Innovation, Knowing the Customer, and Building a Better Mousetrap

Originally Published MDDI November 2005

Orthopedics Trends
As consumer expectations evolve, orthopedics companies will need to adapt to meet changing demands. The coming years will bring about new manufacturing, surgical, and materials trends.

Brendan Gill

Orthopedics trends are being driven by more-active lifestyles, less-invasive surgery, and increasingly personal care. Patient benefits include shorter recovery times, less pain, and better prognoses. The products that are making these benefits possible include artificial spinal disks, artificial bone and skin grafts, joint replacements, and advanced equipment in computer-guided and minimally invasive surgery. All of these elements working together should make orthopedics a $94 billion industry by 2019, says Anthony Viscogliosi, founder of venture capital firm Viscogliosi Bros. LLC (New York City).

Viscogliosi's firm specializes in the musculoskeletal and orthopedics sector of the healthcare industry. He predicts that the $22.4 billion musculoskeletal market will shift “from the hospital to the home” in the coming years.

“There is a growing amount of care in the form of rehabilitation therapy, where care is self-administered,” Viscogliosi says. “Earlier, there was a movement from the hospital to the outpatient surgical center. In the future, there will be a move from care in the doctors' office to the home. Care will get closer to the patient.”

Viscogliosi foresees the rise of telemedicine, the Internet, and phone communication as affecting the way patients will receive treatment in the next 15 years. Patients will be much more involved in their own care, creating a demand-pull market to meet their needs, he says. He predicts that medical device manufacturers will

advertise in brochures available in doctors' offices, clinics, and on the Internet. The Internet's role in patient care will be particularly significant, he says.

“People will become more self-informed,” Viscogliosi adds. “Before the Internet, there was the encyclopedia and the doctor. Now there are chat rooms for [discussing] total disk replacement.”

He also predicts a “consumerization of implant technologies,” in which implant companies reach out directly to potential patients through advertising.

“Companies will be driving patients to the doctor through advertising and Internet channels,” he says. “The patient will get a lot closer to diagnosing his or her care, and then patients will seek out doctors that provide that level of care.”

The Patients of the Future

In the future, patients will be more involved with their care, but who will those patients be? The traditional orthopedics patient base is changing, says Greg Aurand, senior medical devices analyst at Zacks Investments Research Inc. People under the age of 65 now spend more on orthopedics care than they did in the early 1990s. According to CDC, joint replacement surgery for people aged 45–65 has risen 65% from 1991–1992 to 2001–2002. Total knee replacement in that span has risen 128%, from 7.4 to 16.9 replacement procedures per 10,000 people. The rise of the weekend warrior and the injuries that come with activities like mountain climbing will continue to spur demand. Plain old competition is also driving the industry.

“People want a better mp3 player or a better PC—it's a need for better performance,” says Aurand. “Partly it has to do with the aging population, but it also has to do with younger people who need orthopedic care because they wrecked their knees on the slopes or the basketball court.”

Knee implants are particularly in demand, partly because the knee “is the easiest thing to wreck,” Aurand says. Breg Inc. (Huntersville, NC) is meeting that need with its line of sports contact knee braces. The company is also changing knee brace manufacturing with its XT Fusion. The company uses radio-frequency welding to adhere the straps to the brace, which is made of zytel nylon.

“[The design] is a lot cleaner if it's welded instead of sewn,” says Brad Mason, president of Breg. “If you have the straps on the back of the knee and you go into a three-point stance, you squish the knee and can't flex it as far. With welding, you allow for a range of motion.”

Breg has also innovated by focusing on more-form-fitting design. The XT Fusion's four living hinges, or hinges with no moving parts, conform to the medial side of the leg, creating a sense that it “becomes a part of your leg,” says Mason. “The more intimate the fit, the better the function,” he adds.

Manufacturing Techniques

Another company, dj Orthopedics (Vista, CA), tweaked its manufacturing techniques to compete in an increasingly specialized market. For its efforts, the Product Development and Management Association honored the company with its Outstanding Corporate Innovator award. The award criteria include sustained success in launching new products over a five-year time frame, significant company growth from new product success, and a defined new product development process that can be described to others.

“When we started our lean journey in manufacturing, we were doing a lot of things in batch,” says vice president of R&D Rich Gildersleeve. “But we wanted a visual factory, a one-piece flow. We didn't want a lot of batch, didn't want a million of this part, a million of that part.”

The company put lean principles to work in the manufacturing area, devised a five-stage development process, and focused on the “voice of the customer,” says Gildersleeve. The company also turned its attention to value-added products. Gildersleeve defines value-added product development as any task that “takes information or raw material and turns it into something the customer needs.” He cited engineering change orders and product development plans as necessary, but not value-added, products.

“If you find yourself bogged down in processes that do not add value, then you are wasting your time,” he says. “You want your project designers to spend time on things that meet customers' needs. Does the customer really care if you have a nice financial analysis or if you planned the project really well?”

One of the company's innovative techniques included using selective laser sintering to produce its Velocity Brace. The brace, a low-profile, lightweight ankle brace, was created from a 3-D model and formed in a fraction of the time it would take using injection molding. By using selective laser sintering, engineers were able to produce a functional prototype in days.

“The interesting thing about this new machine is that the materials are now structurally sound enough for functional use,” Gildersleeve says. “Injection molding would have added a few months to the project. Now we can get a prototype in a day.”

Laser welding is also having a significant effect on orthopedics design. Laser welding reduces biotraps, or areas in which biological material can collect and not get cleaned out. The process, as it is integrated into a company's supply chain, is reducing costs and complications for orthopedics manufacturers. It is also reducing design constraints, says Larry Walck, manager of business development and orthopedic markets for Mack Molding.

“Orthopedics has embraced laser welding,” Walck says. “Designs aren't limited to a certain type of bracket because you can't find the right rivet.”

Walck also sees a trend toward reducing weight and modular piece count. “Instead of having five different sizes of rasp, we might have just one size with a rasp piece.”

Disposable instruments are another area that Walck has high hopes for. Manufacturing-wise, it's a move away from durable hardware to more disposable devices, he says.

“We're trying to turn a long-term hard tool into something that is disposable,” Walck explains.

Computer-Assisted Surgery

Computer-assisted surgery (CAS) is having a far-reaching effect on orthopedics manufacturing. It increases orthopedic surgery's precision in a dramatic way. With CAS, or image-guided surgery, surgical accuracy is measured in millimeters as opposed to a surgeon's best visual guess. For device manufacturers to keep up, some modifications will be in order. Brainlab, a Westchester, IL–based orthopedics company, offers instrumentation that is fully integrated with CAS. Products like its finely

adjustable knee-cutting block have a tracking array that can be easily attached and removed with a snap mechanism.

“The first stage of adaptation is integration of existing surgical tools to be image-guided ready,” says Marc Mackey, business development manager at Brainlab. “Integration of instruments in the software is critical, as it dramatically speeds the entire navigation setup in the OR and reduces surgical time.”

Another advantage of image-guided surgery is its recordkeeping abilities. It will enable implant manufacturers to collect data on surgical outcomes in an unprecedented fashion, Mackey says.

“CAS is essentially a measurement system that can quantify the kinematics and mechanics of bony anatomy,” he adds. “These measurements are stored on the computer and have the potential to be collected nation- and worldwide. The volume of and the speed with which data can be collected will allow manufacturers to maintain a vastly improved QA and design system that should rapidly accelerate the optimization of implant and instrument design.”

The Spine

Vertebroplasty and kyphoplasty are two fast-growing sectors in the orthopedics industry. Vertebroplasty is an image-guided, minimally invasive, nonsurgical therapy used to strengthen a broken vertebra that has been weakened by osteoporosis or cancer. The procedure can increase a patient's functional abilities, help the patient

return to the previous level of activity, and prevent further vertebral collapse. It is usually successful at relieving pain caused by a compression fracture and can be performed on an outpatient basis. Vertebroplasty is performed by injecting an orthopedic cement mixture through a needle into the fractured bone.

Balloon kyphoplasty, pioneered by Kyphon (Sunnyvale, CA), is a minimally invasive procedure in which orthopedic balloons are used to raise collapsed vertebrae. This technique helps return them to the correct position and heal properly. The procedure has been used to treat more than 175,000 fractures worldwide, according to Julie Tracy, vice president of investor relations and corporate marketing for Kyphon.

“Once you have a spine fracture, you're five times more likely to get a second,” she says. “By using balloon kyphoplasty, we're attempting to diminish the chance for the next spine fracture to occur.”

“Our biggest competitor is a lack of awareness,” Tracy says. “Out of the 700,000 fractures that occur each year, 400,000 aren't diagnosed.”

Bone cement is gaining ground in the orthopedic industry. The material has been around for years, but it wasn't until last April that it received FDA clearance for use in balloon kyphoplasty. The cement is a polymethylmethacrylate that is deposited into the bone cavity. It contains a radiopaque material that allows it to be seen under fluoroscopy.

NuVasive Inc. (San Diego) offers a cervical nucleus–like replacement device called Neodisc. It is designed to preserve motion in the spine's cervical region. Neodisc is seen as a bridge between presurgical treatment and total disk replacement or spine fusion. The company believes that the product will be used in a variety of applications because it is easily revisable and because it is used in a relatively simple surgical procedure. The company is seeking FDA approval at the time of this writing, and the device is expected to be commercially available in 2010.

Viscogliosi predicts that in five years the nonfusion spine technology market will be more than $10 billion. Disk replacement will get the lion's share of the market, he says. Currently, DePuy Spine Inc. has the only FDA-approved artificial disk. Called the Charité, it is used on inpatients with degenerative disk disease.

Orthobiologics

Patients who have an active lifestyle also tend to expect a quick recovery time. Products like CeraPedic's (Lakewood, CO) P-15 putty help make that expectation more of a reality. The putty is a synthetic 15–amino acid peptide that serves as a bone substitute for use in spinal infusions. It is administered through a syringe to the orthopedic defect site. It can be used for spinal fusion procedures that use interbody cages or allograft rings, and to fill fractures or other orthopedic bone voids.

“Using such a material does not require harvesting bone from other parts of the body, which decreases pain and recovery time,” says Andrew Tofe, president of CeraPedics.

Zimmer Holdings Inc. (Warsaw, IN) is also pushing the orthopedics industry forward with its agreement with Revivicor Inc. (Blacksburg, VA). In September, Zimmer acquired exclusive worldwide rights to Revivicor's genetically engineered xenogeneic tissues for regenerative therapies. First, Zimmer intends to develop orthopedic applications, including repair and replacement of damaged tendon, ligament, cartilage, and bone and spinal nucleus tissues.

Revivicor has expertise in the genetic modification of pigs with the goal of whole-organ replacement and tissue regeneration. Revivicor's scientific team produced the world's first cloned pigs and the first pigs that lack the gene for galactose, which can trigger acute immune rejection in humans.

“In the orthobiologic sector, there is a limited supply of available tissue,” says David Ayares, CEO of Revivicor. “By using porcine tissue, we can overcome those constraints. Historically, that tissue has had problems with HIV contamination, but our pig tissues don't have that. Our material is coming from genetically modified pigs, which makes them resistant to rejection.”

Tissue Engineering: Artificial Bone and Skin Grafts

Biocompatibility in bone and skin grafts is an important consideration. Materials that mimic the body's own are in high demand, and companies such as Orthovita Inc. (Malvern, PA) are advancing the technology with products like Vitoss, which enables bone growth or fusion. Vitoss uses calcium phosphate to allow resorption, cell seeding, and ingrowth of host bone. Also, Osteotech Inc. (Eatontown, NJ) offers a demineralized bone matrix made from bone fibers. The fibers combine with surface modification techniques to prevent immune rejection.

The importance of cross-linked polyethylene is also growing. “It has better wear characteristics, less wear debris, and fewer problems with prosthetic loosening than other materials,”says Joseph Ianotti, MD, of the Cleveland Clinic (Cleveland, OH).

Conclusion

The factors determining orthopedic trends are varied and complex. New surgical techniques, increasingly active lifestyles, and consumer awareness will all play a role in changing expectations. The patient benefits will be measured in less pain, faster recovery times, and better prognoses. Advances in materials, CAS, and bone and skin grafts will contribute to these improvements.

To compete, companies will need to learn new manufacturing techniques to lower costs and speed up production. The orthopedics companies that survive will be those that know their customers, adapt to complementary technologies, and innovate.

Copyright ©2005 Medical Device & Diagnostic Industry