“The Father of Invention.”
“Preeminent inventor of medical technologies.”
These are just a few of the phrases used to describe Dr. Fogarty’s innovation-driven mindset and determination to find a better way to solve critical healthcare needs.
Throughout his career, Dr. Fogarty has arguably accomplished more than any medical entrepreneur to date. His revolutionary “industry standard” Fogarty balloon catheter is still used in more than 300,000 procedures worldwide per year and is estimated to have saved the lives or limbs of 20 million patients. The list goes on: He has founded more than 45 medical device companies; is credited as inventor on 165 surgical instrument patents; and has received numerous prestigious awards, including the Presidential National Medal of Technology and Innovation, among many others.
But perhaps most importantly, his inventions have transformed how surgery is performed today and have led to the development of multiple minimally invasive medical technologies that touch the lives of countless patients and their families. In addition, his knack for mentoring and starting new companies has paved the way for entire new generations of innovators, who are now launching their own companies and defining the future era of life science.
And at 83 years of age, Dr. Fogarty’s passion for advancing medical innovation and improving patient care continues. He tours the Fog Shop and shares his knowledge with our innovators almost daily and is playing a pivotal role in helping shape the future of the Fogarty Institute.
We recently had the privilege of catching up with Dr. Fogarty to discuss his thoughts on the progress of the Fogarty Institute as we near our 10-year anniversary, as well as the advancements and future of the medical technology industry.
Q. How has the Fogarty Institute evolved since you first launched the organization in 2007?
The Institute was truly a startup when we first came up with the concept – but a different kind of startup, as it is a not-for-profit. And as with any startup, you learn a lot in the early stages, including the need to continually raise money. That can be very difficult because investing is always a lot easier when there is a clear financial return, compared to investing in funding a goal, which in our case is to ultimately improve patient care.
However, what donors and investors must understand is that in the field of medicine, our primary objective is to benefit the patient, and the only way we can change and improve is by innovating and developing new technologies.
This is very difficult to do because hospitals and physicians are often reticent to adopt new technology due to the potential risk for being sued or losing one’s reputation if the technology should fail or is used inappropriately.
It’s very challenging to raise money for something that is not understood – and this is something we have set out to accomplish at the Fogarty Institute in the past decade – to raise awareness and educate donors, investors and the innovation ecosystem on the various challenges we face.
You almost have to be part of the process to understand how medical technology startups get to market, so we have started to involve organizations and regulatory officials by inviting them to join the Institute as part of our educational program. That gives them an insider’s view so they can better understand the hurdles involved in taking a product from initiation to application here in the U.S.
We feel the Institute has made bold, strong strides in the past 10 years, and we have recently gained momentum by hiring Andrew Cleeland. His experience as an accomplished businessman perfectly complements our perspective as physicians and innovators. We are very optimistic about our future.
Q. Which accomplishments are you most proud of?
We are most proud of the more mature startups and companies that have left the Institute and whose devices are commercially available, including Heartflow, our very first startup, nVision and EchoPixel. If you don’t go to commercialization, you don’t benefit patients.
It is very gratifying to see these young entrepreneurs come to the Institute with innovative devices that show great promise to help people with illnesses. It feels like a “passing of the baton,” allowing us to share the key foundational elements of our careers as physicians, inventors and entrepreneurs with the unwavering goal of improving patient care.
In addition, we are also very pleased with the first-of-its-kind program we established with the FDA to help accelerate medical device innovation by improving communication, collaboration and understanding between the FDA and early-stage medical device innovators, thereby improving the overall efficiency of the medical device approval process.
And we are very happy with the progress we are making with our corporate program and our Japanese partners who come here to immerse themselves in the innovation process.
Q. What are your thoughts about the advancements in medical technology and the future of the industry?
It was more than 50 years ago, when I was in eighth grade, that I started working in a hospital cleaning medical equipment and later as a scrub technician. The progress that has been made since then is truly amazing. We can barely keep up with the evolving technologies in all fields: oncology, cardiology, internal medicine, gene therapy and more. It’s been very gratifying to be part of this evolution.
If I think back to when I was in high school and observing surgeries, there was a different standard – when a physician saw bad tissue, he would cut it out. The bigger the incision, the better the surgeon, it was believed. The concept of less-invasive surgery came to me as I regarded two physicians perform the same surgery with different size incisions – one would make a six-inch cut and the other a one-inch cut. The latter used his index finger to feel how big the cut should be. This showed me that there was a better option for surgery, which led to the invention of the balloon catheter.
Today, the physicians and industry are adapting rapidly to the concept of less-invasive procedures. For example, transcutaneous X-ray therapy has made great strides. The Institute is working on a technology that allows us to ablate or remove tumors. We are now adopting that same concept to ablate atrial fibrillation and ventricular tachycardia.
On the other hand, healthcare costs have greatly escalated, so there is also a decisive trend toward developing new technologies that reduce costs. And we are also seeing a much stronger sense of collaboration. The players in the medical technology industry are recognizing that unless we work together, progress is difficult to obtain because of all the hurdles that startups face to get to market.
The FDA, for example, has recognized that in the past they had increased costs for development, and they are now working toward reducing previously required clinical data that is not directly related to safety and efficacy. That is a fantastic step forward.
There is also increased collaboration within the industry as larger companies are beginning to make more investments in early–stage companies, recognizing that startups can come up with technology that could replace current devices and offer advantages in both performance and cost.
We have to work together to accomplish better medicine and reduce costs. The accelerated pace of innovation has been very gratifying, and we are confident in both the industry and the Fogarty Institute’s ability to help push forward transformative technology that will provide better patient care.