04.04.08
Delivering a Branded Message
Case and tray manufacturers seize opportunities to differentiate their OEM customers’ brands.
By Frank Celia
Contributing Writer
When you think about it, Coca-Cola and Pepsi essentially sell the same product: a carbonated soft drink, flavored with sugar and caramel, plus caffeine. In a blind taste test, most people probably couldn’t tell them apart. And yet the companies spend hundreds of millions of dollars each year maintaining their brands’ identities, beseeching consumers to notice the slightest difference between the two.
The soft drink world illustrates what economists call a “mature” market, a state of equilibrium wherein a few well-established brands, following highly developed industry standards, duke it out over an entrenched customer base. The orthopedic market similarly is showing signs of maturity. Consolidation and shakeout are underway, leaving the industry dominated by a handful of strong competitors—and competition has stiffened. Small, once inconsequential distinctions among products gravitate to the forefront of sales pitches. Nuance and end-user perception take on greater precedence, as OEMs seek imaginative ways to add value to their brands.
In recent years, OEMs have turned to direct-to-consumer advertising, but targeting physicians and medical professionals, who notoriously disdain overt advertising messages, presents a greater challenge. Delivery systems, the cases and trays that hold and transport orthopedic instruments, offer OEMs cost-effective ways to differentiate brands. Vivid and distinct color schemes, bigger company logos, a more convenient latch system, a streamlined sterilization process—these things are a far cry from a highway billboard or a 30-second Super Bowl spot, but industry professionals say they can make a difference.
Medium for a Message
Any product destined for use in a surgical setting will be held to high standards of quality and performance, but delivery systems present an opportunity for a little extra design freedom. Compared to implants or instruments, a broader range of materials is available, and tolerances need not be as tight. This leaves increased leeway for inventive engineering, aesthetic considerations and color variations. Also, because these items tend to have multiple flat surfaces, plenty of room exists for logos, writing and visual images.
Delivery systems also can add value to OEMs’ products by enhancing convenience. Hip and knee replacement surgeries require a wide range of highly specialized tools and instruments—sometimes up to 200 of them housed in as many as 20 delivery systems, which are laid out on a “back bench” in the operating room. Nurses hand surgeons the instruments as needed and must ensure they are replaced in the correct order. Between surgeries, the delivery systems are removed from the OR by the hospital’s Central Services personnel, washed, then sterilized, dried and put back into storage, where they are expected to remain sterile. Huge opportunities for efficiencies exist in this process. Visual images on cases can help nurses find the right place for an instrument, case design can facilitate sterilization, bar codes can aid in tracking instrument sets and so on.
None of this should imply that delivery systems are exempt from performing extra-ordinarily well. Hospital staff demand that cases and trays efficiently carry instruments without breaking or cracking, even if dropped; withstand the harsh environment of autoclave machines; and keep instruments dry and germ-free. But there is a feeling among those in the industry that basic performance levels have reached a plateau. A few years ago, for instance, concern about plastic components of delivery systems being at higher risk for so-called “wet pack”—ie, failing to dry completely, thus allowing dangerous microbes to thrive in droplets of water—was an issue. However, after much research and debate, consensus holds wet pack not a risk if systems are engineered properly. None of the manufacturers who spoke with Orthopedic Design & Technology believed fear of wet pack should constitute a reason for avoiding polymer components in a delivery system.
“It is only an issue if the cases are not designed correctly, if they don’t have the proper amount of steam holes and proper containment,” said Greg A. Hall, director of international business development for Paragon Medical, Inc., headquartered in Pierceton, IN.
Plastic, Metal—or Hybrid?
Photos courtesy of Solvay Advanced Polymers (top and bottom photos) and Symmetry Medical (middle). |
Here again a consensus is emerging: a combination of the two, hybrid systems. “I won’t say our product is better than metal,” said Shawn Shorrock, global medical market manager for Alpharetta, GA-based Solvay Advanced Polymers, which holds the patent on Radel R polyphenylsulfone’s (PPSU) use in sterilization containment devices. “Even though Radel R PPSU is tough and it retains its toughness, if you are designing a very deep case, one with a lot of instruments that weighs 35 pounds or more, you have to have good drop resistance. The OEMs want that. These cases do get dropped, and they don’t want them to crack.” Consequently, in larger cases, such as the ones often used in hip and knee surgeries where depth might be 7 inches or deeper, there is a trend in the business to construct the base from metal and its insides, lid and latches from Radel R, she said. “I think what we will continue to see is more growth in these hybrid systems—to me that is the best of both worlds in trays supporting hip and knee surgeries.” However, in smaller trays, an all-polymer design probably is a better bet, she added.
An attractive feature of Radel R is its wide range of colors. In 2005, Solvay launched a line of transparent colors specifically targeted for use in lids and latches. The bright transparent colors, through which instruments within can be identified, give OEMs more ways to customize the look of their systems. Shorrock noted the new line has been a hit with clients, adding that a fresh color scheme offers a visual way to broadcast that a product is “new and improved.”
Paragon has employed the new Radel R custom-color line in its distinctive latches, which secure the lids of cases. The company views the patented, injection-molded latches as a brand differentiator. Hospital personnel frequently mention the audible “click” that the plastic latches make upon closure, according to Cory Colman, Paragon’s executive vice president of new business development. “They tell us that this instant, definite feedback is very satisfying—they know the case is safely latched and that it is going to stay latched until the OR team opens it. And that click remains even after thousands of closes and thousands of sterilization cycles,” he explained. The latch system has been around for a decade, but the new colors underscore its function. For example, one Paragon client distributes a case with a black lid, bright green graphics and matching green latches.
Paradoxically, although delivery systems do not require the kind of painstaking engineering effort that implants and instruments do, contract manufacturers that thrive in this business have said they need a talented engineering staff to render these materials into a functioning whole—mainly because the OEMs save the bulk of their engineering muscle for designing implants and instruments.
“It’s a growing area of our business,” said Jim Torgersen, general manager of Valencia, CA-based Stoll Metalcraft, who does about a quarter of its business in the medical field and is known for its delivery systems. “It really took off when we started doing more design work, which goes back about four or five years…We’ve got three engineers [in a department of six] who work on design pretty much full time.” A talented, hardworking engineering staff also allows for quicker product turnaround. “I think engineering is the key. If you have good engineers who can turn around stuff quickly and be innovative, that is where you are going to gain market share,” Torgersen said.
Achieving the right mix of durability, weight, ergonomics and implant and instrument protection can be a challenge, agreed Eric O. Satterely, president of Satterely and Associates, LLC, a manufacturer’s representative firm in Warsaw, IN. “Putting the whole concept together takes quite a bit of engineering expertise,” he said. “Some of these cases are multi-leveled, where you are trying to put the implants and instruments in the same case. You have to be able to get them in and out of the case easily, plus the container and its contents need to be able to be sterilized.”
Visual Appeal Ranks High
Manufacturers said OEMs continue to ask for a higher level of visual appeal and complexity in their delivery systems. Bigger company logos (some insist logos be recognizable at a distance of 20 feet), a wider range of colors and 3-D, realistic-looking images all are popular requests. Hence, contractors must master the ability to anodize metal, silkscreen images and etch metal with a laser—or develop a relationship with shops that can provide these services. Aesthetics drive this trend, but practical considerations also apply. Emblazoning precise images of instruments on delivery systems can aid nurses in remembering where items should be replaced.
Silk screening can produce 3-D graphics, but some shops now offer techniques that turn out even more realistic images, so-called “deep imaging” processes. DigiPrint, a proprietary printing technology developed by Warsaw, IN-based Symmetry Medical Inc., was introduced last year. This process combines printing mechanics and digital technology to provide precise, extremely durable graphics on aluminum metal surfaces. The non-toxic, biocompatible graphics are imbedded below the metal’s surface, making them impervious to scratching, peeling and fading. The technology is compatible with any digital source, from simple, one-color drawings to complex photography. Images taken with digital cameras can be transposed directly to a metal surface. Quality is far better than what can be achieved with silk screens on a polymer surface, according to Tony Foley, senior marketing manager at Symmetry.
Customer Convenience
In addition to making cases and trays more convenient in the OR, there has been a simultaneous push to develop systems that are easier for hospital support staff to handle. Employees of a hospital’s Central Services unit clean the cases and instruments of bio burden, disinfect them, see them through the sterilization process, set them up prior to surgery and lug them out afterward. One of the chief hassles of their job is dealing with systems wrapped in cloth or non-woven polypropylene wrap. The wrap allows steam to enter during the autoclave process but keeps microbes out while the case sits in storage between surgeries. But wraps are awkward, tear easily and may conceal handles. In response, many OEMs offer hospitals rigid, sealed containers that do not require wrapping yet still can be sterilized effectively.
Last year, Symmetry Medical purchased Ultra Containers of America to acquire the Ultra System sterilization container. This lightweight, durable container is validated for steam, EtO or ethylene oxide ethienoxide and Sterrad sterilization and comes in a wide range of sizes and depths, making it suitable for the many different instruments used in orthopedics. “It is more cost effective in the long run,” said Foley. “Rather than discarding two layers of wrap after every sterilization, it has a small filter that is easy to replace.”
Paragon made a similar move this year when it announced that it would enter into a reciprocal supply agreement with Center Valley, PA-based Aesculap, Inc. for distribution of custom closed sterilization containers. A subsidiary of B. Braun, Aesculap manufactures reusable rigid container systems (among other products). This cooperative partnership “addresses an obvious market demand for customized closed sterile containers,” according to a statement issued by Paragon.
Another entry in this category comes from Medicraft Inc., a subsidiary of Elmood Park, NJ-based Phillips Precision, Inc., which makes the ONE TRAY system. This system carries filter vent technology one step farther, modifying it to take advantage of the thermodynamic behavior of steam, according to Percival C. Banks, president of Sterile Containment Technology at Medicraft. Standard autoclave cycles occur at around 250 degrees Fahrenheit. The ONE TRAY system is FDA approved to autoclave a 25-pound gross weight at 270 degrees Fahrenheit. “That is commonly what is used in flash sterilization cycles,” said Banks. “So we are using flash parameters, if you will, with FDA clearance for a 25-pound cycle in just four minutes.” This provides a great opportunity for time savings, he said.
Additionally, eliminating wrapping reduces the number of instrument sets in circulation at any given time, Banks noted. “If the OR has five knee replacement surgeries scheduled, Central Services has to provide six sets of instruments, in case one of the sets has a torn wrap or is opened and found to be moist inside. If this occurs, the staff have to assume the set is contaminated and can’t use it,” he explained. Products such as ONE TRAY limit these uncertainties, so there is no need to keep an extra set handy.
This dynamic also assists OEMs when they market implant systems. Fewer systems in the field that can be sterilized and re-used quicker translates to more trials, wider exposure of the new product and less money invested in overhead, according to Banks.
Keeping track of a large inventory of expensive instruments rates high among the challenges facing Central Services. But delivery systems can lend a hand. Bar codes, radiofrequency identification (RFID) or other markers may be adhered to cases and trays, allowing hospitals to track instruments sets by computer. Records are kept online and backed up by a server. A few mouse clicks determine the location of a set. Even photos of instruments can be kept on file and easily accessed. Not only is this convenient, but it’s a time saver when training new hospital employees.
“We continue to see interest in the RFID tracking systems,” observed Hall of Paragon. The company has not produced an RFID delivery system yet but is a “channel partner” with a company that can provide the technology on cue if an OEM requests it. Hall added that he expects electronic tracking to become more popular in the near future. Many OEMs are considering it as a tool to track and manage their instruments sets throughout the distribution chain.
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Hip and knee replacement surgeries have an underlying appeal not likely to fade any time soon. Millions who would otherwise be confined to beds and wheelchairs regain the ability to walk and even run and jump thanks to orthopedic devices. As these implants become more standardized and entrenched, industry leaders say ancillary factors such as convenience, ergonomics and style will play a bigger role in which ones succeed.