Stacey L. Bell04.12.07
All the Right Moves
As the Medical Marketplace Shifts, Contract Packagers Are Choreographing New Capabilities
Stacey L. Bell
Editor-at-Large
Oliver pre-formed pouches, pouches on a roll and header bags are available in Ovantex, Tyvek, foil, film or paper for EtO, radiation and autoclave sterilization and are ideal for a variety of applications, from large or bulky devices and kits to small or low-profile devices and components. Applications include implants, catheters, tubing sets, wound care, procedure trays, components and other instruments. Photo courtesy of Oliver Medical. |
Today’s OEMs are packaging a variety of products in different kits to meet the needs of myriad markets. While a skilled practitioner can easily tear open and assemble the components of a diagnostics or treatment kit, a practitioner at a clinic who uses the product infrequently would prefer a highly organized kit that is more intuitive. And someone at home would need even more instruction.
“It’s common that a product will need several delivery systems, each designed for use in different settings,” explained Rick Crane, vice president of new business development and technical marketing for J-Pac, LLC in Somersworth, NH. “Our challenge is to come up with a minimum number of kits to cover all of the intended uses of the product. The earlier we meet with a customer about packaging a product, the more we can do to limit the number of SKUs that will be carried. We also need to consider the different sterilization techniques the various components within a kit will require and their different expiry dates. By planning early, we can limit those factors, too. There is a lot of magic that can be done in this area.”
The Importance of Early Involvement
Of course, magic can happen only if OEMs recognize the value of packaging and consider its role from the beginning of the product development cycle. “Not many companies truly practice concurrent engineering. The last thing they think of is packaging,” lamented Curt Larsen, a Tonka Bay, MN-based packaging consultant for DuPont and other companies.
Too often, he said, companies will come to a contract packaging service provider with a finished device. When a packaging expert looks at it, he or she may see that a rounded corner here, a fillet there, while not affecting the product’s function, would greatly ease packaging. At that point, however, the customer has invested so much money in tooling that it’s too late to make additional changes.
“Many companies don’t have a core discipline in packaging. Even some big companies have no packaging people on staff. I think they’re missing the boat,” Larsen continued. “With no packaging expertise in-house, you’re not up on the latest designs, materials, standards and testing methods. You also can lose that corporate look/design packaging system from one product to another.”
While waiting until the last minute to create packaging can cost a company more money and headaches, it’s also helpful to have an expert in this discipline review any packaging specifications that have been developed to ensure they truly are the best route to pursue. “A common mistake is to specify something, such as a minimum peel strength, without really understanding the materials,” noted Alison Tyler, technical director of Beacon Converters, Inc. in Saddle Brook, NJ. “Many times a customer will specify a minimum of 1 lb. because that is ‘standard,’ but there are many material combinations for which a 1 lb. minimum is much too high.”
Above is the Snap! single-use packet for drug and medical device markets. This product delivers a single dose of cream, gel, paste or lotion in a disposable package that requires only one hand to open it. Photo courtesy of Tapemark. |
Further, Love added, OEMs tend to use the same material combinations for packaging that they’ve always used because they have shelf-life data on them. However, more are finding that their current standbys don’t hold up to more stringent environmental and distribution testing; therefore, they’re now looking for more robust solutions.
“We’re finding that some customers aren’t achieving the best shelf life they could for their products because they are relying too much on products that have been common to the medical device marketplace for 20 years or more,” agreed Anthony Soria, president of Advanced Concept Innovations, LLC in Lakeland, FL. “They’re using gamma to sterilize their products so they stick with Tyvek poly/mylar pouch materials when new materials with much less volatility in price and availability are now on the market. When [hurricane] Katrina hit, we saw an overnight increase of 15% in Tyvek prices. New flexible laminates and co-extruded materials reduce costs and create attractive-looking packages. They also allow for better-looking print quality on the packaging.”
Packaging for the New Millennium
The way experts approach packaging has changed over the years. It used to be that the device and its packaging were thought of as two separate entities. That’s not the case now.
“Companies are integrating a device with its packaging. Packaging provides an opportunity to clarify and aid in the device’s use,” Crane said. “Another change is that we used to package around the product. Now, the best packaging is produced when you know how the product is used and in what venue and can create packaging that will actually add value to the product.”
The best packaging today serves multiple functions: It brands the company’s offerings, protects the product from a larger array of environmental challenges and balances a cost-efficient design with minimal waste.
Beacon Converters has noticed more of its customers are interested in the branding benefits packaging can provide. “[We see] more image-conscious packaging than we have in the past,” Tyler said. “Pharmaceuticals led the way by direct-to-consumer advertising. We have a long way to go to get there in medical packaging, but we see more and more colored foils and printed packages with company tradedress as an important element.”
Another critical element is that packaging protect the enclosed product from all environmental hazards it may encounter—whether that involves moisture, humidity, extreme changes in temperature or being dropped (cold crash testing) at elevated temperatures. OEMs are concerned with complying with ISO 11607 and have increased their use of standardized distribution testing.
“Some of our solutions are geared toward improved material science rather than just adding mass or thickness,” Love said. Solutions may involve improvements to package design or size, or eliminating folding of flexible products to improve the success rates of distribution and challenge testing. Replacing standard pouch materials with more flexible, tougher materials to eliminate scuffs and pinholing is common, she added.
While it’s essential to design packaging to thwart environmental challenges, some companies are guilty of moving too far in that direction. They could save significant time and dollars—as well as make it easier for users to open their products—if they would rethink their package designs.
“Over-engineered packaging is a common problem,” said Jeff Murak, director of sales and marketing for Oliver Medical in Grand Rapids, MI. “Companies often rely on excess packaging to ensure device safety, but it simply drives up the costs of materials, processing and shipment of the product.”
Excess packaging also can cause problems later. Therefore, a third key to good packaging design is planning for its eventual disposal. “Manufacturers are looking for less material and less waste and getting rid of bulky packaging,” noted Ben Dunn, managing director of Boston, MA-based specialty investment banking firm Covington Associates.
What’s New
In the drive to reduce costs, improve physical properties and ease of opening, as well as meet the special requirements packaging combination products presents, an evolution has been occurring in the packaging arena. New materials and combinations of materials and adhesive technologies are making “a world of difference,” Tyler said.
“Due to increasing costs of traditional packaging materials, customers have stepped up their efforts to investigate alternatives to what they currently use,” Murak added.
Among the new offerings is a new style of Tyvek called Asuron, which is positioned as a premium product with excellent printability and whiteness, Tyler said. She added that Beacon Converters has introduced A34T, which is a “very high barrier to moisture, oxygen, light and also highly puncture resistant and dimensionally stable. We are seeing interest in niche markets—cryogenic, high barrier with high durability needs, lidding applications. And colored foils and metallized films also are available for medical applications.”
Advanced Concept Innovations recently worked with the R&D department at a materials manufacturer to develop a customized material for one of its customers. The resulting 6-mil co-extruded film provides a very low moisture vapor transmission rate (MVTR), excellent seal quality, great clarity and ease in vacuum thermoforming. “Our customer had a really low MVTR requirement for this project, which required finding an innovative alternative material to meet that specification. We’re one of the first companies to use this new material in the medical sector,” Soria said.
TOLAS is in the early stages of development with several customers to create new flexible, clear, high-barrier materials. “Today, there are barrier clear films that can replace or be used with foil. Most of those products, however, experience some cracking if exposed to a strong vacuum or folding, which can affect their barrier properties. This is a more robust solution that we expect to promote to the mass market within the next six months or so,” Love said.
Convenience, ease of use, portability and single-use doses also have become mantras in creating user-friendly packaging designs. To meet these needs, last October Tapemark signed an exclusive, worldwide agreement with Interactive Packaging Group, Ltd., a sister company of Smyth Cos., to manufacture Smyth’s Snap! single-use package for select drug, medical device and consumer markets. The packaging replaces traditional sachets (think of the ketchup packets you get at fast food joints), allowing for more precise placement of the enclosed cream, gel, paste or lotion.
“With sachets, end users had to hold the product in one hand, tear it with the other and squeeze out the product, which could get on their hands. Snap! allows for one hand use and dispenses a specific amount of product into a precise location,” explained Steve Larsen, national sales manager for Tapemark in West St. Paul, MN.
Another material making inroads into medical packaging is Oliver Medical’s Ovantex, which debuted in its final form in April 2006. Ovantex is intended to fill the gap between paper and Tyvek by providing exceptional sterile barrier properties and strength in a breathable, synthetic fiber–based substrate, Murak said. Oliver Medical reports that the product can reduce material spending by more than 35%.
Earlier this year, Plantation, FL’s AccuPlace launched its AEvo labeler and print-and-apply machine to help manufacturers and their contract packagers produce precise label printing and placement. “A 300 dpi thermal print head integrated into the machine prints unique barcodes or product information with zero queue,” explained Manny Montero, AccuPlace’s market segment manager, life sciences. “The same machine model can carry out two different processes: applying labels and complex die-cut components, as well as print and apply.”
AEvo allows placement accuracy of +/- 0.002-inch or better of even the smallest labels, added Guni Bermudez, AccuPlace’s marketing manager. A 600 dpi version is expected to be released by this summer. The company’s new AEvo machine prints super-small labels. This technology can be used to label vials and other hard-to-place labeling on products, Bermudez said.
Adding Value
In addition to ensuring that packaging meets multiple needs, contract packaging service providers are helping their customers in other areas.
For instance, because both material costs and demand for those materials have escalated, some resources aren’t as available as they used to be. Take flexible pouches. The wait time used to be six to eight weeks; now that can stretch to 12 to 14 weeks, reported Tapemark’s Larsen. “Customers need to be aware of material availability so we can meet their timelines and commitments,” he said.
Savvy contract packagers not only are making their customers aware of these challenges and taking advantage of volume discounts when ordering materials, they also are offering novel strategies for OEMs to consider. “For the past two years, we’ve strongly encouraged our customers to bring us into the process earlier and to let us validate more than one product,” Larsen said. “We validate at least two, so if there ever is an issue with availability, we have a fallback plan. Having flexibility in the supply chain is critical.”
Also critical is ensuring that any company hired to package a combination product that includes a pharmaceutical agent be certified in that area. “A lot of contract packagers are not certified to handle both drugs and packaging,” noted Julie Karlson, marketing manager for Tapemark.
Packaging combination products is becoming a larger part of business for some companies. The medical device combination products market experienced sales of nearly $6 billion in 2003, with market share expected to reach $10 billion by 2009, according to Front Line Strategic Consulting, Inc. However, the projected explosive growth hasn’t yet materialized in significant growth for many contract packagers, according to experts who spoke with Medical Product Outsourcing.
J-Pac has seen this portion of its business expand and acknowledged that it does create some challenges. “Combination products can be tough because the pharmaceutical or the biologic often can’t go through terminal sterilization. It splits the supply chain,” Crane said. “We’re seeing more requests for aseptic processing of active implants combined with a need for terminal sterilization of the delivery kit.”
Dunn added, “The whole merging of the drug and device world is a big growth area. With active agents on the device, it’s no longer as simple as thermoforming a package and putting a device in there. Now it must be sealed and packaged differently. Companies that develop those capabilities will prosper.”
In addition, Dunn said contract packagers who will prosper also will tackle several other areas: managing the supply chain for their customers, adding assembly and distribution services to their core offerings, providing additional expertise during the product design phase and perhaps creating a niche specialty.
“The contract packaging space has had a number of deals recently, but it’s not an easily tracked space,” Dunn continued. That said, “the whole medical outsourcing area has been consolidating—and that includes packaging. I expect that trend to continue. Ultimately, the market will be comprised of one-stop shops that offer many services and specialty shops that provide a technique that no one else can do.”
With the many changes occurring both in the types of medical products being produced and in the materials used to package them, contract packaging service providers and their OEM customers would be well served to work together closely throughout the product development cycle.
“Communication is essential,” Tyler concluded. “Don’t rely on a piece of paper to do all of your communicating. Talk with your suppliers, and don’t be afraid to ask questions or ask for advice.”