By Julian Smith
When Richard Van As, a carpenter in Johannesburg, South Africa, cut off most of the fingers on his right hand with a table saw in 2011, he was already designing a homemade prosthesis in his head before he even left the emergency room. But he never imagined that within two years he would be spending nearly all his free time making artificial hands for people around the world.
As he recovered, Van As connected with Ivan Owen, a special-effects artist and puppeteer in Bellingham, Washington. Together they designed a simple yet effective mechanical hand that cost a fraction of the price of a typical prosthesis. Word of the project spread, and now Van As crafts custom Robohands for anyone who can afford the $500 in parts, and many who can’t. “I stopped counting at 100,” he says. “The demand is very great.”
The pair were able to create an inexpensive, useful medical device so quickly thanks to a combination of old-fashioned ingenuity and a cutting-edge technology toolkit. Van As originally found Owen through a YouTube video of a pair of mechanical costume hands he had invented. They talked on Skype and used free computer-aided design (CAD) programs to shape the pieces, emailing files back and forth. Eventually the company Makerbot donated two 3D printers — which create detailed objects out of extremely thin layers of plastic — to fabricate the parts.
This wouldn’t have been possible just a few years ago. Now, the use of maker methods to create prostheses and other homemade medical devices is becoming a surprisingly casual and commonplace occurrence.
Can you hear me now?
Amelia Marzec’s inspiration to design a hearing-aid helmet was both financial and personal. When a tumor left her deaf in one ear, the Brooklyn-based artist discovered that the standard treatment for her circumstances was a bone-anchored hearing aid (known as a BAHA), which requires a screw implanted directly into the skull, and then a hearing aid that snaps onto the screw to vibrate and conduct sound. The surgery costs from thousands to tens of thousands of dollars, and is not always covered by insurance. Insurers rarely, if ever, cover the snap-on hearing aid, which is fragile, has a price tag that can range from $4,000 to $7,000, and requires replacement every several years.
“I realized it sounded like something I could build in my living room,” Marzec says, and that’s exactly what she did, attaching electronics from Radio Shack to a standard construction hardhat. Like the BAHA, the Re-Wired helmet uses bone conduction, routing sound through microphones and amplifiers to a vibration element placed against the forehead. Marzec’s prototype, however, cost only a few hundred dollars to put together — and doesn’t involve surgery.
Even her testing process was creative: for a week she waited on the sidewalk outside the New York Eye and Ear Infirmary asking patients to try it out and offer feedback. (At least one said it worked better than his regular hearing aid.) When the cost of a workshop to improve the helmet proved out of reach, Marzec started her own production lab.
A hacked helmet is a far cry from a hearing aid snapped onto a bone-anchored peg. But Marzec sees her project as proof that it’s possible to create a workable device for a fraction of the cost, without having to endure rounds of surgery and insurance. “You need to go around the system to begin to consider other alternatives,” she says. “I’m always thinking about the worst-case scenario, and there are a lot of folks who are in those situations.”
Made by hand, for hands
Doctors and nurses have been making their own medical equipment since the dawn of medicine, long before a medical-products industry existed. The first stethoscope was a paper cone made by the French physician René Laënnec in 1816; in 1853 the Scottish physician Alexander Wood based his design for a hypodermic syringe on a bee’s stinger. By the mid-20th century, even non-doctors had the resources to create complex devices outside of a laboratory. Earl Bakken, an engineer, put together the first wearable artificial pacemaker in his garage in 1957 and went on to found the company Medtronic.
Today, people like Marzec — many without any formal medical training — can take advantage of access to global supply chains, cutting-edge medical knowledge, and recent leaps in design and fabrication technology that have made the prototyping process faster, cheaper, and simpler than ever before. Even as concerns about safety and liability are only starting to be addressed, medical inventors and other technical tinkerers are already improving and saving lives — sometimes their own.
Innovators share ideas, plans, and inspiration on social networks, online forums, and specialist Web sites like Instructables, which lists thousands of step-by-step directions posted by users. Small wearable sensors embedded in sneakers or bracelets let users record massive amounts of detailed personal health data and analyze it on laptops or smartphone apps. Open-source hardware and software platforms such as Arduino, a simple programmable computer based on a single printed circuit board, offer an easy introduction to complex electronics.
A medical device inventor can now design a virtual prototype using free digital CAD programs such as OpenSCAD or Sketchup. If he or she wants to use Arduino, help is available from experienced users on the health-focused website Medicarduino.net. When it’s time to create an actual prototype, and the traditional cobbling together of available parts isn’t enough, an inventor can buy a Makerbot Replicator 2 for $2,200 or send the digital file to a custom 3D printing company such as Shapeways or Ponoko. To raise more R&D money, designers can turn to Medstartr, which lets anyone help fund promising health care projects with pledges of as little as $1.1
“There is a massive trend in user innovation in our society,” says consultant Peter Kragh. “There’s so much happening, so many solutions and ideas, especially in the medical area.” When he worked for the Danish company Coloplast, which specializes in continence care, Kragh helped patients redesign the company’s devices to better serve their needs — for example, by providing them with plastic welders to create better colostomy bags.
The experience showed him the gulf that can exist between those who traditionally design medical devices and the people who actually use them. “Internal R&D departments often hide themselves in their labs, and when they try to ‘decode’ user needs into solutions, there is a high risk of getting it all wrong,” he says. As a result, “those who use a product often use it in different ways than the engineers intended” — including modifying it or, more and more often, deciding to design their own.
In the United States, much of the motivation to create comes down to money. As one of the very few western democracies without national health insurance, we have by far the highest annual health care costs in the world: $2.7 trillion in 2012. According to the Advanced Medical Technology Association, medical devices accounted for six percent of this, or $156.3 billion, in 2010.
Having a condition that is rare, debilitating or fatal, or knowing someone who does, can be a great motivator for creativity. Take cystic fibrosis, a genetic disorder that causes a buildup of thick mucus in the lungs. Most of the newest treatments, therapies, and medical devices for the condition have come from patients.
Or look at anaphylactic shock, a life-threatening allergic reaction in many people to specific food or other substances. Twins Eric and Evan Edwards grew up with a large range of allergic triggers, and had to inject themselves regularly with awkward epinephrine “pens” to prevent anaphylaxis. In their teens, they invented an auto-injector the size of a small cell phone with a retractable needle and a recorded voice to talk patients through the process. The Auvi-Q was approved by the FDA in 2011.
Even with a working product in hand, it can still be difficult for inventors to break into the medical-device market. Amy Baxter, a pediatrician specializing in pain management, found this out firsthand. When her four-year-old son developed a fear of needles, Baxter set up shop in her basement and created Buzzy, a vibrating ice pack shaped like a bee that numbs the sting of injections.
The decision to try to turn her prototype into a business wasn’t easy, since it would take time away from her practice. Still, she says, “I decided to use my solution as a mother to be a better — more globally impactful — doctor.” Baxter held randomized controlled trials comparing the device to ethyl chloride spray and published the results. But when she launched the product in 2009, she found it nearly impossible to get her product into hospitals.
“It’s the nature of the system marketing to hospitals to pad prices and make items disposable to ensure repeat sales,” she says. Medical sales reps paid on commission will only take the time to push a new product if it is very expensive, with a high profit margin, or if it’s a cheap item that has to be reordered often, she says. “A reusable, low-cost product doesn’t work.”
On the other end, she says, hospitals’ complex budgetary processes often disconnect the physicians who order products — and pass the price on to patients and insurance companies — from their true cost. “Decisions to buy aren’t as straightforward as looking at a catalog,” she says. “There is no easy way to comparison shop, and less incentive in the medical environment.”
The result of all this inefficiency, Baxter says, is not only notoriously inflated hospital prices — like $36.78 for a $0.50 Tylenol with codeine pill and $154 for a $19.99 neck brace — but also a high barrier to entry for devices like Buzzy, which is currently available only online, with no marketing beyond word of mouth.
Duct tape and spit
In the developing world, health care hacking can be a matter of survival. According to Engineering World Health (EWH), which connects poor regions with creative health care technology, it’s not unusual for half the medical equipment in a developing country to be out of service. While wealthy countries often donate used equipment, up to 70 percent of it stops working within months due to a lack of parts or qualified maintenance. Even working equipment is often concentrated, like qualified doctors, in a few facilities in large cities, meaning a trip of hundreds of miles for people in rural areas.
EWH projects range from inexpensive devices that ensure that steam sterilizers are reaching high enough temperatures to electrocardiograph (ECG) pads made from bottle-cap liners and buttons. The non-profit organization runs summer programs that place biomedical engineering students in health care facilities in developing countries. Angela Czesak, a recent graduate from Tulane, was on a summer program in Tanzania in 2011 when she learned that her hospital’s single bili light, used to treat newborn jaundice (an excess of bilirubin), was difficult to move and could only cover one baby at a time.
The overworked staff asked if she could make one that was larger and brighter but still easily portable. Czesak and a partner came up with a rectangular frame that supports strings of bright lights. The design uses only locally available parts: a power switch and blue LEDs (popular for decorating motorcycles) from an electronics shop, a shower curtain to cover the top, and a stand they had custom welded.
“The design was a little over $100,” she says, “but that’s because our bargaining skills weren’t the greatest.” The staff loved the new lights, which could cover three babies at a time. And when Czesak returned the following summer, she found they were still in use.
“In the developing world, we often get shocked at the roughness of prototypes,” says Jose Gomez-Marquez of MIT’s Little Devices lab, a team of researchers who develop inexpensive solutions to pressing medical needs. The lab is part of the Institute for Medical Engineering & Science, also at MIT, a program designed to accelerate the development and introduction of new medical devices. “We forget that’s exactly the same level of fabrication they were doing with the first pacemaker or balloon catheter,” he says. “It’s duct tape and spit, but in this case it saves your life.”
As an example, he points to the clinic of doctor Awojobi Oluyombo in the rural southwest region of Nigeria, where consistently available electricity is spotty and generators are expensive. Under Oluyombo’s direction, the clinic has accumulated a host of homemade devices, including a still to clean water for IV fluids and a wooden operating table that uses the hydraulic jack from a car to lift and tilt. Patients often arrive on a motorcycle that has been turned into a three-wheeled village ambulance.
Oluyombo also helped design a manual hematocrit centrifuge — used to determine the volume of red blood cells in blood — that uses a bicycle’s rear wheel and drivetrain. The device spins blood samples at 5400 rpm, and has proven as accurate as electric models that cost hundreds or thousands of dollars. When the plasticine for sealing tubes of blood runs low, they find that candle wax works just as well. Oluyombo now mentors MIT mechanical engineering students.
“Just because it’s DIY doesn’t mean it can’t be clinical grade and quality,” Gomez-Marquez says. Budget limitations and irregular demand make medical devices especially difficult to distribute and keep working in the developing world. This leads to what Gomez-Marquez calls the “glucometer and Gameboy paradox”: both devices are roughly the same in complexity and price, but only the one made by Nintendo is common even in far corners of the developing world.
Looking at everyday objects as a source of hackable parts leads to prototypes like the IV fluid alarm that a nurse in Nicaragua made out of the electronics from a $2 plastic gun. Another team from MIT built a solar-powered autoclave that uses a satellite TV dish lined with 140 pocket-sized mirrors to focus the sun’s rays onto a wine bottle filled with water. The steam is fed into a repurposed pressure cooker, where temperatures can reach the CDC-recommended threshold of 250° F at 15 pounds per square inch for at least 30 minutes. The design is easy to build, customize, and repair; during field tests in Nicaragua, broken mirrors were replaced with the shiny linings from potato chip bags, which worked just as well.
To help spark creativity among doctors and nurses in the developing world, the Little Devices lab has put together a series of modular MEDIKits (Medical Education Design and Invention Kits). For about $50 each, the kits contain dozens of color-coded parts — everything from surgical tubing and clips to Lego bricks and electronics — that can be put together in different customized configurations. Options include nebulizers, electronic pill sensors, and prosthetic attachments for farmers, who often lose limbs in accidents.
Hacking for health
Organized opportunities for medical “making” are on the increase. In 2012, Hacking Health organized its first hackathon in Montreal to connect medical innovators with health care experts to help refine their prototypes. Since 2009, EWH has sponsored an annual academic design contest for health-care solutions for developing countries. Winning projects have included a low-cost glucometer, spirometer, and X-ray development timer.
Of course, building your own ECG pads is a little different from inventing a better bike light or modifying a Roomba to carry a six-pack. Medical devices involve unique risks and concerns, and malfunctions can hurt or even kill. In China, people have died after using homemade dialysis machines.
At this early stage, legal liability and government regulation are both big gray areas, says Eric von Hippel, an innovation expert with MIT’s Sloan School of Management. Selling a medical device in the United States requires FDA approval — but what about a list of parts and instructions? If a patient assembles a device a company sells in pieces, who is liable if something goes wrong? “It’s unclear,” von Hippel says. “There’s an interesting tension going on, and I think it’s going to increase as people’s ability to make things on their own goes up.”
Gomez-Marquez is currently working with the FDA to develop the idea of pre-approved building blocks for medical devices, what he calls a “regulated alphabet of parts” to streamline the design process.
The key is to encourage ingenuity and collaboration while keeping the process as safe as possible and within the bounds of the law, says Pedro Oliveira of Catolica University in Lisbon, a patient innovation expert. Next month, he will help launch Patient Innovation, an online platform where people with a wide range of conditions can trade therapies and treatments — “like a Facebook for patients,” he says. They are still working on the issues of liability. “We will make it very clear: these solutions have not been medically tested,” he says.
Gomez-Marquez predicts a “tremendous rise” in wellness devices in the next five to 10 years, given the current focus on accountable care and prevention, thanks in part to the Affordable Care Act. In the process, he says, we will have to find a balance between safety and accountability. “Health is not the Wild West,” he says. “But it shouldn’t be 1984 either. This is where DIY is exquisitely powerful: you make it for yourself, your friends and loved ones. You have a vested interest in making it work.”
The more people become involved in medical making, says Baxter, the less the human body will seem like a mysterious black box whose problems and solutions are only within the realm of experts. “The truth is,” she says, “the place where the body interfaces with the rest of the world is just engineering.”
Corrections: This article original referred to Jose Gomez-Marquez as Jorge Gomez-Marquez; our apologies. Little Devices also has shifted to be part of the Institute for Medical Engineering & Science a few months ago. We’ve corrected that.
Jen A. Miller wrote about Makerbot and the potential — or lack of potential — for every home to have a 3D printer in “Home Cooking” (Issue #12, March 14, 2013). ↩
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