02.15.08
Instruments of Change
Instrument manufacturers continue to adapt to meet ever-changing clinical needs.
Christopher Delporte
Group Editor
To the untrained eye, even modern orthopedic procedures—a total knee replacement, for example—could seem barbaric. There’s something a little Medieval about sawing into bone. In reality, however, in the past decade, tremendous advancements have been made in the reduction of surgery duration, length of hospital stays post procedure, improvement of recovery time and durability of implants. Gone are the huge incisions. Now, patients often are up and walking a day after major joint replacement surgery.
Modern design technology and materials provide today’s orthopedic instruments, such as the drill shown above, with unprecedented strength, flexibility and capabilities. Photo courtesy of the Precimed Group. |
Approximately 56 million people in the United States suffer musculoskeletal injuries annually, according to the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. CDC figures also estimate that roughly 6 million fractures occur in the United States each year, and 1.5 million people suffer a fracture caused by bone disease. Statistics such as these will keep orthopedic engineers increasingly busy for the foreseeable future. Research released in December by Medtech Insight showed that in 2006, US sales of orthopedic implant, reconstruction and trauma products totaled approximately $12.2 billion. Sales are expected to increase at a compound annual rate of 6.9%, reaching more than $18.1 billion by 2012.
To keep pace with growth, OEMs work with a number of contract manufacturing partners to develop new and innovative solutions for instruments that work hand-in-hand with the latest devices for optimal outcomes. Typical instruments, particularly for joint replacement, include reamers (acetabular, straight and flexible), screwdrivers, resurfacing tools, handles, guides, cup instruments, drill and taps, among other procedure-specific instrumentation.
According to the suppliers who spoke with Orthopedic Design & Technology, current trends in instrumentation include smaller, stronger and lighter devices. Though traditional materials such as hardened stainless steel remain the gold standard, designers and engineers are using titanium alloys, high-performance plastics and high-tech carbon fiber to respond to end-user calls for improvements in strength and weight.
“While the implant may be the sexiest product in orthopedics, the instruments are critical to ensuring that the clinical outcomes are what physicians are looking for,” said Barbara Lyons, director of global marketing for the Precimed Group, a contract instrumentation and implant manufacturer based in Switzerland (US headquarters are in Exton, PA) that recently was purchased by Greatbatch, a medical device component manufacturer based in Clarence, NY (see Industry News on page 68). “We’re in the business of improving the quality of life. So when you talk to our engineers and our innovators, their biggest concern is how it benefits the patient. You may have the best implant, but you won’t get far unless you have the right tools. The right instrument can make even the best implant even better.”
Chris Rawlins, sales manager for Mentor, OH-based Miltronics and Skye, agreed that instruments play an equal role in the success of any orthopedic procedure. “MIS, for example, is a big part of my business,” Rawlins explained. “The idea is to get in and out very quickly and shorten recovery time, make it faster and less expensive to implant. But the challenges are you’ve got a surgeon working in a confined space with little visibility, with just the guidance of the instrument. So the instrument has to be perfect. Coupled with modern imaging systems, it makes for a powerful combination.”
New Markets, New Technology
The growth of MIS and computer-aided surgery was consistently identified by instrument manufacturers as a critical factor impacting approaches to developing new surgical instruments today. “MIS is at the front of everybody’s mind,” said John Phillips, vice president of operations at Phillips Precision in Elmwood Park, NJ.
Requirements for instruments are becoming more demanding as procedures become increasingly complex and restricted through smaller incisions, forcing manufacturers to provide more compact instruments with increased functionality compared to instruments of the past.
“Our challenge is to stay ahead of what’s coming to the market and try to anticipate how MIS, for example, impacts instrumentation. Innovative instrumentation makes MIS possible,” said Charles St-Maurice, Precimed’s vice president of US sales and business development. “That’s where instruments in recent years have really made a huge impact on the surgical procedure side. When you had larger incisions, you had more room to maneuver, and now the instruments have to be curved, angled and slim-lined so that they fit within a smaller envelope in terms of the wound site and don’t cause any tissue damage while you’re doing the procedure. There is a lot of innovation in design and development work that goes into making a reamer handle, for example. What’s the optimum angle? How many curves can the reamer have and still be effective and maintain the necessary level of strength? How much space do you need between the handle and the acetabular reamer itself?”
To help answer those—and many other—technology and functionality questions, Precimed and Miltronics and Skye engineers routinely work in cadaver labs and often are on hand in the operating room to see how surgeons are using their products so the engineers can note any possible improvements.
“We get right down in the trenches with customers, and surgeons to get direct feedback,” Rawlins said.
St-Maurice added: “Physicians are always very interested in the quality of the product more than anything else. Is this instrument going to help me do my job, better, easier, faster? Will it help to make procedures less complicated? That’s where their focus—and ours—should be, because it translates into better patient care.”
Rawlins said the direct feedback is critical, particularly as instrumentation is designed for new surgical methods and growing sectors, such as spine.
“We supply a great deal of total disc implant components and instruments. Cutting-edge spine fixation technology are dynamic devices,” Rawlins said. “The tolerances are so tight because the implant needs to be so precisely placed in the body through a small incision, and that’s where the complexity of the instrument becomes a key part of being able to do that. Particularly in spine, we’re seeing the increased need for tubular instruments.”
The spinal surgery market is one of the fastest growing segments within the orthopedics industry. According to a new report by research and consulting firm Frost & Sullivan, the future of the spinal surgery industry is driven by minimally invasive therapy and motion-preservation approaches. The market earned revenues of $2 billion in 2006, and Frost & Sullivan estimates it will reach $3.67 billion in 2013.
“Spine is a very fast-growing and extremely competitive sector. If you look at hips, knees—there are some innovations, but the real growth we’re seeing currently is in the spine market,” Precimed’s St-Maurice said.
Phillips Precision also has seen spinal instrumentation begin to outpace some of its more traditional orthopedic sectors.
“You can talk all you want about knee, hip, elbow or shoulder, but spine is really growing right now. Gender-specific knees and hips are great, but spine is really hot,” Phillips said.
For all the possible iterations currently available for orthopedic instruments—whether they be for spinal, hip or knee applications, among others—the process very often starts with selecting the right material.
“Along with instruments that are getting smaller and more refined that do multiple things, we’re also seeing an increase in the use of advanced materials such as Nitinol,” noted Tanya DiSalvo, president of Criterion Tool in Brook Park, OH. Nickel titanium, or Nitinol, which has found applications in other medical devices such as cardiac stent products, is known for its strength and flexibility. It is extremely elastic and able to withstand a large amount of deformation when a load is applied and return to its original shape when the load is removed
“When you’re looking at something the size of a pencil made in Nitinol, it bends. Doctors want devices that will work their way into corners and small spaces. It goes back to the demand for minimally invasive instruments,” DiSalvo added.
Experts also noted increased use of titanium, along with more traditional materials such as stainless steel—perhaps the most common—and cobalt chrome. Carbon fiber also is finding applications because it is strong and much lighter.
What the Customer Wants
Development of the optimal product with the optimal design, materials and features often isn’t done by the OEM alone. In fact, the experts who spoke with ODT said that their OEM clients are looking for earlier involvement with their manufacturing providers and are demanding a wider range of services from one provider.
Precimed’s Lyons noted that while instrumentation has evolved, its route to market has as well.
“Our relationships have changed. Today, compared to just a few years ago, our client relationships are more partnerships,” she explained. “And where you see consolidation within the major orthopedic companies, we also see that on the supplier and outsourcing end. There’s more consolidation, and suppliers are no longer are just one-item job shops.”
St-Maurice additionally noted that orthopedic OEMs realize the cost and quality benefits of an outsourced partnership, particularly if the interaction is early and often.
“Like with many companies, there are financial constraints in this industry, so they are trying to outsource more and take costs out of the equation along with the capital investment and labor,” he said. “And they rely on organizations like ours to support them. They want us to help them to better position themselves in the marketplace. Some customers use us transactionally and limit access to where they just send us drawings and specifications, but most engage us very early, which we prefer. And for them, it’s more beneficial.”
Rawlins described a similar trend at Miltronics and Skye. His company employs new-product-introduction design teams that interact directly with the client from the beginning to provide best-case scenarios for manufacturability and cost. One such scenario is having instruments manufactured in conjunction with implants to ensure optimal interplay between the devices.
“You want the interface between implant and instrument to be flawless. I’ve worked with clients when instruments and implants were made by two different manufacturers. When everything is said and done and the products are launched, the client has implants and instruments that don’t work very well together, even though they were designed by the same person,” Rawlins explained. “So we try to approach it proactively and systematically. It’s a joint development process. Getting involved at the front end is absolutely key. All of our customers are looking for a partnership. They all rely heavily on us to help them through the design hump and move the product to launch phase together, so once designs are FDA approved and ready to run, they are getting flawless products that are manufacturable. That’s where we build value.”
The payoff from early interaction usually means getting new products into the hands of end users as quickly as possible.
DiSalvo said her customers consistently look for high-tech results that enable speed to market. Criterion, unlike Precimed and Miltronics and Skye, serves the orthopedic industry as more of a custom job shop, focused on low-volume prototype and development instruments with a focus on design for manufacturability.
“Our customers are looking for customized instruments made and shipped and ready for surgery in an exceptionally short period of time based on every doctor’s flavor,” DiSalvo said. “Shortening that time is key. They want it out in the field quickly for their 510(k) testing. And the start-up companies want to start making money quickly.”
After a product reaches the healthcare setting, the challenges don’t necessarily end for instrument manufacturers. OEMs expect to have their products on the market for a while, particularly as physicians are a finicky bunch and often get used to certain products.
In recent years, many of the large orthopedic OEMs have been maintaining smaller inventories, and they want their manufacturing partners to help them with supply chain logistics. (For more information on supply chain issues in orthopedics, see “Supply Chain Evolution” on page 44). Instrument manufacturers aren’t immune to that trend. According to Phillips, current lean inventory trends are proving to be a challenge for his company.
“Medical device companies continue to reduce their inventories as a cost-reduction vehicle. Large companies felt they had too much product in house,” Phillips explained. “They are attempting to better manage the supply chain. Smaller lot quantities placed on blanket POs [purchase orders] seem to be the most popular avenue at this time. This works well until there is a spike in demand or a special requirement for a scheduled surgery and companies need the product sooner than forecasted. Using Phillips’ EPM [electronic project management] system, we have the ability to re-allocate our resources with minimal disruption to already-scheduled deliveries. For our customers it comes down to quality, price and supply chain agility.”
St-Maurice agreed. “Ultimately, our customers are expecting speed to market, quality and reliable instruments that will perform and not fall apart in the surgeons hands and, of course, at a reasonable cost,” he said.
No matter what form the relationship takes, one driver that remains constant is the role technology plays in achieving goals: a successful surgery and a healthy patient.
Sterilization Issues: Reuse or Make It Disposable?
Whether an instrument is used in replacing a hip, knee or spinal disc, chances are it will be sterilized after the surgery for use in another procedure. Surgical trays are specially designed to make the process easier. Sterilization of medical instruments is a hot-button issue for the FDA, medical device manufacturers and hospitals alike. In orthopedics, many instruments in the surgical setting are sterilized after a surgical procedure by third parties or hospitals and then used again in another setting. The FDA has begun to crack down on accountability and traceability issues following a number of lawsuits involving reused devices (many of which were labeled by OEMs as “single use”) that led to patient injuries. To make matters even more complex, some instruments even can be found on EBay. Issues of cost, ease of use and rapid turnover for hospitals must be balanced with ethical concerns regarding patient care and safety.
Given the large responsibility involved with ensuring instruments are properly sterilized, many companies are re-evaluating product designs and devising single-use, disposable instruments as a means to reduce the chance of infection and allay some of the industry’s concerns regarding reprocessed devices.
The Precimed Group (headquartered in Switzerland, with its US base in Exton, PA) is one such company working on disposable instrumentation.
“There is a lot of liability surrounding sterilization and cleaning. And if hospitals don’t have to clean and sterilize instruments, there are significant costs that are taken out of the equation when it comes to a full procedure,” said Charles St-Maurice, Precimed’s vice president of US sales and business development. “We’re working to develop full single-use kits that are supplied to customers sterile packed and ready to go off the shelf and into the operating room for one patient. They are made out of materials that are optimal for single use. We do some disposable instrumentation now, but we’re trending toward the complete kits being disposable.”
Barbara Lyons, director of global marketing for Precimed, explained that disposable instruments wouldn’t sustain their cutting ability after use with one patient. And to ensure that some devices couldn’t be sterilized and reused, they would include plastic parts that could deteriorate if autoclaved. (An autoclave is a pressurized device designed to heat aqueous solutions above their boiling point to achieve sterilization.)
She added that current manufacturing processes—including metal injection molding and plastic injection molding, where thousands of parts can be made in less time and less expensively—have helped to make such single-use instruments a reality.
Another trend relates to the design of instruments that contain both reusable and disposable parts. Chris Rawlins, sales manager for Mentor, OH-based Miltronics and Skye, said his company has been working on these types of products for its customers.
“A small portion of the instrument is disposable and the main base could be reused—screw guns, staplers, for example,” he explained. “A typical stapler would be used once and then discarded. I have clients now that are designing them so that the main base is reusable and only a small portion of the tip is a disposable product.”
To Lyons, the motivation is clear.
“This kind of instrument really benefits everybody. It’s a patient safety issue,” Lyons said, adding that such a single-use device would be as effective in a surgeon’s hands as more traditional devices. “We don’t compromise any kind of functionality. If it doesn’t function the same way as a reusable, there’d be no point.”