Better Gadgets, Better Medicine: Biodesign Fellows Join Forces to Rethink Medical Devices

In the fall of 2008, Stanford neurosurgery resident Kevin Chao stopped by Lucile Packard Children’s Hospital to observe an unusual operation. Pediatric surgeon Sanjeev Dutta, MD, removed a young girl’s spleen—through her belly button. Using minimally invasive tools and cameras, Dutta performed the entire complex procedure through a single small umbilical incision, leaving no visible scar.

It was a masterful performance. But as Chao left the operating room that day, he couldn’t help wishing that the surgical tools were better. “When you have to do a procedure like that through one incision, there’s a lot of crowding of instruments,” he notes. “Children are small, and any time you use one instrument, all the others move at the same time.”

Kevin Chao, MD, and Avi Roop, fellows in Stanford's Biodesign Innovation Program, have collaborated to develop an improved pediatric surgical device.

Luckily, Chao is in the position of being able to do something about improving those tools. In addition to being a surgeon, he is a senior fellow in Stanford University’s pioneering Biodesign Innovation program. Shortly after viewing the Packard operation, Chao shared his concerns with three of his teammates at Stanford’s James H. Clark Center. Six months later the group had developed a prototype for a laparoscopic tool kit that gives the surgeon a bit more room to maneuver—and still doesn’t leave scars.

The new Engage surgical system is just one of many valuable products to come out of the Biodesign Innovation program. Over the past decade, graduates have filed some 50 invention disclosures and patents for devices ranging from low-cost ventilators to improved epidural catheters and fetal monitors. More than 20,000 patients have been treated by devices that originated in the program. Several biodesign teams have won major technology development awards, and no less than 10 startup companies are in the works.

Equally impressive are the experts the program has produced: 57 alumni who’ve been trained to go forth and create useful devices that address major clinical and surgical needs. “What I like most about Biodesign Innovation is that it’s not just about making one gadget,” says program co-director Thomas Krummel, MD, the Susan B. Ford Surgeon-In-Chief at Packard Children’s. “It’s about training a generation of researchers to rethink gadgets and devices entirely.”

Silicon Valley Success Story

Like many Silicon Valley success stories, the Biodesign program began with a meeting of minds over breakfast. Paul Yock, MD, professor of bioengineering and medicine, was looking to develop a postgraduate training program in medical technology innovation as part of Bio-X, Stanford’s university-wide biosciences initiative. Josh Makower was a medical technology entrepreneur who had created a model innovation training program at Pfizer.

Paul Yock, MD, and Thomas Krummel, Md, co-direct the Biodesign Innovation program.

The two agreed that Stanford’s Silicon Valley campus was perfectly situated for such an enterprise. It was surrounded by hundreds of med-tech companies and venture capitalists. Its faculty already had a distinguished track record of medical innovation, and its students were among the brightest and most entrepreneurial in the world.

The program began in 2000 with just a few faculty members and limited staff support. Today, Stanford Biodesign includes 15 faculty members, 6 staff, and numerous events held throughout the year. Highly popular graduate courses provide students with hands-on experiences in medical device innovation.

The program also sponsors two multidisciplinary fellowship teams per year, each consisting of four postgraduate engineers, business professionals, bioscientists, and physicians. Roughly a hundred candidates apply for the handful of openings. “Many are business folks who’ve worked in the medical device industry as product managers or in sales and marketing,” says fellowship director Todd Brinton, MD, clinical assistant professor of medicine. “Some went to business school and then to medical school. Others studied or worked in engineering before attending medical school. The main thing we’re looking for is a knack for innovation: the ability to see a problem, observe it, understand it, and dig into it.”

From Inspiration to Realization

Ellis Garai and Pedram Afshar, MD, PhD, are typical of the students in this year’s program. Garai is a UCLA- and Stanford-trained mechanical engineer who spent years in the medical device industry. Afshar attended medical school at the University of Pittsburgh, and also earned a doctorate in robotics and biomedical engineering from Carnegie Mellon. “Coming here was a tough decision for me,” Afshar explains. “Most MD/PhDs practice as clinician-scientists, where they can practice medicine and also perform research. Though I found it intellectually stimulating, primary research may take decades to reach patients. I’m interested in developing technology that can more immediately improve people’s lives.”

Ellis Garai and Pedram Afshar, MD, PhD, began their Stanford training with a six-week "boot camp" in cardiovascular medicine.

Like all Innovation fellows, Garai and Afshar began their Stanford training last summer in a six-week “boot camp” that gave them an overview of a specialty focus area (this year’s topic: cardiovascular medicine), along with a deep understanding of the innovation process. They attended 40-50 lectures given by some of the nation’s top physicians, intellectual property lawyers, venture capitalists, and med-tech CEOs. Then they headed next door to the Medical Center and Packard Children’s, where they spent weeks going on rounds, observing procedures, and talking with doctors, nurses, and patients—always looking for gaps in medical care.

Now it’s a foggy morning in January 2010, and they’re back in the brainstorming room at the Clark Center, thinking about ways to fill those gaps with medical technology. The walls are paneled with white boards covered with scribbled drawings. Behind them, a shelf holds a collection of inspirational odds and ends: LEGOS, bits of wire and rubber tubing, construction paper and modeling clay. “We take trips to Ace Hardware all the time for concept generation,” Afshar explains. “A lot of time you can borrow inspirational ideas from cookware, hardware, and plumbing. The human body isn’t so different.”

An illustration of a prototype being developed a team of fellows in the Biodesing Innovation program.

Going through their hospital notes, the students determine which patient needs would be the best ones to address, given the regulatory hurdles they’re likely to face, as well as the size of their potential market. Each team will pick out a specific challenge and develop a prototype device to meet it. They’ll rough out their models in a more sophisticated lab next door and refine them further in the Product Realization Laboratory at the nearby School of Engineering. Finally, they’ll write a business plan for the device’s development, covering everything from clinical trials to venture capital and staffing needs.

Kids a Tough Sell

So far most of the gadgets created by the Stanford Innovation fellows have been for adults—it tends to be like that in the world of medical technology. Children constitute only 20 percent of the health care market, and investors are wary of getting involved in such a small industry. “And if you think it’s hard to get a device approved for adult use, just tell the regulators that you’re going to put it in newborn babies,” Krummel notes. “Suddenly the hair on the back of their necks stands on end, and they say, ‘Oh. That’s going to be very difficult to approve.’”

To encourage more pediatric technology innovation, the Ewing Marion Kauffman Foundation of Kansas City, Mo., recently funded a fellowship, matching a Stanford Department of Surgery fellowship, for second-year Biodesign students to focus on the needs of children. One of this year’s Kauffman fellows is Chao, the neurosurgery resident who helped create the new laparoscopic tool kit. The other is Avi Roop, a University of Minnesota-educated mechanical engineer and industry veteran who worked with Chao on that project.

Now they’re roaming the halls of Packard Children’s again—this time focusing on the needs of young patients in the orthopedics department. Already they’ve come up with a long list of things that could be better, starting with the dreaded cast room. “Think about it,” says Chao. “You’re 5 years old. You have to have a cast removed, and people in white coats and masks come at you with a saw. And cast saws are really loud and scary, even though they won’t injure soft tissue—yet nobody thinks about making a quieter saw. Or about figuring out a different way to take off casts, or even how to immobilize fractures without casting them at all.”

The two also would like to see better braces for youngsters with hip dysplasia or scoliosis. With hip dysplasia, in particular, “Children have to wear a harness that makes them walk splay-legged until their bones grow and the socket takes the right shape,” Chao observes. “If you ask most clinicians, they’ll say ‘Oh, the brace works just fine.’ But when I see pictures of these kids learning to walk like crabs, I think, ‘This could be better.’”

Perhaps the team’s most exciting initiative is an effort to harness the Internet for pediatric innovation. Earlier this spring, in collaboration with the Kauffman Foundation, they initiated an eight-week online “idea campaign” to encourage collaborations to meet the growing medical needs of children.

A team of fellows in the Biodesign Innovation program has developed an early prototype of a new Engage surgical device. The laproscopic device gives a pediatric surgeon more room to maneuver—without leaving scars.

The idea, Roop says, was to create something like Wikipedia: a website where clinicians, parents, scientists, engineers, manufacturers, and philanthropic organizations could come together, in a global online community, to discuss children’s medical needs and brainstorm solutions. “Our goal was to harness the creativity and collaboration of groups of people,” he explains, “and to shorten the time it takes to get solutions to market.”

Participation in the idea campaign was free, and the online community offered transparent access to post, view, vote, and comment on ideas. The eight-week initiative ended on April 21. Roop and Chao are eagerly analyzing the results.

“We brought people together in a forum that encouraged them to contribute and share their ideas freely,” says Chao. “This is a radical departure from what people are used to in the business or medical world. By leveraging people’s collective passion, genius, and creativity we can hope to achieve something worthwhile.”

After his fellowship year is over, Chao plans to continue his full-time neurosurgery residency at Stanford School of Medicine. But he’ll still be working with Roop to make that laparoscopic tool kit a reality. Their startup company, Miret Surgical, was a finalist last year in the Santa Clara University Boomers Business Plan Competition.