Making a Difference: Innovation Pathway and Entrepreneurs in Residence

Interview with Todd Park Chief Technology Officer of the United States

Prior to becoming Chief Technology Officer of the U.S. in March 2012, and prior to that, CTO at the U.S. Department of Health and Human Services in 2009, Park co-founded three companies that developed web-based and telehealth solutions for doctors and consumers.

Q – Since you joined HHS, what have you learned about making innovation happen in the government?

Todd ParkI’ve learned that a lot of the same rules that drive success in private sector innovation also apply in the public sector.  The philosophy I used extensively in the private sector boiled down to what Eric Ries calls “lean startup” — the whole idea behind lean startup being  that you want to engage customers early and rapidly prototype solutions in collaboration with them in order to achieve maximum success.

We have successfully applied lean startup principles at HHS across a range of key initiatives.  We’ve emphasized the need to rapidly prototype solutions, engage customers in f those solutions as soon as possible, and then quickly and repeatedly iterate those solutions based on working with customers, until we arrive at both an optimal understanding of what customers really want and a solution that delivers what they want..

It’s a technique that a lot of private sector entrepreneurs have used to great effect, and that we’re now using to great effect in the public sector.

Q – How do you then ensure that a good idea or an innovative idea can be scaled up in a government setting, where the culture may be less receptive to something new?

Critical to the success of our growing array of lean startup projects is the following approach:  whenever we  consider an idea to make the government work differently and  better,  the first thing we do is find three to five people at HHS who had that idea a long time ago. They know a lot more about it than we do, and can make the change happen if they’re given the chance.

We band those folks together into a “virtual lean startup team,” and we give them the air cover they need and block down field for them, so they can actually do the thing they’ve always wanted to do.

In the case of FDA, through the Entrepreneurs in Residence Program, we’ve also brought in incredibly talented entrepreneurs and experts from the outside, to complement our best internal innovators. Together, they can make amazing things happen in an incredibly short time.

Q – What’s so great about the Entrepreneurs in Residence Program at FDA?

What’s phenomenal about the FDA’s Entrepreneurs in Residence Program is that it’s a living, breathing incarnation of lean startup within HHS.  FDA has taken its best internal innovators and put them to work together with entrepreneurs with highly complementary experiences and expertise. The result has been an amazing band of doers and thinkers who are rocking and rolling, and making terrific things happen terrifically fast.

Q – Somewhere, somebody has to give you the green light for these innovations. Where does that start?

In every organization, the tone is set at the very top. And since his first day in office, President Obama has been an incredibly enthusiastic champion of open innovation in government..  He supports the whole idea that government needs to partner with the private sector, the academic sector, and the citizen sector, help unleash the creativity of innovators across these sectors, and team up with them to jointly attack our biggest problems and exploit our biggest opportunities. That’s the overall tone that the President has set, and it provides massively fertile ground for innovation.

Q – What excites you most about FDA’s Innovation Pathway?

Two things:  First, the Innovation Pathway will help bring safe and effective medical devices to American patients faster. That will make a huge difference in many lives. And on top of it, the initiative will help medical device companies get their products to market faster and at a lower cost. That will help create jobs and grow the economy.

On another level, I’m enormously excited by the way that the Innovation Pathway project has been run, and by the whole Entrepreneur in Residence, lean startup mode of operation it has embodied. The fact that lean startup has been employed to such great success in the Innovation Pathway project, I think, bodes very well for the replication of this approach  more broadly across HHS and the government in general.

Q – What’s the main lessons you’ve learned from the success of FDA’s Innovation Pathway?

The Innovation Pathway at FDA is a phenomenal example of lean startup in action in the government.  It proves the success of the whole idea of rapid prototyping, engaging customers and stakeholders as soon as possible, co-inventing an optimal solution through hyper-rapid iteration, and doing all of this at warp speed.

Innovation Pathway exemplifies the power of collaboration.  Given the challenges and opportunities that we as a nation face, we’re really only going to be able to get optimal results if we team up as a country.

It’s not about government solving problems by itself.  It’s about the private sector, the research sector, the citizen sector, government, and the public in general, teaming up in truly innovative collaborations to deliver optimal results for the American people.

Balancing Innovation and Safety: FDA’s Innovation Pathway

By: Jeffrey Shuren, M.D., J.D. 

Over the past couple of years, there has been a lot of discussion about balancing innovation and safety—whether we need to have more regulation of medical devices to assure safety and effectiveness—or whether we need less regulation of medical devices to foster innovation.

FDA’s Innovation Pathway is an exciting example of how innovation and safety and effectiveness don’t have to exist on opposite ends of a swinging pendulum. They can be complementary, mutually supporting aspects of our public health mission.

Jeffrey Shuren, M.D., J.D.The goal of the Innovation Pathway is to reduce the overall time and cost it takes for the development, assessment, and review of safe and effective medical devices that address unmet medical needs, so these devices can get to the patients who need them sooner without jeopardizing patient safety.

Another goal is to improve how FDA and innovators work together. We can achieve that with our new Innovation Pathway through earlier engagement and more collaboration.

We’re also experimenting with new ideas—creating sort of a living laboratory or incubator. Through the Innovation Pathway, we are developing and rapidly testing new approaches to pre-market review including the use of a decision support tool that will help assure that the regulatory decisions we make about whether or not to approve early clinical studies are more transparent and consistent. Such a tool can help us decide, for example, whether there is sufficient evidence to allow the device to be studied for the first time in humans.

Additionally, we’re implementing a new suite of information technology tools that will improve FDA’s communication with sponsors.

Like any strong and successful business, when we find an approach that works—in this case, when tested in the Innovation Pathway—we will roll it into our existing processes for other devices where it adds value, thereby leading to improvements in all of our pre-market programs. When an approach doesn’t work, we will throw it out and move on.

And, one of the unique ways we’ve developed the Innovation Pathway is through the Entrepreneurs in Residence (EIR) program, which is supported by the White House Office of Science and Technology as a component of the Administration’s Strategy for American Innovation.  The EIR program brought together experts outside FDA to work with agency staff and leadership to develop the Innovation Pathway 2.0.

Today we are very excited to announce that three innovators with products for patients with end stage renal disease – ESRD – have been chosen to participate in our Innovation Pathway 2.0.  We received 32 applications in response to our January call for innovative treatment technologies for ESRD.  Later this year, we may accept additional applicants from the ESRD challenge onto the Innovation Pathway.

We chose to focus on ESRD because of its public health impact—more than half a million Americans suffer from ESRD—and because management of ESRD is largely dependent upon medical device technology, such as hemodialysis equipment. Most dialysis patients spend long hours in specialized outpatient clinics, lowering quality of life and reducing their productivity. In addition, Medicare covers some 75 percent of ESRD health care costs, which in 2009, topped $29 billion.

We think the Innovation Pathway can help medical technology reach patients with unmet medical needs such as those suffering from ESRD. But, equally as important, we want to apply what we learned from our Innovation Pathway experience throughout our device review processes.

It’s vital to understand the Innovation Pathway does not lower our standards for medical devices.  The U.S. standards of reasonable assurance of safety and effectiveness and of relying on valid scientific evidence have served patients and industry well. The Innovation Pathway 2.0 illustrates that there are ways to facilitate innovation without compromising our standards and patient safety.

Jeff Shuren is the Director of FDA’s Center for Devices and Radiological Health