Executive Spotlight: Joshua Makower, Founder and CEO of ExploraMed

Joshua Makower, M.D. has dedicated his life to the creation of medical technologies that improve the quality of life for patients. He is chief executive officer and founder of ExploraMed Development LLC, a venture-backed medical technology incubator based in Mountain View, Calif., and is also a venture partner with New Enterprise Associates.

Josh also serves as a consulting associate professor of medicine at Stanford University Medical School and is co-founder of Stanford’s Biodesign Innovation Program. He has founded several companies through the ExploraMed incubator that have achieved successful mergers and acquisitions, including Acclarent Inc. (sold to Johnson & Johnson this year); TransVascular Inc. (sold to Medtronic in 2003); and EndoMatrix (sold to C.R. Bard in 1997). Up until 1995, Josh was founder and manager of Pfizer’s Strategic Innovation Group, a group chartered to create new medical device technologies and businesses for Pfizer’s medical device divisions. Josh also serves on the board of directors for NeoTract Inc., Moximed Inc., Intrinsic Therapeutics Inc., ExploraMed III Inc. and Vibrynt Inc.

He will be a part of CHI’s upcoming FDA 510(k) Process Under the Microscope, to be held July 29, in Newport Beach at the Balboa Bay Club & Resort.

Where do most of our ideas for new medical technologies come from today?
Medtech innovations come mostly from physicians and those who see patients’ needs firsthand. As these caregivers treat patients everyday, they can see for themselves which technologies and procedures are working, and which need improvement. It is the inspirations from these experiences which allow them to bring new ideas forward as products.

It’s difficult to imagine a world without some of the innovations that have been developed through this process, such as joint replacements and cardiac stents. Many of these innovations have increased the duration and quality of our lives. Life expectancy is up 4 percent from 1980 to 2000.

How has medical device development changed in recent times?
In 1988, the Institute of Medicine was commissioned to report on how new medical devices were created and developed. Even in those days, new medical technologies came from individual practitioners, entrepreneurs and small firms. It is amazing how much that process has remained the same over the last 20 years!

Even though many of the first insights into these new technologies came from physicians outside the U.S., it was the American economy and the way that we inspire and create business opportunities for entrepreneurs that really drove the development and adoption of these innovations, providing for access to these new technologies for patients.

You talk about a medical technology ecosystem, which starts with those you call “fuelers.” Can you tell me what you mean by this?
Every new technology, every new idea that touches a patient’s life and improves it started with an investor writing a check. The American dream and small businesses are at the heart of what continues to drive the system today. The U.S. has provided incentives for innovators to succeed, and when they develop technologies that improve patients’ lives, both investors and patients are rewarded.

Unfortunately, much of this system is now at risk with the decline of venture capital dollars flowing into the industry. From 2008 to 2009, venture investment in firms pursuing medtech dropped more than $1 billion. I don’t think we realize the full impact that this drop will have on the flow of technologies to improve human health, but it definitely is not going to be good.

What are some of the challenges to that system today?
The survival of small companies is critical for delivering innovation to patients. Innovation depends on the willingness of VCs to continue fueling small companies.

It’s important to recognize that very little money actually flows into medtech innovation out of the total amount of venture capital. Less than 5 percent (of institutional investments) actually goes to VC. Of that, less than 15 percent goes to medtech.

As I mentioned, institutional investments have shrunk, putting venture funds in a difficult place. Overall, this kind of environment threatens to hamper what’s needed to support small startups with innovative ideas.

What’s the biggest take-home message when it comes to the 510(k) process?
The 510(k) process is a fundamentally important pathway for small medtech firms. Many valuable, safe and effective technologies have passed through this process and patients have benefitted greatly. Eliminating 510(k) would be a terrible tragedy for patients and their access to new technologies. To force all new medtech products to pass through a pre-market approval process (PMA) is not practical and would result in halting innovation, delaying or extinguishing important innovations that patients need. We cannot make the process too costly or challenging to navigate for small firms. These processes, if too difficult, will deter even the most talented and creative innovators to even enter in the system. We want to make sure that doesn’t happen. If we want to ensure that we’re going to have safe and effective innovations to sustain and improve human health we need to have systems that are predictable and reasonable to navigate.

Makower will be speaking at CHI’s FDA 510(k) Process Under the Microscope: How Will Changes Impact You? on Thursday, July 29, in Newport Beach. To register, click here.

CHI-Advancing California biomedical research and innovation

California Healthcare Policy Forum Spotlight: Assemblyman Nathan Fletcher

Nathan Fletcher is the State Assemblyman representing California's 75th District and will be addressing attendees of CHI’s California Healthcare Policy Forum in San Francisco at the Mark Hopkins InterContinental on Nov. 5. Assemblyman Fletcher serves as vice chair of the Assembly Health Committee and the Select Committee on Biotechnology. He is a member of the Accountability & Administrative Review, Water, Parks, & Wildlife and Utilities and Commerce Standing Committees. In addition, he sits on the Select Committees on Foster Care, Child/Adolescent Health and Safety, Healthcare Workforce Access, Safety and Protection of At-Risk California Communities and Government Reform.

Q: As a freshman lawmaker, you are vice-chair of both the Assembly Health Committee and the Select Committee on Biotechnology. What sparked your interest in healthcare policy and the biotechnology sector in particular?
A: If you look at my district, I have one of the world’s largest concentrations of biotech, including UCSD, Burnham, Scripps, Salk, all these various institutes and groups like CHI that help to bridge that and the 500 biotech companies that reside here. Also, if you look at the changing dynamics of economics, these are the jobs of the future. Information technology, biotech, clean tech, high tech, agricultural biotech—these are the industries and jobs of the future. If we don’t figure out in America and in California how to innovate and create new ideas, we’re not going to compete in the global marketplace. Whoever figures out how to cure diabetes, Alzheimer’s, cancer from a medical perspective; or to grow drought resistant crops; whoever makes a faster, smaller computer processor or figures out how to transport people faster with less of an impact on the environment; whoever figures out how to create sustainable power. Not only do they get to make the world a better place, but they also will get to sell that to the 95 percent of the world population that lives outside America and I want that place to be California. I’m very interested in this cluster effect and creating centers of innovation and working to get the brightest minds to come here and be part of it.

Q: What do you believe is the state’s role in healthcare reform?
A: The states play a tremendous role in healthcare. So much is administered by the states, even federal programs are run by states and counties, but aside from administering programs and making them work better, the states can be great incubators of new ideas. California is known for being at the cutting edge. It’s a great way to see what works and what doesn’t and California itself provides a very challenging environment. I believe in universal healthcare coverage—I think everyone should have healthcare and that we can design a system where everyone can participate, it’s just a question of how we get there. I also think California should lead on utilizing new technologies like electronic medical records.

Q:You have said that you believe healthcare begins with healthy living and that we should find constructive and creative ways to promote health and wellness. Can you tell me what some of your ideas are for the promotion of health and wellness in California?
A: I think when we talk about healthcare, we skip to the idea of healthcare for sick people and bypass the fact that healthcare should start with healthy living. I’m interested in incentivizing healthy living. I think financial motivators are great. There’s a remarkable difference in the healthcare costs of a healthy non-smoker who exercises and maintains healthy weight and at a certain point, people need to be held accountable.

I think people should be able to buy their own insurance, rather than relying on an employer-based system like we have now. It just doesn’t make sense anymore, now that people switch jobs and healthcare plans so often. We could then give individuals the tax breaks that employers now get and the consumer would get to choose and keep the plan that makes the most sense for them.

Immunizations are another area I’m interested in. I’ve lived in Africa, Asia, third world countries, and one of the saddest things I’ve ever seen is people dying of diseases like polio, which is now preventable. We’re seeing rates of unimmunized children jump in the U.S. and I’m worried about that. I respect parents’ rights but I think there’s a lot of awareness and education we can do. And we have to look at reimbursement and how physicians are paid for vaccinations. If physicians aren’t reimbursed for immunizing patients, then parents will have to go elsewhere and adding another hurdle to a busy parent’s schedule is one more hurdle that hurts all our kids.
Q: You’ve also acknowledged the need for technology and innovation to transform our current healthcare system, which is a topic that we’ll be exploring at the California Healthcare Policy Forum, where you’ll be addressing attendees on Nov. 5 at the Mark Hopkins InterContinental in San Francisco. How do you think technology and innovation can contribute meaningfully to reforming the delivery of care in the U.S?
A: Forty years ago we put a man on the moon and we talked to him. I was at Apple recently and they told me the computing power of the iPhone is equivalent to the entire Apollo project. Thinking about how we now use this technology, I can take photos, trade stocks, get information, watch news programs. Yet, I go to my doctor and he writes down information in my medical record and writes a prescription on a pad of paper that I take to my pharmacist. And I think, what are we doing? So, one application is in the medical record keeping area. I do realize the challenges with confidentiality, but certainly we can overcome this to have a system that allows my physician to see, from cradle to grave, what tests have been performed, any known allergies or chemical reactions, etc, there simply has to be a way.

I think it has a role to play in fraud prevention. I think a real-time stream of data and analysis could elucidate patterns of fraud. And the third way is empowering the individuals to make decisions as far as information. If you’re going to have a knee surgery, you should know how many your physician has done, how many of his operations led to infection, etc. The more information you can provide to people in an easy to use format, the more they’ll be empowered to make decisions about their own healthcare. In short, I see a lot of applications for technology and I don’t believe it has to be a cost center. Of course there would be some initial capital investment, but we really need to make that leap.

Q: You mention education as an important issue for you and your constituents. The biomedical industry in California is vested in improving math, science, technology and engineering education to secure a well-educated and prepared future workforce and has funded many programs to educate teachers and students and expose them to new research and technology. What are some of your ideas for improving STEM education in California?
A: The Hart-Rudman Commission did a pre-Sept. 11th study on the top threats to America and one of their top two or three, including foreign terrorism, was our declining prominence in the fields of science, technology, engineering and math. We really need to have a focus in these areas in education and incentivize students to study these topics. In Florida, high school kids can choose a major like we do in college, so having programs where students can specialize in these study areas could help. We need to adequately prepare students for schools like UCSD early on and incentivize them and invest in them.

The UC system used to be 7% of the general fund and is now down to 3%. I certainly understand of how programs get funded, but if we want to maintain our status as innovators, we have to invest in our universities. We also need to change our mindset with K-12 education. We should fast track college-bound kids. Right now, 80% of 9th graders will not go to collage. We need to offer career and technical education, with some math and algebra and other skills to prepare them to enter the workforce where they can get a good job that is high paying, such as in biotech manufacturing and these other high tech and biotech jobs of the future.

I’m looking forward to attending the California Healthcare Policy Forum on Nov. 5 and meeting the folks who are actually innovating new drugs and therapies and employing people and teaching California’s future workforce. I have a lot to learn from the speakers and from the attendees so it should be a great opportunity.

CHI-Advancing California biomedical research and innovation