Fogarty Innovation

02/27/2026

“It takes just a huge amount of effort to take a relatively straightforward device to the patient’s bedside.”
— James Dunn, MD, PhD

Translating innovation into real-world care is never simple — especially in pediatric medicine, where the need is urgent and regulatory and clinical pathways are especially complex.

Congratulations to Fogarty company-in-residence Eclipse Regenesis, led by CEO Andre Bessette, on being featured in Stanford Medicine Magazine for advancing innovation in short bowel syndrome treatment. The company’s investigative Eclipse XL1 System is a first-of-its kind, device-based therapy for SBS designed to stimulate the body to regenerate lost small intestine.

Moving a pediatric device from concept to reality requires grit, tenacity, resilience, and an unwavering commitment to patients and families. As the article underscores, it also helps to have an ecosystem of support.

To date, Eclipse has treated ten pediatric patients through both the FDA compassionate use pathway and as participants in its FDA-approved investigational study.

You can read the story from writer Erin Digitale here: https://stanmed.stanford.edu/accelerating-approval-pediatric-medical-devices-short-gut/

Stanford Medicine Children's Health
Stanford Biodesign
Stanford Medicine

A spring that lengthens intestine to treat short gut moves from lab to life at Stanford Medicine as innovators tackle the pediatric medical device gap.

02/27/2026

02/25/2026

Dr. Tom Fogarty would have turned 92 today. In honor of, we collected some of his legendary quotes and observations. You can read them here:

Most people know Dr. Fogarty as a visionary and a trailblazer. Someone whose impact on medtech and healthcare is unsurpassed. And someone who has been described as “about as touchy-feely as a steel screw.” But not everyone was privy to his other sides. As Casey McGlynn said, “He had a big ba...

02/25/2026

We are deeply grateful to the entire community who joined us on Monday afternoon to remember and celebrate Dr. Tom Fogarty. Together with friends, colleagues, mentees, and family, we shared stories of his accomplishments, generosity, and mischief. An iconoclast with singular perspective, legendary grit, and a compassionate heart, Tom forged a new era of endovascular care and physician innovation, strengthening collaboration and mentorship across the ecosystem. Let's keep telling the stories and carrying his lessons forward. ❤️

02/25/2026

“When I asked him what was the hardest thing about innovating, he said:

'The problem is you’re always pushing back against the establishment. You’re telling the experts that what they’re doing isn’t good enough. The challenge is changing the status quo.'” —a conversation with Tom Fogarty, MD, as recalled by Tom Krummel, MD.

Tom wasn’t afraid to challenge orthodoxy. He questioned accepted surgical standards, pushed against regulatory inertia, and encouraged physicians to see themselves not just as practitioners, but as inventors capable of expanding their impact.

In our latest article, "The Visionary Physician Who Changed Medicine and Silicon Valley," six of Tom's colleagues share stories of boldness, conviction, humor, and humility, offering firsthand insight into a man who asked tough questions, trusted his instincts, and wasn’t afraid to ruffle feathers.

You can read the full story here: https://lnkd.in/gwwuwJFK

02/20/2026

What was it like being mentored by Dr. Tom Fogarty?
For founders like Brian Fahey, Fletcher Wilson, Jonathan Coe, Gabriel Sanchez, and Véronique Peiffer, it looked something like this:

He would walk into meetings uninvited, critique your prototype on the fly, and then pose a single question that made you realize how much you didn’t know. He might write a $50K check to help you reach your next milestone—and then charge you 25 cents for a chocolate malt ball from the gumball machine in the office.

He was relentless in his focus on the patient and unwavering in his belief that there must be a better way. He loved mentoring, a bit of mischief, and bringing people together at the end of the day.

Because medtech innovation is “damn hard,” he built a community grounded in mentorship and camaraderie, where entrepreneurs help each other win. In doing so, he multiplied his impact far beyond any single product.

Read the story:

There is a  cohort of medtech entrepreneurs who, as Gen Xers, weren’t around during Tom Fogarty’s heyday as an innovator. They launched their careers in an ecosystem he had already helped shape with transformational technologies: the balloon catheter that ushered in a new era of endovascular an...

02/18/2026

We were thrilled to host a delegation of officials, researchers, fellows, and first-time CEOs from the Japan Agency for Medical Research and Development (AMED); Ministry of Economy, Trade and Industry (METI) and Japan Biodesign Tokyo　東京大学ジャパン・バイオデザイン last week.

The half-day gathering introduced participants to the early-stage U.S. medtech ecosystem, encouraged them to take on the challenging—but rewarding—innovation journey, and helped spark meaningful connections. The visit featured opening remarks from Marga Ortigas-Wedekind, presentations from Fogarty companies-in-residence G-Tech Medical and Auricle, and small-group sessions where visiting entrepreneurs shared ideas and received feedback from Fogarty staff.

02/17/2026

What makes an exceptional medtech leader?
In a recent Lunch & Learn, Glenn Snyder of HSMG Advisors shared some of the leadership differences that can determine whether a device stalls—or successfully reaches patients. A few key qualities:
🔹 Big-picture thinking
Great leaders identify a true unmet need, articulate a clear vision for a solution that is meaningfully superior, and empower their team to execute against that vision. They think 3-5 years ahead, and start with the end in mind, planning for commercialization from the earliest stages of product and business development.
🔹 Relentless team stewardship
A CEO’s ability to build and empower the right team is the single biggest driver of a company’s success. Nothing is more costly than a poor fit. Common warning signs: defensiveness or failure to admit mistakes, teams working around rather than with someone, or leaders needing to make decisions that should be delegated. Many CEOs hire too fast—and fire too slow.
🔹 Self Awareness
Self-aware leaders drive progress collaboratively and constructively. They confront problems rather than avoid them, make bold decisions, and adjust quickly as new information emerges. They also aren’t afraid to acknowledge mistakes—and course-correct.

Want to read more? Download the white paper here: https://hsmgadvisors.com/

02/14/2026

“A life is not measured by years alone, but by the lives it touches.” – Author unknown

“Tom’s passing has been deeply felt. Those who knew him understood how much space he occupied—through his engagement, his presence, and his keen interest in the people around him. I will miss the gruff one-liners that belied a genuine desire to help, the cussing that doubled as affection, and his irrepressible, childlike sense of humor. I considered Tom family, and with him gone, there is an absence that reaches into both my work and my life.

For years, I have used the terms innovator, icon, and iconoclast to describe Tom publicly. I have always been particularly fond of the last—iconoclast. Tom was never afraid to challenge untouchable assumptions or rethink entrenched ideas, usually to provoke progress, but sometimes just to stir the pot. He was extraordinary in his support of innovators, giving freely of his time, advice, and connections to anyone with the courage to take aim at the status quo. At the same time, he could be tough and uncompromising.

In my many conversations with Tom, three defining traits stood out:
▪️ He was direct. No one ever left a conversation unsure of where Tom stood or what he thought.
▪️ He was endlessly curious. Well into his eighties, he was walking through the lab at Fogarty Innovation, picking up prototypes, asking questions, and offering advice.
▪️ He cut to the chase. He had a remarkable ability to get to the essence of a problem and imagine a novel solution. To me, this was his superpower—not only seeing clearly what is, but what could be.

This superpower galvanized an entire ecosystem. As Mike Mussallem put it, ‘what I remember most about Tom is how he inspired people to think more boldly. Being around Tom made you believe that no problem was too big or too complicated to tackle. He inspired me, and many others, to never settle for good enough.’

This is the true measure of his legacy—one that ripples outward beyond the millions of patients worldwide whose lives have been improved and saved by his inventions, and into a future shaped by the imagination and conviction he infused into the ecosystem.

As both a defining figure in modern medtech and a character who loved nothing more than a bit of mischief, Tom leaves an enormous absence. For the last few years, my daughter Jordyn and I used the occasion of his birthday to sneak him a contraband meal of KFC and whiskey. I was never sure whether he was most delighted by the food, the company (Jordyn, anyway), or simply the pleasure of getting away with something once again—living life on his own terms.”

–Andrew

The above is excerpted from Andrew Cleeland’s column in Fogarty’s February newsletter. Read the entire message here:
https://lnkd.in/g-dng5Kr

02/11/2026

The inaugural class of 3D Scholars, a program from Dartmouth Health and the Geisel School of Medicine that prepares physicians to become innovation leaders, completed their first focused retreat this week, traveling to Washington, DC, for a deep dive into medical device regulation and policy.

Day one featured FDA alumni Jeff Shuren and Matt Hillebrenner (now Fogarty Director of Government Affairs) sharing insights on preparing for clinical trial submissions. Scholars then visited the FDA campus to meet with agency staff, including CDRH Director Michelle Tarver, MD, PhD. A key takeaway: the FDA is a partner in your journey—build a relationship based on trust and transparency with your review team to move innovation forward together.

Day two focused on reimbursement, featuring a “who’s who” of former Centers for Medicare & Medicaid Services leaders across payment and coverage.

“The 3D Scholars Program is, in many ways, a practical extension of the 3D Symposium, which has run for more than 20 years,” said Hillebrenner. “One of the symposium’s defining strengths is that Dr. Aaron Kaplan brings together voices from across the ecosystem, recognizing that solving hard problems requires perspectives from all stakeholders. Through a yearlong program of classes and retreats, the Scholars are experiencing that same breadth—but with the added advantage of going much deeper.”

In April, Fogarty Innovation will host the Scholars for a retreat focused on early-stage fundraising, product development, and commercialization. Learn more: https://www.3d-scholars.org/

02/03/2026

El Camino Health played a lead role in the DxD HealthTech Pathways program this weekend, starting with a keynote from CIO Deborah Muro.

"There is a tremendous opportunity today to use technology to transform healthcare delivery and improve the patient experience," Muro said. She described pressing challenges across today's healthcare landscape—from a reactive approach to care to talent shortages, rising costs and health equity. Addressing these issues requires technologists who are willing to question the status quo, deeply understand clinicians’ problems, think creatively about technology solutions, and ensure value by carrying them all the way through adoption.

Next was a panel on Careers in Clinical Care featuring El Camino Health providers across disciplines: nurse practitioner Jamie Tsai; physical therapist Kasthuri Veeraraghavan; radiologist technician Leigh-Anne Yeager; registered nurse Mande Manku; physician assistant William Dizon and Dr. Zachary Edmonds.

"Taking care of hospitalized patients is a team sport," observed Edmonds. Illustrating the point, panelists described their roles, shared insights into their career paths, and spoke candidly about highlights of clinical care as well as technological frustrations that could spark new innovation opportunities.

Thank you to Dr. Edmonds for organizing these presentations, and to El Camino Health for its leadership in technology innovation and its commitment to nurturing the next generation of healthcare providers and innovators.

Pathways in Health Technology introduces community college students to careers in the medtech ecosystem through project-based work, innovation education, and mindset training.