On the Road Again, This Time for Good

If it was up to Heidi Steuckrath, she'd be zipping down the backroads right now. Standing in the parking lot at the Office of Regulated Activities, perched behind her beloved Triumph motorcycle on a warm April morning, she can already taste the next chapter of her life.

"For me, I just like being out there in nature," says Steuckrath, who's set to retire this month after almost 25 years at Fort Detrick. "I just like to get out and go. There's so many things I want to see."

But until that final day officially arrives, there's still a good bit of business to wrap up at ORA, where Steuckrath began working all the way back in 2003. After several name changes, the office formally became part of DHA Research and Development-Medical Research and Development Command headquarters in 2018. For someone who's built their entire career living inside the complex world of medical product systems compliance, nailing down a few final details on her way out the door is simply par for the course.

"Never Say No"

Steuckrath's official title is Regulatory Systems Manager, but she's held just about every other title available since starting in a medical bench science role at Baylor College of Medicine and then the University of Houston in the 1990s. Back then, she was hoping to latch onto something – anything – that might further the understanding of medical physiology. Since starting at ORA however, she's been tasked with ensuring that all systems used for the clinical trials routed through DHA R&D-MRDC meet the rigorous standards set by the U.S. Food and Drug Administration. That means keeping tabs on both the physical data and the safety and reporting systems used to support any submission to the FDA. In short, it's a heavy lift – the kind she's always wanted.

"My work ethic has always been that I never say no," says Steuckrath, who has banked her professional reputation on maintaining an "audit ready" posture at ORA; a method of keeping all information up-to-date just in case the FDA decides they want a closer look at a specific set of data. "I always find an answer," she says. "I don't like to leave work undone."

To that end, Steuckrath is already drawing up a detailed transition plan for her many duties, one of which is an integral role in liaising with the Enterprise Information Technology Project Management Office (eIT PMO), which is currently part of DHA's Operational Medical Systems division.

"A Rare Ability"

The eIT PMO, which has a stated goal of facilitating the administration of information technology capabilities across DHA and the Services, might still be a little-known IT shop at the southern end of Fort Detrick if not for Steuckrath, who is credited with shaping the development of its innovative set of regulatory tools starting in 2009. It was Steuckrath who realized early on the potential of the Electronic Document Management System, the eIT PMO's sprawling web-based content management system that allows users to collaborate both within and across organizations in a single, secure environment. Once a user touches a document in EDMS, their digital fingerprints are recorded automatically in a detailed audit system. For someone in Heidi's world, that's a gamechanger on a number of fronts.

"You never know what kind of question you're going to be asked," says Steuckrath, noting the constant and varying demands of leadership figures, primary investigators, and FDA auditors. "If we have a system where I can punch-in a couple parameters and then, boom, I can print out a detailed, validated report tailored to what people want to see – I've just saved how many dollars?"

After quickly using EDMS to revolutionize the tracking of training and certification documents at ORA (which is, itself, a key FDA requirement), Steuckrath began shaping the rollout of various other eIT PMO products, notably helping stakeholders acclimate to a more iterative delivery schedule as opposed to pushing out new tools and updates once every couple of years. After that, she set about urging other Command organizations – the U.S. Army Medical Research Institute of Infectious Diseases and the Walter Reed Army Institute of Research Pilot Bioproduction Facility among them – to adopt EDMS tools, which they eventually did.

"Heidi has the rare ability to see both the regulatory fine print and the long arc of impact at the same time," says Millicent Jordan, the EDMS product lead at eIT PMO and someone who's worked closely with Steuckrath for the past seven years. "Heidi helped us develop tools that turn regulatory readiness into sustained enterprise capabilities. When regulatory complexity decides to show off, she is the person you want on speed dial, even in retirement."

Says Steuckrath regarding the early days of EDMS, "I remember the transition process was very slow and painful at first, but look where we are today. We can't live without EDMS anymore."

"Very Honored"

To be sure, there are other victories to be found in Steuckrath's expansive career. Notably, back in 2013, as part of an effort to investigate the use of a then-novel freeze-dried plasma product by the U.S. Special Operations Command, she helped develop and execute the Freeze-Dried Plasma PI Database to monitor data in real-time. Since the folks at SOCOM couldn't divulge their exact location for security reasons, they had to upload their data to EDMS – data which is still there, by the way – in order to allow clinical monitors at Fort Detrick a chance to verify the information. Under a directive from the White House, they processed the effort and accompanying data within 12 weeks – a record at the time.

"I always took our mission very seriously," says Steuckrath of her work. "I've had a very rewarding career, and I feel very honored that I was able to contribute – if I was able to contribute anything – to overall Warfighter health."

After she puts the final touches on that transition plan, Steuckrath notes she's got a few more emails to send, maybe some boxes to pack up, but that's about it. There will no doubt be a couple retirement parties to attend, maybe a couple souvenirs to give away to longtime coworkers too – and certainly, absolutely, a few more final reminders to stay "audit ready" for the sake of all the precious data. After that, the only box left to check involves hopping on the back of that cherry red Triumph in the parking lot, strapping on her helmet, and pushing off into the countryside, or maybe pushing off to the west coast … or maybe just pushing off to wherever.

"Maybe I'll do some more multi-day trips, maybe some moto-camping; hopefully, if everything goes well, we'll ride across the country," says Steuckrath, musing about her next destination. She pauses slightly before smiling. "I just like being on the road, you know?"