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Innovation’s Promise

Orthopedic firms understand the critical importance of the pediatric sector, but innovation has been slow to meet the needs of patients and physicians.

Christopher Delporte

The innovative gains made in the orthopedic device market are undeniable. New materials and minimally invasive procedures have transformed outcomes. Baby boomers are benefiting from a new generation of hips and knees that last longer and help them stay active at much younger ages. And new spine technology attempts to alleviate back pain without the use of fusion. These breakthroughs benefit millions of patients, and solid market demographics from an aging adult population potentially represent hundreds of millions in revenue for medical device makers.

What happens, however, if you’re not a baby boomer, but just a baby?
The unfortunate reality seems to be that pediatric patient populations frequently get lost in the mix of larger, more profitable patient groups. According to both device manufacturers and physicians, pediatric patients all too often aren’t on the receiving end of the latest technology because of a number of roadblocks, including a burdensome and expensive regulatory process and the financial challenges of serving such a small market.

Pediatric conditions in the orthopedic area include such conditions as scoliosis and other spinal deformities, congenital foot and hip problems, and osteosarcoma, a bone cancer that accounts for about 5 percent of all cancer in children.

“Children deserve access to devices that are safe, effective, and made just for them. Yet today many devices are not made with these considerations in mind, and some necessary devices are not made at all,” said Robert M. Campbell, Jr., M.D., during testimony before the U.S. Senate’s Committee on Health, Education, Labor and Pensions in 2007. The committee’s topic was “Ensuring Safe Medicines and Medical Devices for Children.” Campbell is professor of orthopedics at the University of Texas Health Science Center in San Antonio. He’s also the inventor of the Vertical Expandable Prosthetic Titanium Rib—or VEPTR—which currently is marketed by Synthes Spine based in West Chester, Pa. The VEPTR is used to treat pediatric patients with scoliosis or thoracic insufficiency syndrome, a congenital condition in which severe deformities of the chest, spine and ribs prevent normal lung development.

In his written testimony, Campbell told lawmakers: “Because pediatric disease is generally rare, there is a relatively small market for pediatric devices and there appears little incentive for device manufacturers to make them. Device manufacturers have different marketplace challenges than pharmaceutical companies. New medical and surgical devices quickly become obsolete, so large markets are needed to justify their development and regulatory costs. As a result, children are frequently denied access to the latest technology in life-changing or life-saving devices. Other times, physicians must jury-rig existing devices to accommodate their young patients.”

Figures from the American Acade-my of Pediatrics support Campbell’s claim. According to the Academy, approximately 75% of drugs and a large majority of devices used in pediatric medicine have not been appropriately tested for use in children, and, by necessity, pediatricians often prescribe drugs and devices for “off-label” use, which means the device has not been studied in approved U.S. Food and Drug Administration (FDA) clinical trials.

In September 2007, the FDA Amendments Act was signed into law by President George Bush. In addition to reauthorizing the medical device user fee program with the agency, the law also included incentives for the development of pediatric drugs and devices, as well as improved oversight efforts. Industry experts hope that the move will make the process easier—and more attractive—for companies to invest in the development of cutting-edge devices for children.
Michael Vitale, M.D., associate chief, Division of Pediatric Orthopaedics, and chief of the Pediatric Spine and Scoliosis Service at Morgan Stanley Children’s Hospital of New York-Presbyterian in New York, N.Y., agreed about the frequency of off-label use in treating his patients and the need for a better system to encourage device development. He told Orthopedic Design & Technology that the right devices still aren’t available or are slow to get to market, and, as a result, children may not be receiving optimal care.

“So, when we use a fracture plate, for example, we use one that’s been designed primarily for adults and certainly approved only in adult populations. I know industry is aware of the issue, but the combination of market forces and regulatory burdens really limits their ability to change the situation,” Vitale said.

“Pedicle screws—another example—which pretty much are the standard of care for treating mild deformity, have been approved for use in skeletally mature patients. The reality is that once or twice a week I use pedicle screws in skeletally immature patients, and I’m not way out on a ledge doing this. Every pediatric spine surgeon does the same thing. The problem is that the device may not be optimal for use in kids. Nevertheless, they’re the best available implant right now. So I make the decision to use the device off label. The reality is that if I only used devices that were on label, I wouldn’t be able to take care of the children we treat. It’s a clinical necessity.”

While large orthopedic companies may devote only a small percentage of their resources to this market, a startup in Warsaw, Ind., is taking a different approach. OrthoPediatrics—as the name implies—has made the pediatric orthopedic market its sole focus. The firm was formed in 2006 by Nick Deeter, a 30-year medical device and orthopedic industry veteran, who serves as chairman, president and CEO. The company is working to develop products in areas ranging from trauma and limb preservation to spine and biologics.

“Every surgeon we talk to has their own stories about how they’ve had to bend, cut, twist, drill and modify current implants to fit into a child,” said Deeter. “Clearly, they would rather have off-the-shelf implants to treat these kids. Once an implant is modified, the hospital and surgeon assume all liability for the product, not to mention that almost all of these implants are being used off label. Our strategy is to surround the pediatric orthopedic surgeon with implants and devices that are anatomically appropriate for children, as well as being FDA- approved for use in pediatric applications. So not only will our products solve a problem with being anatomically appropriate, but will also be used for the application they were intended for, which minimizes risk for the hospital, surgeon and patient.”
Deeter said that because his company is charting new waters as a pediatric-exclusive orthopedic firm, the challenge has been to build awareness. He characterized the pediatric market as the “last untouched frontier” in orthopedics.

“Pediatric orthopedic surgeons have not had a strong relationship with industry, and they have asked for help before, only to be disappointed, so there is an inherent lack of trust,” Deeter explained. “That being said, I think we have done a good job proving to the pediatric community that we are here to stay.”

He said the company has benefitted from recent regulatory improvements, describing the new legislation as “streamlining” the device approval process through the FDA. Deeter said OrthoPediatrics has submitted five 510(k)s recently, and all have been approved in fewer than 90 days, with the fastest approval received in 45 days.

“Strangely enough, it appears that we have a regulatory advantage instead of a challenge thus far,” Deeter added. “The FDA has been a tremendous partner and we are very grateful for their help in getting these new devices to the market to help children. There are so many ideas flowing into our company right now that our biggest challenge from an R&D standpoint is filtering through them all and making the decisions about which technologies to put resources behind and commercialize. We have been adding more structure and rigor to that process to have a more sophisticated approach, and that is helping us tremendously.”

Deeter also noted that the company has developed a surgeon advisory board to help the firm understand the challenges faced by pediatric surgeons and what products are needed most.

Another company that has committed to the pediatric orthopedic market is Wright Medical, with its Repiphysis Expandable Implant technology. Every year, approximately 1,000 new cases of bone cancer are diagnosed in children, according to Wright’s figures. Osteo-sarcoma, the most common type of bone cancer in children, frequently occurs in a child’s femur, tibia or humerus, and usually is treated with surgery to remove the cancerous tumor.

Twenty-five years ago, the only surgical option was amputation of the limb. Limb salvage surgery has become the preferred method of treatment. Amputation is avoided and the surgeon removes only the tumor and surrounding tissue. Then, an artificial prosthesis or bone graft is implanted to replace the bone removed in surgery. Although this technique enables surgeons to save a child’s arm or leg, limb salvage surgery does have a significant drawback: The implant does not grow with the child and multiple revision surgeries are necessary to correct the length discrepancies. This means a child must undergo invasive surgery to implant a new, longer prosthesis every time a noticeable limb length difference is identified. Depend-ing on the age and growth rate of the child, four to six surgeries could be necessary to accommodate for a child’s normal growth cycle. Each surgery comes with the risk of infection, as well weeks of difficult rehabilitation.

“Serving the pediatric market is something that we value,” said Patrick Fisher, senior director of ortho recon marketing for Arlington, Tenn.-based Wright Medical. “It’s not a big money maker, so it’s something we do out of goodwill. We have good relationships with the surgeons who use the implants on a regular basis. All you have to do is walk into St. Jude [Children’s Research Hospital in Memphis, Tenn.], and you want to do everything you can to help those kids.”

Repiphysis was developed by French engineer Arnaud Soubeiran and marketed and is marketed andmanufactured by Wright Medical. The implant is made of titanium and plastic and consists of two tubes with a spring mechanism, which is compressed by a locking device. It weighs about the same as a patient’s bone and ranges in size depending on the patient. Instead of undergoing repeated surgeries to extend the bone, as is the case with non-expandable implants, Wright’s device uses an electromagnetic field to slowly lengthen the implant internally.

The lengthening process is a non-invasive procedure that can be completed in about 20 seconds without surgery or anesthetic, according to company officials. When a doctor determines that there is a limb length discrepancy that needs to be corrected, a magnetic field outside the patient’s body starts the lengthening process. The electromagnetic field softens the plastic inside the system, allowing the spring inside the device to expand. Unlike traditional procedures, recovery and rehabilitation are not needed afterward. Instead, a child is able to get up and walk out of the doctor’s office.

“This is a challenging market, but one we’re committed to,” Fisher added. “The fact that we’re dealing with young cancer patients means there are always complicating factors. One is a compliance issue. Kids aren’t always a compliant bunch. It’s one thing to tell a 65-year-old man not to go crazy on his hip replacement, it’s another thing to tell a 12-year-old girl not to do the things she wants to do. Once she feels well, she wants to run, jump and play with her friends, etc. It puts extra stress on the implant. It’s tough to plan for things they’re going to do that you don’t want them to do. We have to make sure the implant is tough.”

Looking Forward

Experts agreed that there’s a lot of promise and that given the technology and innovation present in the adult orthopedic market, the opportunities for pediatric devices are many.

“The possibilities are interesting and exciting,” Vitale said. “The market in pediatric surgery is expanding. We’re realizing that we have the ability to do more for kids and intervene in ways that we didn’t before—and we don’t accept as much morbidity in children as we may have in the past. The market’s growing and industry is aware that it probably has an opportunity to do a little more than it has in the past.”

Vitale said much of the opportunity to treat younger patients is in the spine sector. He described current treatment choices as “sub-optimal,” but not because the technology doesn’t exist.

“It’s because of the dynamics of the pediatric device market don’t allow for it all to come together in a way that is doable,” he explained.

“The future of spine surgery, in my opinion, will not rely so heavily on spine fusion. A number of things are coming together in our world that are going to allow us to identify kids with scoliosis earlier, predict those kids who are going to progress and treat them earlier. And the way we’re going to treat them earlier is by modulating growth by using some sort of device that allows growth on one side of the spine to catch up with growth on the other side of the spine. We’re in the very early days of being able to do that.Part of the reason I am so passionate about this is that it’s not in the best interest of kids to slow down innovation as it has been. We could be doing things a lot better.”