Fostering Innovation
Two-year Fellowships Attract Entrepreneurs to Move Surgical Care in New Directions

BY ANDREW SCHWARTZ

SPRING 2005 -- Frustation can lead to innovation.

Just ask Packard surgeon Thomas Krummel, M.D., about his aggravation with a simple yet essential device: the intravenous catheter.

While awaiting a liver transplant, 16-month-old Bronze Almeida of Hawaii (with his father, Melvin), developed an infection in his intravenous catheter, causing a delay in his surgery. A catheter that resists infection is one example of a needed technology that could emerge from the new Surgical Innovation Program.

For many children being cared for at Lucile Packard Children's Hospital, the catheter can serve as a lifeline for weeks—even months—connecting them to needed fluids and medications, or providing access for a battery of blood draws to monitor their condition.

But the very catheters that save these children's lives also can cause deadly infections. In fact, catheter infections and clogs are a major source of frustration for clinicians and often can delay critical surgeries to repair a child's damaged or injured body.

"It makes you angry when you can't help a patient," says Krummel, the Susan B. Ford Surgeon in Chief at Packard, "particularly when it's technology that's limiting your ability to help."

Krummel's impatience with this and other technical roadblocks has led to a newly created Surgical Innovation Program at Stanford. The program—which aims to attract creative clinicians, bioengineers, and bioscientists for hands-on, two-year fellowships—is the only program of its kind in the nation.

"Our goal is to develop the next generation of innovators," says Krummel, who directs the program. He expects that one of the first innovations to be tackled will be a catheter coated with biomaterials that will prevent clogging and infections.

Right Time, Place, People

"Today's clinical and surgical environment makes it difficult to innovate," says Krummel, explaining why there is a need for such a program. "Extremely busy surgeons get on a treadmill and don't have the time to think about ways we might do things differently."

The program is co-directed by Michael Gertner, M.D., who recently was named by Technology Review magazine as one of the top 100 innovators under 35 for his work in advancing a novel drug coating process.

"The technology for surgery is getting ever more complex," says Gertner. "Most surgeons don't have the technological expertise to innovate. We need to develop a way to bring disciplines together to meet the needs of the greatest number of patients as quickly as possible."

"Stanford is the logical place," adds Krummel, "because the campus is filled with leaders in many fields and because we're surrounded by Silicon Valley where innovation and the medical device industry flourish."

Nevertheless, the program still must find experts with the right combination of smarts and intellectual daring to move in new directions. To that end, program fellows are chosen after an intensive interview process that focuses not only on their academic skills, but also on character traits that foster innovation.

"We're looking for people who can seek and accept new paradigms, work in a team environment, and quickly assimilate new technology in the context of clinical scenarios," says Krummel.

The Bio-X Connection

Surgical Innovation builds on Stanford's Biodesign Innovation Program, begun four years ago by Paul Yock, M.D., and Joshua Makower, M.D. Between them, these two renowned inventors have an impressive collection of patents for medical devices in the fields of cardiology, general surgery, and urology. The list includes the most widely used angioplasty system in the world.

Clearly, they have passed their skills on to the fellows in their program. While focusing primarily on cardiovascular concerns to date, the Biodesign program has done a remarkable job of drawing on the interdisciplinary expertise at Stanford and throughout the region. In just its first few years, Biodesign has generated widespread excitement in the medical community by helping create several new technologies, including a device to prevent strokes during carotid angioplasty, a robotic navigation system for colonoscopy, and a novel technology for harvesting bone marrow for transplantation.

The Surgical Innovation Program will expand these efforts by bringing much-needed technology solutions to the operating room.

Meeting Children's Needs

Surgical Innovation also builds on the rapid growth of children's surgical services at Packard. When it opened in 1991, the Hospital had only a few pediatric general surgeons and virtually no surgical research program; nor were there any operating rooms dedicated to children.

Over the past five years, however, inpatient pediatric surgical procedures have increased by more than 30 percent and are expected to grow by another 40 percent in the next two years. Construction of a dedicated pediatric operating suite—including six state-of-the-art operating rooms—is under way.

Michael Gertner, M.D., and Thomas Krummel, M.D., hope to speed the process of innovation by offering intensive two-year fellowships that span the meidcal, biosciences, and engineering disciplines.

In addition, Packard has successfully recruited a host of internationally recognized surgeons and researchers. Among them are heart surgeons Frank Hanley, M.D., and V. Mohan Reddy, M.D.; Craig Albanese, M.D., an expert in minimal access surgery; Peter Koltai, M.D., a surgeon specializing in pediatric otolaryngology; neurosurgeon Michael Edwards, M.D.; and Michael Longaker, M.D., a leader in tissue engineering and stem cell research.

Their collective expertise provides a unique opportunity for the Surgical Innovation Program to advance pediatric surgery. "Though the program isn't solely for pediatrics, we'd like to ensure that the unique needs of children are specifically addressed," says Krummel.

That would turn today's paradigm on its head, as most medical innovation moves from adults to children. The reasons? Children are a smaller portion of the population, reimbursement tends to be less, and there are more FDA hurdles to jump over.

Krummel hopes to overcome these challenges by focusing on needs that are applicable to both adults and children.

For example, gastric bypass surgery for morbid obesity is enormously successful in adults, but with a catch: the surgery cannot be reversed, despite the fact that clinicians don't yet understand the long-term effect of drastically altering the body's gastrointestinal processes. In children, that lack of understanding is particularly vexing, since children can grow out of whatever biochemical or psychosocial influences contribute to their obesity. If a new technology can help surgeons develop a reversible form of gastric bypass surgery, it will reduce the risks for children and adults alike.

From Boot Camp to Business

But such innovations have never occurred easily or systematically. Krummel and Gertner have created a program that they believe will speed the process and leave innovation less to chance.

In the first year, fellows attend a "boot camp" that exposes them to important practical concepts, such as intellectual property considerations, project financing, and corporate law.

Next, fellows spend extended periods of time by the sides of surgeons, observing and asking questions to identify pressing needs. Working in teams, fellows then prioritize those needs, with a particular focus on creating technologies that can help sooner, rather than later. "A major concern for us is: when will it get to patients?" says Gertner. Finally, fellows work at Stanford's Bio-X facility at the Clark Center to create initial prototypes of their ideas.

In the second year, fellows take their ideas beyond the prototype stage to the point where they at least begin the process of developing real products for clinical use and commercial sales. They pursue seed funding and, in some cases, draw up business plans. At the same time, they might work at a start-up company, pursue a master's degree in bioengineering, or choose another path that can facilitate their efforts.

Fostering a New Generation of Innovators

Krummel and Gertner have based their program on lessons learned from studying the process of innovation. "There's a history of happy accidents, of course, but we believe that there are certain knowable things, such as the need to develop people— surgeons, engineers, basic scientists—who can move easily between disciplines," says Krummel. "Our model is based on people like Rodney Perkins, Tom Fogarty, and Bill New."

All three of these physician innovators have drawn on their eclectic backgrounds to invent or help develop medical instruments that have made significant contributions to saving and improving lives. Their inventions include laser technology for surgical use; the original balloon catheter used in vascular procedures; and the pulse oximeter, a device that monitors blood/oxygen levels in anesthetized patients.

"Their successes illustrate the math," says Krummel. "As one surgeon, each might be able to improve or even save 10,000 lives in his career. If each trains five surgeons a year, over 30 years 1,500,000 lives would be helped. But an invention that enables a new procedure might affect many millions of lives. That's what we're shooting for."