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.

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