Many breakthrough medical technologies begin with a moment of insight. A clinician encounters a persistent problem in patient care and develops an idea for a better solution. Or a researcher develops a new technology and realizes it could transform how disease is diagnosed or treated.
But promising ideas are only the beginning. Turning them into medical devices that reach patients requires navigating a long and difficult path—one that is complex, expensive, and filled with risk.
“The first challenge for these aspiring innovators is time,” said John Morriss, director of Fogarty’s Invention Accelerator Program (IAP). “There are so many elements that determine whether a new solution can succeed as a product and a business. Just understanding the possible regulatory pathways and identifying a strategy can take months.”
Recognizing that these challenges can derail even the most promising ideas, Fogarty Innovation created the IAP to provide the structure, support, and expertise clinicians, researchers, and other first-time entrepreneurs need to translate innovative ideas into successful companies.
Since its inception in late 2020, 24 projects have completed the program (including two pilot projects in 2019). Fifteen originated at Stanford University, five from Stanford Biodesign, three from El Camino Health, and one from Sequoia Hospital.
Nineteen of those projects continue to advance, collectively raising more than $68 million in grants and early-stage investment. To date, nine have incorporated and become companies.
To understand the program in practice, we gathered insights from six innovators whose teams participated in the IAP. We also asked them to share their own innovation stories.
- James Kintzing, PhD, co-founder and CTO of Spirair, a less-invasive way to correct nasal septal deviation
- Sumit Bhargava, MD – principal entrepreneur of Vital Health, a home-based solution for the diagnosis of pediatric sleep apnea
- Kunj Sheth, MD, CEO of Maguro Surgical, a magnetic retrieval device for endoscopic kidney stone fragment removal
- Sindy K. Tang, PhD, principal entrepreneur of easyBAT – a basophil activation test for allergies
- Elisabet Rosàs Canyelles, PhD and Andréas Ward, BSME, principal entrepreneurs of KoolGuard – a device for the prevention of chemotherapy-induced oral mucositis
How the IAP works
The IAP is an intensive six-month program in which the aspiring entrepreneurs work closely with Morriss and Engineer-in-Residence Bernie Andreas to pressure test, de-risk and advance their ideas.
The curriculum is both “comprehensive and specific,” said Morriss, addressing critical elements required for medical device success—from defining the value proposition for different stakeholders and protecting intellectual property, to designing clinical studies, understanding reimbursement, conducting market research, and planning for company formation and capital needs. The program’s short timeline and emphasis on cost efficiency keep teams focused on the highest-priority actions.
Importantly, Morriss noted that while some of these concerns—like planning for product launch—may be years away, understanding them early is essential because they shape decisions made at the very beginning.
“Translating a project involves many things, all at once,” said Tang. “The Fogarty team had the skill set to look at everything together and develop a holistic business strategy that made sense for us.”
A central focus of the program is identifying and addressing the greatest risks facing each project. “Our goal is to determine the key risks about each idea at the outset and make meaningful headway in addressing them during the six-month tenure,” Morriss said.
He also helps limit project risk across the board by making sure teams aren’t settling for easy answers.
“John pushed us to think deeper instead of just answering a question superficially and moving on,” recalled Kintzing. “By pointing out other aspects of a problem to consider, he kept us focused on long-term de-risking, not just building something that worked in the moment.”
The program is typically structured as a partnership between Fogarty Innovation and an academic institution or hospital. The organizations work together to identify promising projects and teams. Program costs are covered by the sponsoring institution – meaning innovators participate at no cost and Fogarty takes no stake in the project or IP generated.
The arrangement ensures the Fogarty team can offer unusually candid advice. “We’re committed to providing a really solid education to the inventors,” said Morriss. “It’s hard to get that kind of feedback anywhere else in the startup world.”
Interdisciplinary perspectives
With a senior coaching staff averaging more than 30 years of industry experience, Fogarty brings deep practical context to each project.
“Our team brings experience across every element of the development process,” Morriss said. “Rather than evaluating issues in isolation, we look at how decisions in one area affect others.”
Fogarty’s signature cross-functional review process – the Fogarty Physical – is grounded in this approach. “We learned a lot from the Fogarty’s team style of asking questions from a holistic rather than subject- matter perspective,” said Kintzing. “It’s a mindset I’ve adopted going forward that continues to add value as Spirair grows.”
Motivating innovators and accelerating progress
The program’s structure—weekly meetings and three formal “company physicals”—helps sustain momentum.
“We look back at everything we did and it feels like four years compressed into six months,” reported Rosàs. “The weekly meetings kept us accountable, pushing us to meet our goals and prove to the IAP team and ourselves that we could drive the project much further than we imagined,” she said.
“We started measuring momentum in hours and days instead of months and quarters,” added Ward. “I started thinking less of ‘How can we solve this tomorrow?’ and more ‘How can we solve this after lunch?’ The frequent meetings helped us become more efficient and better entrepreneurs,” he said.
The three company physicals—held at the beginning, midpoint, and conclusion of the program—serve distinct purposes. “At the outset, we’re drilling in on the areas of highest risk,” said Morriss. “The midterm physical is a ‘kick in the pants,’ triggering a review of achievements and generating a focused plan for what the team wants to accomplish in their remaining time.” The closing physical fuels the preparation of a detailed development plan that guides the team after the program ends.
“When we left the program, our development plan became a roadmap of steps needed to reach market,” said Bhargava. “We still go back to it regularly as we move toward FDA submission.”
Lessons from the IAP: How Innovators Advanced Their Projects
Spirair: De-risking to create a venture-backable company
Spirair was founded out of the Stanford Biodesign Innovation Fellowship. The team identified an opportunity to develop a less-invasive treatment for septal deviation—one of the most common ENT procedures worldwide, and one that had not significantly advanced in more than a century. Their key insight was that cartilage might be reshaped rather than surgically removed.
When the team entered IAP, they were still developing their prototype.
“One of the things that helped us the most was the constant pressure from the mentors,” recalled Kintzing. Even as the team made progress on prototyping, clinical trial design, and other milestones, the Fogarty coaches kept pushing. “They kept saying, ‘That’s great, but here’s the question I would ask,’” Kintzing recalled.
That scrutiny helped the team proactively address issues investors would later raise during Series A diligence. On the engineering side, the mentors pushed them to think beyond the initial design and dig deeper into materials science and experimental design. Through the Fogarty network, the team also conducted a large but cost-efficient national marketing survey to generate credible market data.
“The survey gave us quality data on market size that we could use in diligence conversations,” Kintzing said. The team was also able to start mapping out a reimbursement pathway—which he described as “table stakes” for venture investors once a product achieves FDA clearance.
Shortly after completing the program, Spirair closed a $10 million Series A round. Today, the company’s first product is FDA-cleared and has been used to treat more than 1,500 patients. Spirair has also launched a second product and recently closed an oversubscribed $25 million Series B financing.
Looking back, Kintzing says the early reimbursement planning proved invaluable. “It is coming to fruition exactly as we expected,” he said.
Vital Health: An introduction and roadmap to company-building
For Bhargava and fellow principal entrepreneur Todd Coleman, PhD, the IAP transformed an early idea into a structured development pathway. When they entered the program, they had a clearly defined clinical need and supportive grant funding. Through the weekly meetings and mentorship, they began building a roadmap for product development, identifying essential device features and the steps required to bring the technology to market.
The program also introduced them to the realities of entrepreneurship. Physicians and engineers, Bhargava noted, are rarely trained to think like entrepreneurs. “There is a process…to be an entrepreneur. This was the first time that we saw that process,” he said.
“We are forever grateful that we got into this program because it grounded us,” he continued. “We went from having a cool idea to understanding the work required to make it real. And we think this is a space where we can truly make a difference.”
Even after completing the program, Bhargava still reaches out to Morriss for advice and guidance. “Fogarty has always been our supporters and cheerleaders,” he said.
The team currently has two publications underway, is continuing to refine the prototype, and is actively seeking funding and expertise to address the next steps in their development plan.
Maguro Surgical: Testing assumptions through market research
Founded at Stanford University, Maguro Surgical is developing the MagStone System, a magnetic retrieval device for endoscopic kidney stone fragment removal. The system deploys a coating to magnetize stone fragments and then retrieve them with a specialized wire with a magnetic tip.
For the Maguro team, the IAP marked a turning point in how they thought about their project. Most of the founders are research-focused academics and first-time entrepreneurs, and while they believed the technology could eventually translate, commercialization felt distant. The program changed their mindset, encouraging them to press forward and proactively tackle future risks upfront including regulatory strategy, market strategy, and reimbursement pathway.
One of the most valuable lessons involved helping the team understand their market. Despite the fact that three of the founders are urologists, Morriss encouraged them to validate their assumptions through structured market research.
“We thought we understood how urologists think,” said Sheth. “But the Fogarty team pushed on that and brought in third parties to conduct physician interviews. The process generated more objective market insights without our own personal bias as founders.”
By interviewing lots of different urologists in different settings, the team gained clearer insights into the market, helping them analyze market share, the competitive landscape, and their product’s value proposition. It also informed their reimbursement strategy, allowing them to begin clinical trial planning with both regulatory clearance and reimbursement potential in mind.
Shortly after completing the program, the team formed a company and received FDA Breakthrough Device Designation, another plan that was finalized after several regulatory expert discussions during the IAP. The company recently joined Fogarty’s Company Accelerator Program and is now focused on speeding up their preclinical work to reach first-in-human studies and closing a $4 million seed round.
easyBAT: Building critical partnerships early
The easyBAT team is led by Sindy Tang, associate professor of mechanical engineering at Stanford, whose laboratory develops technologies for measuring biological systems. Tang identified food allergy diagnostics as an important unmet need and developed a basophil activation test designed to improve the safety, accuracy, and reliability of allergy testing.
One of the most valuable lessons from the IAP was learning to think farther down the road.
When her team entered the IAP, Tang believed the team was not yet ready to engage with contract developers who could eventually help build the diagnostic instrument. However, Morriss and Andreas encouraged them to get the process underway.
With help from the two experienced coaches, the team vetted several development firms specializing in microfluidics, identified a strong partner, and began defining metrics. The early groundwork helped them to establish a relationship with a contract developer so that they will be ready to start building as soon as they have funding in hand.
“What first seemed premature ultimately proved to be one of the most valuable outcomes of the program,” Tang said. “Having mentors with industry experience guide the evaluation process helped us understand what to look for in a development partner and avoid pitfalls that can derail early collaborations.”
Today, the easyBAT team continues strengthening the scientific foundation of the technology through publications and grants while seeking funding to build prototype instruments that will enable multi-site validation.
Tang says the long road ahead reinforces the importance of building a solid foundation first.
“Our goal is to make sure the science and engineering are rock solid before we move forward,” she said.
KoolGuard: Learning what it takes to become investable
Principal entrepreneur Rosàs, an assistant director of Impact1, the pediatric innovation focused initiative at Stanford Biodesign, identified a need for a way to prevent oral mucositis (OM)—inflammation and ulceration of the mouth—in patients undergoing chemotherapy.
Roughly a year later, Ward joined the project, and the two began advancing the development of a device to serve those affected by OM. Ward had seen the benefits of the IAP firsthand while externing at Fogarty as part of the Stanford Biodesign Innovation Fellowship, and he and Rosàs were eager to participate.
The program helped the team map out development milestones, connect with experts in engineering, reimbursement, and clinical development, and develop a more realistic outlook and timeline.
One of the most important lessons was realizing that investors would require early clinical evidence before funding the venture. “One of the amazing parts about the IAP experience is that everyone is very honest,” said Rosàs. “The feedback we received was that our project would not be investible until we had some clinical evidence—even a small study that showed a signal and proved that a clinician believed the device was worth testing in patients.”
That insight reshaped the team’s priorities. They focused on identifying the right patient population and designing a pilot study capable of demonstrating early clinical impact. The team pitched their study to the bone marrow transplant division at Stanford and identified a clinical principal investigator for the pilot trial. They are also exploring a second study site at El Camino Health.
The team is now finalizing device design and preparing molds for prototypes that will be used in clinical and usability studies. They have also expanded their technical team, adding students and experienced engineers to help with development and manufacturability as they prepare for clinical testing.
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Looking back, the founders say the program’s impact extends far beyond the formal curriculum. Through the IAP, teams become part of the broader Fogarty community—coaches, engineers, entrepreneurs, and alumni who have spent decades navigating the same challenges and are eager to help the next generation succeed.
“The IAP is a door into the Fogarty community,” said Ward. “You’ll be grabbing a snack and someone asks how the project is going. Five minutes later they’re saying, ‘Oh, I also had that problem—here’s the person you should call.’ People here have lived this journey, and they genuinely want to help. It’s not just ‘reach out if you need something.’ It’s ‘let’s figure it out together right now.’”
For many innovators, that culture of generosity and support is what ultimately turns promising ideas into real companies.