Biodesign: Curing with innovation

Bio Design. COLLAGE BY ANNA COBB / made with photos by L.A. Cicero, MichaelWade, Army.mil and images by Patrick J. Lynch; MEDICAL illustrator; C. Carl Jaffe; MD; cardiologist

In October 2003, when Stanford’s Clark Center opened as the home of the Bio-X initiative, it was hailed as emblematic of the university’s commitment to multidisciplinary research and teaching. As the initiative began taking shape, research groups at Clark coalesced around various themes. Engineers and physicians who were focused on medical devices adopted the name “Biodesign.” Today, their group is a nationally recognized leader in the training of young medical technology innovators.

The training program has two principal components: a yearlong fellows program and a two-quarter Biodesign Innovation course taught by professors from medicine, engineering and business, with an all-star multidisciplinary line-up of guest speakers.

“Biodesign’s objective is to teach medical-technical innovation,” said Todd Brinton, one of the course faculty, a cardiologist, entrepreneur and former biodesign fellow. “All successful organizations in the valley have multidisciplinary approaches. My goal, as a former fellow, a mentor and now one of the faculty members leading the course, is to teach the 50,000-square-foot view of medical technology innovation. As a physician, you can’t know everything; you have to take a step back to see all the pieces, get different viewpoints, learn to collaborate.”

The fellows

There are eight biodesign fellows: This year’s cohort comprises residents from general medicine and neurosurgery, engineers with industry experience, an MD/PhD student and a law graduate. All have multifaceted backgrounds including engineering, computer science, healthcare and business development.

They arrived last summer and immediately got sent to boot camp for five weeks. There, they heard lectures (as many as six a day) on whatever the year’s focus is—this year it is gastrointestinal medicine—as well as on collateral fields essential to developing medical technology: finance, law, patenting, mechanics, policy, etc.

“There are disparate backgrounds and strengths,” noted Kevin Chao, MD, a neurosurgery resident at Stanford and one of the eight fellows. “Early on, it’s easy to identify everyone’s weakness.” He remembered, for example, that one of the fellows with no medical background misspelled all the medical terms. “But it was refreshing,” he said, “because she challenged our strongly inherited beliefs. Doctors have a strong aversion to risk.”

After that immersion, they launch into a second one, this time at the hospital. Divided into two teams, for two months they observe and take notes about everything they see, searching for needs they think could be usefully addressed by new techniques or devices. Amazingly, each team collects some 300 needs, and the fellows spend the last portion of fall quarter culling the wheat from the chaff, checking journal articles, re-interviewing the players, discussing among themselves what makes sense and what doesn’t.

“You don’t know if they’re good or bad till you know the market and the medicine,” said fellow Erika Palmer, PhD, an engineer with expertise in spinal degeneration. “So you need lots in order to get a few good ones.” Each team keeps four needs for themselves, and the fellows give a total of 24 others to the class, which starts in January.

One of the key lessons of the program is how to define a true need. A problem is not the same as a need, and it is essential to never state a need in terms of a supposed solution.

Legendary Stanford inventor, surgeon, medical faculty member and local vintner Thomas Fogarty is quoted in the class reader as saying, “Innovators tend to go out and ask doctors what they want rather than observe what they need. When you talk to physicians, as well as others involved in the delivery of care, you’ve got to learn the difference between what they say, what they want, what they’ll pay for and what they actually do.”

So the process entails a lot of looking and thinking, which is harder than it sounds.

“We’d write down any and all observations,” said fellow Greg Magee, MD, whose medical school thesis was based on fieldwork in Bolivia. “They might be stupid, but there might be a pearl there.”

“You have to keep solutions out of the need,” said Palmer, echoing advice from the “design thinking” experts at the Engineering School’s design program.

“Innovation is a process, not a brilliant hiccup,” program director Paul Yock, a cardiologist and inventor, told the class early on. “The most important question is, how do I identify a need? What is a good need?”

The class

For the class, identifying needs and developing products to address them follows a process similar to the arduous (but fun) one experienced by the fellows. All graduate students, they hail from electrical, chemical, bio and mechanical engineering; management science; genetics; biology; medicine; and business. Most have an assortment of degrees and work experience from related fields.

“You are the future leaders of biomedical technology innovation,” announced Yock on the first day of class. “We are not here so that you can start a company. But we do want you to acquire the skills and knowledge to be able to do that someday.”

Biodesign Faculty

Stefanos Zenios, left, Paul Yock and Todd Brinton check in with each other before class starts.

developing medical devices

Students at the Biodesign Collaboatory at the Clark Center work on developing medical devices. Photos: L.A. Cicero

The course’s third instructor, Stefanos Zenios, gave students a valuable lesson the very first day. Zenios, a professor at the Graduate School of Business (with a courtesy appointment in bioengineering) and an expert in health delivery systems, presented students with a quick pair of medical problems and had them write down two questions. He then called on them and asked whom they would consult to get answers to their questions. Turns out a business student has different questions and seeks different advice than an engineering or medical student.

It became clear as winter and spring progressed that the Bay Area in general, and Stanford in particular, is a good place to learn how to acquire the skills and knowledge Yock referred to. Former students, venture capital executives, inventors, physicians and lawyers explained to the students what they could expect as they take a need, develop a product and implement a business plan.

Greg Lambrecht, for example, president and chief executive officer of Intrinsic Therapeutics (in Woburn, Mass.), who has a long resume of product development and invention, visited the class early in winter, and his advice about formulating needs statements set the tone.

“Try to push your well-trained desire to solve problems into the background,” he said. “Enter the mindset of observation. And remember, everything can change. Feel free to imagine everything.

“The only realities are the patient, their problem and the outcome.”

Choosing a project

The degree to which students had absorbed the lessons on how to frame a needs statement was put to the test in late January at the poster show. The 24 needs from the fellows had been divvied up among the students, who had to decide if they were worth pursuing. Some of the students in the class were not going to work on product development at all but rather just act as consultants, and they also had to figure out which group they wanted to join.

“Today we go from single members of the class to teams,” announced Brinton to the students milling around the Clark cafeteria, posters in tow. “This is where the class gets fun.”

Among the 24 needs were a way to localize the source of chronic back pain (this would make it all the way to the end of the course); a way to reduce fatigue in patients with sleep apnea (ditto); a way to capture heart, lung and bowel sounds in the intensive care unit (declared a no-go); and a way to prevent complications of hypoglycemia in patients with insulin-dependent diabetes (also a no-go).

The instructors and fellows moved from poster to poster asking questions of the students, who explained why the need should or should not survive depending on competition, market problems, focus and mechanical difficulties.

One of the business students, who later left the class, was a consultant. “I’m looking for a project,” he told each presenter as he moved from easel to easel, hand outstretched, like so many other business students.

“I’m looking for a medical need that sparks my interest and doesn’t gross me out too much,” he said later. “Frankly, I’m looking at people more than at projects, looking for future team members who impress me.”

His attitude was echoed in class just a few weeks later by visitor Mark Deem, an inventor with more than 150 patents who is a partner at The Foundry, a medical technology incubator in Menlo Park.

“VCs are more interested in the team than in the business opportunity,” he said, referring to venture capital investors along Sand Hill Road. “A good team can alter and save a bad business opportunity. A bad team can take a good opportunity and tank it.”

And, he cautioned the class, “don’t fall in love with your idea unless it’s really, really good. It must fulfill a need, it must work for doctors, it must work within the healthcare system.”

“Patients,” he added, “don’t need cool technology.”

Concept development

By spring quarter the class had moved on to concept selection and development strategy, and they were ready to hear about such daunting prospects as what Deem called “doing the Sand Hill crawl.”

They also heard from biodesign alumni who have founded medical technology firms. Darin Buxbaum, chief executive officer of HourGlass Technologies, described how he and his colleagues developed a non-surgical technique to combat morbid obesity.

“VCs told us we were crazy; they said there’s a graveyard of companies that tried to develop devices for obesity,” he said. “But a little luck and a lot of hard work paid off.”

But finance is a real hurdle, Buxbaum and everyone else admitted, and venture capital is not the only good source that students should consider.

“This fall, everyone was running to VCs to get money before it ran out,” Buxbaum said in April. “It was like gridlock with VCs. It’s still like that.

“There’s a saying now, flat is the new up. This can be very important when getting second-round funding. People are getting less than before, and the terms are being changed to favor investors.”

By this time, the class was down to eight needs, and teams were busy trying to figure out the best concept for each one. The needs concerned sigmoid diverticulitis, pancreatitis, sleep apnea, chronic back pain, vascularized tumors, deep vein thrombosis, partial small bowel obstruction and preventing fall-induced injuries in the elderly. Most teams comprised students from various fields, each with their own strengths.

project posters

Biodesign students in winter quarter presented summaries of 24 medical needs, explaining why the project should or should not advance. Photo: Christine Kurihara, Stanford Biodesign

Another round of presentations took place in early April, similar to the early poster presentations but this time more focused and with the benefit of two months of research. Among them was one describing ways to prevent elderly people from falling. Team members (a product designer from India, a medical student with a biophysics degree, a biorobotics doctoral student and a business student) explained that their earlier approaches had been heavy on the technology and light on the environment.

So they went back to nursing homes and, simply, observed. They saw a lot. For example, old people hoist themselves up from a sitting position by using their walker, a recipe for falling, and often have impaired depth perception, which makes it easy to trip. Using what they saw, the students came up with a better proposal.

“I love the fact that you went to nursing homes,” said Yock at the presentation. “That makes my heart happy.” His only criticism was that the proposal seemed a bit complicated. “Think of the simplest thing you can do to mitigate the transfer problem,” he suggested, referring to the way in which a walker could assist rather than hinder elderly people from getting up.

“The great thing here is that you guys truly understand the need,” Magee told the group. “You went back and figured it out. This is one of the best things I’ve seen.”

Getting paid

Brainstorming

The Biodesign Innovation class held brainstorming practice sessions at the design school.

Brainstorm

Photos: the Stanford d.school

Meanwhile, Magee and his seven colleagues were still working on their own projects. By mid-spring, each team of four fellows had three concepts, each with its own business, technical and medical challenges.

Reimbursement from Medicare was turning out to be especially important. The government assigns reimbursement codes to devices that determine how much one is paid. So being classified correctly is essential, but not easy.

“The best thing is to have a unique code, but that’s expensive and lengthy,” Palmer said. “We need immediate reimbursement, so we’re trying to come up with a creative way of defining our technology.”

Ten months after he got here, Magee said, “I’ve learned that you really need to hire smart consultants. It’s very political, and these people have been dealing with government for a long time. They can negotiate these waters. But they’re expensive.”

The fellows’ six projects concerned hemorrhoids, fecal incontinence, bedsores, gall bladder ailments, congestive heart failure and laparoscopic tools. Their final presentation was scheduled for June 9. After that, the non-surgical fellows will leave Stanford, the surgeons will remain for another year and they’ll all do what they can to move the projects forward.

“Former fellows all told me that this experience gave them new skills that made them more valuable, that led them to take on new responsibilities, because they had more depth and breadth than before,” Magee said.

“As a physician, it gives you a greater appreciation of how hard it is to invent things. If I’m shown a bunch of data and I don’t quite believe it, I say, do it over again. Now I have more appreciation of how much work and money is involved in that.”

Money, as it happens, is essential. Financial modeling is, basically, “what you’re going to do and how much money you need to do it,” Zenios told the class in spring. “Every strategy, whether it’s intellectual property or reimbursement or clinical, requires a financial component, and this should be done early, not late.”

The guest that day was John White, strategic marketing manager at Acclarent, which develops treatments for ear, nose and throat ailments. His lecture was basically a walk through a series of spreadsheets, preceded by a show of hands on which school the students came from.

“Doctors will be scratching their head during this lecture, and that’s fine, we need them for other things,” he said. “And engineers always need hard numbers.” Sure enough, the engineers and business students wanted more precision than his slides seemed to offer.

Risk aversion

As Yock said at the start, the objective is not to establish medical technology companies, though one or more usually grow out of each cohort. The point is to develop the sort of observational and conceptual skills that might make that possible. For that to happen, graduate students and fellows have to reconsider their assumptions.

“Doctors have a strong aversion to risk,” said Chao. “They say, you can’t do that! You might get sued!”

“Engineers have an easier time with risk,” according to Palmer, “and that affects how we approach problems.”

“I had a medicinal approach to how I think about problems, a very exact approach,” Chao remembered. “But then [another fellow] said, ‘Just estimate! That number is good enough.’ In medicine and engineering you have to be more exact than in business. It was a leap of faith for me, and that was a good challenge.”

It is that combination of approaches that Biodesign aims at encouraging.

“There’s a lot of salesmanship here,” Magee said. “No one’s going to buy your idea just because you propose it. You have to sell the idea to the team.”

And in that process, maybe one becomes a better physician. An engineer or businessperson who can’t tell a catheter from a stent might be able to do something for medicine.

Both Magee and Chao commented on recent medical cases where it turned out that what everyone assumed was true in fact wasn’t. Mammograms, blood sugar levels, PSA tests and the like are all coming under renewed scrutiny.

“We need to think about our own protocols,” Chao said. “We think things are written in stone, but then you start reading articles and you find that they’re all controversial but that the whole world bases medical procedures on some pretty arbitrary decisions. I’m more open now to challenging medical protocols.”

“Once you’re in medicine, you have blinders on, you have no vision of anything else,” Magee said. “So any time you can be exposed to new things, you get a better perspective.

“You spend your life trying to help people, and that makes us risk averse. We might not want to change. We often feel so good about what we do, we don’t want to change. But there are many things we do that should be changed.”