One common approach to academic entrepreneurship in biomedicine is to develop a piece of science in your lab and then look around for clinical or industrial applications. While this approach has yielded many valuable innovations, it is likely to lead academic entrepreneurs to focus too much on advancing technology and too little on real clinical (or marketplace) needs. Likewise, scientists and engineers working in industry, who have been trained to focus on solving problems at hand, may overlook the broader context and miss out on real opportunities in the clinic and the marketplace.
An increasing number of universities—starting with Stanford University and its biodesign program, which was founded in 2001—are attempting to make entrepreneurship more rational and intentional, with courses that offer 1- to 3-year fellowships and immerse early-career scientists in clinical medicine, technological innovation, and entrepreneurship. While such training opportunities aren't abundant, they appear to give participants a real and useful boost toward entrepreneurial and other career opportunities.
One core aspect of Stanford's Biodesign Innovation Fellowship program—and the many other programs that have since been launched in the United States, Asia, and Europe (see box)—is that it is built around small multidisciplinary teams.
Stanford Biodesign Innovation and most of the other programs recruit between three and 12 fellows a year from the engineering, scientific, medical, and business communities. Typically, the recruits have mixed backgrounds: master's degrees, research doctorates, medical degrees, or MBAs. They also have experience in health care, the medical device industry, or entrepreneurial ventures. The idea is to bring together multidisciplinary teams of three or four people with all the necessary competencies for a successful biomedical innovation. "As a team you need to acquire all the skills, but as an individual you will only develop a subset based on the needs of the team and your personal interest," says Sjoerd Haasl, director of the Clinical Innovation Fellowships program launched in 2010 at the Karolinska Institute's Center for Technology in Medicine and Health near Stockholm. Most often, fellows are assembled into teams at the time of recruitment, in a flat hierarchy.
The M+Visión Fellowship in Translational Biomedical Imaging program, offered since 2011 by a consortium that was launched by the Massachusetts Institute of Technology (MIT) and research institutions in Madrid—the region of Spain, not the city—has a more technical slant and draws more strongly on the engineering and scientific disciplines. In contrast to the Stanford program, M+Visión fellows coalesce into teams based on the particular innovation ideas they would like to pursue, taking on roles ranging from leadership to consulting, says Eric Norman, communications director for the Madrid-MIT M+Visión Consortium.
In all of these programs, fellows start with a 2- to 4-week boot camp where they are brought up to speed on specific clinical areas as well as the engineering, management, and business aspects of biomedical technology innovation. They start building rapport with each other and meet a broad range of experts in industry and academia: clinicians, entrepreneurs, and venture capitalists. "At the end of the boot camp period they … have been introduced to a network of people who enable them throughout the year," says Mark Bruzzi, who has been directing the BioInnovate Ireland fellowship program at the National University of Ireland, Galway since its launch in 2011.
Homing in on needs
Fellows in Stanford Biodesign Innovation, M+Visión, and similar fellowship programs are taught to follow a structured innovation process that begins by focusing exclusively on identifying needs for new technology. "There is no lack of needs in health care. The challenge is to … find those needs that are the biggest and most readily solved and try to solve those," Haasl says.
Starting during or right after the boot camp, the fellows spend a couple of months shadowing nurses and clinicians and interacting with patients and families in host clinical departments. Clinical rotations expose M+Visión fellows to a range of medical environments. In all the programs, the fellows' mission during this clinical immersion is to identify several hundred unmet clinical needs.
Fellows then spend several months validating, refining, and filtering those needs through criteria that include the size of the clinical need and the potential for financial returns. Fellows receive a lot of guidance and coaching; the multidisciplinary teams at Stanford (and most other places) assess and select needs from their long list, through interactions with a broad range of experts.
The teams at MIT and in Madrid also present their progress weekly to a panel of engineers, clinicians, business experts, and entrepreneurs. This panel was essential for "making sure that the ideas we were proposing were questions that were going to be interesting to people in the field and, more specifically, that they would have some impact if we got a positive result," says Vicente Parot, a 2011 to 2013 M+Visión fellow.
During the initial phases of all of the programs, fellows are strongly discouraged from thinking about solutions. Pouring so much time and effort into first identifying and understanding unmet clinical needs helps you home in on the real issues, Haasl says. A nurse in an x-ray department, for example, may tell you that she needs a second computer screen, he explains, but fellows may discover instead that what that nurse really needs is a better way of visualizing data, which could be solved with better software. By learning to formulate needs without thinking too soon about a new technology, the fellows learn to be open to a range of possible solutions, Haasl says.
In moving too quickly toward a solution, there is also a risk of wrongly assuming that the size of the problem and the potential for financial returns make it an avenue worth pursuing. New medical technology is expensive to develop and take to market, so you must "validate this need, to be very sure, for example, that it is large enough to compensate for the investment," Haasl says.
Moving toward solutions
Only after fellows have come to deeply grasp the needs and have filtered them down to around a dozen do they start developing technological solutions. Four or 5 months into their 8- to 10-month program, fellows in all the programs start to brainstorm, coming up with a large number of potential solutions. Then they filter those down by applying commercial concerns such as intellectual property, regulatory and reimbursement issues, the business model—and also technical feasibility. The most promising is chosen, and teams spend the remainder of the program developing and testing an early prototype, designing a business plan, and raising seed funding.
M+Visión fellows continue to meet weekly with their panel of advisers as they brainstorm innovations and develop potential projects. A small set of projects is pitched, and the ones that are accepted receive funding for early-stage research. For the M+Visión fellows, the expected outcome is a little different: While teams are encouraged to develop intellectual property that is patentable and work toward launching start-up businesses, they may also aim for results that mainly inform further academic research.
In all the programs, the participants are aiming to anticipate pitfalls during development, all the way through to commercialization. Instead of developing biomedical technology in a traditional, step-by-step fashion, they are "trying to look into the future and imagine all the problems they will encounter along the way, the medical problems, the scientific problems, the technical problems, and the business problems," M+Visión's Norman says. For example, the fellows may propose work on "a superior technology, but if it's harder to use or if it takes twice as long as the gold standard, then it will not be adopted." Such projects are killed off before too much time and investment has been poured into them.
Still, a high level of uncertainty remains all the way through, and one important skill for scientists to learn, whether they intend to pursue an R&D project or a business plan, is to make decisions with limited information. "You always have to make some assumptions, and that is very often a problem … because as a scientist you want the evidence, you want the statistic," Haasl says. "But if you would want to be absolutely sure, it could take you 5 years to validate a need."
Training programs like this are not numerous, and they're often competitive. The Stanford Biodesign Innovation program, for example, typically receives 100 to 120 applications for eight fellowships, and the M+Visión program receives 150 to 200 applications for just 10 places. But these long odds are offset by the considerable benefits for those who succeed: Fellows have an edge when it comes to finding a job or developing their own career opportunities.
A Stanford Biodesign Innovation program survey published in 2013 found that 42% of the program's 106 alumni were working at startup companies, the majority of which grew out of the fellowship program. Another 11% of biodesign fellowship alumni found work in large biomedical technology companies.
"There has been quite an appetite from our sponsoring companies to be able to recruit these fellows, but there also is the recognition that some of them do not want to be recruited—preferring to start their own enterprises," BioInnovate Ireland's Bruzzi says. Those fellows who join BioInnovate from big multinational corporations, in particular, come to "see an opportunity for a startup and are willing to take the chance, knowing that … in a year or two, if it doesn't work out, they'll probably still get a job in a multinational [company]," says John MacNamara, R&D director at Medtronic in Galway, Ireland, a BioInnovate Ireland sponsor.
"A lot of engineers focus on technologies and concepts without really spending time in the market understanding the need," MacNamara says. What makes the fellows so attractive to multinational companies (including Medtronic) is that they bring with them the ability to define and understand needs and to drive those needs into concepts and ultimately products that can be commercialized, he adds.
According to the Stanford Biodesign survey, another 10% of alumni are faculty members, and 13% are undergoing further training and education. For academic scientists, too, the entrepreneurship programs were helpful. "The time that I spent working in the fellowship allowed me to define much better my career goals," says Parot, the former M+Visión fellow. Parot is now pursuing a Ph.D. in biophysics as part of the Harvard-MIT Program in Health Sciences and Technology. He plans to lead an academic group in biomedical optics and to seek commercial applications of his academic research.
During his fellowship, Parot submitted eight invention disclosures to MIT. One of his teams developed a technology that enables a conventional endoscope to produce 3D data with the aim of reducing colorectal cancer mortality. A prototype is being tested in patients at the Massachusetts General Hospital in Boston. The most important lesson Parot learned during the fellowship is that "you can choose to develop projects that are motivated by clinical impact," he says. "And that's something that makes them very relevant."
* Further Resources
► Biodesign Innovation Fellowship at Stanford University
► Stanford Biodesign shares resources online that include a step-by-step description of the biodesign innovation process, case studies, and lecture videos.
► Stanford-India Biodesign Fellowship for Indian citizens
► Singapore-Stanford Biodesign Fellowship for Singaporean citizens
► A list of Biodesign Innovation-like or affiliated programs (including some of those below) is being maintained by Stanford University.
► BioInnovate Ireland fellowship, offered by the National University of Ireland, Galway, Dublin City University, University College Cork, and the University of Limerick
► Clinical Innovation Fellowship run by the Center for Technology in Medicine and Health near Stockholm
► M+Visión Fellowship in Translational Biomedical Imaging launched by the Massachusetts Institute of Technology in Boston and Madrid-based research centers
► Inno X Healthcare Biomedical Design program headed by Aarhus University in Denmark
► Northwestern University’s Center for Device Development Innovation Fellowship for teams of engineers and physicians
► You do not have to become a fellow to sample this new entrepreneurial approach. Some of the programs involve local Ph.D. and master's degree students in characterizing needs or inventing solutions. At M+Visión, the boot-camp lectures are open to the community.
► Opportunities for undergraduates also exist. The University of California, Berkeley, Summer Biodesign Immersion Experience, for example, also offers University of California, Berkeley juniors and seniors majoring in bioengineering eight paid weeks of clinical immersion and needs-finding training.
Top Image: A Clinical Innovation fellow in Sweden working on identifying unmet medical needs. CREDIT: Katja Elmén/ZinQ Studios