Case Closed: Delivery Systems

Orthopedic cases and trays offer form and function, not to mention aesthetic impressions.

Jennifer Whitney
Editor

Orthopedic surgeries have long been well known for their array of customized, unique instruments not seen in other types of procedures. While general surgeons may be content to grab their tools from a simple wire basket, the same can’t be said in this field. Indeed, presentation, containment and protection play a much bigger role in the tools used in bone-related surgeries.

Since some surgeries can involve hundreds of instruments, manufacturers of instrument cases say it’s imperative that each item be properly labeled, laid out in a logical stepwise pattern and be easily accessible. Protection also is important, as the instruments often are very expensive.
 
It’s no surprise, then, that one of the top requests case manufacturers receive is for a delivery system that is as robust and sturdy as it is practical. Even more important, however, is the attention that must be paid to ensuring that the case is optimally configured for instrument sterilization.  

Since today’s OEMs are focused on developing, selling and servicing their implants and other technology, cases and trays usually are the last component designed for a particular surgical system and are almost always outsourced by OEMs to contract service providers. Case manufacturers are well poised to ensure the final product facilitates full sterilization and benefits everyone from the surgical staff, instrument processing centers at hospitals and even patients.
 
“The whole idea is to reduce surgical time,” said Andy Miclot, senior vice president of marketing, sales and business development for Symmetry Medical in Warsaw, IN. “When things are nice and organized, and it’s easy to identify instruments in the cases, it makes everyone’s job a little easier…particularly the patients, as they’re happy the procedure is reduced in time.”

Style and Substance: Material Matters

Before the cases even reach a hospital, today’s delivery systems tend to go through rigorous shipping and distribution processes that often leave them abused. As a result, case manufacturers have spent the past few years developing better designs that allow for that type of handling.

One way to accomplish this is through the use of stronger materials. In the manufacture of cases and trays, the final product consists of plastic, metal or a hybrid of the two. All have benefits and drawbacks; therefore, selection of a material must be carefully weighed.
 
Plastic, which gained popularity within the past decade, can offer certain benefits: it can be more cost effective and lightweight than certain metals, cools faster during manufacturing, can be cleaned as well as metal can and may be customized fairly easily.
 
In addition, polymers enable a variety of textures that can help keep instruments from sliding around during transport, protecting the equipment.
 

Today’s delivery systems come in a variety of shapes, colors and sizes, with multiple options for material selection. Photo courtesy of Paragon Medical.

Even though plastic gained popularity over the past decade, many case manufacturers believe it has lost a bit of its edge in this market because of its propensity to become brittle and crack after repeated autoclaving. In addition, since plastic insulates by nature, and the instruments tend to be metallic and need time to cool down after sterilization, condensation can form and compromise the paper that gets wrapped around the case, breaking the sterile barrier (this problem is known as “wet packing”). After all, the question is, when did the water get into the case and is it sterile water?

“It’s pretty while it’s delivered, but plastic tends to have a shorter service life,” noted Mike Librot, vice president of sales for Medin Corp. a contract delivery system manufacturer based in Passaic, NJ.
 
Plastic doesn’t always offer cost savings, either. When used in trays, polymers can require extra tooling and forming during manufacturing. In addition, resin, in its raw form, is more expensive than some metals, according to Greg Hall, director of international business development for Pierceton, IN-based Paragon Medical. However, he acknowledged that these extra costs often can be mitigated through expert creative design approaches.

Various metals, as with plastic, offer many benefits in delivery systems. The most prominent is reduced wear and tear, as well as less risk of scratching over time—all of which equate to a longer service life, experts say. Furthermore, some companies prefer metal, Hall noted, because certain hospitals may perceive polymers as an impediment to effective sterilization.

Among the metal options, aluminum is one of the top choices for case manufacturers because it is lightweight. Titanium also has gained some ground because it, too, is lightweight and also is inert to high pH levels in detergents and disinfectants; however, it often still is considered too expensive for use in delivery systems.

In Europe, stainless steel—not aluminum—has become more widely used in case manufacture. Sodium hydroxide and other harsh cleaning materials can have a detrimental impact on aluminum over time, Hall noted. The cleaning products also can present problems with anodization, as they slowly eat away at the anodized layer on aluminum cases, causing pitting and stripping.

Color anodizing and 3D silkscreening can be used to create a strikingly attractive yet functional design. Photo courtesy of Medin Corporation.

Medin Corp. has managed to sidestep these issues by developing additional steps in the anodization process. This modified process makes aluminum more resistant to the effects of high pH detergents and disinfectants, Librot said.

When neither a metal nor plastic is preferred on its own, a hybrid combination of the two may be selected. “Some hybrids we’ve been selling have a metal case for the outside with plastic trays inside,” Miclot said. “You have the perception that the case is really strong with the metal, and they’re nice and organized on the inside with the plastic tray.”

As prices for most raw materials continue their upward climb, many case manufacturers are exploring alternatives to the standard materials used in delivery systems. The problem, these experts said, is that any new candidate must be able to withstand the myriad factors—sterilization, shipping, etc.—as well as be validated before use.

For the past four years, case manufacturer Jewel Precision has been working with a plastic-based polymer called PlasTel. “With a patented process, we coat a lightweight aluminum tray with PlasTel. It gives a look and feel of a plastic tray with the sterilization integrity of an aluminum tray. And it comes in several colors. It’s been very popular,” said Jerry Grieco, vice president of the Cedar Grove, NJ-based company.

The preferred thermoform plastic still is Radel, according to Librot. As prices continue to climb, however, Medin Corp. and its Radel manufacturing partner have been investigating a lower-cost alternative that he claims has all the physical and sterilization properties of Radel, but with a lower price tag. He estimates it will be available within the next few months. “It’s an example of how we partner with our suppliers to develop more cost-effective offerings with a notion to be passing on those savings to our customers,” Librot said. “We have an obligation to be more competitive among companies that do what we do. But also we have an overall responsibility to the healthcare system, to try to delivery those healthcare dollars as wisely as possible.”

Design Elements

Regardless of material selection, certain designs take their cues from consumer markets in today’s delivery systems.

In particular, low-profile, thin modules are following the trend of consumer electronics. “The Razer phone is so popular, and the thinner your [computer] notebook is, the more it tends to sell,” noted Grieco. “Of course, thickness is dictated by the instruments in the case, but we’ll try to do the thinnest and slickest design we can come up with.”

Rounded corners and modern, space-age looks also are permeating designs. Case manufacturers say their OEMs want delivery systems that will catch a surgeon’s eye when a sales representative walks into the doctor’s office. As Grieco noted, “Even if an OEM has spent millions developing implants, the first thing the surgeon is going to see is the [delivery system].”

Aside from aesthetics, the most important factor is how well the system performs in terms of facilitating effective sterilization. “More designs are incorporating a universal DIN-size footprint, and more designs are utilizing additional ventilation holes that should result in a lighter set with shorter drying times,” noted Jim Spencer, president of Advantis Medical, Inc., a Greenwood, IN-based manufacturer of delivery systems.

In terms of design, certain other  factors play a role:

Branding initiatives. As the orthopedic market continues its trend of consolidation and competition, branding initiatives are becoming even more paramount to all the players in the industry. Therefore, utilization of vivid, brand-defining graphics is more the rule than exception today. Silkscreening, anodization and lasering all have been used in the past, but the newer trend, experts say, is the use of “digiprinting”—digital images imprinted on the cases and trays.

“If you have a digital camera, you can take a picture and put that image on the case,” Miclot said. “It really helps customize a case. The cases look nice and the image doesn’t wear off as much when you use a digital print. And it can help keep the case from scratching, too.

“In the past, it was just logos being used,” he continued. “Now a customer can take a picture of anything, such as a knee, which helps identify the components in the case.”
 
A blend of standard, modular and custom components also can help differentiate one case from another.

“A lot of customers are looking for modular systems, but they still want their own unique look. We’ve been able to design systems that utilize standard components but are flexible enough to provide the customization they’re looking for,” Hall said.

Weight and balance. These are critical factors in ensuring the delivery system is optimal. The lighter-weight materials available today are aiding the cause for easier transport, not to mention helping to reduce fatigue among nurses and other staff who must transport instruments. This can be particularly important when you consider that a knee surgery might necessitate as many as 20 cases full of instruments to be used.

Balance is important as well, given that an optimally configured system will ensure that the heaviest and lightest instruments aren’t placed on opposite sides of a case.

Instrument positioning. Since instrument protection is vital, case manufacturers spend time discussing with customers the optimal way to position items within trays. Thermoforming, in which a polymer is molded to form-fit an instrument, can help cushion an instrument during transport and also enable operating room staff to locate—by shape—where an instrument should be placed after the procedure according to shape.

Bracket design also is important when thermoforming isn’t used. Jewel Precision has been using rigid silicone brackets that are reinforced with aluminum. And Medin tries to vary the thickness of brackets according to each instrument.

External case “feet.” Some OEMs want their cases to have little “feet” (or “nipple masks”) at the bottom of the case, to help it stand up easier and keep it protected from scratching, as well as keep the case slightly elevated during sterilization to help the steam adequately circulate through the holes.
 
However, in the quest to protect one’s own case, other delivery systems stacked below or above a “footed” case can become prone to scratches from these feet or, even worse, the feet could cause tears in the sterile surgical wrap around the case.
 
Recognizing both the utility and problems these nubs offer, case manufacturers have been working on designing feet that are either rounded (rather than square) or are made of silicone.
 
Labeling. Since many implant systems require numerous trays and dozens of instruments, it can be difficult for the hospital staff to repopulate the trays following a procedure.  Successful companies have overcome this issue by utilizing better graphics and labeling to quickly identify the proper location of each instrument within the trays.

“There are a number of things companies can do to make it easier for the OR staff to use their products,” said Damon Peary, CEO of Bozeman, MT-based Summit Corporate Services, Inc., a provider of outsourcing solutions for the medical device industry. “When recording catalog numbers and lot numbers on surgical reports and patient charts, something as simple as providing peel-off labels with your implants can reduce errors and save OR time.”

It’s All About Sterilization

In the end, it doesn’t matter how attractive or protective a delivery system is if it doesn’t effectively do its job in ensuring that instruments can be fully cleaned and sterilized.

“Sterilization is probably the most important consideration in designing a system. You want to make sure the cases and instruments inside are sterile. Where the holes are placed in the cases and trays is important,” said Miclot.
 
Case manufacturers must apply a science of sorts to ensure that utilization of ventilation holes in the cases are optimally placed and sized to ensure that steam can pass through. “We utilize a formula based on mass, but our designs are largely based on the vast experience in our engineering department. A lot that goes into the distribution of the instruments within the case design is to compensate for mass,” noted Librot.  

The position of the instruments matters as well. For example, an instrument sitting in a custom thermoformed pocket usually has ridges built in that lift the instrument from the bottom to ensure maximum steam circulation. And each tray inside the case might have small feet that will sit on top of the other tray, so there’s nowhere for contamination to build up. If silicone mats are used for the trays, they are designed with ribs and holes as well, to prevent clogging.

Partnership Counts

One issue affecting instrument manufacturers and their delivery systems alike is validation. According to Librot, OEMs are paying more attention to their responsibility for this quality control initiative than ever before.
 
As validation becomes ever more important, Medin Corp. has been working closely with customers to coordinate validation services with an independent third party or simply by offering recommendations for service providers to customers. Since Medin has extensive experience designing and engineering cases and trays that pass validation, the firm has pledged to customers that if a tray doesn’t receive validation and the company finds that it was directly attributed to the tray configuration (vs the instruments inside), the firm will design and prototype a new tray free of charge to the customer.
 
Other case manufacturers similarly have been working closely with customers to ensure that all phases of design and manufacturing are smooth. Symmetry, for example, uses its Total Solutions Model, which offers systems that include both cases and instruments (and even implants, if desired). This type of “one-stop shopping” can shave as much as a year off the time it takes to get a product or system to market, Miclot said.
 
“Customers are always looking for novel ideas and ways to get to market faster so they can earn revenue from product introductions sooner,” he said.

As with many companies serving as a contract service provider to orthopedic OEMs, case manufacturers say they constantly get the proverbial short end of the stick when it comes to timelines. Even though this problem falls square on their shoulders, case manufacturers are figuring out how to achieve OEMs’ goals while improving their own internal systems. For example, Advantis Medical has looked beyond manufacturing and is improving its efficiency in through focusing on logistics. “We have installed a new and sophisticated ERP [enterprise resource planning] system to ensure that our delivery times are the fastest and most consistent,” Spencer said.
 
And the need for belt tightening—ie, lower costs—is another charge for case manufacturers. To keep costs down and service level and engineering up, Paragon Medical has branched into various geographic locations, leveraging cost benefits from operating in areas such as Europe and Asia in conjunction with its six domestic facilities.
 
Advantis Medical similarly looks for opportunities to reduce costs. One tactic has been to purchase raw materials in bulk, which helps the company pass savings to customers. In addition, Spencer noted, “We have also been working with our customers to help them understand the differences between ‘wants’ and ‘needs’ and the impact that different options can have on prices.”

Jewel Precision also has been building partnerships with universities such as the New Jersey Institute of Technology and Stevens Institute to develop new components for its cases and tray designs.

Ultimately, as delivery systems grow more complicated and efficacy and ease of use remain paramount to a product’s success in the marketplace, case manufacturers are well suited to tackle the challenge for their customers.

“Our customers’ problems are ours; their launch date is our launch date,” Librot said. “We evaluate all of our customers’ problems and do our best to offer intelligent solutions.”