Joe Monroe · Healthcare CEO
The product is strong. Growth, execution, or regulation is in the way. That’s the work: getting to the milestones, then turning them into revenue.
The record
The companies that get stuck at the same points: entering the U.S., expanding abroad, or a proven product whose growth has stalled.
Career and company milestones shown for context; not claimed as my individual outcomes.
What I do
Most companies that call are in one of these four situations. The first job is being honest about which one.
Build
Connected lung diagnostics
A real product, and no company around it.
Built the worldwide commercial organization from nothing — the channel, the clinical support, the pricing, the partners. Then carried it through FDA 510(k) and EU MDR.
Grow
UV-C disinfection robotics
It worked. The market hadn’t caught up.
Global VP of Sales for a category that did not exist — FDA De Novo is the pathway you use when there is nothing to compare a device to. Scaled the org to about 100 people and opened federal procurement with the VA, DoD and GSA.
Fix
Orthopedic implants · CEO, President & Treasurer
Proven product. Stalled business.
A twenty-year-old cleared device with real evidence, sitting under a commercial engine that had not kept pace. Cash burn cut by more than half in year one, EU MDR cleared, and distribution rebuilt across 50 countries.
Decide
Rehab diagnostics · CEO, President & Treasurer
Sometimes the answer isn’t another growth plan.
A full commercial, operational and financial assessment for the owner, a look at every alternative, and then the harder answer: an orderly wind-down and sale.
The career
Most of my career, I built companies around brand-new technology, got it approved, and launched it into markets that had never bought anything like it. Lately, I am the operator a private equity firm puts into its healthcare companies. Two different jobs. I have done both.
Venture-backed companies building something that did not exist yet. Three jobs in one: build a real company around the technology, get it through the regulators, and then persuade a market that had never bought anything like it to change how it works.
That last part is the hard one. A new device does not just need a buyer — it needs someone to change a protocol, a budget line and a habit. That is the work.
Xenex — disinfection robots for hospitals. Adoption went from 300 to 1,000+ hospitals worldwide. $38M raised, EBITDA up 13 points, FDA De Novo cleared, and federal contracts opened with the VA, DoD and GSA. A global team of about 100 people.
THORASYS — connected lung diagnostics. Built the worldwide commercial organization from nothing: a 1,000+ distributor and OEM network, hospital adoption, pharma trial sites, and support for a $10M raise.
Ceribell — AI seizure detection for the ICU. 9x growth and FedRAMP approval before its Nasdaq IPO. Gorbel — rehab robotics, U.S. region from under $1M to $4M. Novadaq — first hospital adoption of SPY surgical imaging. Viora — 4x growth and an exit to Sinclair.
The regulatory work is not a footnote here — it is the proof. Xenex cleared an FDA De Novo, the pathway that exists only when there is nothing on the market to compare a device to. THORASYS carried FDA 510(k) and EU MDR. Ceribell cleared FedRAMP to sell AI into federal hospitals. New categories have to be created before they can be sold.
Roughly three quarters of the career sits here, across healthcare technology, diagnostics, digital health, surgical devices and healthcare services.
I partner with a private equity owner — ADDvise Group — and step into the operating seat inside their healthcare portfolio. Different problem entirely. The product already exists and the money is already spent. Someone has to work out what the business is actually worth doing, and then go do it.
GraMedica — CEO, President and Treasurer. In year one, cash burn cut by more than half, a $5M revenue run-rate stabilized, EU MDR cleared and FDA readiness advanced, distribution rebuilt across 50 countries, Premier Breakthrough access won across a network of 4,300+ hospitals, and federal channels opened with the VA, DoD and IHS.
JTECH Medical — CEO, President and Treasurer for the same owner. A full commercial, operational and financial assessment, a look at every alternative, and then the harder answer: an orderly wind-down and sale that protected the owner’s money.
Officer seats, not advisory ones. Signing authority, the board pack, and the payroll are all yours — which is the difference between recommending a decision and owning it.
Not every company should be grown. Telling an owner that early is worth more than another year of optimism.
Roles range from market development to CEO. Company milestones — IPOs, acquisitions — show where the work happened; they are not claimed as personal credit. Full history on LinkedIn ↗
The difference
How I work
Sales came first, then everything else. Over twenty years I have worked in nearly every seat in a healthcare company — not managed it from a distance, done it.
That is why I can tell quickly whether a problem is the product, the process, or the person. Most stalled companies are told the answer is more salespeople. Usually it is not.
It is also why the teams trust the plan. It is hard to argue with a plan from someone who has done your job, and easier to follow one.
And it is why the plan is not just mine to run. I hire people who are better than me at the thing they own, then get out of their way — direct sellers, distributors, OEM partners and clinical specialists, in five regions and more than a dozen languages.
The last part matters more than the first. One person can fix a quarter. Only a team fixes a company.
Reach
I started with a single sales territory in Michigan. The work now runs in both directions across the world, and the direction completely changes the job.
Inbound
Companies outside the United States with a product that works at home and no route into the largest healthcare market in the world.
Regulatory · Market access · Channel · Launch
Outbound
U.S. companies that have won at home and now need registrations, partners and a distribution network that does not fall over at scale.
Registration · Partners · Distribution · Scale
In practice: distribution rebuilt across 50 countries at GraMedica, a 1,000+ distributor and OEM network across five regions at THORASYS, and a global commercial organization of roughly 100 people at Xenex.
Case study · GraMedica
HyProCure is the only FDA-cleared implant of its kind, with more than 100,000 procedures across 46 countries. The product was proven. Sales had stalled. I stepped in as CEO to turn it around.
A twenty-year-old cleared device with real IP, real evidence and global reach, sitting under a commercial engine that had not kept pace with the asset. Underleveraged, not unproven. Exactly the kind of company I look for.
Secured the financing to fund the turnaround. Cleared EU MDR ahead of the deadline, running the regulatory work hands-on at the technical level. Rebuilt how the company sells and earned Premier Breakthrough recognition. Opened federal channels through GSA/FSS and DLA ECAT.
Financing secured. EU MDR cleared. National GPO access. Three federal channels live via Lovell Government Services. A business running below breakeven, back to growth inside year one.
The same read applies in reverse at THORASYS and Gorbel: no engine to fix, so I built one — a worldwide go-to-market from nothing at THORASYS, the U.S. region from under $1M at Gorbel. First launches and turnarounds are the same discipline.
How I got here
Hauling rocks and laying pavers long before I knew what EBITDA meant. One of five kids, so competition and work were normal.
At sixteen I split my time between high school and business lectures at the University of Michigan. By my early twenties I was running a $10M medical device territory — too young to rent a car, old enough to close the deal.
Then five years at KARL STORZ, which is where I actually learned the business. Surgeons in the OR, CFOs across the table, and mentors who never sugarcoated a thing.
That is where I got interested in the question I have been working on ever since: why do some good technologies get adopted, and others — just as good — never do?
The answer is almost never the technology. It is whether someone did the unglamorous work of getting it funded, approved, reimbursed and trusted.
That pattern has held at every company since. Some I helped build from the first sale. Some I helped rebuild when growth stalled. Either way, execution is the strategy.
“Build great teams, move fast, stay humble, and laugh when you can. The work is too hard not to enjoy it.”
Giving back. MedTech Innovator · Value Workshop advisor. Canada’s Drug Agency · MedTech and digital-health advisory. Staying close to founders, and to the market-access systems that decide which technologies actually reach patients.
Recommendations
Forty-two recommendations, unedited and public, say the same five things: leads from the front, strategy and execution both, business sense beyond sales, develops people, calm under pressure.
“He doesn’t hesitate to lead from the front and be hands on. He led a region while rebuilding the team and hiring an entirely new sales force.”
“The depth of his business acumen extends well beyond sales, to finance, operations, and the key drivers of enterprise growth. A rare combination of strategic foresight and hands-on execution.”
“His strategic vision and execution abilities profoundly impacted our growth and market presence. Not just a strategic thinker but a pragmatic leader who makes the ambitious goals he sets achievable.”
“Joe’s intelligence and strategic acumen set him apart as an invaluable asset to our team and our clients. He navigated the complexities of government sales with unparalleled skill and determination.”
“From market-entry strategy to key partnerships, Joe goes above and beyond. His strategic insight and industry expertise will propel your business to new heights.”
Work together
I work with owners, boards, founders and capital partners on businesses that need to build, grow, reset, or make a hard call. Every conversation is confidential.