Fogarty Innovation

07/23/2025

We packed the house for last week’s half-day leadership workshop, featuring Fogarty CEO Andrew Cleeland, operating executive Allan Will, and Zenflow, Inc. CEO and co-founder Shreya Mehta. The session tackled essentials like building high-performing teams and mastering leadership intangibles like vulnerability, culture, self-awareness, and empathy, while a tense, real-world case study challenged attendees to put their leadership skills to the test.

We’ll share more in upcoming newsletters, but here are a few standout takeaways:

🎤 Leadership can be learned and developed.
🎤 Good leadership is about being grounded, intentional, and courageous, not about always being right.
🎤 A leader's first responsibility is to shape the culture - the magical force that transforms a good team into a great one.
🎤 Candor and compassion are key when having to make tough decisions like letting people go. Avoiding these difficult conversations harms the overall culture.
🎤 Leadership requires moral clarity, not moral certainty. Knowing your values and priorities enables you to make decisions even when there is no obvious right answer.

Want to be in the room next time? Sign up to be notified of upcoming educational events: https://www.fogartyinnovation.org/get-involved/

07/15/2025

How can leaders thrive in ambiguity, foster courageous decision-making, and build influence beyond authority? Don’t miss this 1/2-day workshop featuring Shreya Mehta, CEO and founder of Zenflow, Inc. and Allan Will, Chair of EBR Systems, Inc. and SetPoint Medical. Sessions will explore:
🔶 why leadership is a behavior not a title
🔶an interactive case study based on a real-world leadership dilemma
🔶how to build high trust, high-performance teams
🔶lessons from the trenches - a fireside chat with Allan and Shreya

Thursday, July 17 from 1-5pm followed by a networking cocktail hour. Email fogarty-education@fogartyinnovation.org to register!

07/14/2025

Good News Update! Last December, we wrote about Diego, the first pediatric patient treated by Fogarty company-in-residence Eclipse Regenesis for Short Bowel Syndrome (SBS), a devastating condition in which patients struggle to absorb sufficient and life-sustaining nutrients following intestinal resection.

We are thrilled to report that, one year post-procedure with the investigational Eclipse XL1 system, Diego is doing so well that his treating gastroenterologist, Dr. Shweta Namjoshi, medical director of intestinal rehabilitation and nutrition support at Stanford Medicine, has been able to remove his central venous catheter (central line), which was inserted into his chest to provide parenteral nutrition directly into his blood stream.

Diego’s mom, Italia reports: “We are beyond excited for Diego to reach this next milestone in his recovery. It has been a busy year filled with challenges, hope and opportunities. Through it all, Diego has maintained a joyful spirit, a curious mind and that smile that we have all come to know him for. He motivates us to stay strong and continue our loving efforts to provide the best care and life for him and our family. Now that his central line has been removed, we are very much looking forward to a summer with lots of water play - Diego has earned it!"

As the world’s first device-based therapy to treat SBS, the XL1 System is designed to stimulate the body to naturally re-grow the lost small intestine. You can read the first story about Diego here: https://www.fogartyinnovation.org/medtech-startup-eclipse-regenesis-offers-hope-to-young-patient-with-short-bowel-syndrome/

07/07/2025

Entrepreneurs know that confidence matters, and it’s often a real challenge. “It’s a topic that kept coming up as I was working with first time founders and CEOs struggling with taking on big new roles,” said Greg Bakan, former Fogarty director of strategic initiatives.

To help, Greg dug into the research and shared what he learned during a recent Lunch & Learn on building confidence. One of his key takeaways: confidence isn’t always innate — it can be learned and strengthened.

Greg outlined several strategies for developing self-confidence, including managing your inner critic. “It’s easy to fall into the trap of focusing only on our shortcomings or failures,” he said. “Learning to adopt a more balanced and objective perspective helps keep the inner critic from hijacking our thoughts and undermining our confidence.”

You can learn more about Greg’s talk here: https://www.fogartyinnovation.org/why-and-how-confidence-can-become-your-edge/

07/02/2025

Fogarty COO Denise Demarais likes to get things done – from running operations, to coaching startups, to helping founders across the ecosystem answer intellectual property (IP) questions and stay out of trouble.

“In startups, IP is a continuous process,” she explained. “You can’t just file once and think you’re done. You’re always learning and evolving your solution—so you have to keep filing as you go—and before you disclose.”

As a lead coach, Denise draws on her thirty years of operational experience to help Fogarty-incubated companies thrive. For graduate company Raydiant Oximetry, Inc., she helped founder and CEO Neil Ray, MD, rebuild after the unexpected departure of his co-founders.

“I had no startup experience and was at a loss for how to pick up the pieces and go forward,” recalled Ray. "Denise helped me rebuild a team, raise an oversubscribed pre-seed round, and develop confidence and poise as a leader. She believed in me—she convinced me that I had the fortitude to make this happen and motivated me to do it.”

You can learn more about our multi-talented COO here: https://www.fogartyinnovation.org/systems-startups-strategy-fogarty-coo-denise-demarais/

07/01/2025

Thank you! Ross Dehmoobed, VP of Software and Digital Services at ClariMed, Inc., spoke to our educational community about medical device cybersecurity—a critical concern as cyberattacks can not only compromise patient safety but also turn connected devices into entry points for broader healthcare system breaches.

“Medical device companies must be prepared to provide detailed cybersecurity documentation to both the FDA and hospital networks—including plans for secure software updates and incident response—in order to gain regulatory approval and drive adoption,” he said.

To help developers meet these ever‑evolving expectations, the FDA has issued latest guidance aligned with the PATCH Act, which outlines mandatory cybersecurity requirements for connected medical devices—those with embedded software, network connectivity (even via USB), and potential vulnerability to attack. Key elements of the guidance include a security risk management plan, threat modeling, software bill of materials (SBOM), and more.

The most common mistake Ross sees in the startup community? Treating cybersecurity as an afterthought. “Too many teams try to bolt it on at the end,” he said. “Plan for all FDA cybersecurity artifacts up front. No matter the size of your organization, the FDA expects the same core cybersecurity deliverables. Empower your team with training—and don’t hesitate to bring in external expertise when needed.”

06/29/2025

Tom Fogarty made things happen. "'Just do it,' he would say. That was this drive he had, and it was very much tied to the patient outcomes and what he'd seen over the years." - K. Angela “KAM” Macfarlane

Do you know an innovator whose game-changing medical device has meaningfully advanced patient care? Nominate them for the inaugural Thomas J. Fogarty Innovation Prize by July 31: www href="://bit.ly/Fogarty_Prize_2025.">://bit.ly/Fogarty_Prize_2025.

The Fogarty Prize is made possible through a foundational grant from the Linda and Mike Mussallem Foundation. Wilson Sonsini Goodrich & Rosati also contributed to the prize endowment.💚

06/26/2025

They're here! We were thrilled to welcome our 2025 Lefteroff Interns this week. These 22 students will work hands-on with Fogarty companies and staff to advance new medical technologies, participate in lectures and fieldtrips to learn about the innovation ecosystem, shadow medical procedures, and more. It's going to be a great summer!

06/25/2025

Startups incubating at Fogarty Innovation benefit from being located on the campus of El Camino Health, where Fogarty CMO Zachary Edmonds, MD, helps entrepreneurs get early input from clinicians, understand care pathways, and pressure test their value propositions. While this involves multiple touchpoints across the health system, one of the most important is with Chief Nursing Officer Cheryl Reinking.

“In order for new technology to be adopted into acute care settings, you have to have nursing leadership on board,” said Edmonds. “All —or almost all—new technology is going to touch the nurses’ workflow at some point.”

Reinking finds it easy to spearhead nursing involvement in innovation because of El Camino Health's deeply engrained pioneering spirit. The health system has long been focused on innovation and was first in the U.S. to adopt a modern electronic health record system. “There’s always been a real interest—even a demand—to help shape technologies that improve care,” she said.

Learn more about the Fogarty Innovation—El Camino Health partnership, and how they work together to advance high-impact new technologies like the FloPatch from Flosonics Medical: https://www.fogartyinnovation.org/a-foundation-of-innovation/

06/24/2025

Thank you, Zachary Edmonds, MD: El Camino Health; and Diversity by Doing (DxD) HealthTech for helping fuel bigger dreams!
"One of the most pivotal experiences in the DxD program was shadowing Dr. Zachary Edmonds, a hospitalist at El Camino Health. In just one day, we witnessed procedures like lumbar punctures and bone marrow biopsies. Dr. Edmonds greeted us with warmth and generosity, showing us what it means to lead with both skill and heart.
For years, I had dreamed of becoming a nurse. But walking in the footsteps of Dr. Edmonds gave rise to a new dream: the dream of becoming a doctor. A bigger dream."

Student Mariana Rodriguez describes how DxD"s Pathways in Health Technology program helps her on her journey to a career in medicine.

06/23/2025

At a recent Fogarty Education event, Jane Chao, PhD, co-founder and CEO of Ceribell, shared the extraordinary story behind one of medtech’s most compelling journeys: from scientist to storyteller to business leader, and now CEO of a publicly-traded company focused on transforming the diagnosis and management of patients with serious neurological conditions.

Chao’s path defies the typical founder arc. Born in a small Chinese city, she was the first in her family to attend college. Her love of science took her from Peking University to a PhD in biophysics at Cornell. A detour to film school deepened her understanding of human connection, a skill she now credits with helping translate clinical complexity into meaningful patient impact. And a friend’s invitation to an open house at McKinsey & Company led to spending four years at the firm, where she gained a foundational understanding of business that proved instrumental to her career. “I can talk about how hard I worked, how strategic I could be, but there's also a big dose of luck in everything we do,” she said.

Ceribell, a rapid-response, AI-powered EEG, originated with a project to turn brainwaves into music. The realization that seizures produce distinct auditory patterns evolved into the Ceribell system, a combination of easy-to-use hardware with Clarity™, the AI algorithm that is revolutionizing how hospitals detect and respond to non-convulsive seizures in critical care. Chao’s recognition that the biggest breakthroughs don’t always come from tech alone, but from identifying and solving urgent clinical bottlenecks, helped take Ceribell from concept to FDA clearances, to breakthrough designations, and ultimately to a $200M IPO.

As a founder-CEO who has grown alongside her company, Chao spoke with humility and candor about leadership evolution. She credits trusted mentors with helping her recognize and gain confidence in her strengths—freeing her to focus on opportunities for growth. “Once you know your strengths,” she said, “the rest gets easier.”

Thank you, Jane, for sharing your story with our innovation community! Learn more about Ceribell: https://ceribell.com/

06/20/2025

“Some people want it to happen, some wish it would happen, and others make it happen.” – Michael Jordan

This year marks the inaugural Thomas J. Fogarty Innovation Prize, honoring an innovator or team whose vision, tenacity, and grit have brought a life‑changing medical innovation into patient care. The award celebrates Tom’s legacy of courageous, game-changing medtech innovation. My personal hope is that it also serves as a call to action for our industry—for you.

Tom was the OG of bold thinking. He saw problems and developed solutions that were completely outside the box—Tom made things happen! At 15, tired of getting jolted off the back of his friend’s motor scooter, he invented the centrifugal clutch to smooth the engagement of the engine. At 19, while still in medical school, his mentor Dr. Jack Cranley pointed to the dismal outcomes from open surgery to remove blood clots in the legs—which included reoperation and often amputation—and asked Tom to find “a better way.” In response Tom developed the balloon embolectomy catheter. Though initially dismissed—one reviewer famously said, “Only one so inexperienced and uneducated as a medical student would think of this”—the device ultimately transformed vascular surgery and saved millions of lives.

Today, we face enormous challenges: an aging population, a rising burden of chronic disease, unsustainable costs, inequities in care and delivery, and the disruptive ascent of AI, among others. Problems of this scale can’t be solved through incrementalism—tectonic problems require tectonic shifts.

That’s why, now more than ever, we need innovators like Tom to swing for the fences with truly revolutionary ideas. Last week, I delivered a keynote address on this topic titled “Bold Ideas Dying Quietly: Why Medtech Needs Its Revolutionaries Back.” The message was about reviving risk-taking and mission-first thinking in healthcare innovation.

While our industry has evolved to favor lower-risk ideas, it’s worth remembering that while truly novel technologies or therapies may pose more technical or clinical challenges, they often carry less fundraising risk, team-building risk, IP risk, or market-entry risk. When you invent something genuinely new, the field is wide open.

Our community is defined by its commitment to helping others. As you consider your next endeavor, ask yourself: Is it truly meaningful? Will it help contribute to solving the very real problems we face—or is it just addressing the symptoms? Transformative change rarely starts with consensus. It starts with conviction—a brave soul with a bold idea!

If we don’t do it, who will?

—the above is excerpted from the CEO column in the newest Fogarty e-newsletter. Want to receive it directly to your in-box? You can sign up here: https://www.fogartyinnovation.org/get-involved/