Design thinking to help reverse a difficult deformity

Clubfoot is a curable deformity, but in the developing world poorly designed orthopedic braces mean low treatment compliance. This new brace could change that.

Soccer champ Mia Hamm was born with it. So were figure skating star Kristi Yamaguchi and Green Bay Packer and Heisman award winner Charles Woodson. The “it” to which we refer is clubfoot, a congenital deformity that occurs in one out of every 1,000 live births around the world.

The feet of babies with clubfoot grow at a severe inward angle, and without treatment this makes walking very difficult. Running is not even an option.

An infant with clubfoot

Clubfoot is highly treatable, as the success of athletes born with the deformity attests. However, economic barriers and inaccessibility to education mean that the parents of children born with clubfoot in the developing world often lack the resources to attain proper and consistent care. As a result, many of these children suffer and may have difficultly securing work as adults.

A group of students from Stanford’s design school think they’ve found a way to improve and increase clubfoot treatment in the developing world. The team, which consists of a medical student, a mechanical engineer, a recent MBA grad and a material scientist, have prototyped the Miracle Brace, a new iteration of a clubfoot brace that they designed as part of a two-quarter course called Entrepreneurial Design for Extreme Affordability.

Globally, the predominant treatment for clubfoot is called the Ponseti Method. This non-surgical approach involves placing one or both of the infant’s feet (about 50 percent of clubfoot cases affect both feet) into a series of plaster casts, which gradually bring the bones into correct alignment. Following this four- to six-week casting process, the feet and ankles are generally in correct alignment. However, it is vital to for the parents to then put their baby’s feet into a brace for a number of years, to ensure that the correction stays in tact as the baby continues to grow.

“Bracing is where the system falls down,” says Chesca Colloredo–Mansfeld, the executive director of Miraclefeet, an organization that works to improve treatment for the one million children who suffer from clubfoot in the developing world.

“We started supporting clinics around the world and it became clear that bracing was the shakiest part of what we were doing,” she says, referring to the fact that parents often fail to keep their children in a brace long enough or consistently enough once the casting process end. “It’s an educational piece,” she says, “but also it’s around the design of the brace. The braces used in the developing countries are not ideal, they’re not comfortable for the children, they are hard for the parent to put on the children, and they are very expensive.”

Boot is designed for ventilation

State of the Brace
There are a number of different manufacturers and designs of existing orthopedic braces used to treat clubfoot, say Ian Connolly and Michael Ahdoot, two of the team members. In the developed world, the highest quality brace runs for $300, but importing these braces into developing countries makes them prohibitively expensive -- as high are $800, says Ahdoot. So lower-priced (and often, lower quality) braces are used instead.

With the help of Miraclefeet, which proposed that Stanford design school students innovate with regard to the current clubfoot braces used in the developing world, the team members traveled to Brazil. Here, they observed clubfoot treatments in a clinic and interviewed a number of parents. Their brace design, which they were able to quickly prototype using a 3D printer, addresses a number of sources of frustration that these parents expressed.

The braces used in the developing world are comprised of thick suede boots, which are angled outward and attached to a metal rod. The parents must coax the children’s feet into an outer angle and then place the foot into the boot, but with the children often unsettled, crying and fidgety, this can be quite onerous. Plus, the boot makes the child’s foot quite hot.

“The braces are made of warm leather and silicone,” says Ahdoot, “When it’s 43 degrees Celsius outside and 100 percent humidity, parents don’t want to put their kids into these sweat machines.”

Conventional brace, used in Brazil

Bracing for Change
Under the Ponseti Method, a brace is used for 24 hours a day during the first six months following casting, and then the brace (which must be replaced with larger versions as the child grows) should be placed on the child for about half of each day until he or she reaches three years of age.

It’s no wonder then, considering the issues around the poor interface and difficulty of using these conventional braces, that compliance with these guidelines in poor in the developing world. When parents fail to use the brace as prescribed, the children are not likely to overcome their clubfoot completely.

The design that the students created is different in a number of important ways. First, the boots are flat plastic sandals with cloth, Velcro straps, which makes them well ventilated and easy to place on the child’s food. The boots are detachable from the bar, as well, so the parents can first place the boots on the child, and then coax the feet into an outward angle and secure them onto the bar, rather than trying to do both motions at once.

Finally, the bar onto which the two boots attach is flat, so that once the children become toddlers and are ready to begin standing, they will be flat on the ground. “They might even start shuffling along the ground with the brace on,” says Ahdoot. The metal bar used in the incumbent design, however, is curved, which means that children can’t stand flat on the ground while wearing the brace.

“We’ve taken a user-centered approach in designing the brace,” says Connolly. “We looked at the needs of the parents and kids.”

Larger braces are used as the child grows

Making it Real
The next step for Connolly and his team is to put their Miracle Brace prototype brace in front of an institutional review board, which will put the device through review protocols for experimental trails. If the brace is deemed safe and ethical, the next step is to put the brace through clinical trails, during which they’ll start testing the brace with patients.

“From there, we’ll troubleshoot, work out any design problems, and then start production,” says Connolly. “Then we’ll start looking toward production.”

Based on quotes they’ve received from U.S. manufacturers, the team believes it could mass produce the brace, via injection molding, for around $27. Because conventional braces can be made for as low as $15 in orthopedic shops in the developing, world, however, they hope to be able to bring the cost of their price to below $20 in order to make it more competitive. In some parts of the developing world the braces used cost between $150 and $200, so the Miracle Brace could enter as a much more affordable option.

If they’re able to reach that lower cost, the brace could also compete well against higher-cost braces in the U.S. as well, says Miraclefeet’s Colloredo–Mansfeld.

“I’ve been incredibly impressed so far,” she says. “I was sent their team member’s resumes and I was blown away by each one of them. I have high hopes that we’ll get something that we’re really going to use,” says Colloredo–Mansfeld.

“This is not just an interesting project for the design school class, it’s a real problem that needs to be solved.”

Photos: Courtesy of Ian Connolly

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