Medsider: Learn from Medtech and Healthtech Founders and CEOs - Why Practicing Strategic Patience is Critical for Medtech Entrepreneurs: Interview with Dr. Tej Singh, Founder of Fist Assist Devices

Episode Date: July 15, 2020

Over the last 20 years, Dr. Tej Singh has served as the Founder and Chief of Vascular Surgery for three large, multidisciplinary vascular programs in Silicon Valley. He has vast experience with renal failure and vascular access procedures and is acutely focused on his first company, Fist Assist Devices. Dr. Singh’s company is developing the first renal care wearable device for venous enlargement and dialysis enhancement. In this episode, Dr. Singh and I talk about the primary challenge that First Assist Devices is trying to solve, the origin story for their first product, his approach to mapping out clinical trial strategies, and much more.      Interview Highlights with Dr. Tej SinghWho is Dr. Tej Singh and what is his background?What are Fist Assist Devices and what challenges are they trying to solve?The origin story for their first product and the critical inflection points for the company.    How Dr. Singh evaluated the IP landscape for his first device. Dr. Singh’s approach to mapping out clinical trial strategies.How he navigated the insurance coverage and reimbursement landscape.His unique approach to strategic patience and why it’s crucial for medtech startups.Dr. Singh’s favorite book, the leader he most admires, and the advice he’d give to his 30-year-old self.See more...

As a vascular surgeon working with engineers, sometimes having that consumer feedback, having, you know, someone like a high school student put it on and give feedback on. I think sometimes we were so excited making prototypes that we thought were going to work from an engineering vascular surgery perspective, but there is a consumer. And when you think of wearables, it is really consumer driven. The consumer has to put it on. The consumer wants to do their day-to-day activities. the consumer may not wear a short sleeve shirt or a long sleeve shirt.

So all those things come into play. But luckily, the nice thing about an external wearable and an external device is the changes can be made pretty quickly and pretty simply without major costs. And so there was a lot of learning there about our device. Our device is probably on now version number eight. And if you look at version one compared to version seven, so many different changes have been made in terms of size, Velcro, wrap, different ways that the device, will sit on someone's arm. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews.

Now, here's your host, Scott Nelson. Over the last 20 years, Dr. Tej Singh has served as the founder and chief of vascular surgery for three large and multidisciplinary vascular programs in Silicon Valley. He has a vast knowledge regarding renal failure and vascular access procedures and is acutely focused on his first company, fist-assist, devices to help improve fistula maturation via non-invasive external methods revolving around his intellectual property on vein maturation. Fist assist devices, a Silicon Valley MedTech startup is focused on developing the first renal care wearable device for venous enlargement and dialysis

enhancement. Founded in 2013 by Dr. Singh, the company is currently funded through angel investors and amazingly has zero debt. In this interview, here are a few of the topics we chatted about. The big challenge that fist assist devices is trying to solve for. The origin story from the first product and the key inflection points along the way, how Dr. Singh evaluated the IP landscape for his idea, Dr. Singh's approach to mapping out a clinical trial strategy, how Dr. Singh navigated the insurance coverage and reimbursement landscape for his first device, Dr. Singh's approach to strategic patients and why it's crucial for med tech startups, and Dr. Singh's favorite business book, The Mentor He Most Admires, and the advice he'd give

to his 30-year-old self. There's a lot more we cover in this wide-ranging discussion, but I wanted to call out a few things before we get started. First, if you're new to these Medsider interviews and want to be updated when the next one goes live, head on over to medsider.com and enter your email address. Rest assured, you won't be spammed. In fact, the only time you'll hear from us is when a new conversation goes live. Again, it's super simple. Just visit Medsider.com.

And right there on the homepage, you'll see the opportunity to enter your email address. Second, if you continue to enjoy these interviews, please give us a rating. In your podcast app, just open the reviews tab and click on the old five stars. Thanks again, it really helps us out. All right, without further ado, let's get to the interview. All right. Welcome, everyone to another additional. of MedSyler Radio. And on today's program, we've got Dr. Tej Singh.

Dr. Singh, welcome to the show. Appreciate you coming on. Thank you very much, Scott. Glad to be here. All right. Let me provide a kind of a high-level background or bio of yourself, and you can certainly correct me or correct me if I'm wrong on any of these points or certainly fill in the gaps as well. But over the last 30 years, Dr. Tej Singh has researched arterial hemodynamics in response to increased and decreased flow, not only as a college student, but a medical student as well. as a vascular surgical resident.

Dr. Singh, you've got over, you've got an active 20-year career as the founder and chief of vascular surgery for three large multidisciplinary vascular programs there in Silicon Valley. And really, the point of this conversation is really talk about your company, fist-assist devices, which is acutely focused on renal failure and vascular access procedures, which you founded, I believe, in 2013. And amazingly, which I hopefully will get into this part of the conversation, amazingly, has zero debt, which is almost unheard of for most med tech startups. So again, is that kind of a decent background?

Did I miss anything there, Dr. Singh? You said it, Ralph. You know, I did my undergraduate at med school at the University of Chicago where a lot of this initial research for this device was created as a student. Of course, at that time, I was focusing on being a clinical doctor and a vascular surgeon. And then really the seeds of the company, while they started in Chicago, the real growth of the ideas happened when I was a vascular surgery fellow at Stanford University here in Silicon Valley and have been here in Silicon Valley since 1993.

Very good. Yeah. And just to kind of wrap up. And I'll provide a little bit more of Dr. Singh's background in the show notes for this interview. But MBA from Auburn University, you did your general and vascular surgery residency at Stanford, I believe, MD and undergraduate bachelor's at the University of Chicago. Is that correct? Yes, absolutely right. And then, you know, and I've had the benefit of learning further about the business side of health care at initially Auburn, but definitely in ongoing classes at Wharton Business School and at the Stanford Business School where I just recently completed the lead program.

Really using those opportunities to add to the business side of our company and as we lead our company into the next 10, 15 years, there's a lot of opportunity for further knowledge. And so I really took advantage of that. Very good. And so on that note, we're going to certainly get into really how your first device that fist-assist came to be and some of the, you know, how you've been able to successfully navigate, you know, a lot of the complicated, you know, waters that most MedTech startups experience in their formative years. But before we get there, let's help set the stage for everyone listening in terms of what

you're working on with fist-assist and really the challenges that you're trying to solve. So can you maybe give us a quick elevator pitch on the device that you're currently commercializing? Yes, Scott. That's the real focus of obviously this interview today. But we've been really lucky. I think having been a vascular surgeon and a lot of nice things have lined up with me initially as a college student being able to start doing animal surgery and making arteries and veins connect. And then, of course, studying how those arteries and veins adapted continued my passion with the mentorship I had at Chicago. at Stanford with great vascular surgeons, especially Christopher Zerens, who was my student mentor, med school mentor and then surgical vascular surgical mentor at Stanford. And basically, I noticed at that very young age that arteries and veins adapt, they adapt to flow,

they adapt to different conditions. And as a vascular surgeon and developing a busy practice here in Silicon Valley, I started seeing that there was an opportunity for my patients and all patients to have bigger veins I realized that that was a clinical problem. It was a clinical problem in dialysis patients. It was a clinical problem in simple blood draw. So really at that point, the launch of fist-assist devices in my mind was starting. I thought we would be able to take all the research we were doing in Chicago and at Stanford,

get an intellectual property on a device, a device that would do something which has been unheard of, which is take the basic science, which, of course, I was a big part of, the clinical science and the exercise science that was happening all over the world in Europe, in Asia, and America, and make a device that captured all that science to do one thing, which is to make veins bigger on the arm. And having big veins on the arm helps with dialysis for the haemodialysis renal failure community, helps with fistula enlargement for that community, and a bigger scale helps the global world who needs bigger veins so they can get blood draws, have an easier time with that. And so fist-assist devices is positioned ourselves as the arm-veined

dilation company. Got it. And this initial kind of idea, you mentioned that the early, I guess, makings of the idea was when you were in residency at Stanford, correct? Well, I think the initial ideas came to me as a college student. I was able to, at a very young age when I was accepted to medical school, I had the flexibility to do some animal surgery research in a summer at the University of Chicago in the vascular surgery and pathology laboratories of Dr. Zerans and Seymour Glagoth. And they enabled me at a very young age to start connecting arteries and veins for studying how arteries adapt to flow. But what I really realized was that the arteries were one part of it, but the veins were a big part of the adaptation that nobody really focused on.

But until I became a surgeon after completing Stanford, I then really realized that the veins are crucial. Vane enlargement is crucial on the human beings' arms. And I will also say that I had a luxury of also having the opportunity to go to Japan and work with some world-class pathologists, including Dr. Masuda at Akita University, who was really one of the world's experts in vein and artery adaptation to flow. And so for me, all the things lined up from the age of 18 all the way to the age of now, but mostly up until I finished my training in the early 30s to really understand veins and adaptation. So I was very blessed to be a vascular surgeon completing a vascular surgery educational program and at the same time having a device in the back

of my mind as I was going through my life. Makes a lot of sense. And so on that note, can you give us a little bit better idea of this device? So I think everyone listening understands that, of course, when you're drawing blood out of a vein, there's definitely a need for a bigger vein, especially those that have had issues, you know, with needle sticks that have gone bad, so to speak, I guess, for lack of a better description. But especially crucial when in terms of the patient population that's undergoing dialysis, you know, the need for bigger veins to help mature fistula, if you kind of mentioned along this line. So there's definitely like the needs go, extend far greater than just, you know, blood draws. But can you help us understand a little bit,

at least at a high level, what your device, give us in context, what's your device doing to help, you keep veins open, helping large veins, et cetera. That's been the focus of what we've been able to do for the last 20, 20 years, 25 years with this company. And if you think about it, everybody has arm veins, and everybody knows that exercise or putting a tourniquet or putting an elastic band, any type of compression, because veins are very superficial under our skin, where arteries are deeper, any type of compression will make the vein bigger.

If you take the basic science terms of wall shear stress, tensile stress, distensibility, capacitance, all these terms have been studied for many, many years in the basic science world. Exercise science has told us that if you exercise and do arm exercises with some type of compression on your arm, you will dilate your veins. So the basic science, clinical science, a lot of that clinical science was actually being done in Slovenia, basically showed that to make veins bigger, a combination of exercise and compression of your superficial veins can get you there. We took all that basic science, clinical science, exercise science, a lot of those experiments on while shear stress, tensile stress,

and at the same time, papers were coming out which said that those patients who need fistulas for dialysis, a fistula is a connection between the artery and the vein. If you enlarge the vein, either before that surgery or after that surgery, the patient has a much better chance of better quality dialysis and a better quality cost-effective dialysis with less interventions and less treatments in the future, which of course will decrease health care dollars. We took all of those concepts and took the basic science of those concepts and made a pneumatic, intermittent compression, fully patented device, which is a wearable to be worn on the arm, which has an intermittent pneumatic compression feature, which is computer programmed,

to do everything that the basic science and the sciences that we've talked about does and make it a wearable for patients that is external and non-invasive. And the fisticistocysts device is the only global device that can be bought by a patient that can be worn on their arms below the shoulder or below the elbow, very easily, comfortably applied. You can wear it from one to six hours a day per your choice, and you will be exercising and helping stimulate vein enlargement, which can help with dialysis, needle placement for phlebotomy, or eventual ongoing fistula exercise and maintenance to keep your fistula going. And this is the concept that led to the device and where we've positioned ourselves today

on the eve of a global launch. Very good. And hopefully that helps set the stage for the rest of the conversation that shows the people wrapping their heads around what this device is, kind of what it does. And in the show notes to this interview at MedSider.com, I'll certainly provide a link to FisDist As well as a video where you can kind of get a little bit better idea

of kind of what this device looks like and what it does. But on that note, Dr. Singh, you mentioned that really kind of the idea of formulation or the iteration of this product concept really started back to when you were in college and then, you know, sort of stayed with you throughout med school and even in your general and vascular surgery residencies. But based on kind of some research that I did in front of this conversation, it seems like that the idea kind of was on the backward for a while, kind of sat there, but very curious as to what, like, was there an inflection point or what sort of the impetus for you to really start working on it to make this sort of this idea, you know,

come to life. And one of the reasons I ask this is I, you know, there's a lot of people that listen to these medsider interviews that have other really great. ideas, you know, ideas that probably have some legs, but they are never really, you know, ideas are a dime a dozen, you know what I mean? And you've been able to take something and take an idea and actually build a company around it. So can you take us back in time and give us a better idea of how this actually begin to come to life? Yeah. So, you know, it's a great question, Scott, and I reflect back on what I've done with this. And, you know, initially it was a curiosity. and, you know, life is complex. And as a young surgical doctor, a person who's now got a young family,

you know, my whole life, I have positioned myself to take care of patients. And I completed my training. I was at that point married. I had three young boys. And of course, to me, the priority was I put so much effort into a clinical career. I wanted to make sure I was able to provide for myself, my family, and give us every opportunity to thrive. and at the same time for me to have that personal satisfaction of being a surgeon. But in the back of my mind, this device really was lingering, and it's only when I realized as I started being a busy surgeon, that I needed patients every time I heard of a patient saying, I wish I had bigger veins, I wish my fistula would develop,

I wish my blood draws weren't as painful or as difficult. This light in the back of my brain was, well, I've thought about this. I've thought about this. And I had it in the back as something. which eventually, and I think everybody who lives in Silicon Valley drinks the water here, and you always think of things differently. You want to think about changing the paradigm. But I wasn't going to sacrifice my life. I wasn't going to sacrifice my family life. I wasn't going to sacrifice a busy surgical career. But it was a hobby. It was a hobby that was basically

something that I thought I could give the world, I could help the patients of the world with. But until I got into my MBA program at Auburn University, and I met some great, mentors there in Stan Harris, Umet Mitra, Tom Baker, who taught the class on business law, when I realized that how you can take a concept, protect it, make a business around it, that really was the first time I took the basic science and my clinical experiences and flipped the switch to say, well, now it's time to give the world this device. And once again, I was very lucky that as a vascular surgeon, I was living in this world. I saw the problems in this world. But that course and that MBA course, truly at Auburn, got me to think

about the potential of this device. And many of the people that I mentioned from Auburn are a part of advisory role or partners with me on this company and in various forms. And so having a team assembled that started at Auburn and then I just kept adding to it, we just continued to grow. And the focus was, I think, looking in the mirror and seeing that a business could be made and me while I was a full-time vascular surgeon could make a business with that degree. That was the flipping point and that happened at the end of 2013. Very good. And I think maybe the lesson learned, at least what certainly comes to mind from my perspective,

is that you had people around you, right? Certainly you were proactive enough and interested enough to participate in an NBA program, but you have people around you that you could lean on to maybe help move this idea from, or move this concept from idea to reality, you know, and the steps that you needed to take along that path. So that's great to hear. So on that note, Dr. Singh, and I certainly don't expect you to remember all of the details because, you know, we're recording this in early 2020.

And, you know, this was, you know, seven, eight years ago now. But this product is relatively straightforward. You've been able to condense a lot of the existing science and make it very simple and then sort of packaged into a very straightforward wearable. Can you walk us through, you know, how you evaluated the IP landscape at the time because I think most people when thinking about a product that's as simple and straightforward as this, they would naturally think it's not patentable, right? Or that may be difficult to create the sort of the wall as necessary to actually build a business around this. So can you talk just a little bit more

about your thoughts related to IP kind of in those early years? Yeah. So once again, you know, I think you hit it on the head. You know, look at, if you look at the phases, there was the research phase, great mentors I've already mentioned. There was the business school phase, great mentors there. And so then when I started thinking about this, and once again, I think being a vascular surgeon, every day struggling with arm veins, every day struggling with patients in my own cases that didn't go well because the veins were too small. So what you do is you start building a bigger team. And the first team I wanted was I wanted to see that, okay, if there really is a role for a pneumatic compression device, is there any experts out there? And I was luckily in 2006 and 2007 able to call up a company down in San Marcos, California, under the direction of Ed Arkins. And Ed, and I spoke, and I told him that, of course, I had an idea.

And he said to me right off the bat, don't talk to me on the phone until you got a patent. And that was the first warning that I had that I better keep this idea to myself and I better get a patent. And, you know, Ed, who has been very instrumental in this company from the research and the prototypes, you know, he had a company that made pneumatic compression for the legs. And so when I looked at his website and I said, well, my device is very different. Mine is for the arms. Mine has different things. I then found, and I was very lucky, just by going through the yellow pages back in 2007, I think we actually had yellow pages. I found a patent attorney.

I explained to him my device. He said, well, let's go for it. And we spend a year and a half at significant costs writing up a very elaborate patent for fist assist and our device. And pushing that through while we had some resistance initially from the Intellectual Patent Office, the U.S. Patent Office, we basically were able to get that patent as a single compression device for an arm-vane application. And that was crucial for the success of where we wanted to go. And with that, we started getting the nondisclosure agreements. The discussions with Ed Arkins went to a very high level.

And that helped us launch where we wanted to be for the next five, six years. So I would say that, yes, you have ideas, you want to maybe speak to a couple people that you trust about it, get people around you who are experts in it, don't reveal your secrets, but then get that intellectual property patent. And patience. And we're going to talk a little bit about this today. the patients in this process, you cannot push this process through. And patients can be used to your advantage. So once we got the intellectual property, I think that happened in 2008. We were off to the races.

We had a unique device. And then, of course, we had to go back to the people that helped us with prototypes. And ACI Medical was very instrumental in making prototypes for us, doing the initial trials. I took the trials to the country that was dear to my heart, which was India, where I was born. and there was a great vascular surgeon program in Bangalore India, and that vascular surgeon, Dr. Desai, offered to be very cutting edge with us and doing the first efficacy and feasibility studies in India. And those trials went so well with a very large prototype,

which has subsequently been improved on. But we rallied the Vascular Society of India. I presented there. I got the whole country's endorsement that this is great for Indians. As a fellow Indian, I know we all have small veins. and I thought that the Indian population would benefit. Our initial angel investors were my mom and dad. And my dad was a businessman who was very successful,

and I rallied him, showed him the device, and he became our number one investor. And so brought the team together. It started with the concepts to the patent, to the prototype, to the trials, to the funding. And you're right, when you mentioned we are debt-free. This company has been funded 100% by the Singh family, which is my mother, my father, my wife,

psychiatrist. You need to have a psychiatrist on these companies because the ups and downs of the landscape and the hills and valleys of a startup, if you don't have a psychiatrist on their team, you're going to be in trouble. Luckily, we had one that was directly connected to me. But the company from efficacy and feasibility success to regulatory processes all really has been moving along at a very good pace with very good people. That's great. I'm certainly looking forward to the part of this conversation where you get to chat a little bit more detail about this concept. of strategic patience.

Because it seems like this has been a trend, you know, throughout your, your experiences with fifth to cyst is like this idea of being patient, but also persisting and pushing things forward. So I'm looking forward to that part of the discussion. But before we get there, let's talk about a few of those things that you mentioned, right, prototype development, which is crucial in any med tech startup. And that's not cheap either. So you mentioned that ACMI, I believe, was the company that helped you out there.

But were there any lessons that you look back on during those early stages of prototype development that are worth mentioning, whether they were lessons learned or things that you really did right? ACI Medical was a company that had made pneumatics for the legs. And we challenged them, and I credit Ed and his creativity at Arkins, the CEO of ACI, to make a device for us for the arm. And naturally, you know, we learn a lot. We learn a lot about different materials, different batteries. computers, software, even Velcro. There are different types of Velcro. If you have too stiff of a Velcro,

it's hard for patients to take something off their arm. If you put too much Velcro because you think it's going to keep a device on someone's arm so they can jog, if the Velcro is too stiff and they pull it off, it can pull away the fabric from the battery case. And so there's so much learnings, and I would say this,

that as a vascular surgeon, working with engineers, sometimes having that consumer feedback, having someone like a high school student put it on and give feedback on. I think sometimes we were so excited making prototypes that we thought were going to work from an engineering vascular surgery perspective, but there is a consumer. And when you think of wearables, it is really consumer driven. The consumer has to put it on.

The consumer wants to do their day-to-day activities. The consumer may not wear a short-sleeve shirt or a long-sleeve shirt. So all those things come into play. But luckily, the nice thing about an external wearable and an external device is the changes can be made pretty quickly and pretty simply without major costs. And so there was a lot of learning there about our device. Our device is probably on now version number eight. And if you look at version one compared to version seven, so many different changes have been made in terms of size, Velcro, wrap, different ways that the device will sit on someone's arm. So all of those are learning.

And luckily for us, ours was external learning, which I think is a lot easier than internal learning. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Miarid, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs.

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