Tuesday, April 11, 2017
The Business of Government Hour-TV - a video companion to our flagship radio program: Episode: Understanding the US Food & Drug Administration's IT Strategy

What is the FDA’s IT strategy? How is FDA changing the way it does IT? What is FDA doing to leverage the advances of mobile technologies? I explore these questions and so much more with our very special guest, Todd Simpson, Chief Information Officer, US Food and Drug Administration. Also joining us from IBM is Tim Stitely.

You can download the entire conversation at iTunes or businessofgovernment.org.

Here’s an excerpt:

Theme 1: “Mission, Challenges, & Leadership”

That dovetails into my next question which is if you had a sense of giving your top three management challenges, what are they and how have you sought to address them?

That's a great question. I would say interoperability is a major problem at the FDA, and system duplication is another major problem at the FDA. It's not a technical problem but I think the culture is – I'm not going to classify it as a problem per se but it's something that's a challenge. Overcoming that culture and working across all the various groups and all the various personalities, the regulators to the scientists, and bringing everyone together and making sure everyone understands all the nuances of the business because a scientist wants to solve a problem, wants to cure cancer, do whatever that scientist is doing and they don't want to wait for a technology problem. They don't have patience for a technology problem and that's where we have to be vigilant. We have to come in and enable that business and make sure that everyone has the right tools to do their job.

You've transitioned into your role, in your current role, what has surprised you the most? I'll put a second point to that as well. What similarities are there in the role that you're doing today from where you've come from?

I think what's surprised me the most is how well the team has kind of come together to execute. I'll talk about this later. I'm sure there will be questions. We released a strategic plan a year-and-a-half ago and I've been able to execute about 40% on that. I've never seen this kind of support, this kind of ground swell of enthusiasm in the federal workforce. Comparing it to other places that I worked, I've worked with some really good people and some really good agencies, but the FDA is unique in its people assets, I would say.

That's a great way to do it. It's funny when you think about the Air Force, your time in private sector, your time through your federal experience. What makes an effective leader in your mind? Perhaps you could tell us who has influenced your leadership style.

When I came into the federal government, I remember getting a lot of really weird looks because I had kind of an intolerance for some of the things that I saw and I didn't understand why things had to take as long as they did and just some of the nuances of the federal government. I think that I've maintained that private sector look and feel. In fact, it's not that I long to go back to the private sector but I do invite more of a private sector look and feel to the job that I'm in right now.

I believe in driving accountability, holding people accountable for the job that you're giving them, having very clearly defined roles and responsibilities, and just making sure that you're communicating your expectations. I think that if you follow those rules and if you look at everything through a business lens and you try not to personalize things or bring your ego into it, I think you'll have a successful go of things no matter what you're doing. For me, that's been the secret.

You said earlier it's like diplomacy but you really need that sense of leadership when you're operating especially as CIO in a federated model. The collaboration aspect is really important.

I think if you're looking for personal traits – other people, Jack Welch and others have done this and a far better job than I could do – but I think integrity and honesty and just being transparent. It's not just talk. My strategic plan incorporates a balanced scorecard approach. On everything that I did with the formulation of that strategic plan, the dissemination, the execution, everything is transparent.

I produce a balanced scorecard report on a quarterly basis. My customers can see every single line of service, how much we're billing them. They may not be happy with their bill but they are at least privy to how we're coming up with the numbers. We're doing things every day to try to refine our cost model to bring more transparency to that cost model so our customers know the value that they're getting and can make better decisions to cut costs and things like that

Theme 2: “IT Governance, Spend, & Cloud Migration”

Todd, would you tell us more about your efforts to develop an effective FDA wide IT governance structure?

That's a great question. One of the first things that I did when I came to the FDA was I created an Office of Enterprise Portfolio Management. We now have a comprehensive portfolio of projects and we have a weekly, reoccurring PMO meeting, Project Management Office meeting, where all of the centers that have projects come and speak to those projects.

Everything is broken down so that we're watching the schedule, we're watching the costs, and we're watching the scope to make sure that everything stays on track. That is how we're actually moving the ball down the field. All of our work is either represented in some kind of a trouble ticket or in that project work. The project work is now moving very quickly because when something starts to go a little bit off, we catch it right away, we escalate right away, and we get it right back on track. Most importantly, we're using the PMO process to align our investments.

Of the $724 million that's spent in IT, I'm spending about $322 million of that. The rest of that is being spent independently by the centers. I have a job per FITARA to report back to the CIO of HHS what that spend is. What I do is I use that governance process, that PMO process, to track all of those investments, to track all that work, and we use the capital planning process as well to do basically comprehensive end-to-end investment alignment of all of our projects.

It leads nicely into this issue. Every federal agency, you're managing legacy systems and applications that are deeply rooted in the agency's computer environment. What are your efforts to migrate to the Cloud?

That's a great question. We have spent a lot of time penetrating the Cloud over the last 22 months. Upon my arrival, we did not have an authorized Cloud environment and there was no prospect of one. But through some creative negotiating and assuming a little bit of acceptable risk here and there and putting plans of action and milestones in place to correct and deal with that risk, we've successfully now joined forces with six different Cloud service providers. We're offering infrastructure, platform, and software-as-a-service through a Cloud brokerage model.

We spent the last 23 months basically positioning that Cloud infrastructure because we know that it's just the foundation of what's ahead for us. We can't build the DR infrastructure that we want without leveraging the Cloud. We can't guarantee that we can exploit the elasticity of the Cloud if we're not in the Cloud. So the next Listeria outbreak and then next time we have to do genomic sequencing, do I want to have millions of dollars worth of assets sitting with dust on them waiting to be spun up or do I want to exploit that elasticity model? So we now have that.

And we have major platforms. OpenFDA is one of them, but we have over 20 different applications now in the Cloud. I would say that we are at the leading edge of the Cloud. Now where does that position the FDA? I think what it does is not only does it position us to do some really creative things with like our high performance computing environments – we have three disparate high performance computing environments and they're all perching end of life. When they were built, they were built to solve problems and there wasn't a reinvestment strategy baked into that.

The whole notion of the reinvestment strategy is relatively a new thing from the FITARA standpoint. We're really starting to get good at it along with the chargeback models and that kind of stuff. When we look at rebuilding that high performance computing environment, do we want to invest millions of dollars into on-premise high performance computing or do we want to take what we have and leverage it against the Cloud and maybe build a new platform and strategically build it leveraging that Cloud infrastructure?

I want to just kind of segue a little bit. While we've been building that Cloud infrastructure, as part of the strategic plan, we've been very, very busy automating processes and preparing for what I'm calling a digital transformation at the FDA. So I'll give you an example. We have automated our field inspection processes. Over the last year, we've completed 18,000 field inspections through automated means. So the field inspectors that used to have to write the reports on paper and take GPS coordinates and take pictures of the rotting cabbage, they don't do that anymore. It's all in real-time. The reports are produced at the submit end of the button. We have that.

We have automation through our Customs and Border Protection System now. So I think at last count we had 36 million lines of lighting through our new automated system where everything that's coming in that's getting plucked out of those crates by the Customs and Border people and saying the FDA needs to look at this, that's all automated now. These are huge advancements in the way that we're doing business.

We're also digitizing. Where we once had literally rooms filled with inspection reports, it's all automated now. It's not all automated but there has been a major effort put forth to start automating. I don't want to get too far ahead with what is reality and what we still have to do. But this digital transformation is upon us.

And so just to kind of bring closure to this question, we have nine different centers and each of the centers are embarking upon their own digital transformation. I think my job is to make sure that we find that common grey area of overlap. Because if not, you've got one center that may say, hey, we're reinventing ourselves, we're looking at our business processes, but lo and behold they're being fed from the Office of Regulatory Affairs' Compliance Management System. And I equate that to building a sports car that you're going to drive on a dirt road.

We have to think holistically about this digital transformation. And I think leadership gets that, center leadership gets it. It's not that it's something that isn't going to happen but it is going to be a challenge. That's really where we all need to come together at the FDA to make that happen.

Theme 3 – Focusing on the Future with Advice

So turning to the future – I'm going to combine two questions – what are your highest priorities over the next couple of years? And more importantly, what emerging technologies hold the most promise for achieving those priorities?

I think data is one of the biggest ones. We're going to be immobile if we don't get our arms around the data. Dr. Califf once said publicly that the interoperability issues at FDA were so great that we would be toppled by our own weight if we didn't solve those problems. I think data is big. The interoperability and the duplication, solving the duplication issue, which we're well on our way. We're conducting a rationalization exercise as part of the strategic plan where we've identified all the software that's in use across this federated environment.

There are some situations where we do have duplicative pieces of software in play and we're going to go after that kind of stuff and get everybody – basically we're building a technology road map for every single application that we use. We're going to define its life cycle up front. It's okay to have two or three of the same types of software if the nuances are so specific that they have to be that way to map up to the requirements but we're going to know what they are. So having complete mastery of the environment is really where we're going to solve that duplication issue.

The interoperability issue really comes down to the new technologies; the Cloud, that's really big. There are micro services, development micro services that we're looking at, changing the way that we do our development, our development methodology, looking at the way that we structure our development shop around that, looking at the types of appliances and code, the standards that we employ, which all this stuff is in motion, by the way.

What advice would you give someone who is thinking about a career in public service?

I would say go for it. I'm a public servant. I love what I do. I feel like it's, for me, I would rather work for the American public than for the bottom line. But that's just my personal preference. I would say that if you're considering a career in public service, just do everything you can to be the very best. Don't say, well, if I were doing the private sector payoff, I may do things differently. I never looked at it that way. I always tried to stay at the cutting edge on my certifications. When I felt like I needed more education, I went back to school. I pushed myself really hard and I just wanted to be a value add wherever I was.