Q&A with Dr. Thomas J. Fogarty: How the Fogarty Institute for Innovation is nurturing breakthroughs in medical technology
BREAKOUT LABS: First off, congratulations on being awarded the Presidential National Medal of Technology and Innovation. Can you tell us your observations about how the environment for inventors has changed in the 50 years since you invented the embolectomy catheter? What has improved and what has become more challenging?
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Dr. Thomas J. Fogarty[/caption]
DR. THOMAS FOGARTY: Thank you. I am humbled and honored to have my achievements receive this level of recognition. Our country and our industry have a number of significant challenges to overcome to continue innovating and getting solutions to patients quickly and safely. Through the work of the Fogarty Institute for Innovation, we are striving to help the next generation of innovators and entrepreneurs create products that will truly make a difference in people’s lives.
The answer to your question is that things have changed significantly. It’s much more challenging than it used to be. It’s challenging from the standpoint of regulatory issues that we deal with, the reimbursement issues that we deal with, and it’s much, much more difficult to raise any money for early stage medical devices. That’s very, very different than when I started.
BOL: What are some of most significant obstacles for those who want to get new solutions into the world where they’ll help patients?
TF: Well, from the standpoint of the innovator, sometimes they don’t know it, but the most difficult thing they’re going to have to deal with is recognizing they don’t know what they are doing the first time around, and very often that leads to significant problems. Having said that, getting technologies out to help patients, number one it costs a lot more, and very significantly more, than it used to, so that makes it difficult. The venture community’s recognized that it’s difficult to get a return on its money, and so they don’t invest in early stage technologies. That makes it extremely difficult. There’s more and more regulation. There’s more and more oversight. There’s more and more lack of understanding of what you have to do to get a product to the marketplace. So all those things compound issues and bring up new issues that we never used to have to deal with.
BOL: What inspired your creation of the Fogarty Institute?
TF: What inspired me is pretty much what we’ve been talking about — the need for new technology. We can only improve healthcare and reduce costs through a process of innovation. And that has to be done or we’ll continue to go backwards. So, to do that in some environments it’s become very difficult. Interestingly enough in an academic community, where I used to be, it’s even more difficult. So I made a conscious decision if I was going to be able to deal with these issues more efficiently, I had to leave academia, so that’s what I did.
The environment that I was brought up in, it was a private hospital, and I found things much more easily done in a private hospital environment simply because the total focus was on patients. In academia you have many, many other things that you’re obliged to do — apply for grants, write publications, teach classes — and so you have less time. So I want the Institute to be an environment where all an innovator’s time can be focused on innovation, the people around the innovators are totally supportive of what the innovators are doing, they recognize its value, and they do everything they can to help.
BOL: Can you describe your mentoring process and talk about some of the mentoring resources available to your companies in residence?
TF: The Institute offers a number mentoring resources. Like a lot of incubators and accelerators (by the way, I hate those terms, and we’re trying to think of a new one to describe the Institute), we have experts — investors, legal, regulatory, and others — come in to provide monthly seminars and provide office-hours to our companies and fellows.
But we go beyond that. We’re located on the campus of El Camino Hospital in Mt. View, and so we’re surrounded by practicing physicians and other clinicians. We utilize this proximity to physicians to provide our companies with ongoing and frequent mentoring by physicians relevant to their technologies. This is critical to efficiency and success.
Also, the Institute doesn’t just depend on outside experts visiting our companies. We actually have mentors on our staff — people who have offices side by side with our companies — who can advise companies multiple times per week. These persons are experienced Silicon Valley CEO’s and product development experts. The degree of mentoring we provide, without trying to take over the company, is pretty unique.
BOL: What are some of the products being created by the companies you’re mentoring? What are some of the clinical needs being addressed?
TF: Clinical needs addressed by some of our current and former companies include post-partum hemorrhage [the #1 cause of maternal mortality worldwide], early detection of ovarian cancer [20% survival rate for the most commonly diagnosed stage], treatment guidance for functional GI disorders [effects 10–20% of the US population], and treatment guidance for coronary blockages [>1M US cases per year].
The work the Fogarty Institute does to support its companies reduces human suffering and saves lives. With each new company we support, this benefit will grow. It’s noteworthy that four of our current companies address needs relevant to maternal and infant care. This illustrates how the Institute has assumed the role of recognizing especially under-served areas of clinical need, and focusing efforts to make sure life-saving products in those areas are made available to patients.
BOL: How do you know who is most likely to succeed in turning their creative idea into a practical solution?
TF: Well, it’s a combination of things, but there’s not just one quality. It’s a series of qualities that you need, and you actually often don’t know if they have those qualities when you start. But essentially you need someone that’s totally committed, they’re hard working, they accept failure, and look at it as just a learning curve. You’re going to fail, but then you’ve got to go in a different direction.
So, those are primary issues that I look at in an individual. I want to make sure they have the right motives, and the motive should be primarily to help patients, and if you do that well you’re going to end up reaping a harvest of some money. But if you start off saying “I’m going to make a bunch of money by doing this”, usually it doesn’t work.
BOL: Aside from the personality traits you’ve just described, is it possible to characterize who’s the ideal company or innovator team who would successful be at the Institute?
TF: What it really takes in the field of medical technology is a bright clinician and a very bright engineer, and that’s the team you start with and that’s all you really need at the beginning. As you mature you’ll find out you need other people doing different things. But the core of it is to really have an engineer who understands medical technology, and to have a clinician who understands clinical needs. Those are two primary components.
One of the problems we get into, or I see, is at the early stages we bring in people we really don’t need. They don’t really add to your efforts, but they cost more money. And so the team tends to get confused. They tend to get in the way of one another. Really small committed teams are the best start. Two critical elements we look for in candidates that come into the Institute are (1) honesty and (2) persistence. If these are found to be lacking, they will be gone.
BOL: You’ve said that your innovation hub represents a new educational paradigm. Can you explain how FII complements traditional educational organizations?
TF: In the realm of medicinal science, a key objective of academia is to do basic research that provides insight about how to cure disease and benefit patients. Academia is generally successful at doing basic research and gaining new medical insight, but it frequently does not have the experience or knowledge needed to translate medical insight into the commercialization of technologies. This inability is due to the fact that most university charters prevent faculty and students from using university resources to conduct commercial development activities.
Since academics are largely prevented from conducting commercial activities, it’s no surprise that traditional academic organizations do a poor job of training students in this process. This fundamental problem — the inability of traditional academia to teach students how to translate medical discoveries into commercializable products — thwarts the development of new business opportunities, and delays the availability of important new treatments to patients.
This problem cannot be solved by traditional academic organizations. Unlike some things that can be learned from a classroom and a book, the only way to learn how to commercialize an innovation, is to do it. The Fogarty Institute provides a new kind of educational paradigm that supports real commercialization of real medical technologies, and thereby allows innovators to “learn by doing”.
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Applications for residence at the Fogarty Institute are due by 11:59PM PST January 4, 2015, and an application and instructions can be found online at: http://www.fogartyinstitute.org/innovation-apply.html.
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