Matt Hillebrenner operates intuitively on two levels. Even as he is fully engaged in the task at hand, he is assessing the bigger picture – considering what is motivating participants, what is missing from discussion, and what broader ramifications might be at play. This dual clarity has been a throughline across his career.
His unique combination of technical proficiency, situational awareness, and interpersonal insight made him a gifted and effective leader at the FDA Center for Devices and Radiologic Health (FDA-CDRH), where he rose from a biomedical engineering reviewer to leading more than 1,500 employees as Deputy Director of the Office of Product Evaluation and Quality (OPEQ). During his 22-year tenure, he helped launch innovative regulatory approaches such as TAP (Total Product Life Cycle Advisory Program), championed improvements to existing programs and processes, and was a staunch advocate for open dialogue and collaboration across the organization and beyond.
Given his impact and reputation, it is not surprising that, when Hillebrenner and Fogarty CEO Andrew Cleeland first discussed the possibility of working together, Cleeland’s instinct was to persuade him to remain at FDA.
“Matt has a deep commitment to advancing public health combined with a proven ability to interpret the interests and constraints of multiple stakeholders—regulators, patient groups, and industry alike—and translate them into workable solutions,” said Cleeland. “That skill consistently benefited the agency and the broader ecosystem.”
However, when Hillebrenner made it clear he was ready for a new chapter, Cleeland wisely pivoted and brought him aboard as Fogarty’s Director of Government Affairs.
Today, as part of Fogarty’s senior coaching team, Hillebrenner helps medtech entrepreneurs navigate regulatory pathways and engage effectively with other government agencies including the USPTO, CMS, and NIH. He also partners with chief commercial strategy officer Marga Ortigas-Wedekind to deliver educational programming that deepens regulatory literacy and provides up-to-date insights.
Learning to Work Hard
The oldest of two sons, Hillebrenner grew up in a suburb outside Chicago. His dad was a civil engineer and his mom worked in human resources. Although he played multiple sports, by high school the competition outpaced his abilities. A friend who was a lifelong swimmer convinced Hillebrenner to give the swim team, a “no-cut sport,” a try.
It turned out to be transformative.
“I was terrible,” Hillebrenner recalled. “I was so slow the coaches had to assign me my own lane, but I learned how to work hard and make progress toward goals.” Three days a week, even in the frigid Midwest winter, he was in the pool for extra practice by 5:30 am. At the end of his freshman year, when the team needed competitors for unpopular long-distance events, he volunteered. “I thought, I’m not very good at sprinting so why not,” he recalled.
While he improved markedly, he “never got close” to making the state meet times and cutoffs. But he achieved something even more valuable – a feeling of personal accomplishment as well as a sense of belonging and commitment to the team. “We supported each other both in and out of the pool, and that laid the foundation for what became lifelong friendships,” he described.
This approach – a willingness to work hard and say yes to difficult assignments – ultimately opened numerous professional doors for Hillebrenner, with other rewards that were just as meaningful along the way.
Finding the right path
Hillebrenner’s dad wasn’t the only engineer in the family. All three of his dad’s brothers were engineers too, and Hillebrenner expected he’d go down the same path. But it wasn’t until a college counselor introduced him to the relatively new field of biomedical engineering that he knew he’d found the right fit. “The idea of taking engineering principles and applying them to the human body totally enthralled me,” he said.
He completed a dual bachelors-master’s program at Tulane University. After graduating, he interviewed with the cardiovascular group at FDA, a perfect fit given his master’s research in computational cardiac electrophysiology, and launched his career as a biomedical engineering reviewer working on pacemakers, defibrillators, and leads.
From the start, Hillebrenner was struck by the culture. “At FDA, improving patient care isn’t implied—it’s written into our mission. But more than anything, I was impressed by the dedication of my colleagues to public health along with their intellectual ability, collegiality, and willingness to help one another,” he said.
He also found abundant opportunities to grow and learn. “My first supervisor actively promoted my professional development by encouraging me to work across multiple review groups – a practice that was rare at the time,” he said. “She supported it even though it meant less direct work for her team.”
Saying yes
A few years in, Hillebrenner was offered the chance to step in as lead reviewer for a high-profile, novel heart failure device midway through review of the premarket approval application. With a complicated regulatory history to catch up on, it was a daunting task. It was also more than a little unorthodox to switch lead reviewers at that stage.
“After laying out all the challenges involved, they said, ‘Would you like to take this on?’” recalled Hillebrenner. “I didn’t have a reason to say no, so I agreed.”
The ensuing review process was long and complex, involving regular interactions with cardiovascular division leadership and everyone else up the chain including the Director of CDRH as well as the outside experts who had been on the advisory panel. The increased internal and external exposure served as a launching pad, helping to springboard Hillebrenner into his first management role: Chief of the Circulatory Support and Prosthetics Branch.
Bringing next-gen technology to patients
The promotion not only put Hillebrenner on a leadership track – it also came with the responsibility of overseeing the regulation of transcatheter heart valve therapies just as they were entering clinical trials in the U.S. These new technologies involved a host of unique considerations, including new materials, delivery mechanisms, and clinical treatment paradigms. Moreover, in addition to the technical challenges, evaluating the devices revealed even bigger issues around communication and team culture.
Hillebrenner quickly recognized that, in order to effectively regulate these disruptive technologies, an evolution (if not revolution) of long-established regulatory practices was also going to be necessary. Through a combination of strategic hiring, creative problem-solving, and advice from mentors, Hillebrenner and the team navigated a path forward that would support market approval of transcatheter heart valves in the U.S. This experience also underscored the importance of strong alliances across the entire ecosystem, as Hillebrenner witnessed first-hand how partnerships between professional societies, government agencies, industry, and the clinical community were necessary to bring this game-changing therapy to patients.
Leadership, Relationships & Values
Just a few years later, Hillebrenner became Deputy Director of the Division of Cardiovascular Devices and continued moving upward. He attributes his rapid rise to a little bit of “right time, right place,” and more importantly, strong people skills. “Where I thrive is in my relationships with people,” he said. “For me, it’s never been about technical mastery of hardcore engineering principles – it’s about combining a ‘good enough’ comprehension with an understanding of the people in the room and how to help them work together.”
While not focused overtly on the next job, Hillebrenner has also always been aware that the relationships and reputation he was building every day would influence his future. “The way you carry yourself on a day-to-day basis says more about you than the things you’ll say in a 45-minute interview,” he said. “You lead by example in the choices you make about your words and actions every day.”
Helping innovators
One of the things Hillebrenner loved most about his time at FDA was his role as an advocate for public health and for the people doing the work. “You don’t need years of technical training to stand up for what’s right and for good people trying to serve patients,” he said. At Fogarty, he is thrilled to continue that calling, using his public-sector experience to help companies engage effectively with regulators and agencies whose decisions shape commercialization pathways.
In his new position, Hillebrenner splits time between Fogarty’s headquarters in Mountain View, California, and his home in the Washington, DC area where he lives with his wife and three children. When they are together, he enjoys hiking with his wife, talking all things sports (go Bears!) with his sons, attending his daughter’s musical theatre performances, and traveling to explore new places and cultures.
The family is also deeply engaged in community service. During the pandemic, the entire household helped secure vaccine appointments for thousands of individuals—particularly those with work schedules or other socioeconomic barriers made access difficult. “Working as a ‘vaccine hunter’ was eye-opening. I learned more about disparities in health equity and access than I’ve learned in my entire public health career,” he shared.
Today, in his work at Fogarty Innovation, Hillebrenner continues what has always mattered most: helping people who want to improve patients’ lives find the right path forward.