Do-it-yourself medical device course
By TRACIE WHITE
Jessica Connor is making a life-size model of a lamb’s tongue out of silica.
“I’m not sure this is going to work,” she says, holding it up in the light for her colleague, Gary Binyamin, to view. He pauses, sets down the metal prototype that he’s been molding into different shapes and shrugs.
“Maybe we’ll have to try again,” he says, glancing at the tools of their trade scattered across the workbench on that winter morning: metal wire, silica, an actual lamb’s tongue, plaster of Paris. The two are part of a team of four Stanford fellows tinkering around like kids in their dad’s garage workshop. Connor, a biomechanical engineer; Binyamin, a chemical engineer; and two surgeons-in-training, Bilal Shafi and Carlos Mery, make up the 2005-06 Biodesign Surgical Innovation Fellowship team at Stanford, a new addition to the Stanford Biodesign Program, created to train future inventors of medical technology.
Their plan is to transform all this stuff — picked up at Ace Hardware or the art supply store, mailed away for, bought for $5 a pound at the Mountain View International marketplace (the lamb’s tongue) — into a new and improved treatment for sleep apnea. Prototyping, it’s called. And they’ll do it over and over and over again until they’ve got it right.
This is hands-on education. The fellows find their own supplies. They come up with their own ideas. When something goes kaput, they fix it. When a new idea works, they file a patent. Sometimes they even start their own companies or market their own devices. Mentorship and collaboration are key, but if you want to be an inventor, the theory goes, you invent. It doesn’t matter how many advanced degrees you’ve got. You build. You fix. You brainstorm. You tinker.
After all, Ben Franklin flew his own kite. Edison made his own lightbulb.
“You have to do it with your hands,” says Tom Fogarty, MD, one of the real-world medical device inventors who donate time to help out with the program. “Then you can recognize the needs. You have to multi-task. You have to be a jack of all trades. Never say ‘That’s not in my job description.’ ”
Innovation as a discipline
The workshop where the four fellows are molding lamb’s tongue models is in a laboratory in Stanford’s Clark Center, a monument to modern architecture, with windows for walls, designed to foster collaborative research among scientists — clinicians, engineers, physicists, chemists, surgeons. The building stands between the medical school and the engineering school on a campus that encourages entrepreneurialism within a community renowned for its innovation.
Where better to train the inventors of tomorrow, ask the fellowship’s developers. Thomas Krummel, MD, the Emile Holman Professor and chair of the Department of Surgery, says the program “is not about producing new technologies — it’s about giving bright, young physicians and engineers the education and experience of how to invent. It’s like the old proverb that the best way to feed someone is to teach him how to fish.”
When future inventors are at a loss, they should be able to look across the room for advice, says Krummel. And that’s what this fellowship team has done. They spent the past year working together in the same room — the surgeon tapping the shoulder of the bioengineer who reaches across the table for the chemist. Their mission: to create a medical device that will improve patient care.
“Right now technology innovation is not taught in academic medical centers — it’s left to serendipity,” says Paul Yock, MD, inventor, cardiologist and founder of the program. “As clinicians we can treat patients one at a time, and we do a great job at that. But if we invent a new technology, that can help thousands or millions of patients.”
Yock, who lovingly refers to the new science as “gizmology,” says the goal is to create biomedical Edisons, who will invent devices to improve patient care exponentially. Perhaps the entrepreneurial bent of the program has raised some eyebrows, Yock says, but doctors are currently behind the curve in the technology field, and creating a biodesign program integrated with the medical school is one way to catch up.
“Some schools would balk at being so entrepreneurial,” says Yock. He points out that teaching innovation is a different type of science from the traditional research-centered approach. It’s much more practical.
“This is not your standard, hypothesis-driven research,” he says. “We look for important gaps in biomedical technology. Finding and characterizing the need is the key intellectual challenge. The goal is to vastly improve the lives of as many patients as possible.”
To do that, the program teaches needs identification, inventing and technology transfer, and then, because there are financial transactions, it teaches ethics and policy. Graduates have gone on to work in the medical technology field, some focusing on developing new technologies, others on developing the business. He points to one recent graduate, David Miller, who created the company Innospine, which markets and develops technology to treat low back pain, and was recently acquired by Kyphon, a medical device company in Sunnyvale, Calif.
The emphasis on interdisciplinary collaboration within biodesign reaches farther than just the Clark Center or even across the lawns of the Stanford campus. The biodesign fellows themselves are exposed to all kinds of medical innovators out in the “real world.” To create a product that will eventually make it to the patient, it’s essential to work with industry, the program preaches.
“It doesn’t help to invent something for patients if it will never be developed and manufactured,” says Mike Gertner, MD, who co-directed the surgical team with Krummel. “It’s a waste of your time.”
Stanford’s location bordering Silicon Valley, aka “the medical device valley,” helps make a strong industry-academic collaboration a possibility. More than 200 medical-device companies account for $15 billion of the local economy. Many of the innovations that have sprouted in Silicon Valley have come from Stanford faculty themselves, including Yock, who has invented several successful cardiovascular devices and founded a company, now owned by Boston Scientific, to produce and market ultrasound technology he developed.
Faculty from Stanford and other universities and business people all contribute to teaching the biodesign fellowship. Many of the lectures are conducted by off-campus experts. The “secret sauce” of the program is the 150 experts drawn from the outside world who donate time to the program, Yock says. Legends like Fogarty, a National Inventors Hall of Fame inductee and inventor of the balloon catheter and dozens of other successful medical devices, make themselves available to the fellows to pass on their worldly wisdom.
“I have a personal interest in trying to replicate the mentor experience,” says Yock, who credits his success as an inventor to an early mentorship process that included Fogarty and John Simpson, MD, PhD, another prominent Silicon Valley medical device innovator. “My mentors made innovating seem do-able. They helped me believe that it really was possible for somebody like me to develop something new.”
Know the needs
When the fellows first started in the biodesign program more than a year ago, their instructions were to immerse themselves in the world of surgery. That meant hours, days, weeks, months spent listening to patients explaining exactly where and how it hurts, pestering nurses with questions and observing everything from open-heart surgeries, gastric bypasses to cochlear implants.
“You name it, we saw it,” says Mery, one of the four fellows.
The fellows’ first school assignment was to identify problems in the clinical setting. “Certain clinical needs just jumped out at us,” says Binyamin. “Things like the need for a less-painful method of harvesting bone marrow, and a method to prevent and treat pre-term labor.” By fall, the team had compiled a list of 380 clinical needs, which, after much brainstorming and debate, they eventually narrowed to two: congestive heart failure and sleep apnea. (Attention would-be inventors: That leaves at least 378 clinical problems to be solved.)
“We take people who are relatively unbiased because they come from a variety of backgrounds and put them into an environment where they are watching doctors, patients, nurses in action,” says device developer Josh Makower, MD, who co-developed the fellowship program with Yock and is based in Menlo Park, Calif. “It’s amazing how many problems get identified, how many latent needs get uncovered.”
Key to deciding which problems to attack was determining which would have the greatest amount of clinical impact — which would help the most people or help people the most.
“Most inventors come up with an idea and try and push it on the world,” says Yock. “We’re trying to flip the process. First we find the need, then develop the device.”
The fellows next became experts in their two chosen topics and, after much research, decided to focus on finding a solution for sleep apnea.
Sleep apnea is a condition that causes the soft tissues in the throat and back of the mouth to collapse. As a result, the sleeper periodically stops breathing, which leads to fitful, unrestful sleep and even poses a risk of death. Current treatment relies on a machine plugged into the wall connected to a mask that is worn at night and forces pressure into the mouth and nose to keep the airway open. Kids in particular seem to hate the device, often ripping off the mask in their sleep. Surgery is the next step.
Only 10 percent of the estimated 1.5 million sleep apnea patients seek treatment, partly because of the lack of options.
“It’s an unmet need if there ever was one,” says Krummel.
“We’re working on a device that will keep the soft tissues in the upper airway out of the way,” explains Binyamin, back in the lab this winter, working once again on perfecting a prototype for his team’s sleep apnea device. “Something that will give a little extra tone, support. Something that won’t bug you while you’re trying to sleep.”
By spring, the fellows had developed an early prototype of their device. They filed intellectual property under Stanford’s name and started work on a long-term plan to either start their own company or license the product someday to another company interested in marketing it.
After seemingly endless brainstorming sessions and countless attempts to create better prototypes, they had a solution: a graceful, metal needlelike device about 5 cm long, designed to keep the airway open during sleep. Patients would be able to have it inserted during a doctor’s visit and could have it removed just as easily. (At this stage, the team wants no more said about this in print. Device development is often kept secret until the time for market launch to avoid tipping off competitors.)
The team has built up enough revenue from contest money and grants to continue developing the device. After the program ends and they go their separate ways, they say they’re committed to getting the invention into the hands of the doctors and patients who need it most.
But what they’ve learned from the fellowship will make a difference far beyond just developing a single device, the fellows say. Innovating has become a way of life.
“The gap between doctors and technology is growing larger and larger at a pace that’s unbelievable,” says Mery, a future surgeon. “Medical school trains you to do things one certain way. This program tries to get away from that. It gets you thinking, ‘Is that really the best way?’ ”
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