by the European Committee for Standardization (CEN; Brussels), is also helpful, but not as broad as ISO 11607. The CEN standard deals with materials and materials evaluation. FDA's quality system regulation follows the ISO standard much more closely.
Also paramount is the European Union's (EU) Packaging and Packaging Waste Directive, which requires packages be designed to increase reuse and recovery and mandates use of recycled materials. Companies that cannot recover their own materials may fund the recovery and recycling of others.
As a result, device packagers are placing pressure on suppliers to come up with lighter-weight materials that can be reused or recycled. But while lighter-weight materials are less expensive, recycled materials are more expensive.
Another potential problem for manufacturers exporting to member states of the EU is the mandate that requires the printing of as many as 13 languages on device labeling. This could drive up printing costs and cause problems if translations are not done accurately.
Possible solutions include printing the five main languages—English, French, German, Italian, and Spanish—and having European distributors affix labels with the remaining relevant languages, and using symbols instead of text as much as possible.
Back home, U.S. device packagers have their hands full with FDA's new rule requiring all devices and packaging that incorporate any natural-rubber latex to be labeled as such. A recent stay of the rule as it applies to cold-seal packaging will help alleviate some of the pressure to meet the September 30 deadline for complying with the rule, but packagers are still faced with the choice of printing the latex warning or devising an alternative to latex packaging. Some suppliers are developing natural rubber—free cold-seal coatings to address the problem.
There is also great anticipation as to how FDA will implement the Modernization Act of 1997 as it pertains to medical device packaging. Medical device packagers may not need to present as much data to FDA as they used to, but they will have to make sure they have thorough documentation in their own files. They also need to keep track of which new standards will apply to their materials, products, and processes. As the act directs, FDA will continue to recognize additional international standards, so medical packagers should keep their eyes open.
SOURCES OF SUPPORT
Given all these changes, it is natural for any device packager to feel overwhelmed. But, thanks to several industry associations, medical packagers have several sources of support. When FDA informed industry that cold-seal packaging must bear a latex warning, the Health Industry Manufacturers Association (HIMA) responded with a citizen's petition asking for the agency to stay the requirement. Even though FDA rejected HIMA's argument that cold-seal packaging does not present a health risk, it did grant a temporary stay.
Also, to help packagers understand recent regulations, groups like the Flexible Packaging Association and the Institute of Packaging Professionals are preparing guidances and offering conferences on packaging validation and other relevant issues.
Today's medical device packagers are not without support. But they must stay up-to-date on industry developments and not be afraid to ask industry associations or suppliers for help.