Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published October 1999
MEDICAL
Case Study in Design: Packaging Redesign Tames Complexity, Creates Brand Identity
In existence for approximately two decades, ultrasonic aspiration systems are used to perform tumor and tissue removal with minimal trauma to surrounding healthy tissue. The CUSA EXcel ultrasonic aspirator, for instance, developed by medical device manufacturer Valleylab (Boulder, CO), has historically been used for neurosurgery, including pediatric cases, as well as general surgery applications such as liver resection. With improvements in technology, however, the use of such devices is steadily expanding into new clinical applications. The challenge for Valleylab is to incorporate advancing technology into these systems while making them easy to use. By developing new packaging for the most recent generation of CUSA components, the firm was able to both broaden brand awareness and make the system easier to use, contributing to increased product demand.
Color-coded sleeves enable nurses to identify components quickly.
The CUSA EXcel ultrasonic aspirator consists of a console unit, three handpieces, and a wide variety of surgical tips and other accessories. It represents the third generation of Valleylab's ultrasonic aspiration system. The product's introduction in December 1998 featured many enhancements, including an entirely new handpiece and associated accessories, which opened the door to additional system uses. During product development, Valleylab recognized an opportunity to redesign packaging to help promote awareness of additional surgical options as well as to simplify setup.
"Our goal was to encourage sales of the Valleylab CUSA EXcel system as a product family with many diverse uses, as opposed to simply a console unit with disposables," explains Valleylab's ultrasonic product manager Kari King. "We felt that redesigning the packaging could help accomplish that."
The company also had a third goal. Years ago, Valleylab had acquired the CUSA system in a merger with another supplier, taking over all subsequent product development and manufacturing. Throughout the intervening years, many customers remained unaware that CUSA was actually part of the broader Valleylab product line. Valleylab saw the CUSA packaging redesign project as an ideal way to build and extend the overall Valleylab brand.
VERSATILE, YET COMPLEX
Two handpiece families are now available for the CUSA EXcel system: the larger, more powerful 23-kHz handpiece (straight or angled version) and the new compact 36-kHz handpiece. Each of the different-sized handpieces requires a separate family of accessories that are essentially equivalent but under no circumstances interchangeable.
The newest 36-kHz handpiece and its associated accessories extend the CUSA EXcel system's capabilities, providing more flexibility for surgeons, while at the same time potentially creating more complexity for the nurses and central service technicians responsible for system setup. This is largely due to the nine different surgical tips of varying sizes available for the 36-kHz handpiece, all of which are small and visually difficult to distinguish from one another. In addition, each tip requires a specific flue and O-rings for proper assembly. Add to this the existing 23-kHz handpieces—which take five other surgical tips, plus flues and O-rings—and you have the makings of a potentially confusing and mistake-prone situation.
Another key component of the CUSA EXcel system is the sterile manifold tubing that attaches to the handpiece, providing suction and irrigation capabilities during surgery. The tubing is also handpiece-specific.
Valleylab had to determine how to package these accessories in a way that would clearly indicate two separate families, simplify component identification, render each family's functions immediately obvious, minimize preoperative system setup time, and promote safe, correct product assembly.
PREVIOUS PACKAGING
In the past, CUSA parts were housed in 15 different CUSApak assembly kits. Because the packaging evolved along with multiple iterations of the handpiece and related sterilization methods, certain package elements became artifacts of an earlier generation.
The CUSApaks appeared to lack internal consistency: some kits included manifold tubing plus a tip model and related parts, while others didn't include tips at all. In addition, the large CUSApaks were almost identical in appearance. The key identification mechanism was a small nine-digit part number. Nurses or assembly technicians often pulled and opened the wrong kit in error; this, in turn, encouraged pilfering, left multiple kits unusable, and resulted in costly resource waste. Also, confusion about package contents sometimes led to handpiece misassembly, which caused expensive and highly inconvenient system malfunctions.
CUSTOMER REQUIREMENTS
When Valleylab embarked upon packaging redesign for the CUSA EXcel system, the company hired national product and brand development firm Volan Design (Boulder, CO), which had experience designing medical products, packaging, and graphics. Together with Valleylab, Volan Design conducted focus groups in multiple locations throughout the country, extensive one-on-one interviews with product users as well as with Valleylab employees, and on-site audits to observe the CUSA EXcel system in use.
A PETE tub with a lift-out tray enables nurses to deliver a sterile tubing set easily and quickly.
"We talked to the people who interact with the Valleylab packaging—the OR nurses, the central service technicians, the storage room stockers, the materials managers," says Volan Design's principal Wendy Volan. "We discovered that manufacturers typically do not solicit input from these populations—and yet they are the people most intimately familiar with existing packaging issues."
When the research revealed that OR storage facilities were usually filled with similar-looking blue-and-white peel packs that nurses found difficult to identify, unwieldy, and bulky, Valleylab and Volan Design realized that they needed to distinguish clearly between the many individual CUSA EXcel system components. In addition, they recognized an opportunity to differentiate the entire CUSA EXcel product line from the multitude of other products on the typical hospital's storage shelves.
CODING INNOVATIONS
The team decided to develop a layered system of color coding, complemented by extensive graphic treatments, to simplify the innate complexity of the accessory line.
"We realized that color coding for medical device accessory identification wasn't really being done," says Susan Ritter, manager—packaging engineering, at Valleylab. "And yet, it was the perfect solution to our problem. We developed a system that would eliminate the existing confusion between accessory families, contributing to better inventory control and more-efficient product assembly."
Each of the two separate handpiece families was assigned an overarching color scheme: the 36-kHz handpiece accessories were identified with the color blue, and the 23-kHz handpiece accessories were identified with the color green. These colors were applied to the packaging for every related family accessory (sterile or nonsterile) at the primary, secondary, and tertiary levels. In addition, certain product elements were also color coded to reflect the handpiece family relationship, such as O-rings and handpiece connectors.
Furthermore, color coding supported a modular packaging scheme based on tip size. This was in response to comments from nurses in the focus groups, who asked that the highest priority information be emphasized prominently on the end of the package: "We need to see the tip sizes at a glance, with reorder information next in importance," the focus groups requested.
One additional fluorescent color was assigned to each of the four distinct surgical tip diameter sizes. Although the tips themselves are not interchangeable across handpiece families, the diameters are the same. For example, the CUSA EXcel Micro Tip, with a 1.57-mm diam, was assigned the color pink. The Micro Tip intended for a 23-kHz handpiece is coded with the colors green and pink. In contrast, the Micro Tip meant for a 36-kHz handpiece is coded with the colors blue and pink. This holds true for individual kit packaging as well as for printed and imprintable case labels.
TIP ASSEMBLY KITS
Once the color-coding scheme was determined, Valleylab and Volan Design turned their attention to the tip assembly kits. They decided that the single-use, nonsterile, disposable-tip assembly—consisting of a surgical tip, O-rings, flue, and a tip cleaner—would be housed in a rectangular, reclosable PETG clamshell tray, with a solid bleached sulfate (SBS) sleeve. Tray dimensions had already been determined based on the size of the kit components. Encasing the clamshell in an SBS sleeve was seen as an ideal way to make the best use of available display space. The folded sleeve acts much like a videocassette sleeve, clearly showing all pertinent identification information, including color codes indicating tip family and size and a large graphical representation of the clamshell's contents on the front. The back of the sleeve contains a common instruction panel, with room for in-line imprintable information such as manufacturing date, expiration date, lot number, and bar code information. The graphics, in particular, were considered critical to promote easy identification of the kit's contents and to minimize any translation requirements for the product's worldwide release.
REDUCING STORAGE SPACE, MANUFACTURING COSTS
The clamshell shape was chosen to maximize scarce hospital storage space. The design team felt that the stackable, reclosable design was inherently more stable, was easier to manage, and made better use of available space than other alternatives. Users have found it easier to stack and grab the tip assemblies packaged in the smooth SBS sleeves than the previous, larger CUSApaks or products housed in the more prevalent peel packs.
Of the CUSA EXcel system's 14 total surgical tips, six were short, and eight were long or extended. This led Valleylab to limit the number of PETG tray styles to two—one short and one long—each able to accommodate the small variations in tip size and shape without sacrificing a close fit.
"We told our thermoformer that we wanted to minimize the different packages, so we worked closely with them to ensure good fits, stability, and proper presentation, overcoming a number of design challenges along the way," recalls Valleylab's project engineering specialist Art Schoenman. Meanwhile, Valleylab marketers reviewed the evolving design for ease of use.
Ritter adds: "Limiting the number of clamshell and SBS sleeve sizes to two makes it possible for us to substantially decrease cost by increasing volumes. On the other hand, we now have 14 graphical variations of SBS sleeves to identify the unique tip assemblies. However, from an internal inventory standpoint, I'd rather store these flat sleeves on the shelves than the bigger clamshells, so the balance works well."
STERILE TUBING PACKAGING
One of the most important CUSA EXcel accessories is the disposable manifold tubing, designed to simultaneously deliver irrigant to the surgical site and suction away diseased tissue. The tubing attaches directly to the handpiece and is introduced into the sterile field just prior to surgery. Because of this, the tubing needed to be packaged separately in a sterile, two-part PETG container, consisting of an inner tray and an outer tub with a Tyvek lid.
The design challenge lay in incorporating a simple mechanism for delivering the tubing into the sterile field. To achieve this, the team created the primary tray to hold and feed the tubing to users when necessary. This tray can be either lifted out using its paper-tape handles or passed into the sterile field using the specially molded handgrips on the bottom of the outer tub.
FDA AND THE MDD
Because the CUSA EXcel is intended for distribution in the United States and Europe, the design team had to obey packaging guidelines established by regulatory bodies in both places. The system obtained both premarket notification (510(k)) approval from FDA as well as the CE mark under the European Union's (EU) Medical Device Directive (MDD). The CE mark packaging requirements governed Valleylab's choice of materials, from plastics to adhesives and varnishes.
"Due to the lack of landfills, most waste is incinerated in Europe. That's why the EU requires the use of materials that burn clean and ash-free," Schoenman explains. "We also chose materials that could be easily recycled, in order to be environmentally sensitive." Ritter points out that a country like Germany levies fines if materials aren't disposable within the municipal waste stream, something manufacturers want to avoid.
Volan Design also deliberately relied on graphical elements in the packaging, in order to minimize copy to be translated as the CUSA EXcel system became available in additional countries. At present, the packaging copy exists in 11 languages.
OBJECTIVES ACHIEVED
After nine months on the market, the CUSA EXcel system, together with its newly redesigned packaging, is enjoying significant success. According to King, nurses are reporting higher confidence when assembling the products for use, as well as overall safer storage—all as a result of the reengineered packaging. Valleylab has enjoyed great success in systems sales since the initial release. Although physicians typically recommend purchase of the system, King points to several recent cases where nurses have been influential in the decision. "The packaging is so much easier for them to work with now, so they like it better," she says.
The creation of an overall product family identity also appears to be paying off, as the awareness of additional surgical uses builds. The past months have seen usage of the CUSA EXcel system expand into new clinical applications, from liver transplantation to gynecological procedures. "By creating an intuitive, easy-to-understand packaging system, we will help our customers envision a whole new set of applications for the CUSA EXcel system," says King, "and that was a very important part of our project's goal."
