Opportunity in Motion

Advances in spinal and other small-bone implants round out an already robust market.

Jennifer Whitney
Editor

Upon examination our celebrity-fueled culture, it’s no surprise that the recent annual meeting of the American Academy of Orthopaedic Surgeons featured a number of iconic athletes who have benefited from the latest orthopedic advancements. Sharing tales of life before and after hip replacements, tennis legend Jimmy Connors held court at Wright Medical’s booth while Olympic gold medalist Mary Lou Retton spoke on behalf of Biomet. Their experiences served to exemplify how advancements in the joint-replacement field have given new lease to people previously afflicted by debilitating pain and reduced quality of life.

Joint replacement surely has come a long way, especially when you consider its origins. A little less than a century ago, in 1913, a man named Sir Robert Jones developed what was probably the first arthroplasty procedure, which involved inserting gold foil between an arthritic hip’s damaged femoral head and acetabulum. Along with that rudimentary practice, the industry has witnessed early attempts at implants made of wood, ivory and even some metals that were neither biocompatible nor durable. Even in the not-so-recent past, many of the initial materials used simply were too brittle to withstand the rigors of heavy impact or created too much wear debris.

As science evolved, however, surgeons and other orthopedic professionals have learned from their studies of joint function. These insights were not easily obtained, given that cadavers and skeletons didn’t allow researchers to see their next generations of implants in action. As technology evolved and improved, today’s inventors are developing advanced devices that wear well and come with fewer problems due to research facilitated by computer modeling, simulation, virtual reality testing and other innovative means.

Now, implants are assessed according to design, fixation, bearing surface and materials. And the strides being made are utterly amazing. These strides, in turn, are what are fueling the major growth in the orthopedic sector. Following is an examination of a few of the market drivers.

Spine Technology: New Frontiers

Many patients have benefited from the advancements provided by spinal fusion procedures, but people working in the orthopedic industry are even more excited by what’s coming down the pipeline in motion preservation technology. In fact, they say these upcoming products will have enormous implications for people with disk problems.

“New spine technology is indeed exciting and we expect it to be the next big thing in our industry. In fact, we’ve seen consistent growth in this area of our business in general and look forward to it achieving the same success as our staple products,” said John Phillips, vice president of operations for Phillips Precision, Inc. in Elmwood Park, NJ.

He should know. Not only does his company manufacture products for companies such as Biomet and Abbott Spine, Phillips’ father, Francis, who started Phillips Precision 40 years ago, recently went from serving as a contract manufacturer of spinal technology to a recipient of the technology after suffering from a ruptured disk. “Three months after the surgery [in which he received a spinal implant to replace the disk], he was able to walk again and was playing golf on a regular basis,” Phillips recalled. “That wasn’t an option 10 to 15 years ago. You could only go to bed back then and hope the pain would go away.”

Hailed by market research firms as “one of the most dynamic and exciting segments” (Millennium Research Group) and “the hottest topic around” (Espicom Business Intelligence), motion preservation technology has intrigued the industry with its impressive growth and predicted value over the next several years. Millennium Research Group valued the US spinal implant market at more than $3.3 billion in 2006, and Espicom Business Intelligence forecasts the market will achieve 16% growth annually until 2011.

While much of the technology is still too new to truly know where it’s headed, patients are demanding whatever is available now. One recent study of 461 prospective spinal fusion patients found that nearly half would rather wait for a motion-preserving implant than undergo a spinal fusion procedure, according to Espicom.
 
“A lot of the old systems [including spinal fusion] were static, and the new systems allow a lot of mobility, which is more encouraging for patients,” explained Jack Fulton, vice president of sales and marketing for Specialized Medical Devices in Lancaster, PA. He also noted that previous incarnations of these systems often came with risks.

Today’s motion preservation implants are nothing like the horror-inducing stiff rods used in previous decades. Andrew Nield, director of sales and marketing for C5 Medical Werks in Grand Junction, CO, noted, “There is a wealth of new technology being designed, tested and manufactured that may revolutionize the motion preservation spinal market.” He pointed to examples such as the development of ceramic-on-ceramic spinal implants, which come with the proven benefits of ceramic-on-ceramic hip joints. He believes such technology offers the possibility of low particle generating implants.

Of course, he did caution that one of the most important factors that will affect the growing market—which experts agree is currently being flooded with innovators from small startup companies—is reimbursement. “Not only do spinal implant manufacturers have to come up with state-of-the-art technology that benefits the patient, they need to have data that proves the benefits over existing technology,” he said.

No Small Market for Small Bone

Along with the progress being touted in the spine market, manufacturers are seeing equally impressive strides in other small implants. The market value, $450 million in 2005, according to Millennium Research Group, reflects the growing investment in areas such as ankle, wrist and shoulder technology.

“The biggest scores in terms of percentage growth are seen for ‘new’ types of implants like ankle, wrist and small bone in general,” said Jean-Paul Burtin, vice president, marketing and international sales for Viasys Orthopedics in Wilmington, MA. “It is hard to predict the success of such implants. Some of them are quite new (wrist) and some are improvements of existing ones (ankle, fingers, toes), but—so far—they are not as very successful as large joints.”

Smith & Nephew received FDA approval for its Birmingham system last year and other companies are expected to follow suit. Shown is Smith & Nephew’s Birmingham Hip Resurfacing system. Photo courtesy of Smith & Nephew.

Burtin specified shoulder technology as an area in which the industry has seen particularly interesting advances. “Shoulder is developing rapidly. It’s not a new implant, but there has been progress with design and surgical techniques with what surgeons are doing with implanting them. Shoulder has improved a great deal.”

In smaller bone technology, such as that for hands and feet, smaller companies tend to dominate the market at present, according to Fulton. In his experience, many large OEMs are purchasing startups as a smart way to gain entry into newer markets. “As the market gets saturated, the larger OEMS are looking for new areas of growth. Small bone is a good market, either through acquisition or development,” he said.

In particular, the boom in minimally invasive surgery procedures especially is evident in implantation of wrist or foot plates, Fulton said. “This is something the large companies weren’t focusing on, but now they’re seeing it’s one of the larger growing segments. The hips, knees and so forth are doing new things, but those markets are fairly saturated,” he explained as a rationale for the attention toward small-bone implants.

Gone are the days when a surgeon’s only option was to use external fixation to treat bone injuries. Now, many patients don’t have to rely on braces or have screws holding bone together being bracketed outside the skin.

Hips and Knees Better Than Ever

Valued at more than $5 billion in 2006 by Millennium Research Group, the US large-joint reconstructive implant market for knees and hips remains the industry’s bread and butter. According to the AAOS, 233,000 hip replacements were performed in 2004. As the population ages and grows more obese, or as younger patients keep OEMs interested in rolling out new hip resurfacing technology, the market is poised to keep growing.

As the public’s interest has grown in large-joint replacement, orthopedic OEMs capitalize on it both through targeted marketing campaigns and, more important, improved designs and technology. Ken Birdsong, president and managing director of Doncasters Medical Technologies, said one of the most advanced categories of large-joint implants he has seen are those made of metal-on-metal combinations. His company, which is headquartered in the United Kingdom, currently is working on 12 different metal-on-metal programs for customers.

“It is estimated by some industry experts that by 2010, metal-on-metal will encompass 25% of the hip market,” Birdsong said.

Metal-on-metal bearings aren’t exactly new—the first generation unveiled in the 1960s phased out after concerns surfaced about component loosening and biological incompatibility of the alloys used at the time. Manufacturers improved both the design and technology over time, however, and now the metal-on-metal hip systems not only are viable, they appear to be investments in the future.

Why the interest in this type of technology now?

“As the metal-on-polyethylene joint articulates, the polyethlyene wears and releases into the surrounding joint space,” Birdsong explained. “In its simplest form, the debris is then viewed by the body as a foreign substance and then releases enzymes to remove the debris. Once this occurs, the surrounding joint space bone is also attacked, which then erodes and the joint space loosens and the implant fails due to cyclic fatigue. Replacing polyethylene with metal helps prevent osteolysis [bone degeneration].”

With the metal-on-metal design, he continued, these implants help synovial joint fluid circulate and stay between the components, which offers a range of motion comparable to a natural joint and reduced risk of dislocation.

Arguably one of the most talked-about technologies in the hip market is hip resurfacing, which helps preserve bone and can last longer than traditional total-replacement systems. Ever since Smith & Nephew announced FDA approval for its Birmingham system last year, discussion has abounded about this technology and more companies are expected to gain approval for their own hip-resurfacing systems this year. As of press time, British manufacturer Corin had just received a conditional approval from the FDA for its Cormet 2000 system (which Stryker would market in the United States). An FDA review panel will consider Wright Medical‘s Conserve Plus system within the year, and Biomet also is working on a system.

How will the increase in hip resurfacing impact the total hip-replacement market? “It’s a good thing for the industry as a whole,” noted David Ehlers, director of business development for Metal Craft Machining & Engineering in Elk River, MN.

Along with the hip market, the knee-replacement segment has been garnering attention as well. Burtin of Viasys said that he believes knee sales will experience “the largest growth” in the next 10 years and beyond. Part of the reason is that in the United States, the number of knee arthroplasties has exceeded the number of hips—and other westernized countries are showing similar trends now, he said. Indeed, the minimally invasive knee market in the United States and Europe was valued at more than $1 billion in 2006, according to Millennium Research.

The market certainly isn’t being hurt by the marketing campaigns coming from manufacturers of these knees. Last year, Zimmer made a splash after it gained FDA approval for its Gender Solutions knee (a new female hip also is expected by years’ end). Some in the industry have debated whether there’s anything “new” about these implants—many sources interviewed by ODT said a good fit with any implant is all about proper sizing and that these knees are simply adding an array of new sizes suitable for a woman’s anatomy—but Zimmer’s product information claims that these implants are shaped more like a woman’s knee and, therefore, fit and function better.

Resurfacing isn’t just for hips, either. Birdsong noted that strides are being made with resurfacing of the knee joint space as well. The procedure is not as extensive as hip resurfacing, he said, due to it being cartilage resurfacing and replacement versus bone resurfacing.

“The view for knee resurfacing is merely the replacement of the damaged or worn cartilage between the distal femur and the tibial proximal surface via a replacement metallic device that has been recently introduced in the United States,” he said. “I think this product has great promise.”

Constructing Innovation: Material Developments

The implant market surely will rely on traditional favorites for tomorrow’s innovations—titanium alloys, stainless steel, cobalt chromium, ceramic and polyethylene were cited often by manufacturers as the most popular materials in design today. However, a few other materials are gaining the reputation as “ones to watch.”

Among metals on the market, various manufacturers cited Zimmer’s Trabecular Metal as one of the more unique introductions for encouraging bone formation and attachment. Resembling bone, and therefore mimicking its physical and mechanical properties more closely than pros-thetic materials, this material is 80% porous. According to Zimmer, Trabecular Metal implants are fabricated using elemental tantalum metal and vapor deposition techniques that create a metallic strut configuration similar to trabecular bone.

Many of the individuals who spoke with ODT said PEEK polymer also is being used much more often in implants and components, as this material is lightweight and offers many advantages. For example, spacers used in spinal procedures used to be made of metal, but now materials such as PEEK can help restore motion better than metal can.

“Metal sometimes can create stress shielding,” Birdsong said. “PEEK allows you to absorb an additional amount of stress.”
 
Finally, biomaterials will play a larger role in newly developed systems due to the flexibility and cushioning these materials can offer, experts said.

According to Dana Schramm, director of engineering at Donatelle in New Brighton, MN, future considerations in the field may include bioresorbable materials to help reduce costs and further support eliminating an invasive extraction process.

Manufacturing for the Future

With demand growing for implant technology, manufacturing partners have no shortage of work. Many companies find that the best way to meet the needs of their customers is to invest in their own in-house resources to better strengthen their offerings.

“The manufacturer has to be able to do multi-axis machining. Three- or four-axis capabilities are no longer enough to keep up with the complexity,” said Ehlers of Metal-Craft. “Three-dimensional programming is becoming a must, as [is] the most sophisticated tooling you can buy.”

Larry Whitney, vice president and chief operating officer at Precision Technology, Inc. (PTI) in Norwood, NJ, shares a similar viewpoint. “Manufacturing needs to utilize the latest in machining technology at all time,” he explained. “The key to producing complex geometries and holding tight tolerances is to complete as much of the part in as few setups as possible. Surface finish issues [also] have become more critical over the past few years.”

As a response to the tighter tolerance and more complex components required by device manufacturers, C5 Medical Werks has built a state-of-the-art ceramic component facility in Colorado, equipped with all new manufacturing and test equipment, in addition to a class 10,000 cleanroom.

“Device manufacturers are going to rely, in the future, on component manufacturers with greater expertise, such as those with device grade ISO 13485 certification,” said Nield. “Although not required by a component manufacturer, smart companies are differentiating themselves by matching the quality standards of the device manufacturers.”

Whitney agreed, noting, “We are currently involved with many of our partners in quality programs that, in the end, will provide ‘dock to stock’ orders. To our partners, this means there will be virtually no inspection done at their facility, with all inspection and documentation done and stored at [our facility.]”

Along with keeping an eye on quality, Phillips believes that orthopedics is “probably the toughest business to be in to get an accurate time and cost assessment.” Therefore, his company invested in a comprehensive enterprise resource planning software system that tracks everything occurring at the facility. “It will flag us if any one area is falling behind on their commitment, so we can react before it becomes reality,” he explained. “Ten years ago, I couldn’t tell you if we were on target with an order of parts until we got about two weeks from the quoted date. This system takes care of that for us.  I can go into the system and, in a minute, tell you where every component is in the process and when it is scheduled to be completed.”

Tom Caron, vice president, sales and marketing for Donatelle, said his company has been answering the orthopedic community’s needs by examining both internal processes and machinery. “We continue to invest in technology to decrease the product realization timeline, to support the increased complexity and changing needs of our customers and to support ongoing total cost solutions,” he explained. “It is easier to get cost out of a product at the design phase than at the validation phase.”

Part of that strategy, he added, includes addressing cost containment through forming partnerships with customers as early in the product life cycle as possible.  “The product realization timeline is greatly reduced because these products are designed for manufacturability from the onset,” he concluded.    

Although contract manufacturers and other orthopedic suppliers strive to keep costs low for their customers, raw-material price limitations ensue. Therefore, any competitive edge helps. “As a supplier, we have always strived to help our customers to contain cost by improving our processes,” Burtin said. As a result, Viasys opened a new process/product development center called LaunchQuick that offers services such as rapid prototyping and short-run production while giving customers access to process development engineers and their laboratory.

Similar to this one-stop-shop mentality, Specialized Medical has moved toward full-service offerings by bringing more stock and materials in-house and by adding finishing and packaging services to its menu of services. One unique offering, Fulton said, has been the company’s development of a validated implant cleaning process. Noting that some companies had serious issues with this type of cleaning years ago, Specialized Medical developed a proprietary process for cleaning implants.

“We can verify that there’s not trace elements on our parts when they ship,” Fulton said. “We have it validated by a lab—both the implants and the bath solution.”  

* * *
The ultimate goal of any implant is to reduce pain while increasing mobility and function. With all the advances currently on the market and coming down the pipeline—and the investments being made in the manufacturing process itself—it appears the implant market surely will keep both the general public and orthopedic community fascinated in decades to come