Joe Monroe  ·  Medical Device CEO & Operating Partner

I build, scale, and turn around medical device companies.

CEO and Operating Partner for medical device, diagnostics, and healthcare technology companies. I build commercial engines, lead turnarounds, scale growth, and prepare businesses for acquisition. Twenty years operating from product development through exit.

Build · Commercialize · Scale · Reboot  —  in the seat, full-time, idea to exit
Medical device CEO & operating partner

Most executives avoid complex, FDA-regulated medtech. I run toward it.

A medical device executive trusted by boards, private equity firms, and founders to commercialize, scale, and turn around FDA-regulated medical device and diagnostics businesses.

Joe Monroe, medtech CEO and operating partner, inspecting a precision component with a clean-room technician

Medical device and healthcare companies are hard to run. Strict FDA rules. Long approvals. One mistake can sink the company. Most executives stay away.

I have spent twenty years growing them: get the product approved, then build the team and process that sell it. Now for the private equity firms, boards, and founders who need an operator for their most complex medtech and diagnostics companies.

Medical device commercialization

From product development to commercial growth. I run every step.

Most executives own one stage of a product's life. I have run all of them, from idea to exit. That is how I see where growth stalls and where it compounds.

01
Idea
Spot the opportunity
02
Develop
Build the product
03
Approve
FDA, EU MDR, clearances
04
Market access
GPO, payers, channels
05
Adoption
Win clinicians and patients
06
Growth
Scale the commercial engine
07
Exit
Strategic sale or IPO

Click a stage to see the companies where I did that work.

22
Companies across my career
20 yrs
In regulated markets
$45B+
Combined deal value of companies I worked in
7
Companies acquired by larger players
Track record

Medical device companies I've helped grow.

CEO · Current

GraMedica

A medical device company. I rebuilt how it sells, won national GPO approval, and opened federal contracts with the VA, DoD and IHS.

Former CEO

JTECH Medical

A 35-year-old physical-medicine diagnostics brand I ran as CEO, applying the GraMedica playbook: tighter packaging, wider channels, automated reporting.

The gauntlet

What it takes

FDA approval. EU MDR. Audits. GPO. Reimbursement. All of it has to be in place before you can sell a single unit. I have handled it and grown the business anyway.

Commercial engines rebuilt Regulated products launched Companies scaled toward exit Federal and institutional channels opened

Companies across my career

Twenty years, every seat, from the field to the C-suite. I came up carrying the bag and worked nearly every function: sales, regulatory, operations, finance. These are companies I helped commercialize, scale, turn around, or operate, not companies I claim to have run alone. Outcomes are public milestones, not personal-performance claims. Filter by what the work needed.

Hillrom
Connected-care platform · $10.5B to Baxter
Medline
Med-surg giant · $34B LBO → 2025 IPO
Novadaq
Fluorescence-guided surgery · $701M to Stryker
Agiliti
Hospital equipment-as-a-service · $2.5B take-private
Ceribell
AI bedside EEG · Breakthrough · IPO 2024
Accuray
CyberKnife radiosurgery · category creator (Nasdaq)
Karl Storz
Endoscopy leader · family-held · ~€2.2B
Arjo
Patient-handling leader · public (Stockholm)
Invuity
Surgical lighting · IPO → $190M to Stryker
RF Surgical
Patient-safety RFID · $235M to Medtronic
Xenex
UV disinfection robots · FDA De Novo · category leader
Viora
Energy-based aesthetics · 510(k) · sold to Sinclair
Enovate
Point-of-care EHR workstations · sold to Ergotron
Gorbel
Fall-safe rehab robotics · sold to DIH
RF Technologies
Infant-protection RTLS · recurring revenue · PE-owned
Thorasys
Effort-free lung diagnostics · startup · FDA 510(k)
Richard Wolf
German endoscopy · U.S. commercial build-out
Graham-Field
DME / post-acute · distressed turnaround
CooperSurgical
Fertility & women's health roll-up · NYSE: COO
Polaris
Rebuilt America's first motorcycle brand
Case study · GraMedica

I took a twenty-year-old device and relaunched it.

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 in January 2025 to rebuild its commercial trajectory.

Joe Monroe mapping a commercial growth plan for a medical device company
100,000+
Procedures across 46 countries, a proven device
Breakthrough
Premier technology recognition for a device first cleared in 2004
VA · DoD · IHS
Federal channels opened for the first time
The situation

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.

What I did

Rebuilt how it sells from the ground up. Earned Breakthrough Technology recognition through Premier, opening more than 4,300 hospitals. Cleared EU MDR ahead of the deadline. Opened federal contracts so the VA, DoD and IHS can buy. I ran the regulatory work at a technical level, not from a summary.

The result

National GPO access. EU MDR cleared. Three federal channels live. A twenty-year-old device with a brand-new commercial trajectory.

Not a one-off

I applied the same playbook at JTECH Medical, a 35-year-old physical-medicine diagnostics brand: high-margin, proven, and under-marketed for years. A de-risked asset with a stalled engine, exactly the pattern I look for.

Global market access

Seventy countries. Both directions.

Most executives know one market. I open them. Over 70 countries entered, from registration to distribution: foreign companies coming into the US for the first time, and US companies expanding abroad. Every country has its own approval process, and I have run them.

Tap or hover a country to see its regulatory approval pathway and market-access route.
70+
Countries entered. Each one a different approval path, a different partner on the ground, and a different set of rules to clear before a single unit can sell.
Inbound

Into the US, for the first time

Foreign manufacturers with a proven product and no US footprint. I build the regulatory path, the channel, and the commercial engine to land it here.

Outbound

Out to the world

US companies expanding abroad. Registration, in-country partners, filings and distribution across every region, run as one coordinated push.

Registration

Approvals and clearances, regime by regime.

Partnerships

In-country partners and distributors that actually sell.

Filings

The documentation each regulator demands, done right.

Distribution

Channels stood up and supplied, market by market.

Board & industry advisor

I also help shape the healthcare markets I work in.

MedTech Innovator

Advisor in the Value Workshop program, run with AdvaMed, at the world’s largest medical device accelerator. I mentor founders on the commercial, regulatory, and reimbursement path to bring breakthrough technology to market.

Canada’s Drug Agency

Advisor on health technology assessment frameworks for MedTech and digital health reimbursement submissions. I advise on real-world evidence, economic modeling, and clinical value.

How I work

I came up in the trenches. I never left.

Sales, regulatory, operations, finance. I know the file, not the summary.

Who hires me

Who I help, and when.

Best fit is a healthcare or medical device company from about $25M in revenue with room to grow, where the money is already in place and the job is to operate, not fundraise.

What

A real business with a stalled engine

A company with a real product but a sales engine that has stalled or was never built.

Where

Where complexity keeps others out

Any market shaped by a regulator or heavy complexity. Medical devices, diagnostics, life sciences, regulated finance, defense, industrials, food and agriculture.

Situation

A moment that needs an operator

A first commercial launch. A scale-up that needs an engine. A turnaround after an investment. Growth that has stalled. A carve-out. A gap in leadership. A plan that needs someone who has done it before.

Role

I take the wheel

A senior operating seat, from SVP through the C-suite: Chief Commercial Officer, COO, or CEO. Responsible for the results, working closely with the board and the investor. Not advisory, not part-time.

For private equity, venture & family offices

The operating partner for your hardest company.

You backed a company in a regulated market. A typical operator is fighting the rules while the plan slips. That is the problem I solve. I protect what works, get it through the regulatory process, land a value-creation plan in the first 100 days, and grow how it sells until it hits the plan.

Give me the company that depends on a regulator's approval. I will run it like it is my own.

Joe Monroe, regulated healthcare CEO and operating partner, in a boardroom
Recommendations

Ask the people who worked for me.

Forty-two recommendations say the same five things over and over: leads from the front, strategy and execution both, business sense beyond sales, develops people, calm under pressure.

“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.”

Jaime FiaccoCommercial Strategy Consultant, MedTech & Healthcare AI

“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.”

Irene HahnChief Operating Officer, greater:SATX

“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.”

Albert MouawadMcKinsey & Company

“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.”

Joshua CoppSVP, Global Products & Services, Vantive

“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.”

Brandon GehresChief Financial Officer, Sanovo Technology Group

“He integrates variables across every area of operations into a meaningful picture of a business problem, and its solution. Composed under pressure.”

Keith LebelVP, Commercial Operations, Morgan Scientific

“An in-depth understanding of the US healthcare system, from market access to product positioning. He rallied a cross-functional team to a clear commercial strategy, US and global.”

Doreen MiaoVP, Marketing & Strategic Development, Thorasys

“An incredible ability to inspire teams, align goals, and execute initiatives with precision.”

Christian GossmannManaging Director, Thorasys

“Twenty-plus years in this business, and Joe is one of the sharpest leaders I've worked with. Meticulous, methodical, highly focused.”

Randy RamosCeribell

“I watched him transform a challenging territory with grace and determination. His calm, steady presence was an anchor for our team.”

Jenn AbeshouseRegional Sales Director, Ceribell

“I had more growth in my two years with Joe than in my previous seven years of sales combined.”

Ryan RoetmanGovernment Account Executive, Xenex

“The truest sign of a great leader is whether you'd work for them again. I would, happily. He's one of the good ones.”

Danielle JamesReported directly to Joe, 3 years

“A rare combination of strategic vision and tactical execution. His ability to navigate complex regulatory environments and forge partnerships across borders has been instrumental.”

Michael WillsSales Representative, LeMaitre

“He brought breakthrough technologies into crowded markets and drove them to market-leading sales, with an unbiased, data-driven perspective.”

Rachael SparksCo-Founder & CMO, Phase Advance

“Exceptional ability to bring new products to market and pioneer entry into new verticals. He doesn't just meet targets; he builds pathways for sustained growth.”

Karina CobosChief of Staff, Xenex

“A driver in expanding the business into new markets, building an exceptionally strong network of partners and distributors. A genuine strategist.”

Lennart LundbladClinical Science Director, Thorasys

“His leadership was fundamental to strengthening the company's success, a remarkable blend of integrity and creativity aligned to the strategic vision.”

Stefánia D. DancsRegional Manager EMEA-APAC, Thorasys

“Joe knew what to say, how to do it, and most importantly, how to engage and deliver.”

Tabitha JaramilloDirector of QA & Regulatory Affairs, Thorasys

“He has a history of taking startups and growing them into successful businesses. Goal-oriented, focused, and highly ambitious.”

Brian ShefferlyTerritory Manager, Getinge

“His ability to navigate complex, fast-paced sales environments and deliver under pressure is truly impressive, a strategic mindset balanced with intuition.”

Greg Del CampoSales Director, Ceribell

“The best leader and mentor I've had. He led from the trenches with vision, integrity, and an unwavering commitment to excellence.”

Sarah HarsCeribell

“He single-handedly developed a detailed sales-enablement program and articulated our value to the C-suite and the largest hospital networks in the nation.”

Michael PoncherRegional Sales Manager, Xenex

“He puts his people first and himself second. He steps back and lets others take credit, and stands in front to take responsibility.”

Jason LealForum Financial Management

“He can assess any situation, quickly identify challenges, and create a clear path forward. He calmly inspires confidence and leads with clarity and humility.”

Steven PaulArea Sales Director, BD

“One of the most dynamic professionals I've ever met. He builds specialized strategies for his team that are both effective and efficient.”

Taylor MorrisonSenior Clinical Account Manager, Ceribell

“Never afraid to roll his sleeves up in the field to get deals across the finish line. First class through and through.”

Thomas EvansNational Account Executive, Xenex

“He's mastered the balance of strong, driven, and motivational while staying empathetic, honest, and kind. Exceptional in a leader.”

Amanda JonesAccount Executive, Xenex

“Leading a team of nearly 30, his business acumen is impeccable. He created an environment where sales and marketing worked cohesively.”

Kimberly ManganelloMarketing Project Manager, Xenex

“A continuous learner, competent, confident, and results-focused. He builds relationships on trust and doing what's right.”

Erik BekkedahlRegional Sales Director, Tri-anim Health Services

“Exactly what you look for in a sales leader. He engages his team with the corporate goals in a way that's motivating and accountable.”

Mark YorkRegional Sales Director, Route 92 Medical

“He looks at the big picture of where we want to go while also getting into the dirt and working onsite with his people.”

John RizzoRegional Account Director, Ceribell

“His deep knowledge of go-to-market strategy in the medical field made him a key player in shaping the company's strategic decisions.”

Jonathan PhamProject Manager, padoa

“No matter the challenge, he keeps everything running smoothly, making even the most difficult obstacles seem manageable.”

Caitlin Weber, MBARegional Account Director, Ceribell

“One of the most inspiring leaders I've worked under. He brings a stress-free energy to a high-demand environment.”

Amanda JamesClinical Account Manager, Ceribell

“He approaches every challenge with integrity, a positive attitude, and a drive for excellence.”

Alyssa TomaselliDirector of Training, Ceribell

“Since his arrival, our team has experienced improved organization, strategic planning, and efficiency.”

Tessa WhiteleySales Representative, Morgan Scientific

“He encouraged us to perform at our best and complete some of our greatest work. A leader of real calibre.”

Andrew LivernoisTerritory Account Manager, STERIS

“He follows through on promises, values differing opinions, and faces challenges with poise. He builds confidence in his team.”

Simone (Garcia) PrestiaSr. Customer Relationship Manager, Xenex

“A true open-door mentor and a master at creating a culture that thrives on collaboration.”

Jennifer ThomasSenior Account Executive, Xenex

“Extremely focused on each individual and the outcome they were trying to achieve. He would make an elite addition to any company.”

Tom ArnoldAccount Executive, Xenex

“He came in as VP of Sales after the pandemic and took our team to the next level. His knowledge of healthcare from the C-suite down was incredible.”

Koco GunnWorked with Joe at Xenex

“Skilled at building and encouraging a team in an ever-changing environment to find ways forward.”

Sam D'AnielloTerritory Manager, Kurin
Every recommendation is public on LinkedIn. See for yourself →
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