How doctors can support medtech innovation [PODCAST]

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“Feedback in the assessment stage is always useful for improving the design of a device — especially as it relates to improving long-term aspects, such as patient outcomes or cost-effectiveness. This kind of feedback can only come after a device has been on the market and in use for a while, and after doctors have had a chance to see the long-term effects that use of a product has for their patients — for example, in the recovery period following procedures.

The involvement of doctors is of utmost importance in all stages of the development of any medical technology. Doctors should recognize the value their feedback holds for improving the technologies they will ultimately use. When it comes to understanding the problems in need of solutions, doctors should see themselves as partners in the development of medical technologies that will serve the ultimate goal — better care of and outcomes for patients.”

Lena Levin is a health care executive.

She shares her story and discusses her KevinMD article, “Here’s how doctors can support medtech innovation.”

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Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.

Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show we have Lena Levin. She is a health care entrepreneur and a co-founder of Via Surgical. She wrote the KevinMD article “Here’s how doctors can support medtech innovation.” Lena, welcome to the show.

Lena Levin: Thank you, Kevin. Thank you for inviting me. I’ve been listening to your podcast for so long, and being on the other side of the podcast, that’s really exciting for me. Thank you.

Kevin Pho: Well, thank you so much for joining me. We’ll get into your article in a little bit, but first off, can you just share your story and journey to where you are today?

Lena Levin: Yes. So I moved to Israel in my early nineteens, from Russia. I made aliyah, what we call it in Israel, and immediately I joined the university circles. I started to study, and this is where I met my co-founders. We were just students dreaming about creating an impact, as I think any young people do during their university time, and we were thinking in technological terms.

Back then I was a Technion student, and this was a very important decade for Technion, when this university won three Nobel Prizes, two in chemistry and one in natural science. So we were just in the middle of this bubble of innovation, of this startup hub, and we were thinking and playing with different ideas. And as any students do, we participated in the international entrepreneurship competition of Technion, and we won first place. This is how we started. This is how I became an entrepreneur.

So my first idea, it was by chance. I was thinking to do something that has an impact on the world, but I really didn’t know what to do. I mean, I’m not a surgeon, not even a physician, although later I took several courses just to understand the structure more in depth. And I was thinking either about green energy or health care, something that helps the world and the people.

So the idea won first place, we got exposure, and we were funded at the very early stage of our career, just graduating from the university. And then the first thing I did, I just flew to the first surgical conference. I remember it as today. It was SAGES in Phoenix, I think in 2012, maybe ’11. And I started to meet with the surgeons. For me, as a young entrepreneur, very inexperienced and with nothing to offer except my idea, I started to meet with key opinion leaders, the people who are sages in the surgical arena, just starting to talk to them.

And at my first meeting, I was scolded. This very well-known professor scolded me, basically very publicly, saying, “You know, you use pictures in your presentation from my book, and you don’t even mention me.” So I had to learn very quickly how I operate as a CEO, as a co-founder, as an entrepreneur. And the idea was rejected.

So I came back very devastated, but on my flight back, I met a surgeon from New York, and he said, “Yes, I don’t like the original idea, but you know what? I would really like to help with spreading large meshes during minimally invasive surgery.” And this is how we started our first startup, PolyTouch Medical. It was sold to Covidien back then, just within two years of R&D, at the very early stage. And this is how my entrepreneurial path started.

Now I deal with a different problem, but in the same field, in the field of minimally invasive surgery: How do I create instruments that make surgeons better surgeons, that make outcomes for the patient better?

Kevin Pho: Now, as you know, with the American health care system, there’s famously a lot of inertia, and sometimes it’s very difficult for physicians in America to adopt new technologies. Can you talk about some of the challenges that you face as a health tech entrepreneur in getting physicians and medical systems to adopt new technology?

Lena Levin: Paradoxically, I didn’t meet this attitude. I see that U.S. surgeons love Israeli startups. I always felt welcome, and I always got honest responses in terms of the idea and helping. My company wouldn’t exist without the help of our medical advisory board, who are all U.S. surgeons. So I really owe them all, and I’m very grateful. Without their honest feedback, and being with me and testing the device and being through all the steps of R&D, even coming to Israel and doing the labs here, they were very dedicated and very supportive.

In terms of the adoption, then, OK, I received the FDA. So what’s next? It’s not a startup anymore. So here, yes, a lot of training is required. It’s not just the level of key opinion leaders. It’s the regular surgeons who are there day to day during the operation, and they need the device to be perfect. So I think this is where we are right now, just meeting with surgeons and understanding their needs.

And I know where their resistance comes from. Imagine that you are trained for almost 20 years to be a surgeon a certain way, and now you have to change it completely. So it takes time. But now, finally, when they see their patients after the follow-up period and when they see their feedback, I believe that what we are doing is really helping the patients.

Kevin Pho: So let’s go to your KevinMD article, and it’s titled “Here’s how doctors can support medtech innovation.” Now, for those who didn’t get a chance to read your article, can you just walk my audience through it and share the story of why you decided to write it?

Lena Levin: Because the role of surgeons maybe is underestimated. You know, when a startup makes an exit or an IPO, we usually talk about co-founders. We rarely talk about the surgeons’ role. But I owe a lot to surgeons. I’m not a surgeon, and the way that I’m talking is just describing my experience.

The first time in the OR, as an MBA student, with nothing connected to surgery, never, and being an observer, standing in the corner and seeing a surgeon performing, for me it was really like a surreal experience, almost a miracle: this transition of surgeons from being, just minutes ago, a person to somebody else who is 100 percent focused. So being within this experience and seeing them performing their task, a very difficult manual task, but in a very precise manner, it’s almost inhuman, you know, even in the most complex surgeries.

And this is where I come in, and I start asking them, “Why do you do this? And why do you do this? And why do you attach, and why do you cut here and not there?” And they couldn’t really answer. They just said, “You know, we were trained this way.” So there’s a lot of knowledge that has been rolling up for centuries, almost. Surgery and suturing have existed for more than 2,000 years. It’s all built on sutures, while I’m coming somewhere in the mid-21st century and saying, “OK, let’s do it another way.” And this is where we need them.

The way they describe it suddenly changes their consciousness: “OK, really, why do I do this? Why do I screw into the soft tissue? Because it’s not a wall. We know it cannot really hang something or hold something. Why do we not suture? Because there’s no automatic suturing device. So why is there no automatic suturing device?” And it’s more like the behavior of a five-year-old child, when you ask, “Why? Why? Why?” When you’re an entrepreneur, you kind of go to this stage again, and in order to have this conversation and keep developing, you have a surgeon, or a parent, to answer why. So this dialogue is super critical to any startup that develops medical devices.

Kevin Pho: Now, to my clinician audience who wants to get more involved with health tech startups, how can they make that connection with those types of companies, and how can they be more involved in that whole arena?

Lena Levin: Just being open to proposals. When I think about my medical advisory board, which has run with us for a decade already, it’s almost like a family. And the first time I met them was at the conference. They were the only ones who agreed the first time to meet with me and to listen to my first crazy idea, which, now I know, was nonsense. But they were open, they were gentle, and they were honest and suggestive.

I know that surgeons are working very hard, and they have almost no spare time really to spend with a lot of entrepreneurs. But for those who really want to, they just have to make themselves open to meet young entrepreneurs and be engaged. My surgeons, I call them “my” because I feel very connected to them, but even at the most difficult time, when the R&D was stuck, they always helped us. They came to Israel, they did labs, they did labs in Boston and in other countries, making explanatory videos. This support is so valuable and so critical for medical device company success. I cannot really underestimate it.

Kevin Pho: Now, I was wondering if you could briefly take us through the life cycle of an idea. So can you go through the steps from your idea to a working prototype, and tell me about those interactions that you have with your medical advisory board in between? How long does it take? What’s the pathway?

Lena Levin: It was difficult. My first idea, we as a team, I should say. Our first idea, it’s always a brainstorming. It’s never one person. So you talk with your team and you talk with surgeons. So the first idea came from playing with very exotic materials. Back then, as I said, Technion won two Nobel Prizes in chemistry, so it was very innovative. We started to look at new materials. We played with super-elastic metals, and we played with bioabsorbable materials, and we thought about combining them together. And then we said, “OK, where can we apply it?” And we talked to plastic surgeons, we talked to general surgeons, we talked to intensive care, just thinking where we could use it. And this is where it started.

Immediately, plastic surgery said no. The general surgery said, “You know, in minimally invasive surgery we have a great opportunity to have less impact on the body, less damage to the tissue, but we do not really have instruments to do so.” So for example, back at that time, in order to spread the mesh, you had to be very invasive, using trans-fascial sutures to pull up the mesh and do it manually. So the whole concept of minimally invasive surgery was compromised by doing damage with trans-fascial sutures, which are very invasive and later very painful.

When we hear it, we go back to our lab, we close the doors, and then we start trying various concepts. As soon as the concept gets approval of, I would say, almost 100 of the surgeons. I would not start any project if I do not hear from most of the surgeons all over the globe, “Ah, great idea. I love it, I need it, I want it.” Otherwise, you would spend the next 10 years just for nothing. You really need the surgeons to be engaged at the idea level.

And then we go back and forth: the first prototype, the second prototype, and the labs that we are doing together with the surgeons or without surgeons. My first lab was with schnitzel at home, and so we do it on bacon or something similar. And then only when we see it’s working do we go to the lab. So at the first lab in Israel, the device didn’t work, and it was very devastating for the surgeons who flew from Boston and from the U.S. And then we rapidly got back to the lab, fixed it, came back the next day, and then it worked. So one of the surgeons said, “Can the device always come with the co-founders? So you should market you both together.”

And then they are exposed to everything. R&D is a very tedious process. If I had known all the obstacles in advance, I’m not sure I would have gone through this part. But it’s also very rewarding, because as soon as it works, and today, as soon as I know the patients are turning around healthy with my device inside, which of course will absorb within a year, and nothing will be left, I’m very grateful for this experience, to be that impactful in the world.

After R&D, there is a critical stage for FDA. This is where surgeons are performing clinical, pre-clinical study. We are working together on the protocols, and then holding fingers and waiting for the FDA response. And then there’s the clinical, or post-FDA clinical, stage, where we start marketing. And this is very stressful, because it’s the first time that the device meets a real patient, all kinds of patients and all kinds of surgeons. It’s not just a supportive medical advisory board but any surgeon, and they have to use it, and they have to be satisfied, and the patient should feel well. This is the most important part. So for me, it was the most stressful part. The R&D is fun. FDA is difficult, but you can do it. There’s nothing stressful. Either you pass or not. But as soon as you pass, all the responsibility is on you.

Kevin Pho: We’re talking to Lena Levin. She is a health care entrepreneur and co-founder of Via Surgical. She wrote the KevinMD article “Here’s how doctors can support medtech innovation.” Lena, what’s your take-home message that you want to leave with the KevinMD audience?

Lena Levin: I think that the surgical community, and I talk more about surgeons, but really any physician, and maybe, Kevin, you as a physician know it, I love the atmosphere of community. Even if I come to conferences, I value this a lot. I really think that it should be in any professional community, where people support each other and help each other. I both experienced it as a co-founder of a medical device company, and I also see how surgeons treat each other, so I value it a lot.

And maybe another message is the motives. With external technology, we use it for ourselves, you know: best phone, best pen, best tablet, best car. But here, this is very unique, because you use technology, or surgeons use technology, for somebody else, to make the outcome better, to make the patient feel better. And this shift of focus is very subtle, but it has a lot of impact, I think. And this is something that founders are also doing when we use technology to create a product for someone else to use.

Kevin Pho: Lena, thank you so much for joining me and sharing your time and insight, and thanks again for being on the show.

Lena Levin: Thank you.

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