By Erik Swain
The convergence of the medical device and pharmaceutical industries will bring new opportunities for medical device packaging.
New packaging techniques for combination products, advances in printing and package testing, and services to help firms meet new regulations and standards are some of the factors that could boost the medical device packaging industry’s growth. However, it remains to be seen whether these changes will help the industry address one of its primary concerns—controlling costs.
The U.S. demand for sterile medical packaging should jump 5.2% annually to reach $1.8 billion, or 10.5 billion units, in 2006, according to a study by The Freedonia Group Inc. (Cleveland). Major growth factors include the aging population, more-rigorous infection control standards, and the convenience of sterile packaging formats.
The fastest growth should come for products that add value and provide greater efficiency, the report states. Those include custom surgical trays, prefillable syringes, and plastic bottles.
Sterile-tray demand is projected to grow 6% per year to reach $476 million in 2006, helped greatly by more demand for high-value custom surgical trays and multiple-compartment trays. Expected growth might have been even higher if not for competition from lower-cost bags and pouches, and poor adaptability to larger-sized products. The report projects pouches to grow 5.5% to hit $417 million in 2006, based on versatility and cost advantages over rigid formats.
Prefillable-syringe demand will hit $215 million in 2006, an annual increase of 5.6%. Their advantages over hypodermic systems, from infection prevention to faster response time, will be a major growth factor. At 6.5%, plastic bottles will show the fastest growth rate of any in the sector as they reach $130 million in 2006. The strong market for ophthalmic preparations will help them. Plastic IV containers will show 3.6% annual growth, and vials will show 2.9% growth. All other formats are projected to show 4.6% growth per year.
Plastic resins will account for more than 70% of the materials used in sterile medical packaging. Leading the way will be polyvinyl chloride, thermoplastic polyester, and high-density polyethylene. However, the report expects device companies to become more cost-conscious in their package selection, thanks to managed care price controls.
Cost considerations remain at the forefront of many packaging-related decisions, as margins are tight and the economy is still in recovery.
“There is still some consolidation in the industry taking place, so device companies are still placing pressure on suppliers to look relentlessly at ways to reduce costs,” says consultant Douglas Stockdale, president of Stockdale Associates Inc. (Rancho Santa Margarita, CA). “That is leading to just-in-time inventory for packaging components, and forcing suppliers to consider how to improve the value of the services they provide. In the past, a supplier would provide a packaging material. Now, they need to find ways to get in sooner in the value chain. An example would be providing a pre-sterilized component.”
At the same time, he says, device companies “have a growing awareness of total distribution cost. In the past, they would focus on the cost of the package itself. Some are more receptive to solutions that reduce total cost but might be a more expensive package. For example, making a package smaller but sturdier may be cheaper even if it ends up heavier. That means you can ship more at once, and the overall savings in freight might offset the extra costs of materials.”
With the increasing popularity of combination products such as drug-coated stents, some experts see the medical device packaging industry converging with the pharmaceutical packaging industry. This, they say, will force device packagers to become more familiar with regulations and procedures for drug packaging and could present opportunities for the two industries to learn more from each other.
“The impact of combination products will be felt at every step in the creation of packaging, from the creation of new products to meet new performance needs to the testing and new regulatory compliance requirements,” says Miray Pereira, global business manager for DuPont Medical Packaging (Wilmington, DE).
“Combination products may be beyond the scope of traditional medical device packaging concepts,” says Hal Miller, director of packaging technology for Johnson & Johnson (New Brunswick, NJ). “Now, if you are adding a drug to the product, that brings in additional regulations [from FDA’s Center for Drug Evaluation and Research]. Not only does that present challenges to [end-users] who have to choose and qualify materials, but it also presents them for the supplier base. All of us will have to become familiar with FDA’s container-closure guidance, its stability guidance, and USP test methods. Traditional device industry suppliers have typically not dealt with these. And [the Center for Devices and Radiological Health] is learning what to look for and what to ask for when it reviews drug-device combinations. It will be a learning curve for everybody for a while.”
Stockdale agrees. “Device companies are anticipating more work by bringing drugs into the device itself,” he says. “There will be challenges placed upon packaging systems and challenges to the skill sets of device packagers.” For example, some device packagers might now have to work with isolators.
“We’re now seeing cases where the device itself may be used to apply drugs to the body or to protect a drug for extended periods of time,” says Carl Marotta, president of Tolas Healthcare Packaging (Feasterville, PA). “These products may be more sensitive to environmental changes, and may need characteristics such as higher humidity resistance and better resistance to harmful gases. The main packaging criterion is no longer just protecting the device.”
Some technological sectors have made significant advancements in recent years that could boost their popularity.
“I see a significant trend for device manufacturers not using gaseous sterilization to move into impermeable packaging,” says consultant Donald Barcan, president of Donbar Industries Inc. (DBI; Long Valley, NJ). “The material’s impermeability totally obscures every kind of virus, bacteria, or foreign matter from entering the package under virtually any conditions.” He cites biaxially oriented nylon laminations as a structure with much potential, especially since some firms have found ways to downgauge them while not compromising functionality such as puncture resistance and peelability.
The increasing popularity of print-on-demand technology is presenting a new set of challenges for device packagers, Stockdale says. “How do you handle short runs with it? What does it mean for the packaging and processing equipment? It lends itself well to standardization and reduces labeling stock, allowing for tighter controls. But what do you do to make sure that what you’re printing on demand is correct? Vision systems could be a solution.”
Barcan also sees an increased demand for vacuum packaging systems. “These could be interesting for companies that need added protection for their products,” he says. “But they only work with impermeable packaging materials, and some firms are developing new sealing equipment that can be used with them.”
Marotta sees promise for steam-sterilizable packaging. “It’s a process with virtually no by-products,” he says. “It’s a challenge to develop materials and package designs that can withstand the extreme conditions of steam sterilization.”
Device companies are expected to give more consideration to transportation and in-process packaging in the near future, Stockdale says.
“The distribution system, especially cold-chain management, is becoming a bigger issue on the regulatory compliance side,” he says. “There are a growing number of 483 citations coming out over what companies are doing to validate their distribution systems. There may not have been as much emphasis on that in the past.
“I also sense that FDA is looking more at in-process packaging, especially for combination products. For example, if you are packaging a system with monoclonal antibodies, and shipping it to another facility as part of the manufacturing process, FDA wants to know what you have done to evaluate the work-in-progress container system. Does it meet the same requirements as the final container?” These issues will especially come into play with combination products, he says.
Progress continues to be made on package testing standards. ASTM International’s (West Conshohocken, PA) F02.60 subcommittee on medical packaging has one standard in place for a nondestructive testing method for porous packages, and another appears to be on the way. Next, says John Spitzley, technical fellow – packaging, Medtronic Inc. (Minneapolis), “We may look at a biocompatibility guidance standard. We may develop a test that evaluates pouches for pinholes and leaking better than what we’ve got now. It’s tough to do it efficiently without getting false positives or missing defects. There is more and more pressure from device manufacturers for better test methodologies for evaluating pouches.”
Further out in the future, biosensors could play a bigger role in package testing. “Biosensors are things that look for microbes instead of holes. Not everyone has embraced it, but it could be broad-reaching, applying to food and military packaging as well as packaging for surgical devices,” says Laura Bix, PhD, an assistant professor at the Michigan State University School of Packaging (East Lansing, MI).
Device manufacturers who hope to be able to follow the same packaging procedures for the entire world should pay attention to the ongoing revision of ISO 11607, “Packaging for Terminally Sterilized Medical Devices.” The new version may become harmonized with the European Committee for Standardization’s (CEN) EN 868-1, which is followed by most European device manufacturers instead of ISO 11607. A crucial concern is whether CEN will expand its standard to encompass the processing and validation of packaging. Currently it only covers issues regarding materials. “The key issue is, will CEN accept it, and if they do, will the European Union basically mandate it as part of the Medical Devices Directive?” says Miller.
“I was surprised to find out that the ISO standard is not widely used in Europe at all,” says Spitzley. “That makes it a little more difficult for the world in general to try to comply with European standards, where they rely on 868-1, which does not cover package design and testing and manufacturing. I don’t think 868-1 will go away, but we hope to at least get the Europeans comfortable with the ISO standard.”
ISO’s Technical Committee 198 met in June to incorporate feedback from member nations, and a committee draft ballot should be voted on by the time of the committee’s next meeting in December. CEN will not vote to update their standard until the ISO document is ready for a final ballot, which won’t come until mid-2004 at the earliest.
Device manufacturers may also see the benefits of complying with ISO 11607 as their firms implement ISO 13485, which is being revised. ISO 13485 covers quality systems for medical devices. “As device manufacturers begin to transition to the revised ISO 13485 for their medical device quality management systems over its proposed three-year transition period, they will see the value of having a harmonized packaging standard,” says DuPont’s Pereira. “This will increase the value of having a harmonized ISO 11607/EN 868 as the standard for the packaging component.”
Following ISO 11607 should also facilitate and provide a consistent framework for third-party inspections, which Congress began allowing under the Medical Device User Fee and Modernization Act of 2002, she says.
Medical device packaging has been known as a steady, consistent market not prone to turbulence. That may change as device technology converges with drug-delivery technology and as new regulations force device manufacturers to reconsider their packaging processes. There is a risk that the industry will struggle with this transition, but if it goes smoothly, the rewards could be worthwhile.