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Speaking from a historical perspective, Don Cummings, CP/L, FAAOP, director of prosthetics at Texas Scottish Rite Hospital for Children, Dallas, says, “Things are certainly better now than they were years ago. When I started here in 1987 there were very few components, feet, knees, and so forth for kids. The market has adjusted some, so that most companies that produce prosthetic components now also have at least a relatively small line of pediatric components.”

Since adult foot sizes start at 22cm, which fit many ten- and 11-year-olds, more foot choices are available from early adolescence on, Cummings says. “It’s the 12- to 18-month pull-to-stand toddler age up through preadolescence that’s still a problem. You may not have enough space to fit in a component that you’d like to use, and you’re forced to make other choices.”

Identifying the Challenge

Gerald Stark Jr., MSEM, CPO/L, FAAOP, senior upper limb clinical specialist with Ottobock, Austin, Texas, identifies four paradoxes of design that engineers and manufacturers continue to struggle with when developing O&P devices for children:

Packing “super powers” into a miniature package. “Kids are super athletes,” says Stark. “What kids do on the monkey bars every day would be equivalent to an adult climbing to the ceiling, swinging from joist to joist, and jumping from the ceiling to the ground in one bound—like an Olympic gymnast. We have components that are about 70 percent the size of an adult component; yet in terms of scale they have to bear far more punishment with load and impulse modes than any adult device sustains. How can you test for that?”

A disproportionate investment for a limited return. The pediatric share of the prosthetic market is miniscule in comparison to the overall prosthetic patient population. While 48 to 50 percent of all prostheses are made for patients age 61 and over, only 3.4 to 5.1 percent are produced for patients from the ages of one to ten, Stark says. “With any new product, manufacturers would like to sell about 200 the first year to know that the product is viable,” he adds. “With kids, you might only sell a dozen per year, and reaching the breakeven point may take years to attain.”

Dealing with a moving target. “You found the ideal solution for your patient—great,” says Stark. “Then, six months later, they grow out of it. They’re also a moving target in terms of their interests. If you make a leg for a kiddo who’s playing baseball—then he decides he doesn’t like baseball and wants to do swimming or art—you have to change with him.”

Keeping the parents happy as well as the children. “The anxiety of the family system greatly affects the way the prosthetist handles the fitting,” Stark says. “Maybe the child would be best served with a dynamic carbon bladed foot, but mom really wants to see a foot with toes. Usually kids are very adaptable and happy with a variety of solutions, but as prosthetists, we must often deal with the more rigid expectations of the family.”

Creating a Super-Powered Package

Children are tough on their devices; experts agree that it’s not a case of if, but how soon, their pediatric patients will break them. Matt Perkins, president and CEO of Coyote Design and Rehab Systems, headquartered in Boise, Idaho, points out that providers and manufacturers of both orthotics and prosthetics have similar issues and problems.

“The strange mix of high activity level versus size and weight makes it a really interesting challenge. I’m a good example. I broke a lot more stuff on my prosthesis when I weighed 60 pounds than I do at 200 pounds. To keep everything small and lightweight, but still flexible for small kids, makes durability a big issue.”

Stark agrees, and describes one child who was elated that his prosthetic knee had begun providing additional side motion after he broke a side link in it while sliding into second base. “He was just happy he got it to take control and move his leg in a new way.”

He recalls another case where a degree of durability was sacrificed for better results. “I kept making his partial foot more rigid and beefier and he kept breaking it. I switched gears and made a more flexible option that could break more, but was easier to replace.” Stark adds that while the patient did break the foot more frequently, the boy felt that the flexibility allowed him to walk more easily, and the ease and reduced fabrication expense made it easier to replace.

Although there may not be as many pediatric options as practitioners might like, adapting adult devices for pediatric applications is not a good idea, most agree. Cummings warns that proportionately downsizing adult components becomes costly in terms of lost strength and durability.

Andrew Pedtke, MD, an orthopedic surgeon and CEO and cofounder of LIM Innovations, San Francisco, addresses the issue with a popular pediatric mantra: “Kids are not little adults. You can’t take an adult medication for heart failure and decrease it to 15 percent of its dose and give it to a kid who has congenital heart disease. And you can’t take…a socket and just shrink it.”

He points out that since the majority of people with limb loss are adults, and the majority of those adults are male, even women have a difficult time being fit with devices that are anatomically ideal for them; children, with their smaller market share and greater variability, get even less attention. “O&P training is not subspecialized; we just don’t have a lot of prosthetics training where you focus specifically on children, which puts many practitioners at a disadvantage.”

Yet, paradoxically, pediatric O&P specialist Matt Albuquerque, CPO, president and founder of Next Step Bionics & Prosthetics, headquartered in Manchester, New Hampshire, points out that “kids need that functionality even more than adults. It’s very important for their development to be able to reach certain milestones at an early age. If not, problems result from that for the rest of their lives.”

He says that some manufacturers are beginning to address children’s emotional needs, not just their functional needs, by offering limbs that allow personalization in the form of colors and applied characters.

Sometimes, Cummings observes, the sparser selection of pediatric options forces practitioners to be creative, modifying adult components to suit a pediatric application, as was done when fewer pediatric components were available—for instance, reversing a shoulder joint to use it as a knee joint. “It’s a little more labor intensive to do outside joints, and it’s less durable, but you may not have enough room for the size knee that you’d like—or the right polycentric knee doesn’t exist. I think it helps to be familiar with times when we didn’t always have components and would still be able to make them with other choices like outside hinges or outside joints.”

Stark stresses the importance of optimizing designs for child use, and points to Ottobock pediatric knees that allow children to get down on the floor more easily. “Kids sit cross-legged, or even bowlegged, so we created a rotator in the knee that allows them to do that.”

Upper limbs include extremely small batteries to power more programs, and offer more fitting options, which are also streamlined for prosthetists who don’t see as many pediatric patients— utilizing input from pediatric specialists at various children’s hospitals.

Bernie Veldman, CO, CEO of Surestep, South Bend, Indiana, points out that children often don’t fit into the product categories manufacturers create for them. Research and development (R&D) for Surestep products is typically done at 13 affiliated clinical practices that have 90 to 92 percent pediatric patient populations. “Each child comes with a different set of skills and a different ability and disability. We have to work with them individually and it’s not as cut and dried as it is with adults.”

Partnering with physical therapists to help children achieve specific goals, Veldman recognized that there was nothing available for children with hypotonia. The high-tone bracing previously provided to simply position them correctly was often left in the corner because the children did better without it. The Surestep SMO (supramalleolar orthosis) he pioneered in 1999 was designed not to position this patient population better, but to help children with low tone function better, with individual modifications tailored for each child. This population turned out to be vastly larger than anticipated. Researchers conclude that hypotonia can be a symptom of more than 600 genetic disorders, with still more waiting to be identified.²

“We had no clue,” says Veldman. “We weren’t treating the low-tone population back then; when we finally came up with something that served that population, it took off like wildfire. I had never dreamed that it would become what it has.”

But is innovative pediatric O&P success really as simple as building a better mousetrap for a needy market segment?

There’s been very little development work on pediatric products in general, says J. Blount Swain, president of Ability Dynamics, Tempe, Arizona, which recently introduced the RUSH™ Kid pediatric foot. He speculates that microprocessor knees and hydraulic ankles haven’t entered the children’s market because downsizing such high-tech products is a challenge that most companies haven’t wanted to tackle.

“A lot of children are placed on running blades, which are good for straight-line running,” he observes. “But they’re not as good for walking and playing dodgeball and other activities. I think there’s a presumption that a lot of children want to run—but they’re not running the 100-meter dash a lot— they’re out being more creative than that.”

Small Market, Large Investment

Swain points out that developmental creativity for pediatric devices comes with a price tag that manufacturers may never recoup. He estimates a $500,000 minimum investment in the pediatric products Ability Dynamics has brought to market. “The challenge for us from a technical perspective was the whole downsizing issue of making a miniature version of the adult foot.”

Ottobock has addressed the issue of smaller numbers by making prostheses more modular, Stark notes. This allows prosthetists to custom create a finished product from optional interchangeable pieces. “With most products, you’re looking for a payoff of a year or 18 months on your investment. With kids, we accept it as much, much longer— as much as three or four years before we recoup development costs.”

Although the costs of R&D and beta testing in both dollars and man hours vary dramatically depending on the product, all agree that those costs can be significant. Perkins estimates that regardless of the product, spending less than five figures is impossible— and that assumes a best-case scenario when everything from napkin drawing to prototype works perfectly. “The longer it takes, the more issues, the more hurdles, the more challenges, the more complexity, that number goes up in a straight line, sometimes—the same is true for your time investment.”

Regulations and restrictions from entities overseeing new product development are increasing as well, further slowing the process, Stark says. “Getting through the regulatory issues sometimes takes longer than the design process itself.”

“If, as a profession, we can start showing that outcome changes are bringing about long-term benefits to kids through the course of their life, that will make reimbursement easier for everyone,” Albuquerque notes. “We talk about the long-term effects of not being fit correctly—limping, compensatory motion, hopping—all of those things that end up happening because we’re not doing what we should up front, at the beginning.” Children who have amputations, he says, suffer more damaging effects in the long run than seniors if they are deprived of appropriate prostheses.

Pedtke also comments on those differences. “A 70-year-old [person with diabetes] who gets an above-knee amputation is not likely to be more mobile than they were prior to their amputation. They’re going to move inevitably in the direction of decreased mobility. A child who has an amputation, or is born with a limb deficiency, is on an unlimited forward trajectory. We can’t define how disabled they will or will not be. They’re focused on growing, getting better, more functional, and feeling more powerful.”

The reality, he points out, is that a child is also going to need more sockets and more replacements than an adult, because he or she is growing and changing and putting significant demands on devices from a durability standpoint. For that reason, access to care is critical, he stresses. “How fast you can get them a new device and service the technology is essential for their experience and use of healthcare resources throughout their life.”

Potential reimbursement issues related to the more frequent service or replacement required for children’s devices may cause concern and potentially demotivate manufacturers from pursuing additional pediatric products, some sources speculate.

Growing, Changing Patients

The moving, growing target pediatric patients represent calls for innovative thinking in the realm of adjustable O&P solutions that grow with the patient. W. Brent Wright, CP, BOCO, with EastPoint Prosthetics and Orthotics, headquartered in Raleigh, North Carolina, says that such successful pediatric innovations depend on productive exchanges of ideas between practitioners and manufacturers. Based on his recollection of a LIM Innovations adjustable socket for adults, Wright contacted Pedtke when faced with a two-year-old patient with a transfemoral amputation who was in need of a comfortable prosthesis. Pedtke and developers at LIM worked with him to create an adjustable brim, and modified it to fit over a socket and Coyote Design locking mechanism fabricated by EastPoint.

“It allowed her more comfort and adjustability, so now she is able to fully don and doff the leg and she wears it all day long. At three years old now, she actually walks very well. It’s pretty impressive. But the reality is that there are not a bunch of tiny kids running around with an above-the-knee amputation. It doesn’t make business sense to create a product. There’s not a huge market for it; however, for the right child it can make a lifetime of difference.”

Perkins points out that the continually changing nature of pediatric patients impacts R&D complexity. “The difficulty that I see is that you have to make the product durable enough that it withstands the usage of the patient. The issue with that is determining what length is that usage. A three-to-five-year cycle is standard for adult products, but you don’t necessarily need a kid’s product to last that long because it will never fit them that long. But it has to last long enough that it doesn’t fail during its lifetime— whatever that is.”

Orthotic innovations also come with their own set of challenges, Stark says. Unlike prosthetics, which are dealing with a limb absence, orthotic solutions are working with an abnormality of the body that is still present. “A prosthetist can just replace the knee with a different knee. Obviously, the orthotist has to work with the knee that they have, and avoid creating new issues at the ankle by overcorrecting at the knee or hip.”

And where people are excited and happy that the child is receiving an arm or leg to replace something missing, orthoses are often regarded as unwelcome additives—cumbersome, awkward, and unnatural.

While Wright cites some companies that have been innovative in developing new orthotic solutions, he feels that orthotic development for the pediatric population still lags behind that for the adult population, despite his expectation that “the market for orthoses is going to be a lot bigger, since a lot more kids that are affected by spina bifida, Down syndrome, and other issues are becoming increasingly active and pushing the limits of conventional designs.”

Keeping Parents Happy

Sometimes children see what athletes are doing, and want a similar prosthesis—one that shows off its high-tech function. “If parents aren’t current with that information, and prefer something that looks more like a human limb, there can be a conflict or dissonance that has to be negotiated,” Stark says. “Kids are usually just happy with functionality in most cases since they do not have prior expectations.”

Swain says that while the RUSH Kid was developed with the needs of children with lower-limb loss in mind first, his team was surprised to discover that a device that breaks less often has a positive impact on the entire family of the wearer. “I consistently hear the comment, ‘Now that I can have a product that I don’t have to continually go back to the prosthetist and have it adjusted or adapted or replaced…, it’s really changed our whole family dynamic.’ Because typically families have other able-bodied children, and a prosthetic breakdown impacts the whole family. Often all their lives have come to revolve around the prosthetic needs of the pediatric amputee.”

A new and improved O&P device can have far-reaching effects on lives beyond the patient it was designed for—something our experts agree that designers and manufacturers may also want to keep in mind.

Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer.

References

1. U.S. News & World Report. 2015. Healthbeat, Doctors, families seeking more medical devices built just for kids. November 2. www.usnews.com/news/politics/articles/2015/11/02/new-push-for-pint-sized-medical-devices-to-treat-sick-kids?page=2.
2. Lisi, E. C., and R. D. Cohn. 2011. Genetic evaluation of the pediatric patient with hypotonia: Perspective from a hypotonia specialty clinic and review of the literature. Developmental Medicine & Child Neurology 53 (7):586-99.