Drivers of Design
Cost pressures, new materials and product marketability increasingly are influencing orthopedic device designs.
Jeffrey Kapec was about to grab some food at an outdoor clambake one day last summer when he noticed an older man with a cane standing in line for lobster and, well, clams. For the most part, Kapec is not the kind of man who is easily distracted, but there was something—perhaps it was natural curiosity or simply the sight of the cane—that led him to ask about the stranger’s affliction.
“He was probably in his late 60s,” Kapec recounted. “And everybody was asking him how he was feeling. He said, ‘Pretty well, no problems.’ So I said to him, ‘Did you have a sprain or something?’ And he said, ‘No, I just had my hip replaced last week.’ I looked at him and thought ‘Last week? And he’s standing in line at a clam bake?’ If you looked at that scenario 20 years ago, that guy certainly wouldn’t be at a clambake a week later.”
Kapec is right. Two decades ago, that guy wouldn’t have been anywhere near a clambake so soon after receiving an artificial hip. He most likely would still have been recovering from a procedure that was more invasive, more risky and in all likelihood, more painful. But an explosion of innovative new orthopedic implant designs and surgical techniques over the last 20 years has improved the quality of the replacement parts and hastened patients’ recoveries, allowing them to resume the active lifestyles to which they’ve grown accustomed. Trend-setting baby boomers, in their constant quest for remedies to the debilitating aging process, have created an enormous demand for these procedures and devices in the last decade. Between 2000 and 2009, in fact, the number of annual joint replacement surgeries in the United States nearly doubled, going from 575,000 in 2000 to an estimated 1.1 million in 2009, according to industry data. One in 30 Americans are now walking around with at least one new joint; 11 years ago, that number was one in 60.
While baby boomers have been a driving force behind much of the innovation that has occurred in the orthopedic implant market, they are not the sole source of inspiration for surgeons and design engineers. Other muses include cost, reimbursement rates, materials, testing, marketing, new technologies and surgical procedures, and the desire to both simplify surgery and reduce recovery time.
The emergence of minimally invasive surgery, for example, has inspired a plethora of device designs in recent years, including the Micronail Fixation (wrist) implant from Wright Medical Technology Inc., the Axle Interspinous Fusion System from X-spine Systems Inc., the Taperloc and Balance Microplasty hip stems from Biomet Orthopedics, and the extreme
Lateral Interbody (spinal) Fusion system from NuVasive Inc., among others.
Minimally invasive surgery has become particularly popular among younger patients because it minimizes scarring, reduces pain as well as recovery times, and results in less blood loss than traditional “open” procedures. Many doctors prefer this technique as well due to the improved recovery times generally associated with it. Still, minimally invasive surgery has its drawbacks—it can impair the physician’s visual field and limit the choice of devices used for the procedure. Such disadvantages, however, have not discouraged doctors and design engineers from refining the technology in an effort to perfect the system. Such determination has given rise to another surgical technique that further reduces recovery time and is quickly gaining traction in the industry: the direct anterior approach to hip replacement.
In this approach, surgeons place a hip joint through an incision on the front of the body, enabling the implant to be placed between muscle planes rather than through muscle planes (the customary method used in traditional posterior placement procedures). This technique reduces muscle damage as well as complications from dislocations and unequal leg length following procedures, industry experts said. Patients undergoing the anterior approach also tend to recover more quickly, leaving the hospital in one or two days as opposed to the typical three or four days associated with traditional hip replacement surgeries.
Though the impetus behind these new surgical technologies seem patient-centric, they increasingly are being influenced by an industry-wide trend to reduce overall healthcare costs. More efficient surgeries and accelerated recovery times can help curb escalating costs for both hospitals and implant manufacturers, industry experts claim.
“The latest trends in orthopedic implant design are migrating from innovation to cost and outcomes,” said Steve Maguire, general manager at Orchid Design, a division of Shelton, Conn.-based Orchid Orthopedic Solutions, a contract design and manufacturing firm serving the orthopedic, dental and cardiovascular markets. “The healthcare environment is the driver of this shift and doing things faster, simpler and at a lower total cost is the direction we see. As such, proven implant designs are being replicated and lower manufacturing costs are the driver. Instrumentation that is easier to use and helps a surgeon with repeated surgeries also is a focus. We have seen investments in navigation, both manual and navigated with computers.”
Here’s how the healthcare reimbursement system is supposed to work: Fueled by demand from an aging population, orthopedic implant manufacturers sell their products to hospitals for healthy profits (an artificial joint can fetch between $3,000 and $15,000, according to industry estimates). Hospitals, in turn, fully recoup the implant’s cost from taxpayers and policyholders by billing Medicare or private insurers.
Here’s how the process actually works: Implant manufacturers sell their devices to hospitals at exorbitant prices (the gross margin on implants sold in the United States hovers around 80 percent). Hospitals, engaged in a life-or-death struggle to stay financially afloat, do their best to recover the implant’s total cost from Medicare or private insurers. And they fail.
Hospitals have been locked in this dead-end reimbursement cycle for more than a decade. Between 1991 and 2006, for example, the average list price for coated hip implants skyrocketed 171 percent while Medicare payments to hospitals rose only 19 percent. Such disproportionality has led many hospitals to set price caps on orthopedic devices, forcing the hands of major manufacturing companies.
Besides wreaking havoc on hospitals’ finances (and ultimately, physician salaries), declining reimbursement rates have made it more challenging to design innovative devices, industry leaders told Orthopedic Design & Technology. Products that offer no value to the healthcare system and fail to generate new reimbursement codes will be difficult to market. Therefore, it is essential that surgeons and engineers factor reimbursement rates and product marketability into the design of an orthopedic device.
“Reimbursement is a significant driver of orthopedic device design,” said John Mulvihill, vice president of sales and marketing at CIRTEC Medical Systems, a contract design, development and manufacturing company with offices in Los Gatos, Calif., and East Longmeadow, Mass.“The healthcare system has got to be able to pay for the implant and there has to be some cost benefit that the company receives upon reimbursement. If the designers can develop an innovative new implant that translates into a new reimbursement code and has a significant impact on lowering healthcare costs, they’ll win big.”
Designers also will win big by keeping the current regulatory environment in mind when creating a new device. The U.S. Food and Drug Administration (FDA) has been reviewing new device applications with more scrutiny over the last two years in an effort to bolster the agency’s safety record, a move that ultimately will force manufacturing companies to spend more time and money developing and marketing their products. Designers can minimize costs and maximize their chances of successfully marketing a product by determining the proper regulatory path for their creations. For instance, designs that incorporate a new technology or material generally need premarket approval (PMA) from the FDA, a process that involves the filing of an investigational device exemption application so the product can be used in a clinical study to collect the scientific evidence needed to support the PMA submission, and securing Institutional Review Board approval for the clinical study itself.
Such regulatory hurdles can become quite time consuming and expensive for companies.
“Certainly the regulatory environment is a challenge for products getting to market now, almost to the point where it is stifling innovation,” charged Brian R. McLaughlin, business development manager at Orchid Design. “The more innovative your implant solution, the higher likelihood you are to have to do clinical trials and make the road to commercialization that much longer and that much more expensive.”
A much quicker and less expensive path to commercialization is available through the FDA’s 510(k) clearance process, a 35-year-old approval system (now being refined) that endorses devices that are “substantially equivalent” to existing products. Most medical firms prefer this simplified approval process— statistics indicate that manufacturers have cleared about 90 percent of medical devices for the U.S. market through the 510(k) system since the program’s inception in 1976.
Healthcare reform, however, threatens to complicate the FDA’s device approval system and force designers to wrangle with a new set of factors during the creative process. With the new law focusing on reducing healthcare costs and improving the quality of care, experts predict that regulatory agencies will place more focus on evidence-based medicine. Medical organizations such as the American Academy of Orthopaedic Surgeons (AAOS) already have instituted guidelines on the matter to help its members get accustomed to using the best available evidence when practicing medicine.
In September, the organization released a guideline on vertebroplasty, citing studies that indicated the benefits to patients were equal to placebo procedures. The AAOS also has created a guidance that discourages its members from using arthroscopy to treat patients with degenerative knee arthritis. Surgeons predict the evidence-based movement will make insurers more reluctant to reimburse for procedures. “The payors, in an effort to control expenses, will demand a higher level of proven effectiveness to make sure the treatments they are paying for are worth it,” David Ott, M.D., an orthopedic surgeon in Phoenix, Ariz., told Becker’s Orthopedic & Spine Review late last year.
Besides stemming the flow of reimbursement dollars, a stronger focus on evidence-based medicine also is likely to lengthen the amount of time it will take to commercialize medical devices. Such a consequence is bound to frustrate product engineers and inventors who have watched their new product applications become mired in more regulatory red tape in recent years. Average decision times by the FDA jumped 20 percent between 2002 and 2008, going froom 97 days in 2002 to 116 days in 2008, according to statistics from the Advanced Medical Technology Association (AdvaMed) in Washington, D.C. The number of days applicants spend gathering more information for the FDA also has risen, nearly tripling from 19 days in 2002 to 51 days in 2008. Consequently, these delays have prompted an increasing number of companies to abandon their 510(k) applications: AdvaMed data shows that 510(k) withdrawals skyrocketed 89 percent in just five years, going from 9 percent in 2004 to 17 percent in 2009.
With the device approval process so unreliable and reimbursement rates strongly influencing new product development, more companies are turning to design for manufacturability (DFM) to reduce costs. Industry experts consider this trend to be the fallout from explosive market growth in the early part of the new century, when manufacturing firms were less concerned about cost and more concerned with the unique marketability of their product.
“We certainly expect a big push in 2011 in design for manufacturability,” noted Josh Sprague, vice president of Hoosier Inc., a full-service spinal contract manufacturing company based in Corona, Calif. “All of our clients are being forced to find ways to reduce cost and the reality is that cost reduction rolls downhill. One of the reasons that design for manufacturability is really taking off now is that the spine market six or seven years ago was on a path of rapid expansion, and when that happened, everyone wanted to get their products out quickly, with less regards to cost. Now that things have settled down, it’s time to reduce some cost.”
“In the past some of our customers didn’t care about the difficulty of manufacturing a device because their products were innovative or the added complexity gave them more security with patent protection,” Sprague continued. “Maybe the product was designed to be pretty when it really didn’t need to be. Now that the market has grown more slowly, engineers have more time to examine the manufacturing aspect of a product. The name of the game now is price, simplicity, and how fast can you get me my parts. It’s a win win for the OEM, patient, and the vendor when the parts are easier to make.”
Orthopedic implants and their components, however, are not always so easy to make. Their designs can be complicated by the some of the very factors that drive innovation, particularly testing and material selection.
With implants prone to material wear, device testing is paramount and should be incorporated into the design and product development process. New designs generally are evaluated for feasibility; at that stage, a prototype is made to function like the final product (but does not necessarily look like the finished piece). Feasibility testing evaluates the device against the design requirements and early-stage risk analysis, industry experts said.
Materials play an equally important role in the development of orthopedic implant designs. For decades, the choices for implant materials had been limited to metals such as stainless steel, titanium, cobalt-chromium and tantalum, and polyethylenes such as PEEK (polyetheretherketone). But these substances wear over time in the body, producing friction and particle debris that aggravate the surrounding tissue and cause the implant to loosen. Improvements to existing metals and the introduction of new materials such as ceramics and bone growth substitutes has been a significant driver of device design in recent years.
For example, researchers at the Fraunhofer Institute for Manufacturing and Advanced Materials in Dresden, Germany, developed a titanium “foam” that may prove to be a better material for use in orthopedic implants. The researchers believe the foam’s porous structure will better grow into the implant, which itself would be lighter because less material is used. Having already experimented on defective vertebral bodies and stressed bones, engineers and researchers are now designing full-fledged foam-based implants.
Similarly, scientists from Tel Aviv University in Israel are modifying a machinery-monitoring technique used by Israeli and American air forces to evaluate and improve orthopedic implant designs. The technique—called ferrography—entails the extraction and analysis of tiny iron particles (hence the name) from lubricants such as oil and grease to determine wear in machines. The Tel Aviv scientists are exploring the possibility of using bioferrography to test the extent of joint damage by extracting wear particles from synovial fluid, for instance. The technology may benefit implant manufacturing companies, as the technique potentially could predict the life span of artificial joints during research and development.
“Biologics is an area that is moving very quickly,” said Kapec, a principal and executive vice president of Tanaka Kapec Design Group Inc., a Norwalk, Conn.-based design consultancy. “There’s so much being done now in the area of bone growth. The approach to [implant] design used to be more mechanical in nature but now biologics is being used along with mechanics to get the body to accept that bone growth and make sure it’s unified to the bone. That’s where the science is going.”
Science also is venturing into areas that one day might totally eliminate the need for metal, plastic or ceramic implants. Platelet rich plasma therapy is used in dental implant procedures to regenerate new tissue and help the body heal more quickly and efficiently. This technique is based on the science of platelets, which—among their many functions—form blood clots and release growth factors into wounds. These growth factors include a platelet derived growth factor, a transforming growth factor beta (TGF) and an insulin-like growth factor. Bone morphogenic protein—a relative of TGF—has been shown to induce the formation of new bone in research studies conducted on animals and in humans. Adding platelet rich plasma and bone morphogenic protein to an implant site allows surgeons to grow bone more predictably and faster than traditional methods, experts claim.
“The abilities of these substances is more biologics but they’re being classified truly as implants. That’s how they’re coming through the FDA,” noted Anand M. Vora, M.D., an orthopedic surgeon in Illinois who also teaches orthopaedic surgery at both Northwestern University Medical School and the University of Illinois Medical School. “Bone morphogenic protein and platelet rich plasma are really hot topics right now. The platelet rich plasma involves taking platelet rich healing cells to initiate healing in all phases of treatment. It’s a very interesting area that shows a lot of promise.”
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Innovative implant designs and surgical techniques along with advances in technology have created an enormous demand for orthopedic implants in the last decade. Much of this demand has been driven by baby boomers seeking to maintain their active lifestyles, though the market also is being influenced by new materials that improve the durability of joint replacement parts and younger patients looking for less invasive alternatives to traditional surgical treatments. Indeed, the global implant market is expected to grow 7.8 percent annually over the next five years, swelling to $41.8 billion in 2016, according to GBI Research. The joint reconstruction sector is forecast to grow at nearly the same rate (7.4 percent annually), expanding to $22.9 billion in 2016. And while trends such as minimally invasive surgery and computer imaging of diseased joints most likely will continue to influence implant designs over the next half decade, industry experts predict that cost will play an even more important role, as both orthopedic manufacturers, hospitals and health insurers attempt to reduce healthcare costs. As one resident expert told ODT: “It wasn’t always about reducing cost—it used to be about getting your product to market. The primary consideration was time to market and then innovation. Back in 2007 and 2008, OEMs would say ‘let’s get this product to market and we’ll figure out the money later.’ Well, it’s now later. It’s time to figure out the money.”