What Do You Do with an Idea? The 25th Annual Fogarty Lecture Celebrates MedTech Innovations that Changed the World

by | Nov 2, 2023 | Alliances, Fogarty Innovation, Thought Leadership

For 25 years, the annual Thomas J. Fogarty Lecture series has inspired us to engage with the healthcare visionaries who have taken the stage to share stories of inventions and leadership that have transformed patient care. In a special 25th anniversary lecture last month, four speakers on the forefront of healthcare innovation – Tom Krummel, MD, lectureship founder; Carla Pugh, MD, vice chair of innovation, Stanford Surgery; Josh Makower, co-founder and director, Stanford Byers Center for Biodesign; and Andrew Cleeland, CEO, Fogarty Innovation – came together to revisit the most influential ideas presented over the years and describe their efforts to shape the path ahead. 

How Can I Make This Better?

Pugh started by reflecting on the remarkable 25-year duration of the series – an impressive span during which her own career as a surgeon-innovator matured in parallel with the growth of the medtech ecosystem. To convey the impact of the lectureship and the leading role played by its namesake, she quoted several previous Fogarty lecturers: 

 “As I’ve learned more about the history of medtech in the valley, it’s become even more clear to me that Tom Fogarty was the seminal figure – the Godfather,” said Paul Yock, MD, the founder of Stanford Biodesign, and the sixth Fogarty lecturer.

Noting that Dr. Fogarty’s mantra – how can I make this better? – has become a drumbeat that unites and motivates healthcare innovators everywhere, Pugh next quoted Deborah Kilpatrick, CEO of Evidation Health and the 18th lecturer: “The Fogarty Lecture is our community’s chance every year to have a new conversation about translating inventions into patient impact and give a new answer to Dr. Fogarty’s constant question.” 

Next, Krummel, whose accomplished career includes chairing the Stanford Department of Surgery, co-directing Stanford Biodesign, and serving currently as chairman of the board of Fogarty Innovation, shared his inspiration in starting the lectureship series (and Fogarty’s unimpressed response). “The notion was that big ideas and conversation would inspire new big ideas,” Krummel recalled. “But when I proposed the concept, I got the usual Fogarty snort. ‘Who would care?’ asked Fogarty. ‘Would anybody come?’” 

Pausing to take in the room filled to capacity with over 300 attendees including the guest of honor himself, Krummel said, “It turns out that the Fogarty Lecture was a good idea.” 

The very first lecture was given by Fogarty, who shared his story as a scrub tech in the 1950s, watching the expert surgeons of the day making groin-to-knee incisions in an attempt to remove blood clots. “Scrub tech Fogarty made a simple observation,” said Krummel. “Those patients all came back to the operating room for an amputation.”

Despite the poor outcomes of that approach, Fogarty’s revolutionary “better way,” the first balloon catheter solution, was initially vilified. “The paper was never published, and his boss at the time told him that the procedure bordered on malpractice,” said Krummel. “But ultimately it revolutionized not just embolectomy but the entire field of endoluminal therapy in the cardiovascular system.” 50 years later, Fogarty was awarded the National Medal of Technology and Innovation from then-President Obama. 

Krummel went on to share three takeaways from the previous 24 lectures:

  • Ideas are fragile and implementation is hard. “The plain reality is that most startups fail – even those few that do get early funding,” he said. “Nearly all of the past 24 lecturers, described missteps, mistakes, trials and tribulations, and dark days of staring into the abyss because they had no money. But they used what didn’t work to inform what did and found a path forward.” 
  • If it’s so hard, why should we bother? “Because when you develop a new solution, the impact is profound,” said Krummel. He offered examples of technologies that changed the world, including the heart-lung machine, which enabled the entire field of cardiovascular surgery, and the first commercially-successful pulse oximeter which revolutionized anesthesia safety.  
  • Mindset matters. “The future isn’t an existing destination – it’s something we create through the choices we make and the endeavors we undertake,” Krummel said. He cited John F. Kennedy’s speech to the nation about why the U.S. should lead space exploration: “We choose to go to the moon and do other things not because they are easy, but because they are hard, because the goal will serve to organize and measure the best of our energies and skills, and because the challenge is one we are willing to accept.” 

Patient-Centered Innovation – the Biodesign Process

Continuing the theme of pursuing ideas that can change the world, Makower took the stage to talk about Stanford Biodesign. The center, which seeks to advance health outcomes and health equity through innovation education, translation, and policy, was co-founded 23 years ago by Yock and Makower with the goal of training aspiring innovators to solve important problems in healthcare through technology innovation.  

“Stanford Biodesign was founded on an idea, which is that innovation is a discipline that can be broken down into steps and taught, and that it starts with the needs of the patient,” said Makower. Today, that discipline is known globally as the biodesign innovation process, and Stanford Biodesign has grown from a single group of four fellows to touching 500 people each year through its fellowships, classes, executive education, international endeavors, and other partnerships. 

Makower has also expanded the focus of Stanford Biodesign in three key ways: 

  • Biodesign Life Sciences – this is an effort to equip trainees to expand the realm of potential solutions to their identified needs, going beyond medical devices to consider inventions in other life science domains such as biotechnology. 
  • Global Health Equity – “Often, we try to address health equity after a solution has been invented, and this can be difficult and expensive to implement,” said Makower. “This effort involves using the biodesign process to introduce health equity upstream when a problem is first encountered.” The first footprint in this area is East Africa Biodesign, a partnership with the University of Global Health Equity, the University of Rwanda, and Kenyatta University, funded by the Bill & Melinda Gates Foundation. 
  • Policy – Stanford Biodesign’s new Policy Program develops data-driven research and trains future policymakers in all aspects of healthtech innovation – from IP to reimbursement. The goal is to develop leaders who will contribute to balanced, data-driven decisions that help realize the full potential of technology innovation in the health sector.

An Interdependent Community of People 

The final speaker, Andrew Cleeland, opened with a response to the question posed by the title of the 2023 lecture: What do you do with an idea?  

“The answer,” Cleeland said, “is best captured by this quote from Dr. Fogarty: ‘An idea by itself has no importance whatsoever. It’s the implementation of that idea and its acceptance by others that brings true benefits to our patients.’” Accordingly, implementing ideas – helping innovators and entrepreneurs deliver their ideas to patients – is the core mission of Fogarty Innovation. 

“It is a daunting journey, and one that involves balancing the needs of an interdependent community of people,” Cleeland said. He described that community as patients, their families, physicians, regulatory agencies, insurers, payers, investors, acquirors, entrepreneurs and startups. “Over the last ten years, as this ecosystem has matured, it has also gotten more complex,” he said. The result is that very few medtech startups – roughly five out of every 100, survive to an exit.

The goal of Fogarty Innovation is to help fledgling companies make it out into the world and thrive. One of the ways FI does this is by providing “full-contact coaching,” a term that captures the daily, in-the-trenches interactions between FI staff and its resident entrepreneurs and companies. 

“We call it real world education,” said Cleeland. “It gets back to Dr. Fogarty’s grittiness. Our coaching comes from the hard-earned experience of our senior team, who have 450 years of experience in 80+ companies and have returned over $6 billion to investors through acquisitions and IPOs. Each one of us has also had at least one colossal failure. We’re here to leverage all our domain and functional expertise to help our companies succeed.”

Cleeland went on to detail FI’s roster of incubation programs that accelerate the invention, development, and deployment of new technologies into clinical care. These include the Invention Acceleration Program (IAP), which helps academics and researchers vet early stage ideas; the short-term Company Accelerator Program (CAP) for later stage companies that need help achieving specific goals, and the longer-term Company-in-Residence program. Other endeavors include a strategic bet program that brings projects out from within larger companies including Medtronic, Terumo, and Mitsubishi to help them become standalone entities. “This is a true acceleration program, not build-to-buy,” said Cleeland.

Cleeland also described FI’s educational programming, which includes a core curriculum for innovators, timely guest lectures from industry experts, half-day workshops, the Lefteroff Summer Internship program, Diversity-by-Doing HealthTech (DxD) in partnership with Stanford Biodesign, and the FDA Fellowship program, which involves both in-person visits and a series of online webinars that seek to educate both sides while humanizing and improving the interactions between FDA and startups. 

“We are here to have an impact,” said Cleeland. “The way we can do that is to leverage our experience and our non-profit status to educate stakeholders, help companies deliver their technologies to patients, and forge stronger alliances amongst innovators, academia, industry, and government.”

“So to answer the question, what do you do with an idea, I would say that you challenge it,” continued Cleeland. “And if it holds up through those challenges, you incubate it, nurture the idea, and change the world.” 

Cleeland closed by thanking both Krummel and Fogarty for the impact they have had on the medtech industry and on millions of patients. “Tom Fogarty is an iconoclast, and by this I mean he will always look to disrupt,” said Cleeland. “He will never accept the status quo. I think that, as a community of innovators, we have taken that to heart.”

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