One begins to appreciate the difficulty and importance of protecting medical devices when you consider that a failed package is sufficient reason to toss a $2,000 drug-coated stent. For more insight to recent challenges in medical packaging and a peek at new developments, especially for combination products, we posed several questions to Edward L. Haedt, vice president of marketing for Perfecseal Inc., Oshkosh, WI, (perfecseal.com). The company develops and manufactures healthcare and pharmaceutical packing.

MD: What trends do you see developing in the packaging of combination products?

EH: The next generation of packaging for combination products will require greater flexibility in sterilization technologies. This means allowing for sterilization parameters that are beyond current standard parameters. Flexibility also allows for new sterilization techniques or modifications to existing techniques. Packaging combination products requires materials which offer greater protection from oxygen and moisture, longer shelf life, and they must work on existing form, fill, and seal equipment.

MD: How does packaging combination products differ from packaging traditional pharmaceuticals or medical devices?

EH: Packaging materials for combination devices must support all regulatory and technical requirements thaat relate to sterilized medical devices and pharmaceuticals. In addition, the most notable combination products, drug-eluting stents, are expensive and delicate items. Their packaging systems must be protective, high performance, and have almost zero defects to make certain these sensitive products are efficacious in use. Obviously, these products have higher value than a syringe or an oral tablet. For that reason, medical-device manufacturers place stringent demands on combination-product-packaging materials and systems.

MD: What are the greatest challenges of packaging combination products?

EH: One of the biggest is providing the required level of quality, which translates to reliability, ease of use, and surpassing rigorous package specs. Quality also refers to zero failures, especially zero defects in sterile barrier (sterility) properties of the package.

One bad package could make a $2,000 drug-coated stent unusable. Combination products are often used in high-risk surgical procedures so it is critical that the package provides absolute protection for the device. At the same time, packaging materials must open easily so the product can be aseptically removed.

MD: How has your company advanced the packaging of combination products?

EH: We use high-barrier-foil laminates coupled with ethylene-oxide sterilizable Tyvek in a sterile-barrier package that provides excellent protection from moisture and oxygen, and it's easy to open in an OR. The next generation of these packaging systems for combination devices will have a built-in compartment for desiccant, which will further protect the device from exposure to moisture.

MD: What venues would you suggest for finding new packaging ideas?

EH: The Interphex/PharmaMedDevice show seems a good venue for companies that have emerging combination products to learn about sterile-barrier-packaging systems and other new combination products. We exhibited at this show in Philadelphia in March this year, and will return to the show when it opens at the Javits Convention Center in New York March 17 to 19, 2009.