Joint Reconstruction in Review

Orthopedic companies look to mix cutting-edge devices with cost-effective results.

Christopher Delporte

The joint reconstruction market may seem to be a relatively mature industry serving a mature patient population. Think it’s reached its plateau? Not so. Industry insiders claim there’s plenty of room for growth thanks to continued strong demographics and a robust innovation pipeline that will open the market to younger, increasingly active patients. Opportunities for growth go beyond new implant development and new materials, experts said. Refinements to implant procedures are an important part of the cost and quality equation.

According to a recent report from Global Markets Direct titled “The Future of the Orthopedic Devices Market to 2012,” the joint reconstruction market, which was valued at $12.2 billion in 2008, will continue to drive growth in the orthopedic device sector. The global joint reconstruction market is expected to grow by more than 9 percent annually to reach $17.4 billion by 2012 and is forecast to contribute 45 percent of the overall orthopedic devices market value, the report said. Key growth segments within the joint reconstruction sector are gender-specific knee implants, as well as and hip and knee resurfacing product lines.

New product innovations, newer procedure techniques and positive clinical outcomes of products introduced in the past four years are some of the key growth drivers in this sector, according to Global Market Direct’s analysis.

Patrick Treacy, vice president and general manager, Knee Reconstruction, for Stryker Orthopaedics, a division of Kalamazoo, Mich.-based Stryker Corp., told Orthopedic Design & Technology that device firms’ constant challenge is in keeping up with physician and patient demands, and performance is the name of the game.

“Demands for performance aren’t slowing down, they’re speeding up,” he said. “When I started back in 1989, the goal of total joint replacements was to enable patients to live on their own without pain. But today, it goes far beyond that. We want to give patients more.”

No matter how successful the technology, however, the costs of modern healthcare play a factor in how patients access these performance advances.

“We also have to meet those demands from an economic point of view—particularly with the focus on healthcare reform,” Treacy said. “A key part of our strategy is how we can provide cost-effective solutions so that high tech doesn’t necessarily mean high cost. As we look at the performance side, we also look at how we’ll be treating a greater number of patients with the same level of funding that the government is able to provide and that our economy is going to be able to sustain.”

Within Stryker, Treacy said the company has coined a phrase to describe the balance between device performance outcomes and healthcare savings and efficiency. They call it “orthonomics,” and the benefit often requires a longer-term view.

“There are opportunities that perhaps at first may be slightly more expensive, but if they can reduce the burden of revision surgery, for example, then it’s worth it—and less expensive—in the long term,” he added. “Cost reduction doesn’t mean there’s no room for innovation. That’s our plan for the future—cost-effective solutions driven by technology improvements.”

MIS, Patient-Specific Care

Doing more with less seems to be a mantra in business today. But when it comes to medical device innovation and its impact on patient care, achieving more with less can be a good thing—think minimally invasive surgery, smaller implants (or no implants at all) and shorter procedure times.

Innovations in minimally invasive technologies, for example, have enabled patients to now choose alternate orthopedic procedures instead of the complex and painful surgical procedures. Resur-facing technology offers an important option for patients seeking a more conservative alternative to total joint replacement. This bone-conserving approach results in a better range of motion and less risk of dislocation than traditional total replacement.

Cory Colman, senior executive vice president for Paragon Medical, a Pierceton, Ind.-based supplier of instruments and implant manufacturing solutions for orthopedic OEMs, said minimally invasive approaches across all areas of joint replacement are here to stay.

“If you look at technology that’s leading the future of care, one thing we’ll see more of is greater use of arthroscopy,” Colman said. “It is technology that helps with the minimization or even the delay in joint reconstruction. Whether it’s the ability to get in visually and see what’s happening with the joint or the ability to make repairs, I think we’re seeing that technology is really driving to reduce the surgical or joint reconstruction event. As you get to some of the under-penetrated areas, you’re going to find that large-joint utilization numbers will be strong for a long time, but preventative and less-invasive care will make serious inroads.”

Both Colman and Treacy said patient-specific devices are poised to revolutionize care in orthopedics.

“We’ve seen greater emphasis on patient-matched or custom-matched implants and instruments,” Paragon’s Colman said.

Without the best surgical technique, even the most innovative implant will have trouble living up to its durability and longevity claims, Treacy added.

“Simplifying surgical techniques and allowing the surgeon and surgical team to provide a more reproducible operation time and time again is critical,” he explained. “It’s about a combination of materials, design and surgical techniques and technology that will allow us to provide a reproducible yet personalized approach to patient care.”

One of the orthopedic companies that has moved forward with patient-specific instrumentation is Wright Medical Group in Arlington, Tenn. Alex Winber, Wright’s U.S. director for knee marketing, called the company’s new Prophecy preoperative navigation guides technology with “incredible” potential to “revolutionize the way total knee arthroplasty is done.” Prophecy was formally introduced during the most recent annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) in February.

The Prophecy program uses basic CT or MRI scan technology to map precise implant placement and alignment. The imaging data is used to develop patient-specific guides that snap into place on the bone, following the unique curvature of the patient’s bone anatomy. The images are taken a few weeks prior to surgery, and the special guides are created using rapid-prototyping technology. Previously, orthopedic surgeons would use visually guided instruments such as an intramedullary rod to align the knee. With this process, there is no more drilling into bone canals.

“Computer navigation’s big claim was that it could increase accuracy and decrease the outliers—the number of patients a surgeon would do that would be out of alignment,” Winber said. “Computer navigation turned out to be very time consuming. Preoperative navigation fulfills the promise of inter-operative navigation, with greater accuracy, reproducible results and without all the time constraints. Every knee is as unique as a fingerprint. Prophecy also allows us to really fine tune the kind of implant that’s needed. It’s such a big advantage. All this results in better wear and long-term function.”

Winber said he expects the technology to expand beyond knee replacement and that physician adoption of the technology has been positive.

“We actually have surgeons calling the company to learn more,” he said. “They’re not changing their routine. We’re allowing them to do some of the things they’ve always wanted to.”

Among the companies that also have introduced similar technology are Warsaw, Ind.-based Biomet with its Signature personalized patient care system, and OtisMed in Alameda, Calif., which offers its custom-fit OtisKnee system.

Advances in Care

There are always challenges to innovation. That’s a given no matter what the industry. Healthcare is truly a moving target. Shifting demographics, increased patient demand and a financially strained healthcare system (to name a few) are significant hurdles.

“Our patients are getting younger,” Winber said. “The 65-year-old patient now is more active than the 65-year-old patient 20 years ago. They expect better functions, less-invasive and quicker results and rehabilitation time from their implants.”

Treacy cited results from a recent study presented at AAOS that predicted that by 2011, 50 percent of total hip patients will be younger than 65 and by 2016 greater than 50 percent of knee patients will be under 65.

“That’s a complete change,” he said. “We’re really seeing a migration toward a younger patient, which brings with it another whole host of challenges. It’s not just the performance of the implant and getting back to the kinds of activities that those patients are going to require, but it’s also going to demand the technology to get these patients back to work. Before, a lot of patients weren’t working. Today’s patients are still working.”

Treacy said developers are focusing on what the results of longer-wearing implants will look like. Because implant patients are getting younger, companies have more data on long-term performance.

“Take stress shielding or ball remodeling, for example,” he said. “What’s that going to look like when an implant has been in 30 or 40 years? We’re starting to identify these variables, for instance, in a 20-year hip. Now we know how the bone and the body will react 20 years out. It’s beginning to give us an idea or how will the body react after 30 to 40 years. It’s a stepping stone to a lifelong implant.”

Colman and many others continue to keep a close eye on the biologics market. “I’m quite sure we’re going to see some significant growth in biologics,” Colman said. “I think we’re going to see implantables that are smart tools able to give feedback as far as wear and load. Biologics and coatings will create new care options, including replacing or delaying the need for a reconstructive event. I think we’re even going to see something as unique as the actual forming of the bone mass inside the body rather than using an artificial joint. That’s pretty forward looking, but it’s not science fiction.”

The report from Global Markets Direct backs up Colman’s foresight. The market was valued at $5.4 billion in 2008 and is expected to grow by 9.3 percent annually to reach $7.5 billion by 2012, the report estimated. It also claims that orthobiologics is the fastest-growing segment within the orthopedic devices sector with more than 100 products at different stages of clinical development. The study’s analysis predicted increased use of orthobiologics such as bone morphogenic proteins and autologous growth factors in orthopedic and spine surgeries to drive segment growth in the next five years.

Treacy also noted that there’s been “a lot of innovation” in the small-joint market, bolstered in part by large-joint breakthrough technology.

“There’s growth that really has been spurred by much of the technology that has been developed in large joints,” he said. “There’s more and more discussion about ankle replacements. That market is still very small, but if you look at the amount of ankle fusions that are done, the need for innovation in that area is clearly apparent. A lot of technologies and materials used in hips and knees are finding their way into smaller markets.”

To reach these lofty goals, a robust R&D effort is required, experts said.

“Stryker’s research and development is driven by our commitment to understanding and continually meeting the evolving needs of our surgeons and hospital customers and their patients,” Treacy explained. “As such, we focus our efforts on products and innovations that will not only help surgeons improve patient outcomes but do so in a cost-effective manner. As an example, Stryker is very focused on developing instrumentation that increases OR [operating room] efficiencies while promoting better patient outcomes as well as on developing infection control products and processes that keep patients healthier and keep healthcare costs down. Only by continually assessing customer and market needs can medical device companies bring effective, meaningful innovation to market.”

On the supplier side, Colman said extensive R&D capabilities are critical to his clients’ needs.

“We have a global design center that assists clients with the development of implantable components and instrumentation in most all orthopedic areas—hips, knees, spine, trauma or sports medicine,” he said. “Very often we’re involved from the very beginning. Customers will say, ‘We’ve got an idea that we think has merit, but we don’t have the resources to develop it.’ We become an extension of our client’s internal activities, including working with physicians, being involved in cadaver studies, etc.”