Andrew Cleeland’s first window into medical technology was not a garage, a venture fund, or a gleaming Silicon Valley lab. It was Australia’s Therapeutic Goods Administration, where a biophysics student arrived for work experience after the students with better marks took the hospital placements. He likes to tell the story without retrofitting destiny onto it. The assignment was accidental. What followed was not. Inside the agency, he learned that invention lives inside a web of evidence, judgment, and public responsibility. A promising object could not travel on cleverness alone.
That early view from the regulator’s desk became a useful piece of luggage. Cleeland carried it from Melbourne to Denver, from large medical-device companies into Bay Area startups, through two consequential CEO tenures, and eventually into the nonprofit he now leads. His career reads less like a ladder than a tour of the entire playing field. He has been the person asking for evidence, the executive trying to assemble it, the operator raising money, the board member asking difficult questions, and the coach helping someone else survive all four roles.
Fogarty Innovation, based on the El Camino Health campus in Mountain View, is where those perspectives now meet. Cleeland became CEO in January 2017. He arrived after leading Ardian and Twelve, two startups acquired by Medtronic in transactions worth more than $1.7 billion combined. A conventional next act would have been another company and another chance to repeat the pattern. He chose a harder-to-summarize ambition: make the lessons repeatable, not merely the exits.
A two-year move that kept going
Cleeland grew up in a suburb of Melbourne with his brother and their single mother. He took on responsibility early. Sport supplied another education. Natural ability pushed him into captaincy, and Australian Rules football took him to the semi-professional level. The game is fast, physical, and continuous. Players cover ground, absorb contact, and make decisions without waiting for the field to arrange itself politely. Cleeland has said sport taught him how to build teams and lead under pressure, with character carrying as much weight as skill.
After his time at the TGA, an opportunity with Telectronics took him to Denver. He had never lived outside Australia. He moved alone and expected to stay for two years. More than three decades later, he was still in the United States. The temporary posting became a career, first at Telectronics, then at Baxter Healthcare’s Novacor division, and later at Radiant Medical, a Bay Area startup where he served as vice president of clinical and regulatory affairs.
Radiant also brought Thomas J. Fogarty into Cleeland’s orbit. Fogarty, the surgeon and inventor whose name would later sit above Cleeland’s office, invested in Radiant in 1999. He would become an early investor in both Ardian and Twelve. Their relationship accumulated over decades, one company and one conversation at a time. On Cleeland’s desk today are books Fogarty gave him, including a volume titled The No Bullshit Rules. The title fits the mentor Cleeland describes: direct, curious, and impatient with fog around the real problem.
“Everything we build is on someone’s shoulders.”Andrew Cleeland
Two companies, one deeper lesson
At Ardian, Cleeland led a company working to turn an old physiological insight into a practical technology. The business was still before revenue when Medtronic agreed to acquire it in a deal valued above $1.3 billion. After a period at Medtronic, Cleeland returned to an early-stage CEO seat at Twelve. Medtronic acquired that company too, in a transaction valued at up to $458 million. Back-to-back outcomes removed the easy explanation of luck. They also clarified what he wanted to do next.
Building one startup demands a singular focus. Building an environment for many startups demands a portfolio of attention. Cleeland saw that another 15 or 20 years might allow him to guide two or three more companies personally. Fogarty offered a way to work with four or five at once, while training founders, convening experienced operators, and repairing gaps across the broader system. The unit of impact could shift from one product to the conditions that make products possible.
His stated reason for joining Fogarty was gratitude with a deadline. The industry had looked after him, and he wanted to give back in a way that was both meaningful and effective. Writing checks or taking board seats would have helped individual companies. Building an institution could preserve practical knowledge, widen access to it, and last beyond Fogarty’s active involvement, beyond Cleeland’s own tenure, and beyond whoever comes next.
The overlooked draft picks
Cleeland’s football language returns when he describes the founders an incubator can serve best. The obvious prospects, backed by famous labs, experienced executives, and deep-pocketed investors, often find support on their own. He is interested in the equivalent of late-round or undrafted players who have talent but lack the expected school, network, or moment of recognition. Fogarty can afford to engage new CEOs, difficult concepts, and teams without abundant early funding.
The principle is practical, not sentimental. Early-stage device companies fail in more ways than a prototype can reveal. They misread a market, underestimate a regulatory path, choose a reimbursement strategy too late, or recruit a team for the company they have rather than the company they need. Experienced coaches can see around those corners. The work resembles film study: slow down the play, expose the assumption, and let the founder make a better next decision.
A meaningful problem, technical insight, and the nerve to begin before every answer is available.
Pattern recognition across evidence, funding, teams, regulation, markets, and timing.
Lessons move between companies, disciplines, and cohorts instead of disappearing after one exit.
A founder leaves with stronger judgment, even when the original idea changes direction.
Cleeland once described Fogarty’s work as three pillars: incubation, education, and alliances. He later corrected the picture. Pillars stand separately. These activities are integrated. A startup’s hard question can become an educational program. A relationship with an agency or strategic company can become an alliance. That alliance can give founders earlier context, while founders give institutional partners a closer view of how young companies actually work.
Consider regulation, where Cleeland began. Fogarty has hosted FDA fellows inside the early development environment. Regulators see the tradeoffs a tiny team faces before a process becomes a submission. Entrepreneurs see why the agency asks for rigor and how public responsibilities shape its decisions. Neither side abandons its role. Both gain a more useful model of the other. Cleeland’s career advantage is visible here: he knows the rooms, but his larger contribution is getting them to speak before misunderstanding becomes expensive.
“Innovation doesn’t stop at borders. Our patients are everywhere, and so must be our ideas.”Andrew Cleeland
An institution with memory
The next chapter widened in October 2025, when Fogarty Innovation announced a strategic merger with the Cardiovascular Research Foundation. Fogarty would remain in Mountain View and become CRF’s West Coast Innovation Hub. The combination joined hands-on early-stage coaching with a global research and education platform. In Cleeland’s telling, the point was not size for its own sake. It was a shorter, more connected path between an idea, the people who test it, the institutions that evaluate it, and the communities that eventually use it.
That same month, more than 300 people gathered in San Francisco for the inaugural Thomas J. Fogarty Innovation Prize. The winning team received an unrestricted $100,000 award and a bronze medallion carrying a bear and the Latin phrase A Posse Ad Esse: from possibility to actuality. The bear was a private joke made public, a nod to a fishing trip when a hungry brown bear woke Fogarty from a nap. The phrase was the serious part. Ideas matter when disciplined teams carry them into use.
Cleeland has written about hope as the expectation, grounded in trust, that progress is possible. He carefully separates it from passive wishing. Hope is fuel. Strategy supplies direction; evidence and work supply motion. His version of optimism has calluses. It comes from contact sports, regulatory scrutiny, uncertain financing, and the long gap between a convincing slide and a functioning company.
Build the builders
There is a quiet reversal in Cleeland’s story. As a young regulator, he evaluated what inventors brought forward. As an operator, he learned to bring ideas through the maze himself. As a CEO at Fogarty, he now helps other people acquire the judgment to navigate it. The object of his work has moved from device, to company, to person, to ecosystem.
The progression explains why he talks so often about shoulders. Fogarty’s balloon catheter contributed to later generations of tools. Veteran operators transfer pattern recognition to first-time founders. A regulator learns from an engineer; an engineer learns the regulator’s constraints. One startup’s expensive lesson becomes another team’s early warning. Experience stops being a private asset and becomes shared infrastructure.
Cleeland still brings a captain’s concern for the room. He has said part of his job is to make sure joy is present there. The detail matters. Serious missions can produce humorless cultures, and humorless cultures can make people protect appearances instead of asking for help. Joy lowers the temperature enough for candor. A coach can challenge a founder without reducing the founder to the mistake.
His own aspirations are institutional rather than biographical now: a sustainable organization, a connected global community, and a path that helps worthy ideas move faster without pretending the work is easy. The two-year assignment that carried him away from Melbourne became a life spent crossing boundaries. The current task is to make those crossings easier for the people coming next.
A company can be acquired. A program can end. A charismatic founder can leave the building. Cleeland is working on the harder form of continuity: habits, relationships, and shared memory strong enough to keep generating good judgment after the original architects have stepped away. If it works, Fogarty Innovation’s most valuable product will not sit on a shelf. It will walk out the door in the form of better builders.