The Million-dollar Fit: Companies Develop Affordable Prostheses for Use in Less Resourced Countries
May 2018 Issue
Every year thousands of people in impoverished countries undergo amputations. However, contrary to popular belief, armed conflicts or landmines are not usually to blame. Rather, the primary cause of most of these amputations is other types of trauma, such as automobile and train accidents.
For example, Yellamma, a 25-year-old single mother in India, received a lower-limb amputation when she was hit by a bus as she left the hospital where she worked as a nurse. The hospital provided her with a prosthesis, but the device was ill fitting and she was unable to wear it for very long due to severe discomfort. She ultimately lost her job at the hospital.
Lanieta, a 14-year-old girl from Koro, a remote island in Fiji, began having severe pain in her left leg in February 2016. She traveled by boat with her mother to Viti Levu, where she was diagnosed with osteoscarcoma and physicians performed a transfemoral amputation. However, there was no viable prosthesis that Lanieta could use on Koro's volcanic rock terrain, so she was unable to return home.
"Access to prosthetics is very much unequal across the globe, where young, otherwise healthy, amputees in low-income regions who would be good candidates for a prosthesis may only have access to crutches, a wheelchair, or an inappropriate, outdated prosthetic limb," says Rob Weiss, product manager for D-Rev, a San Francisco-based nonprofit that designs and delivers medical devices for low-income regions and populations.
Finding a Suitable Prosthetic Option
Every year, millions of people need either a new prosthetic knee or a replacement of their current device. They have a host of options with varying costs. There are microprocessor knees that provide users with increased stability and maneuverability over non-microprocessor knees. But they come with a hefty price tag and are primarily designed for the market of higher-income countries where third-party payers cover some of the cost. Polycentric titanium knees are an alternative, at a fraction of the cost, but do not offer the advanced functionality of microprocessor knees. At the lowest end of the cost scale, single-axis knees designed for use primarily in less resourced countries cost around $100.
Donated prostheses from high-income nations are often seen as a possible solution but may not be appropriate for the environmental conditions and other needs in less resourced countries. According to the World Health Organization (WHO), of the medical devices donated to clinics and hospitals in India and other developing nations, roughly 70 percent are ultimately never used and end up in the "equipment graveyard" because they aren't conducive to local conditions.
"We too often see donated medical devices in low-resource hospitals and clinics that end up not being used or maintained because they were never desired by the practitioner nor met the needs of patients in the first place," Weiss says.
A Bold Goal
Without a functional prosthesis, people with amputations are stripped of the ability to be efficiently mobile, and with that, can be deprived of the basic right to live productive, healthy lives.
D-Rev and a handful of other companies in the United States and Canada are working on a bold goal to develop and provide more affordable, adjustable, and high-quality prostheses to people with amputations in less resourced nations, while keeping their companies profitable.
"We're trying to solve the problem that 54 million amputees have. Most of them don't have access to a device that works well with their day-to-day life," says Erin Keaney, PhD, COO of Nonspec, which she cofounded in Boston in 2013, with the social vision of ensuring its device would be as accessible to as many people worldwide as possible.
Similarly, the motivation behind LegWorks, with its research and development facility based in Toronto, Canada, and its headquarters in Buffalo, New York, was to produce and deliver high-functioning and affordable prosthetic technology globally, says Jan Andrysek, PhD, PEng, its chief technological officer and a scientist at Holland Bloorview Kids Rehabilitation Hospital in Toronto. "The impetus came from the realization that researchers and companies were largely focusing on developing evermore complex and costly prosthetic devices, which due to lack of affordability, would be accessible to only a very small part of the world's amputee population," he says. "Few were focusing on developing functional and concomitantly affordable [sustainable over the long-term] solutions for people."
Initially, Nonspec concentrated on developing an upper-limb prosthesis. "When we first started, we were most interested in the engineering aspect, and making a fully articulating hand is incredibly complicated," Keaney says. However, with almost half of amputations worldwide occurring below the knee, it made sense to Nonspec to start developing a prosthesis for the largest population of people, says Keaney, who received her degrees in plastic engineering with a concentration on medical devices from University of Massachusetts Lowell (UML).
Nonspec's limb kit is designed to International Organization for Standardization (ISO) standards, which tests for high impact and a cycle testing of four years of walking, Keaney says. "We designed for these standards from the beginning, engineering the device to meet the incredible forces we use while walking, knowing that our price point wouldn't matter if we weren't bringing the expected quality to the table," she says.
About a dozen people with transtibial amputations have been fitted with Nonspec's limb kit, which includes the patented pylon device made mostly of plastic and some aluminum that weighs less than a pound. The kit was designed with adjustment in mind and an end goal to provide a system that can be adapted to the user in the clinic and on the go, Keaney says. Nonspec currently manufactures its limb kits in-house with CNC machining, in which computer software controls the manufacturing process, at a cost of less than $10. "We're able to keep our device affordable because we have designed for manufacturing from the beginning," she says.
Nonspec's approach is to deliver its kits to clinics throughout India so that they are available at a user's first visit and can be adjusted while the patient practices walking on the limb, Keaney says. "This leaves more time for the clinician to interact with the amputee, teaching them basic physical therapy, and how they can make adjustments for day-to-day comfort as needed," she says. "This means only maybe one, if any, follow-up visit, so they can be more active more quickly."
When it comes to producing LegWorks' All-Terrain Knee, there are two main components that go into the process: functionality and affordability. LegWorks developed two novel controllers that make the knee joint highly functional, Andrysek says. The AutoLock stance phase controller locks and unlocks the knee to provide stability over all types of terrain from cement to sand. The variable cadence controller is a simple, effective, nonfluid swing phase controller that allows for a smooth, efficient gait at multiple walking speeds. "Both mechanisms are simple, durable, and easy to manufacture and maintain," says Andrysek, who added that LegWorks has conducted numerous clinical trials in different parts of the world to test and validate its technologies.
The second part of trying to make LegWorks' device affordable is its business model, with the company developing its market in higher-income countries, including the United States, to support the needs of users who are less able to pay for devices, Andrysek says. "Our strong customer base in high-income countries has allowed LegWorks to operate and work with various partners providing technology affordability in low-income countries," he says.
All Roads Lead to India
Nonspec first set its sights on India to begin its work because of its high population and number of people with new amputations annually. The company participated in an exchange program through UML to develop a clinical team in India. "It allowed us to be in-clinic developing our product with our customers and end users," Keaney says. "With such a large population and a location craving new technology to meet them, we saw a great opportunity."
D-Rev launched its ReMotion Knee, a polycentric knee joint that acts like a human knee and mimics human gait, to the global market last August for a retail cost of $80. "We designed it by closely listening to patients and practitioners. To be accepted in their community, patients wanted their leg to look ‘normal' while sitting and walking," Weiss says. "We built a cosmetically appealing design without sharp, unnatural edges that poke out under pants, and with a polycentric geometry that reduces awkwardness and stumbling, compared to the low-cost single-axis knees."
Patients in less resourced countries also must travel long distances to reach their prosthetists, and practitioners needed a knee joint with straightforward adjustment and limited need for maintenance, Weiss says. "No complex pneumatics or hydraulics," he says. Electricity, or the lack thereof, was also taken into consideration. "Many users also have unreliable access to electricity," he says. "Building an expensive, computerized knee requiring a daily recharge was out of the question."
Historically, D-Rev started its product development with an eye toward India. When bringing the ReMotion Knee to market, the nonprofit took its launch a step further by working with clinical partners in Indonesia, Guatemala, Ecuador, Mexico, and Cambodia, as well as India, Weiss says. More than 500 people with transfemoral amputations have been fitted with the ReMotion Knee in 28 countries since the company's full launch of the device last summer (after a soft launch in 2015). "Our total sales are double that, but as a mission-driven organization what we really care about is impact," Weiss says. "We want to know not just how many knees are sold, but how many patients have actually benefitted." D-Rev uses field research and customer feedback to develop a proprietary algorithm to estimate how many patients are benefitting from the ReMotion Knee, he says.
LegWorks did not design its All-Terrain Knee to be economical, but sought rather to create a durable, functional, and cost-effective device that meets ISO standards, Andrysek says. "This is especially important to low-income countries where access to clinics and expertise and resources to repair advanced and complicated prosthetic technology may be limited."
LegWorks has provided its knee in 19 low- and middle-income countries and fitted more than 500 patients with transfemoral amputations, Andrysek says. "While the numbers are important, at these early stages the outcomes are even more so," he says. "It's not just about fitting a prosthesis but making sure that the amputee is able to use the prosthesis for years to come."
In addition, LegWorks is working on two major projects in Tanzania and Cambodia—fitting patients with the All-Terrain knee and performing, monitoring, and evaluating studies to generate evidence relating to the deployment of the technologies, Andrysek says. In Tanzania, the company is focused specifically on studying the socioeconomic impact. "We hope that this work will start to build evidence to inform healthcare providers about the benefits of providing quality prosthetic rehabilitation," he says.
While the devices of LegWorks, D-Rev, and Nonspec are readily available in less resourced nations, getting the people in need to the clinics and hospitals where the products are offered can be problematic.
Many new patients with amputations may not know where to find professional prosthetic care, says Weiss. "Many of them live in rural areas and aren't receiving care. By chance, they will have seen a video of our product. They'll write to us and say, ‘I've watched your video, where can I get this?'"
Weiss says D-Rev often ends up playing matchmaker between patient and prosthetist. "We contact the prosthetist about the situation and if the prosthetist is willing to help them, then we let the patient know," Weiss says. "This is not something we anticipated happening."
While these companies have been successful in producing low-cost prostheses for use in low-income countries in a relatively short span of time, this achievement has not come without tribulations, from managing grueling travel, to being accused of being too young to develop an appropriate medical device, to working with teams and partners on the other side of the world.
"Some of our biggest challenges have come from managing a team on two different sides of the world, both with timing, language differences, and cultural differences," Keaney says. Nonspec has had to address the challenges of managing all the moving parts for its business with a small team, Keaney says. "We've taken courses and accelerator opportunities to gain skills and mentors with the skills that we lack to move forward," she says.
One of D-Rev's biggest challenges has been leverage, Weiss says. "We don't have the resources or the brand names…, so it's on us to compensate with innovative engineering, great service, and clever marketing," he says. Bringing a high-quality product to market means applying principles of professionalism in product design and manufacturing, according to Weiss. "One way we achieve this is by working with partners to multiply our expertise and get our products over the finish line," he says.
When it comes to facing challenges, size often doesn't matter, Andrysek says. Providing access to basic healthcare needs is a challenge that even the biggest organizations such as WHO or the United States Agency for International Development (USAID) also face. "While I believe that we have made some important progress, there are still millions of amputees without a prothesis," he says.
With nearly 90 percent of people with amputations in less resourced countries with little or no access to prosthetic devices, "there's still a lot of work to be done," Andrysek says. "Our greatest challenge is that we are a relatively small social for-profit company, and what we are tackling is a big and challenging problem. We have been working hard to raise awareness about the problem and our work, in an effort of establishing productive partnerships to support our mission so that we can sustainably grow our reach and impact around the world."
Mobility in Low-Income Countries
No one at LegWorks or the hospital forgot about Lanieta, the teen from Koro. Physicians and clinicians met with a physical therapist at the hospital to inquire about getting her a prosthesis. After testing different knee joints, it was determined the All-Terrain Knee would work best for Lanieta given Koro's uneven landscapes. She was successfully fitted with the device and ultimately returned home.
Though the challenging surfaces make it necessary for Lanieta to use a cane for assistance, she has adjusted to a more normal lifestyle and returned to school, Andrysek says. "We believe there is strong evidence to suggest that prosthetic rehabilitation makes economic sense," he says. "Sure, it may not be cheap, but let's say a country spends $500 to provide a prosthesis to an amputee, a person who can now work. In low-income countries, the average capital income is on average $500, so over the functional life of a prosthesis, which is typically three to five years, there's an overall net economic benefit. On top of that are the social and societal benefits of empowering individuals with disabilities to do more."
Betta Ferrendelli can be contacted at email@example.com.
Editor's note: This article represents a sample of many organizations seeking to address the need for O&P services in less resourced countries. Read about other similar companies in the May issue of EDGE Direct.