The 24th Annual Thomas J. Fogarty MD Lecture featuring Mir Imran

by | Oct 31, 2022 | Alliances, Education, Thought Leadership

The Fogarty Lecture was once again a huge success with over 250 people attending both in person and virtually. Now in its 24th year, the Fogarty lectureship was established to bring together a diverse community in Silicon Valley that focuses on leaders in discovery, invention, innovation and entrepreneurship. The event is sponsored by Fogarty Innovation, Stanford Byers Center for Biodesign and Stanford Department of Surgery. 

This year, the lecture featured Mir Imran, chairman and CEO of Modulus and InCube Labs in a fireside chat with Dr. Tom Krummel, chairman of the board of Fogarty Innovation and venture partner at Santé Ventures.

A prolific innovator, Mir has spent his 40+ year career developing and commercializing breakthrough medical technologies that have saved countless lives. One of his earliest achievements as a healthcare entrepreneur was developing the first FDA-approved implantable defibrillator, and he hasn’t stopped since. Today Mir holds more than 1,800 patents and has founded 20 technology and life sciences companies, 15 of which have been acquired or gone public. He’s a fellow in the National Academy of Engineering and the National Academy of Inventors, the founder of life sciences venture fund InCube Ventures, and a member of numerous advisory boards. He is also a passionate advocate for providing underprivileged youth with education and training in innovation and entrepreneurship in both the U.S. and India.

Mir discussed his revolutionary approach to defining “innovation,” and how this insight about problems led to successfully bringing groundbreaking technologies to market. The full recording is available here

Below are highlights of the fireside chat.

Q. You developed a unique way to think about the process of innovation and how to work through challenges and potential solutions. Tell us about that and how it has allowed you to bring so many groundbreaking technologies to market.

My journey started in the late 1970s. As a young engineer, I was extremely intrigued by the entire process of what we now call innovation or invention. Throughout history, it has been described as an accidental occurrence, which made me wonder if it was, in fact, always serendipitous. I thought there might be a process for innovation that I could follow, and I was interested to learn what it might be. There weren’t a lot of books on the topic at the time, but I was doing some inventing on my own, and I knew I was following a series of steps that I couldn’t articulate. 

Therefore, I decided to become an observer of that process I was engaged in to see if a pattern would emerge. It took the next 15 years of conscious observation and trying to figure it out until I began to see some hope of understanding the process. At that point, I also decided to define the vocabulary of innovation.

When we talk about innovation, we use the term very loosely, so it has different meanings for different people. But in the context of practicing innovation, I decided to define it because you cannot teach something unless you define it. The simple definition I came up with was that innovation is the identification of a problem that’s worth solving, then understanding the problem so deeply that you can frame it very succinctly. Innovation is not the solution. To me, the solutions are the inventions that emanate from that framing.

Defining it has really helped me because from that point on, I have only focused on problems. I don’t care about solutions because once you identify and frame a problem, even without solving it, there can be a dozen people who solve it with many different inventions.  

Q. Tell us about your first disruptive innovation, the implantable cardioverter defibrillator. 

The work began in the mid-seventies when I went to Rutgers New Jersey Medical School to give a talk and met Dr. Michel Mirowski, a cardiologist who lost his best friend due to sudden cardiac death. At that time, I was working on implantable deep brain stimulation systems for psychiatric research, so I had some experience that I thought might be applicable. 

However, the defibrillator journey was difficult because we didn’t have a great understanding of cardiac arrhythmias. Because we knew people died of spontaneous fibrillation, the first device we designed detected only fibrillation, but not tachycardia, so “spiky “signals were ignored. The result was that the first set of patients would have an episode and fall down, but the device wouldn’t work and shock them until their ventricular tachycardia (VT) would deteriorate to ventricular fibrillation (VF) and they were on the brink of death, which was a big concern. Realizing our detection was inadequate, we stopped the clinical trial. 

With the help of Dr. Roger Winkle who was at Stanford at the time doing program stimulation to induce tachycardia arrythmias, we perfected our technology. I recorded the cardiac signals to make the technology even better, and it ended up having a tremendous success rate. In the ‘80s Eli Lilly came in as an investor and later acquired the company. 

Q. Moving on to your newest adventure, which was Rani Therapeutics, the disruptive technology for the oral delivery of biologics…tell us about this development.

Of all the projects I’ve worked on, that was probably the most difficult. It started with a casual chance conversation with a senior executive from Eli Lilly, who shared that they had acquired a company which had invested a lot of money trying to convert a peptide into an oral formulation. The project had failed, and they were shutting down the company. He said they had very low expectations because it had never been done before. So my first question was, “Do they have equipment for sale?” and the second was “Why did they fail?” I later found out through research that there had been 150 separate attempts.

I thought about the issue and remembered we don’t have sharp pain receptors in the GI tract, like we do on the skin. I thought, why can’t we make a pill that you swallow and goes into the intestine, transforms itself into an injection and delivers a pain-free injection? Sounded like a piece of cake, right? Well, it wasn’t, but that’s how Rani Therapeutics was born, and today we can deliver 100% of the biologic drugs that are on the market. We are also developing our own drugs and we will of course also work with pharma companies.

For Mir, solving the oral delivery of biologics was just one more “problem” that he has approached as he has since the beginning, using the definition of innovation he personally developed: focusing on problems, framing them carefully, and then letting the solution evolve. 

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