“One of the things I’ve done is very quickly get into a start, stop, continue and modify mode,” he said. “Basically starting with the highest dollar value, the highest impact projects, and reviewing them one-on-one to see what we can accelerate and what may need to take a different course to ensure success.”
Perakslis, who also is FDA’s chief scientist for informatics, said the Office of Regulatory Affairs (ORA) project, called MARCS, currently is under the agile approach. The program is modernizing ORA’s business processes around seven legacy systems.
For instance, last year the FDA piloted mobile devices for inspectors to work in the field.
“They brought a device to an egg farm and were able to save a tremendous amount of time and energy by conducting the inspection electronically,” Perakslis said. “When the inspector got back to the office, most of the report was pre-populated.”
MARCs also includes workflow and document management and moving to an electronic document system and digitizing paper records.
Along with modernizing their business processes, Perakslis said getting inspectors the right data anywhere, anytime is just as important.
“One of the IT projects that was an early deliverable of MARCS was a system called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT),” he said. “In the last few months since it’s been out, if [a food importer] has a higher predict score, we are seeing already a strong correlation that there will be a violation involved in that inspection. That is what you want. You want to find the bad stuff and not all the good stuff.”
Perakslis also is looking closely at how the cloud can improve the FDA’s business processes.
Under the network modernization effort, he said the FDA has virtualized about 60 percent of all servers, and is consolidating the number of servers and data centers.
“What you will see now as the next steps of that is to finish the data centers and the technology consolidations, move more fully to internal and external clouds and get to the next step of connectivity,” Perakslis said. “I think by going to Internet2 and using the Internet at your wide-area network, you can get speed to value.”
He said he wants to move as many systems to external clouds as he can as long as FDA is confident in the security of the offerings.
Perakslis said email is a prime candidate for the cloud, but the agency already has put CDRH Innovation 2.0, which was a different approach for vendors to submit medical devices for approval.
“It uses crowd sourcing and a challenge type mechanism,” he said. “What they did was a put out a challenge for devices that could be useful in end-stage renal disease, a very large unmet medical need. In a period of six weeks, we did three IT projects. They looked at more than 30 applications and picked three or five that they are now pursuing for aggressive review.”
Perakslis said getting a medical device through the process for small company can be onerous.
“We came up with the idea of putting out what are some of the unmet medical needs and encouraged innovators to bring us their ideas, not in the form of a full blow FDA submission, but in a small digestible form,” he said. “We could very quickly evaluate them, pick the ones that look promising to us and then go back to these people to learn more. We gave them new technologies and tools to get their ideas to us.”
Perakslis said he’s trying to use the cloud for both innovation and efficiency programs.
“If you just pick easy things, you never get through it,” he said. “Run the hard experiment first because people know you can do the easy ones. If you only pick the easy apps, you could have a five year pathway to the cloud. But in one year you move some of the hardest to the cloud, then some of the easiest stuff flows like water.”