Fine-tuning the Instrument Set
Creativity and problem-solving help orthopedic manufacturers rise above the competition.
Jennifer Whitney - Editor
Turn on the television or read a magazine and it’s obvious that the topic of orthopedic surgery isn’t just a discussion among industry professionals anymore. As the population ages and healthcare strides enable people to live longer, more active lives, the frequency of injuries and problems such as back or knee pain increases.
Offset cup impactor for minimally invasive total hip replacement. Photo courtesy of Precimed, Inc.
As a result, companies have started tapping into the lucrative market of what’s often considered elective orthopedic surgery by directly marketing implants and related procedures to consumers. And as consumers become more educated about the benefits of minimally invasive procedures, they are increasingly demanding this type of surgery and are subsequently helping drive the need for OEMs to deliver instruments that facilitate these operations.
In a $12 billion orthopedic market poised for exponential growth—spinal procedures alone are growing at a rate of 20% annually—minimally invasive and computer-guided surgeries are growing in popularity, especially among younger surgeons, who are adopting innovative techniques early in their careers. With procedures such as knee replacements currently performed with minimally invasive surgery (MIS) only about 3% of the time, the market will keep flourishing as more surgeons adopt these techniques. This means that manufacturers must address the need for smaller, simpler instruments that enable patients to incur the least amount of tissue/bone damage and resume their daily activities as soon as possible.
While answering these needs, manufacturers are also addressing surgeons’ needs—as well as their desires—by using a variety of innovative designs and materials to create instruments that facilitate quicker procedures and complement computer imagery guiding the surgery.
As the typical decision maker at a hospital, surgeons are much like the average consumer shopper: they know what they want. Quality, longevity, precision, a good feel and stability (ie, an instrument that doesn’t move or shake during use) are all imperative to them. Beyond those needs is a more pressing one: simplicity.
“Surgeons like to use instruments they know how to use that aren’t so complicated that they need five courses to learn how to use them. They want instruments that can help them perform a procedure faster,” said Andy Miclot, senior VP of marketing, sales and business development, as well as investor relations officer for Symmetry Medical in Warsaw, IN.
From a design standpoint, today’s instruments must address the need to finish a procedure quicker than it may have taken in the past. Surgeons want their patients up and walking within hours after surgery, not days. Therefore, design must focus on ways that help ensure the least amount of trauma to the area being operated on.
In addition to patient benefits, surgeons also care about the feel of an instrument. “It’s like when you pick up a good pen and it’s got a nice feel to it and you think, ‘Wow’—it’s not like holding a Bic pen ... it’s all about the feel for doctors,” said Tanya DiSalvo, president of Criterion Instruments in Brook Park, OH.
In speaking with professionals who help manufacture orthopedic instruments, some common themes emerged regarding recent trends in instrument design.
Newer handle features
Gauthier Biomedical's large silicone fixed T-handle with a no-play AO connector offers a precision connection to standard instruments. Photo courtesy of Gauthier Biomedical.
Surface finishes are also being customized with varying textures to enable more leverage or grips on the handle. These considerations can be especially important as surgeons wearing latex gloves encounter fluids that can create slippery environments.
“The silicone handle is still the best non-metal handle providing the best grip, balance and ergonomics,” reported Doug Slomsky, director of sales for Teleflex Medical-OEM in Bannockburn, IL.
A well-organized instrument set often determines how much time will be saved during a procedure. In the technical, mechanical environment associated with orthopedics, manufacturers are getting creative by adding color to instruments themselves—not necessarily for aesthetics (though as the brand recognition section below will describe, this is a consideration as well), but for better utility.
“In the past, kits were pretty bland and generic,” explained Michael Gauthier, president of Gauthier Biomedical in Grafton, WI. “Now it’s more aesthetics and function. People want to see what instrument can go with an implant, so they now can color code. These features make instruments more useful than in the past.”
Miclot agrees. “A well organized instrument set means [surgeons] can go from one instrument to the next without having to hunt them down. Good graphics and color coding [including color coding instruments with implants] help them get the right instrument as quickly as possible.”
Because silicone and other materials can be customized with color, suppliers are now offering custom colors in both kits and instrument handles. Using the Pantone Matching System (PMS), different dyes can be blended and molded with various durometers (measures of hardness).
Today’s instrument sets are more organized and lightweight than those used in the past. Photo courtesy of Symmetry Medical Inc.
Additional features, such as custom-colored silicone handles or touch points with silicone padding, are minute details that may aid a manufacturer’s quest to offer an instrument that will stand out from the competition. Since similar instruments by competing manufacturers may vary in size by only 1-3 mm, differentiating features can make all the difference in a surgeon’s selection, Slomsky reported.
Weight, size allowances
As noted previously, MIS and computer-guided surgery are greatly influencing instrument design. The type of procedure also dictates size parameters. For cervical spine or neck procedures, instruments tend to be much smaller than those for lower back surgery. For knee and hip procedures, the instruments are even larger.
The new technologies being used today in the OR often require tighter tolerances on instruments, especially in hip and knee procedures. Precise measurements are extremely important when manufacturing an instrument that will be used in computer-aided surgeries, since these procedures don’t allow as much room for error as more traditional surgery may have. Tolerance also becomes an issue when you consider that the instruments must correspond perfectly with an implant being used.
Because instruments have to reach into slimmer portals—a hip incision can now be about three inches, compared with the original 11 inches—products have to be smaller, longer and slimmer. “A lot of innovation comes from understanding the surgeons’ needs, especially when learning new techniques and procedures, like the limited view sites of minimally invasive protocols,” said Barbara Lyons, director of marketing for Exton, PA-based Precimed.
Manufacturers are also paying attention to how much instruments weigh. The core of an instrument might be constructed with particular attention to making the overall piece lighter for ease of use during surgery. A lighter weight also can appeal to the individuals who must carry entire instrument sets into the OR. Miclot pointed out that nurses often carry instrument sets back and forth, and it’s obviously easier for them to lift an 18-lb set versus one that’s 30 lbs. Such factors can contribute to facilitating quicker procedures and ease up the exhaustion factor associated with performing intricate surgery.
Most major instruments being used in orthopedic procedures today are reusable. While the future may see a trend toward developing more disposable instruments to reduce liability risks, most manufacturing partners don’t see it happening anytime soon. Thus, the key issue right now is to ensure that designs address sterilization, cleaning and re-assembly requirements.
Array of Metals: Material Selection
While many of the design features outlined previously can enhance the success of an instrument in the marketplace, OEMs remain acutely aware that one of the most important considerations in instrument manufacture is the material being used. Suppliers report that a limited number of alloys or other materials have the necessary combination of strength and other properties to be used in the body. Compatibility with other components of the instrument as well as an implant is also factored. In addition, since many surgical instruments are reused, materials have to be compatible with sterilization methods to avoid corrosion.
While ideas for design may remain unlimited, suppliers and contract manufacturers say that the number of materials leading the pack in instrument design is generally limited to the following categories:
• Stainless steel remains popular.
Unfortunately, the right type of steel is tough to find at times; in fact, some grades are becoming scarce. Regardless, OEMs and suppliers are finding new uses for different grades of steel. In particular, nickel-free stainless steel reportedly offers higher levels of strength and better corrosion resistance; however, DiSalvo has found that it’s been difficult to find many suppliers that offer this material.
• Titanium is the strong newcomer.
While titanium isn’t new to the implant field, this strong alloy is lightweight and thus has been increasingly utilized in instruments.
• Nitinol offers unique applications.
Formerly used in dental braces, manufacturers and suppliers have figured out that the malleability of this material—a shape memory alloy—offers a high degree of flexibility. Criterion Instruments finds that nitinol’s “bendy” properties are particularly useful in drills. “It’s not stiff, so [surgeons] don’t have to drill a straight hole,” DiSalvo explained.
Gauthier Biomedical recently developed a silicone-coated nitinol wire for use in spinal surgery. The material has graduations that allow surgeons to bend the wire to approximate the curve of a spine. Once the wire takes form, surgeons can then bend the titanium or stainless steel rod to match the curve of the wire. An added benefit is that the wire is reusable—once the wire reaches boiling point during sterilization, it straightens itself.
• BioDur is gaining ground.
Manufactured by Carpenter Technology Corp., this alloy has often been used in implants and pins. With low corrosion resistance, ease of fabrication and edge retention, BioDur is making headway into instruments. DiSalvo reported that its incredible strength is what’s driving this trend.
Outsourcing Partners Help Guide Decisions
While the design stage can be quite exciting with all the unique features and material options, manufacturers still must contend with the need to compete in a tough reimbursement climate. And after overcoming any regulatory hurdles, OEMs also have to consider any potential liability problems with a new instrument.
With so many products in their pipelines, manufacturers often find it difficult to focus on every aspect of bringing a new instrument to market. Many who choose to focus on implants outsource the development of accompanying instruments. After all, facing the obstacles that can cause headaches is often easier when an OEM finds a trustworthy and knowledgeable co-development partner or contract manufacturer.
“We have big customers and they have big needs and they have huge demands,” Miclot said. “Our sales force is constantly working with our customers to resolve any issues that come up.”
One major reason behind the shift to outsourcing is the high cost of investing in equipment to manufacture new products. Companies interviewed by Orthopedic Design & Technology reported that they spent anywhere from $100,000 to $750,000 in the past year on new machines and computer technology. Supply partners are investing in everything from wire EDM to laser marking to CNC machines, and so on. With tolerance requirements being so tight and the need for precise, smooth components, money isn’t the only consideration when purchasing such sophisticated equipment—for every machine a company invests in, the supplier needs to find an educated operator to run it.
The payoff is that the newer equipment offers 30% to 40% faster production, saving everyone involved time and money.
Whether the customer is a large OEM or small startup company, suppliers are increasingly devising other unique solutions to the challenges manufacturers face in today’s competitive market. Some companies are adding prototyping capabilities to their repertoire to address engineering issues or tight timelines. Others are offering storage solutions, quicker deliveries, bundled products, blanket orders and other options that are cost-reducing measures and help speed time to market.
Companies such as Precimed have been simultaneously developing their design innovation while working in tandem with customers to solve dilemmas. “I think customers and OEMs are looking toward strategic partnerships rather than just vendor relationships,” Lyons noted. “That will impact instrument design, because the OEM can focus on the implant and we can concentrate on innovation in instrumentation.”
In providing this innovation, contract manufacturers and other suppliers realize that costs are a big factor in the development process. Therefore, many companies will develop a standard line of instruments that can be customized with more or fewer features, depending on an OEM’s budget. Other companies, such as Symmetry Medical, will assemble a set of instruments in an OEM’s packaging to help reduce costs (and save inspection time). Miclot explained that Symmetry’s approach enables a customer to inspect all completed sets at once before shipping them to a distributor—if a set contains 100 instruments, for instance, the OEM won’t have to pay for any of the components until the entire set is complete and approved. A bonus to such an offering is reduced inventory costs.
Teleflex Medical’s Orthopedic OEM division focuses on supply chain management by combining steps—the result being more efficient manufacture of large quantities and fewer redundancies.
Slomsky offered this advice for OEMs looking to outsource: “Determine what is needed in a partner long term ... Does the capacity have scale, investment, improvement and cutting edge innovation? If a customer neglects any one of these items, there is a risk to the supply, quantity, competitiveness and longevity of the product line.”
Furthermore, since suppliers and contract manufacturers usually aren’t privy to the feedback OEMs receive from surgeons in the OR, DiSalvo believes it’s crucial that manufacturers remember to pass on comments they hear so instruments are continually improved.
The Bottom Line
As consumers continue to demand sophisticated surgical techniques—and surgeons readily adapt to using them—the market for instruments will only grow as the orthopedic market skyrockets. Working together, manufacturers and their outsourcing partners are making great strides in creating both useful and creative designs that are sure to be even more innovative over time.