Healthcare Innovation: Taking Visionary Ideas to Market as a Physician Founder

[00:00:15] Ghazenfer Mansoor: Hello and welcome to Lessons from the Leap. I’m your host, Ghazenfer Mansoor. On this show I get to sit down with entrepreneurs, founders, and business leaders who talk about the bold decisions, pivotal moments, and innovative ideas that shape their journey.

This episode is brought to you by Technology Rivers. At Technology Rivers, we bring innovation through technology and AI to solve real-world industry problems. If you’d like to learn more about us or work with us, head over to technologyrivers.com and tell us about your project.

Today on Lessons from the Leap, we are joined by Dr. Ned Swanson, President and Chief Medical Officer of Polarity Bio, where he’s helping advance regenerative therapies for complex non-healing wounds. Ned, welcome to the Lessons from the Leap.

Give us your intro, tell us your story, how you got here from where you were. So yeah, this is your time to share anything, and then we’ll go deeper into those.

[00:01:05] Ned Swanson: Yeah, absolutely. Thanks for having me. Excited to be on with you and to be discussing these topics.

I started my career pursuing first bioengineering and then medicine with the goal of becoming an academic plastic surgeon. So I was really interested in reconstruction and how to bring people back to their original form and function. So you can think of things like trauma, cancer reconstruction, pediatric, craniofacial cases for kids born with deformities.

And along the way, I happened to come across the opportunity to launch Polarity Bio, which is the company I’m currently a part of, as you said. And the real inspiration behind it was: can we regenerate skin in its full thickness, functional state?

So can we essentially heal wounds with skin that acts and functions just like normal skin? So that is what we did about 10 years ago.

We launched Polarity Bio and we created a product called SkinTE, which uses the patient’s own skin to create a product that regrows their skin within the wounds, or at least that’s what it’s designed to do. We’re currently undergoing FDA review right now, so it’s not approved for use yet, but our first indication will be for diabetic foot ulcers.

So patients with diabetes who have gotten a wound on their foot. We’ve run two randomized trials within that space and are excited to be bringing the product through the FDA review process now.

[00:02:56] Ghazenfer Mansoor: Cool, cool. Thanks. So what was it about regenerative medicine and tissue re-engineering that convinced you that this is the area where you wanted to build and create rather than simply practicing medicine?

[00:03:10] Ned Swanson: Yeah, I think it was from what I was doing every day in training to become a reconstructive surgeon. There were big problems that we didn’t always have the perfect solution for. And you could really tell that this was a field that if you could create a product that’s able to regenerate tissue, that there was a big need for it.

And I think plastic surgeons are at the forefront of the regenerative medicine field, regenerative medicine research, because of this. They see it every day. They are trying to treat very complicated problems with a lack of tissue and a lack of tissue that matches the problem they’re trying to fix.

So it’s just something that was natural within that field to really be pulled into wanting to bring regenerative medicine forward. I would say on the balance of that I was also doing transplants. So face and hand transplants were becoming a thing while I was training.

And there’s a question in my mind, is that where the field’s going, or is the field going towards regenerative medicine? And I think after the last 10 years we can see that they both advanced significantly and they’re starting to sort of blend together. So that was also something we predicted back then.

We actually wrote a paper about it, that in the future these very unique transplant surgeries like a hand or a face transplant would start blending with regenerative medicine approaches. And I think that’s where we’re headed now.

[00:04:51] Ghazenfer Mansoor: And what are the challenges that you’re coming across in this field as you’re trying to solve this problem, from a regulatory perspective as well as adaptation?

[00:05:02] Ned Swanson: Yeah. I think the first biggest challenge for tissue engineering and regenerative medicine is how do you get a blood supply to the new tissue you’ve created. So that was a big problem in the past where if you take cells and tissue out of the body and you start growing them in the lab, they’re gonna start growing beyond the blood supply you can get when you bring it back to the patient.

So no one has quite yet figured out how to integrate a blood supply into something we’re growing in the lab. And one of our big aha moments at Polarity Bio was let’s not grow it in the lab. Let’s get the tissue and the cells ready to grow and ready to regenerate tissue, but get it right back to the patient and let that growth happen on the patient.

So instead of incubating and culturing the product, we let that occur on the patient, serving as their own bioreactors. So that was, I think, one of the biggest first hurdles to get over. How can you get regenerative medicine to become a scalable solution? And that was getting around that need to essentially engineer a blood supply into the products you’re creating.

I think getting over that hurdle, the next hurdles you see are, like you said, the adoption: how can we make this as simple and as close to an off-the-shelf product as we can, despite the fact that we need to get a piece of the patient’s own skin.

We need to create the product and then ship it back in a very short amount of time. I think it was kind of the next big hurdle to get over.

And thankfully we were building Polarity and building out the system while I think a lot of logistics issues were getting solved around the world for other reasons: Amazon, FedEx, et cetera. A lot of very quick turnaround logistics became routine. So that’s something we’ve taken advantage of in our logistics system.

And I think the next step is what you’re talking about, right ahead of us is adoption. So how do we get a product like this adopted despite the fact that we have some extra logistics and pieces involved than a lot of physicians are accustomed to with the current therapies.

[00:07:26] Ghazenfer Mansoor: So what is the current process? Would the physicians have to go through some different training to adapt this, or is that a normal procedure they’re used to? They just have to learn this product? And do you have to go through that clinical trial process? Just curious on that part.

[00:07:46] Ned Swanson: Yeah, a little bit of both. So the procedure for us to create SkinTE, it’s just a three centimeter by one centimeter ellipse of skin. So you can think about the shape of a football, but down to three centimeters.

And this is a procedure most physicians, especially surgically trained physicians, can do. It’s not overly complicated, but with that said, we’re definitely gonna have a big emphasis on training with new users, not only to be able to take the piece of skin, but how do you package it up, how do you ship it out, and what are the tips and tricks needed to do that efficiently.

And then putting the product on and doing that in a way that gives it the best chance of essentially getting the wound closed. And a lot of that relies on how you put it on, how you put the dressings on, and how you educate the patient.

So simple procedure, but I think integrating it with the entire process, there’s gonna be a big emphasis on training as we go to market with this, if the product is approved in the next six months here.

[00:09:00] Ghazenfer Mansoor: Okay, cool. Thanks for sharing that. So as a founder, what have you learned about building a company around the idea that may take years of research, development, validation before you see its full potential?

I know in a normal way, I would say non-trial based products are usually… you go into the market quickly, you try to get the customer very quickly, and this is a very long process. So what have you learned in this process?

[00:09:31] Ned Swanson: Yeah, it’s a great question. So I think one piece is we actually brought the product to market rather quickly out of the gate. It was through a different FDA regulatory pathway, which we have since changed. But initially the product was on the market, available to treat any wound type.

[00:09:55] Ghazenfer Mansoor: Yeah.

[00:09:56] Ned Swanson: And within that three year time period, definitely got a sense of where are people using it, where is it bringing value, where is it not. And that helped dictate our path forward.

Once we spoke to the FDA, decided to take a different pathway to market, to select diabetic foot ulcers as our first indication, a lot of that came out of that initial time period on the market with the product. So kind of a unique situation, not something typical in biotech.

But we were able to leverage that experience, kind of like you said with non-regulated, non-healthcare products. That’s typically what you do. So we got a little bit of a taste of that.

I think outside of that experience, as a founder, tons of learnings across the board. Anything from how to continue financing the company. What are the strategies behind that?

[00:10:53] Ghazenfer Mansoor: Yeah.

[00:10:54] Ned Swanson: In terms of hiring and building a team out, what strategies help bring success on that front? I think that’s still one of the most challenging areas of building the company. And we’re about to do it again in terms of building out the commercial team as this product comes to market.

So I think we’ve built a very big network within the biotech and wound care space. And so now we can lean on that as we go to hire people to build the team out. I think out of the gate without having that known network, it was a lot of trial and error.

And I think what we’ve learned is to really try to work with people before we bring on full time, in order to make sure they’re a good fit, and we’re good fit for them, before we keep building.

And beyond that, tons of details. So our team who runs the trials has learned a ton. We’re basically running our eighth clinical trial now.

So all the knowledge that they’ve gained, we’ve gained over the years through those trials has paid extreme dividends in this process. And we look to continue that momentum because we’re not gonna stop at diabetic foot ulcers.

I think we’re gonna try to get this product back into every wound type that we think it could be valuable for. So we’re gonna be launching trials and other indications in the near future.

[00:12:27] Ghazenfer Mansoor: Absolutely. No, this is the right approach, I think, and this is very common in ours. Our business is healthcare software development, where the idea is to put the product out really quickly. So rather than just building a whole product for two years and then launching, that’s usually too late.

You wanna put in front of the customer as quickly as possible, test with one market. So even that’s a right approach even from a sales perspective as well. If there are any issues, you can identify really quickly.

Try in a smaller segment, one region, so that you’re not just putting in nationwide and all of those, and then there are challenges, that becomes a lot more challenging. So I think this…

[00:13:08] Ned Swanson: Yeah, I was gonna say we’re kind of planning to take that approach. If it’s approved and we launch it, we’ve got a few regions already picked out that we’re gonna specifically target with a small team, make sure everything’s going smoothly before we grow it nationally.

So I think what you’re saying on the sales side, we’re taking a similar approach.

[00:13:31] Ghazenfer Mansoor: Yeah. And because as you’re building a team, you’re growing in terms of the funding. Is it granted mostly? Is it P funding, venture funding? How are you guys funding?

[00:13:48] Ned Swanson: Yeah, we’ve had a sort of long journey as a company. It’s ten years, as I said, but the last three… we were originally public, we went private three years ago. And since then it’s been a core group of high net worth investors, actually the main group that initially launched the company with us.

So big believers in the technology, big believers in the company and the product. And they’ve really supported us through these last three years. And I think what we’re going to do going forward for the commercial launch, there’s many potential avenues.

But at least through approval, this core group of investors has really taken us through this last phase three trial and all the way up until this potential decision point with FDA. So only one real institution in that round and otherwise signed net worth and family offices.

[00:14:46] Ghazenfer Mansoor: Okay, cool. So are there any risks in this procedure, in this whole process? And if there are, how are…

[00:14:54] Ned Swanson: Yeah.

[00:14:54] Ghazenfer Mansoor: …you trying to mitigate those?

[00:14:56] Ned Swanson: Yeah, with any procedure. So if you’re cutting a piece of skin out, there’s always a risk. And the primary risk is that when they suture it closed, it doesn’t stay closed, it opens up or it gets infected, just like with any incision you put on the body.

So we’ve been really looking at where and when those complications happen more frequently. So we’ve seen that it happens more frequently if they take it on the outside lateral side of the leg versus the medial inside of the leg. So those are things.

Other things we’ve seen are wrapping. We have them wrap the whole leg in a compression wrap, so having that go all the way up over the harvest site. So really ways to minimize swelling, edema, pressure from causing complications on that incision.

Beyond that incision, it’s really a lot of similar risks to just having an open chronic wound. So nothing overly specific we’ve seen with the product other than that harvest site. So we think that’s where people should really be focused the most on reducing complications.

And then on the flip side, how do you give it the best shot at working while these wounds are on the bottom of the feet? So that happens from repeated pressure hitting spots that people can’t feel on their feet because they have diabetes.

And so when we put the product on, or the physicians put the product on, they really need to protect that from getting pressure on it repeatedly. So that includes building up a bunch of felted foam around the wound. So they put the product on, they put the dressing on, and then they build up this essentially wall of felted foam around the wound.

So if the patient were to walk on their foot, the pressure isn’t directly hitting where the product is in the wound. It’s hitting everywhere else on the bottom of the foot. And then they also wear what’s called an offloading boot.

So it’s a big boot. It kind of looks like you’ve seen people wear those walking boots when they break their feet. And that keeps that pressure evenly distributed as well.

So I’d say there’s how you prevent complications from taking in the harvest of the skin, and then how do you give it the best shot at working once you put it on, or the things we’ve been focused on in both the trial and with planning out the training program we’re gonna be implementing.

[00:17:27] Ghazenfer Mansoor: Cool. So in today’s time AI is everywhere. How is AI impacting Polarity Bio, and how are you leveraging AI in this business?

[00:17:45] Ned Swanson: Yeah, I think there isn’t a huge integration of AI into our actual product because it’s a multicellular therapy that uses the patient’s own tissue and cells. There isn’t AI integrated into the product itself, but it’s definitely surrounding it.

Where in the trials, all the images being captured of the wounds and calculating how big the wound is and how it’s closing or opening, that was all sort of AI generated data. And obviously that’s some of the most important data from the trial: how big is the wound, is it closing?

In other pieces, we’ve used AI and big data to look at what actually happens to these patients over time with diabetic foot ulcers. So if you take every patient who’s had a diabetic foot ulcer in the past few years, really trying to understand what their journey is, what treatments they get, where they end up in the healthcare system. So using it on that front.

And then I think just on a pure company side, we’ve been really leveraging it as much as possible in our day to day work. So a small team, a small startup trying to be lean and mean. We’ve gotten a huge leg up using all the different AI tools you can to get our day to day work done.

And I think it probably helped us get all sorts of pieces done a lot faster with a lot smaller team than we would have in the past, just five years ago.

[00:19:20] Ghazenfer Mansoor: Yeah, absolutely. I think, yeah, the important part is AI, like the data. So once you have a lot of data, you can also get a lot more insights.

So as you are doing more and more of these procedures, you will have a lot more data, like what was the input and how this turned out to be. And I think AI can definitely make a huge difference. But are you also leveraging some external data?

Because there’s already a lot of data on all of these different patients. Not necessarily the same outcome obviously, but that data itself, AI can give you a lot more insights. And obviously it’s much faster than the traditional way of doing it.

[00:20:01] Ned Swanson: Yeah, no, we’re in the middle of doing a huge project looking at all the patients with diabetic foot ulcers over the past five to six years in terms of what’s a predictor of good outcome, bad outcome, what treatments actually worked.

Our main goal is actually to create a staging system for diabetic foot ulcer patients. So you come into the office day one, based on you as a patient and your wound itself, can we predict your chances of healing, your chances of an infection, an amputation, and your risk of death?

So these are all things that are incredibly linked within a patient with a diabetic foot ulcer. Once they have an amputation, their five year mortality looks worse than cancer. And it’s obviously a sequence of events.

So you have an open wound. The longer a wound’s open, the higher chance it gets infected. Once it gets infected, a higher chance you get amputated. And then your mortality risk goes up.

So, we start to stage patients based on when they walk in the door. ’Cause what’s happening right now in wound care is everyone comes in, and then you get the same treatment for four weeks. And based on how you do in that treatment, that kind of opens doors up to you to other advanced treatments.

When our view is, it should be like cancer, where you walk in, you have your diagnosis, you get your staging system, and then that kind of dictates the treatments you should be getting right out of the gate. Not waiting to see how it goes.

It’s nothing that you would do with any other disease in medicine, treat everyone the same, give them the same rudimentary care, and then decide later, based on how it went, what treatments you should be getting downstream. So I think that’s where we’re gonna be leaning on all the data that exists and then using AI models and whatnot to continually update it.

[00:22:04] Ghazenfer Mansoor: Can you share more on what AI models you guys are using? Is it more of a public LMs, or have you built your own and trained your own models?

[00:22:16] Ned Swanson: Yeah, we’re working with a couple different groups outside of our company. So a couple other companies, one who has the data and one who models it to do this. I think these are all custom built models from the biostatistician group based on their knowledge of wounds with our knowledge and what’s available in the data.

’Cause a lot of these wounds, coming in out of the system, right? If you have sixty thousand wounds you can look at, many will disappear and then they’ll reappear, and you gotta fill a lot of the gaps of the time when they’re not actually getting the care where you can get the data.

So a lot of the models are really to extrapolate what’s occurring in between those time points.

[00:23:02] Ghazenfer Mansoor: And how is technology playing a role in the Polarity Bio business in general, other than AI? Obviously AI is solving one problem. But are you guys technology heavy, or is it more of a still… because obviously the core product is non-software?

[00:23:25] Ned Swanson: Right.

Yeah, I think our team’s pretty small. We have about twenty people in the company. We’re able to pivot and move quickly.

So I would say we try to stay current with technology as it improves and adopt it quickly as a team. I’d like to think that we’re staying on the cutting edge of things, but it’s only to the degree that it actually helps us with the work we’re doing.

We’re not going to implement AI just because we wanna say we did it. But we use it pretty heavily day to day. From as…

[00:24:03] Ghazenfer Mansoor: Okay.

[00:24:04] Ned Swanson: …simple as recording calls and having the minute notes come out, to building documents, building presentations, and everything in between.

[00:24:18] Ghazenfer Mansoor: So looking ahead, what do you think will be the next major leap in biotech, and what needs to happen for those innovations to move from promising ideas into real-world patient care?

[00:24:32] Ned Swanson: Yeah, I really think it is regenerative medicine. I think the word’s been thrown around a lot, and I don’t think it’s been necessarily true to what we envision when we think of regenerative medicine.

But I think as we look towards the future, hopefully we can serve as the beginning of this wave where you can really address any disease, any issue in your body with a true regenerative medicine approach. So we’re starting to see it in cancer with a bunch of different cell therapies. We’re starting to see it in genetic diseases with gene therapies.

And now what we could bring to the table is, if approved, it would be one of the first regenerative medicines for a common chronic condition. So all these other regenerative medicines have really been very focused on a niche area of medicine, whether it’s a genetic disease or a rare cancer.

And I think we could start entering into that phase of doing this for a much broader population with our therapy. So I think all these things are kind of coming together at the right time to push the field forward in this direction.

[00:25:47] Ghazenfer Mansoor: Cool. We have been talking to Ned Swanson, who has shared such a valuable insight with us today. Ned, where can people learn more about you and your work? Is it a website? Is it…

[00:25:58] Ned Swanson: Absolutely. Yeah, you can go to our company website www.polaritybio.com. We also have all the different social media channels where you can learn more about us, and that’s the best way to access more info on us and what we’re doing.

[00:26:19] Ghazenfer Mansoor: Thanks. And we will include those links in the podcast description. Okay, so before we wrap things up, just a little pivot to our rapid fire round. So I’ll ask two, three simple questions, just quick answers. So medicine or entrepreneurship, what challenges you more?

[00:26:47] Ned Swanson: I think entrepreneurship for sure.

[00:26:50] Ghazenfer Mansoor: Yeah, there’s learning every day, but it’s enjoyable as well. What’s one quality every great biotech leader needs?

[00:27:03] Ned Swanson: Need to be humble, for sure.

[00:27:08] Ghazenfer Mansoor: Regenerative medicine, biggest opportunity or it’s the biggest challenge?

[00:27:14] Ned Swanson: I think it’s the biggest opportunity.

[00:27:18] Ghazenfer Mansoor: What’s one health care problem you’d love to see solved in your lifetime?

[00:27:23] Ned Swanson: Alzheimer’s.

[00:27:26] Ghazenfer Mansoor: That’s a good one. What’s one lesson you learned the hard way as an entrepreneur?

[00:27:43] Ned Swanson: Think everything you learn the hard way as an entrepreneur.

[00:27:47] Ghazenfer Mansoor: True, that’s a good way. So one word to describe the future of biotech.

[00:27:55] Ned Swanson: Personalized.

[00:27:59] Ghazenfer Mansoor: That’s a good one. Ned, this has been a great conversation. You have shown us how science, technology, and entrepreneurship can come together to create meaningful impact in healthcare. Thanks for joining us.

[00:28:12] Ned Swanson: Thanks for having me. This was fun.

[00:28:14] Ghazenfer Mansoor: This episode is brought to you by Technology Rivers. At Technology Rivers, we bring innovation through technology and AI to solve real world industry problems. We do this in two ways.

First, by helping businesses streamline and automate their operations, the second by partnering with startup founders, entrepreneurs, product owners to create innovative software products from SaaS to web mobile. A big part of our focus is healthcare, where we built HIPAA compliant software products for health tech companies.

If you’d like to learn more about us or work with us, head over to technologyrivers.com and tell us more about your project. Thanks for listening to Lessons from the Leap. If you enjoyed today’s episode, don’t forget to subscribe and share it with someone who would find it valuable. Thanks.

[00:28:59] Ned Swanson: Thank you.