Revolutionizing the Way People Experience Cancer Treatment with Kate Dilligan, Founder and CEO at Cooler Heads: Audio automatically transcribed by Sonix

Revolutionizing the Way People Experience Cancer Treatment with Kate Dilligan, Founder and CEO at Cooler Heads: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Paul Grand:
Hey everyone, thanks for tuning in! This is Paul Grand on the Outcomes Rocket MedTech podcast. I’m super excited to have you back with us. If you hadn’t had heard of me before, I’m the founder and CEO at MedTech Innovator, which is the world’s largest medical device accelerator. Now you can learn more about medtech innovator at medtechinnovator.org. If you look in the show notes, you’ll find a link to MedTech Innovator’s website. In this podcast, I interview leaders in the medtech industry. I interviewed medtech innovators, stakeholders who are working to improve outcomes. There’ll be a link to the show notes to a post about this episode on LinkedIn, and I invite you to join the conversation. Let us know what you think. I want to hear your thoughts. So my guest today is Kate Dilligan, the founder and CEO at Cooler Heads. Kate was diagnosed with cancer in 2016, and at that time she was an executive at a tech company she helped found after earning her MBA at Stanford. As employee number two, she was a key part of the team, which grew the company to over one hundred employees and raised over one hundred and thirty million dollars from investors. Prior to business school, Kate was one of the top fundraisers for Democratic congressional campaigns. She has a BA from Smith College. Welcome to the Outcomes Rocket MedTech, Kate.

Kate Dilligan:
Thank you so much for having me. I’m really pleased to be here.

Paul Grand:
I am terrifically excited to have you here now for all of our audience. Kate is actually one of the five finalists in the MedTech Innovator 2021 competition out of over a thousand companies that applied to be part of the program, so very excited to share her story with you today.

Kate Dilligan:
I’m thrilled. MedTech Innovator has been just transformational for us at Cooler heads, and it’s such an honor to be a finalist.

Paul Grand:
Well, we’re honored to have you as a finalist, Kate. So let’s start off and get a little background on you. I want to find out what inspires you. So what inspired your work in the medtech industry and founding Cooler Heads?

Kate Dilligan:
I decided to take the plunge and move from tech into med-devices because of my experience as a cancer patient. At Cooler Heads were building the products, content, and services that cancer patients and survivors need to thrive because as a patient, I really identified that there’s a huge gap between the often and, in my case, certainly outstanding care that I got from my doctors. But when it came to side effect management, I was really left to my own devices and it was Google and Amazon, and goodness knows, I was not willing to go down the cesspool of Facebook groups. And so what we’re building at Cooler heads is products that providers and patients can trust, and our first device gets to something that was really important to me as a chemotherapy patient. Our first device is the first fully patient-administered portable solution for scalp cooling, which eliminates chemotherapy-induced hair loss for patients with solid tumors. And this therapy has really been, I almost described as a red-headed stepchild, honestly, of cancer treatment because the current devices are so expensive and so hard to use. And when I was undergoing chemo, I found out that there was a way for me to keep my hair and I simply leaped at it. But it was the solution that I was offered was literally ice packs that were cooled with dry ice that was with velcro on and off my head every 20 to 30 minutes. And you know, at the time I was working in tech and I’m like, so what we’re trying to do is bringing a scalp temperature down to about 68 degrees for several hours during and after chemo. And the best we can do is gel packs like, that’s what we’re doing. I’m like, No. There’s got to be a better way to do this. So I started Cooler Heads as just sort of an idea of like, Hey, could I build a better product? Could I make this product? Could I make scalp cooling the truly scalable standard of care? And we’ve grown our vision to really encompass bridging this gap inside effect management because I’ve been that patient. I’ve sat there and been told that just how sick I was and how bad my treatment was going to be. And there’s just a huge gap in me in the landscape for a company that is addressing these core needs of patients. And that’s what we’re building. And so that’s what inspires me is I’ve been there. So the people who I’m aiming to serve, I relate to their journey because I was in their shoes just a couple of years ago.

Paul Grand:
I’ll tell you some of the best companies that we’ve seen come through Medtech Innovator over the years have had that same kind of I want to fix myself or I want to fix something that that was affecting me personally. I knew there was a better way. So that’s really terrific that you have that kind of a journey here as well for yourself. So let’s get a little more specific on this particular product. So tell us about the product and specifically what unmet need then is it addressing, you know, tell us how it works and how it’s better than what’s out there.

Kate Dilligan:
Awesome. So scalp cooling, as I said earlier, it’s medically induced hypothermia. So you have to bring the patient’s scalp temperature down to sixty-eight degrees before, during, and for two hours following each chemotherapy infusion, so the patient is going to be wearing this thing for between four to seven hours on average. And there are devices that have been cleared by the FDA, but the challenge is with them is fundamentally threefold. Is A, they are really expensive and the reimbursement landscape is changing, but patients can expect to pay between three and eight thousand dollars. But for the infusion centers, these devices are administered by nurses at the infusion center. And so this is actually a huge problem for them and why only about 20 percent of infusion centers in the United States offer this therapy. Because if you think about it, it’s before, during, and for a few hours following each chemotherapy infusion. Will infusion centers get paid by providing infusions to patients, not having patients take up valuable infusion center resources like that chair, and just sitting there doing this alternative therapy and tying it to nursing time. So this is a huge barrier to adoption. And then lastly, the fit is a huge problem with the current solution. So, you know, this is a podcast. And so I don’t think people are going to see us, but I can guarantee anybody who’s listening to us. We all have different shaped heads. Heads are oddly shaped spherical objects. And so imagine trying to get something that’s rigid, like a gel pack evenly around a patient’s head. Because what happens with scalp cooling as that chemotherapy is coursing through the patient’s blood, it’s attacking all fast-growing cells because that’s what cancer is. And so if you have gaps in the coverage on the head, if it’s not evenly attacked, that chemotherapy goes to those hair cells that aren’t cold enough and attack those hair cells. And so that’s where patients wind up with patchy bald spots. And so what we’ve done is we’ve said, OK, it’s too expensive. It’s a huge throughput problem for providers and it fits very poorly. So what we’ve done is AMA we’ve developed the first fully patient-administered portable device for scalp cooling. So what does that mean? It means that Amma is comprised of a portable cooling unit that basically is the form factor of a wheeling briefcase like what an airline pilot uses. So it’s designed for patients to bring it with them to chemo. And then they put on our flexible cooling wrap, which is made of material so it remains pliant even when it’s cold, which is really important. And then we have an outer compression cap that you inflate with air pockets, with an air bulb, like a blood pressure pump. And so we created a solution that’s easy for patients to bring with them and to quickly put on at the infusion center. But because of that portable cooling system, it has three different power modes. It operates plugged into the wall. And then we use this other magic technology that I’m sure the listeners have heard of called a battery, which once the patient is done with chemo, it enables them to unplug it from the wall and simply continue their therapy as they walk out to the car where it all throughout the car ride and then they finish up their treatment at home. So we’ve solved the infusion center throughput problem. We’ve also solved the cost problem because we’re launching with the product in our pilots at a $1200 flat fee for the duration of chemo. The list price will be a flat fee of $2000, but we’re also solving this crazy variable pricing that’s dependent on how many chemo infusions you have and how long you’re in chemo because that’s certainly impacted me as a patient because I get eight cycles of chemo over four months. My cool cap therapy was incredibly expensive, and I believe as a survivor that if you want to keep your hair, it should fundamentally be one price. And then, as I was describing the problem, we’ve also solved the fit problem. So we really kind of went through and I knew what the patient’s problems were. But in the first year, the company spent a lot of time talking to doctors and understanding what their problem with the device was. And you know, we’re really excited that we have leading institutions like City of Hope and UCSF that are going to be doing postmarket studies on our device because they believe that this is a transformational technology.

Paul Grand:
Well, that’s a really exciting description of what the differences are over the existing standard of care, the existing, you know, options for patients. So when a patient is using this at home, they could do this on their own time, on their own schedule. They don’t have to, as you said, block out four hours or whatever to go over to the infusion center. It’s a different, kind of schedule. So I understand the value prop and tit’s still as effective as it would be, right? And you’ve already proven that in your work to date?

Kate Dilligan:
Yes. Yes, we have. So where we are, the device is very close to being cleared by the FDA. So I’m sure there are going to be a lot of medtech geeks listening to this podcast and this is a class two, 510 k And we submitted our five 10-K file in May, and we got two questions back from the FDA on our files, both of which we’ve resolved. We’re just finalizing the test report on one test they asked us to. Well, one test that we decided to rerun to be as thorough and our response to their question that they had. So we got our additional information letter on day seventy-one of the 90 day 510-K process that we feel like we’re right around the corner and we have solid answers to that. And just one thing I want to mention to what you were saying, Paul, about the different use cases behind our device. You know, there are some companies that are looking at doing, how do we do in-home chemo? Like, how do we take chemo? And, you know, we saw that with COVID. I heard stories of people doing chemotherapy in their cars like literally, hospitals were having people do chemo in their cars at the beginning of the pandemic when everybody was just trying to get their sea legs. And so as chemo is transitioned like dialysis out of these centralized locations, we’re there with Amma to provide patients with this therapy that’s so important to their overall quality of life and well-being, wherever they’re getting treatment.

Paul Grand:
So I have to ask, Amma, where does the product name come from?

Kate Dilligan:
So Amma came from a couple of brainstorming sessions with some very good friends, and it turns out Amma means mother in Tamil. And so we were looking for something that was accessible and kind of would connote strength. And I want to clarify for anybody listening, you know, cold therapy is appropriate for men and women, but I think most of us have an affinity for our mothers just as a sort of like comfort and strength. And you can do this and you can get through this. And so it was certainly not met with any cultural appropriation, but just sort of a nod to as the cancer patients, chemotherapy patients really kind of want that overall sense of security and strength. And that’s how we came up with the name.

Paul Grand:
It’s a great origin for the name. It makes a lot of sense to me. So you have talked a little bit already about how the product is better than what’s out there today. I know in building a product, there are always setbacks, there are always things that come up that you can’t expect, right? I know there are things that happen. I’m sure you’ve iterated a lot on this device. So maybe could you share with us, you know, in that journey where there are any setbacks and how did you overcome them? What was the key learning?

Kate Dilligan:
Gosh, several. You know, the key learning that I have is, you know, throughout my career after I left politics, I went to business school. I co-founded a company that you were talking about in the description, and I wound up leading a business unit that was building digital signal processing solutions for the intelligence community. Now stick with me because I am going to your question. Paul and I had never worked in the intelligence community before in the classified space and on government systems that were processing battle space data. But what I learned was to surround myself with subject matter experts and to ask a lot of questions. And so I take the tack as a CEO that I am not the person that has all the answers. I’m the person that asks all the questions. And I think that that’s been really important to my success of going from working in tech, working in politics to now being in the med device space is surrounding myself with a group of advisors who have been there, done that successfully in the past. And I think as a first-time founder, it’s been incredibly helpful for me to have that mindset of always being willing to ask the follow-up question and not feel ashamed about it. You know, one of the great things about Medtech Innovator is we do these weekly seminars with subject matter experts on a variety of subjects, and it’s been great to be able to just throw out questions to other people. So I’ve always kind of kept that as one of my core tenets of how I run the company. And then the other one is always have a fallback position. And so always think if Case A doesn’t happen, then what do we do about Case B? So something that went wrong is with our alpha units, we had significant housing problems like the housing was cracking and really wasn’t just a strong enough polymer for that portable suitcase unit that I was describing earlier. And so and the engineering firm that we were working with, we got together and we just started asking root-cause questions and asking questions of the vendor and not really taking it’s good enough for an answer. And so being able to really dig into the usability components of it because for us that housing is really important, having a secure handle, having a secure framing for this machine that’s going to be taken in and out of cars and having infusion centers was really, really important. And so that was really, really key. And then on building the team front, because that’s the other thing that you have to do as a founder is there were somebody that I wanted to bring on as a business lead, and it turned out that the negotiations just weren’t going well and it just wasn’t going to be a good fit. But we haven’t filled that position yet. But I have three other candidates now in the wing because I refuse to be married to just one solution. And so always being willing to look around the corner and figure out, OK, well, if not this, then not that like not letting myself be trapped or be like, it has to be this way. So that flexibility and being willing to ask questions down to the root cause is what’s allowed us to get here.

Paul Grand:
I just have to take a second, Kate, and just acknowledge what a great piece of advice that was for the listeners here. So being able to look around corners, see things that might be obstacles or might be failure points, and planning those backups is so important, so it’s great that you were able to do that, I know you weren’t a first-time founder, so you know you had a little experience on the tech side before to guide you along.

Kate Dilligan:
But med-devices, it’s a different space. It’s a different space.

Paul Grand:
It really is. And that usability piece that you mentioned is also, so important, you know that it’s, you know, this is something that you were you were developing as a solution for you in some ways, right? Because you’d been there. But there are thousands of other people that have to use this product who have a different life than you and a different lifestyle and everything else. So again, you know, designing something is going to work for them that has the durability, you know, oh, those are all such key things. Especially you’re tackling a challenge, by the way, Kate, that a lot of people haven’t had a tackle in the med-tech space, which is a device for use in the home. You know, a lot of people, right? A lot of people are building devices and this device is for use by trained professionals in a hospital setting or in a care setting. And you know, that’s the expectation. These people have probably been trained. They’ve read the manual, et cetera. They’ve done it thousands of times. Now you’re giving something to a consumer and saying you need to use this the same way a trained professional would be using that product. So that’s I know, an added challenge, any learnings from that that you want to share as well.

Kate Dilligan:
So, you know, getting back to, you know, finding experts. So again, this is getting into med device geekdom, but the FDA has very specific guidance about what they call human factors testing, which is fundamentally Paul exactly what you’re describing, is the Usability and what are the failure modes. So if somebody uses this wrong, what is the worst thing that can happen? I’m very grateful to the FDA as somebody who’s had a lot of medical care in my life. I’m not trying to pin them as the enemy. This is the entirely appropriate thing for them to do. If somebody doesn’t use it correctly, what is the worst outcome that we’re fortunate that for our device because there’s going to be a lot of consumer devices or I would imagine there are very few consumer devices, I should say that would be like a class three devices where if it was used correctly, it could cause permanent damage or, heaven forbid, death. And so for us, what happens if the device isn’t used correctly is that you get ineffective therapy. Well? Well, that doesn’t take somebody from stage two to stage three cancer. For me as an entrepreneur, that is a disaster as a business outcome. And so we really took to heart our human factors testing and we found an absolutely fantastic firm here in San Diego. Mindflow Design. Happy to give Chris Ross that shout-out. His team was fantastic to really walk through what is the use-related risk analysis? And then how do we bring in a group of people to try the product and walk through the use case that are representative of chemotherapy patients? So we recruited a test population of people who had digestive distress, that had depression, that had pain disorders, that had sleep problems because we were trying to find people that that weren’t well, because chemotherapy patients aren’t well, those are all very common attributes of chemo patients. So really taking that human factors, testing seriously early, and doing iterations on the usability, which is where we found out the problems with the housing and the handle early on. They’re like, OK, we’ve got to fix this. This is just going to be a really big problem, really digging into that because a lot of entrepreneurs I know rail about the guidance. But if you really lean into it and be like, how do we solve the guidance is trying to get us to do it this particular way and we lean into it. We’re probably going to wind up with a better product, which is what we did.

Paul Grand:
Yeah, great advice. I completely agree with that. Lean into that guidance. It’s there for a reason and it will help you in your process. It’s not designed to hold you back. It’s designed to help you have a better product. So great advice. Let’s go back to that FDA one more time. I want to just again point out for our listeners. So I know you, as you said, you’re getting close to an FDA clearance for this device. That’s really terrific. So tell us a little more again about that process and anything else that’s been exciting for you at this moment.

Kate Dilligan:
I’ll say so our first. So shout out to Alison Komiyama, our acknowledged strategist here in San Diego. Again, Alison and her colleague Pierre have really been holding my hand throughout this FDA process. And so we decided at the beginning of productization to start talking to the FDA early. And so before we really started formalizing any kind of formal development of the product, we had this really terrible prototype. But we did a pre-submission and we went and Pierre and I flew to Maryland and we went we met with the FDA in person. Remember that everybody when we could do in-person meetings, it was great. And what was really exciting for that first interaction with the FDA is having three medical oncologists on staff at the FDA saying this product is needed. We get what you’re doing. And they gave us a lot of really constructive feedback and they’re like, We get it, we’re on board. These are things that we’re going to want to see. And so really kind of using that as our touchstone or our guiding light. And so back to the human factor testing, we did another pre sub last year to say, Hey, FDA, we heard your guidance on that first meeting that you were going to care a lot about our human factors testing. This is what we’re thinking about. What do you think? Got that feedback rolled that into what we actually did as part of our testing process. So I really view the FDA as a partner. I’m sure there’ll be things that don’t come up in the end that’ll make me unhappy at some point. But again, at my previous company, when I was working in the intelligence space, we had incredible government oversight because it was all designed to keep our national security safe. The FDA oversight is designed for us to keep patients safe. And so by having that as sort of our touchstone, I mean, we’ve been successful. But you know, yesterday there was a webinar that you led Paul about, about market access and how do you deal with repair strategies. And one of the pieces of advice was to start talking to payers early, start thinking about that early start talking to the FDA early because it really guided decisions that we made and allowed us to be much more capital-efficient and time-efficient. It’s allowing us to get into the market faster.

Paul Grand:
Wow. Great to hear that that went so well. And I’m saying, wow, because this is something you know again, for someone who’s a first-time CEO and a medtech company, you know you’re making a lot of the right choices. Kate, which is really, of course, one of the reasons why we picked you for med tech innovator in the first place. You know, you were checking all the right boxes and executing well, and we wanted to make sure you’d be successful. And that was the whole reason for picking you to be part of the accelerator and the advice that you just gave about the FDA and pre subs, talk to them early. That is just what I tell people all the time. Don’t think of FDA as a barrier. Think of them as your partner. They want to get this technology to patients as badly as you do and to be sitting there, as you said, with a bunch of oncologists who could look at you and say, this is really needed, we want to help you make sure you do this right. That’s really what this is about. So that’s really great. You had a great attitude and you’ve always had a great attitude. But really, you know that that really makes such a difference in how you just look at the FDA and how you look at this process. So so that’s really great to hear. So we’ve talked a lot about your technology and what you’re doing and all the things that are going on. I want to make sure we take the opportunity now to kind of reflect back on the conversation before we conclude here. I’d love to have kind of a closing thought from you that everyone can think about that you want people to take away again from your experience or what you want people to take away just about Cooler Heads and about the opportunity, or maybe inspire somebody to be an entrepreneur or whatever you want to do now. I’d love to hear that from you. And then also let us know where Outcomes Rocket listeners can get in touch with you.

Kate Dilligan:
Absolutely. I founded Cooler Heads because I was a patient, but I was also fortunate enough to be surrounded by people who told me I could do it. And so having done a different tech startup, having an MBA, like work in politics is fundamentally entrepreneurial. Like the thought of it wasn’t overwhelming. But then you’re thinking about like, am I going to go out and raise money? Because when you’re super early-stage founders, you’re asking people to invest in you like they’re investing in an idea. And so I would just want to encourage and hopefully inspire people to take the risk and do it. And as I’ve done, just start asking questions, find people because people are happy to give advice. Advice is free and find people that are in the space and just start asking for advice because those early people that I asked for advice are now on my cap table and have been transformational as I build the company. I will say as a cancer survivor, I will say that I view things very differently now. So when things go wrong with the company, I’m like, OK, well, how are we going to fix it? I think I take a very different view because I’ve been in that medical oncologist’s office and told I had a potentially life-threatening disease. So I think that helps, too. But I would really encourage people to take the leap because the things that I regret in life are the things that I was too chicken to do. And so it’s Hard. But when you look back like this was an idea that I had at the beginning of 2018 and we will have something making a difference in the lives of patients next year. Do it. There’s no other. You’re the master or the mistress of your own destiny and would love to talk to anybody who wants to reach out. I’m very easy to find it. Kate Dilligan on LinkedIn or Kate@coolerheads. Like all one word. Very, very easy to find.

Paul Grand:
Super inspiring story. I’ve been inspired since the very first time I heard the story. And by the way, like you mentioned, I heard it from a lot of the people who you’ve been talking to and who probably are in your cap table, as you mentioned on your capitalization table, meaning they have stock in the company now because they believe in you and they believe in what you’re doing. And you’ve been lucky along the way to have some of these really great people that you found and they’ve joined you in your mission. And in the same way, you know, those people reached out to me in advance after you applied to Medtech Innovator to say, Hey, I know Kate applied, you’ve got to take her. She’s incredible. What they’re doing is incredible. You’ve got to work with this company, so I could not be happier that you were selected to be part of our finals competition, which is just such a huge thing, you know, at the end of the year

Kate Dilligan:
I’m thrilled.

Paul Grand:
Yeah, no, I’m thrilled, too. I was thrilled as you are, trust me because we look back and we look at this process where literally we started with 1100 plus companies and to get down to the five finalists, it’s really hard because, you know, hundreds of those companies were terrific. And so to get to the five is just, for us, kind of agonizing because we want to put everybody on that stage, and eventually, we make it down to this to the top top five and to see you in there after having such strong support going in, you know, is just really, really thrilling for me. And I know the people who have been supporting you, who reached out to me are going to be very happy, too. So I’m thrilled that you’re not only part of MedTech Innovator forever as part of our family, but that you’re also a finalist. And I want to encourage everyone who’s listening. Go to medtech innovator.org. You’ll see on the top of the website you’ll see a banner about the finals. You can click on that. It’ll take you to a place you can subscribe so we give you a notification just like, you know, signing up like an Eventbrite kind of form. We’ll tell you when the finals are and you’ll be able to tune in and be there live as Kate is competing for the first prize, which is $350,000 dollars nondiluted funding. So make sure you do that. And again, Kate, I’m so happy to have you here. I love this discussion of hearing the story and you’re just a terrific person. Everything we look for in an innovator so thanks for being who you are and thanks for doing what you’re doing.

Kate Dilligan:
Thank you for this opportunity, Paul. I’ve gotten so much out of this community, so I’m incredibly grateful. Thank you.

Paul Grand:
You’re welcome and thank you again. And for those who are listening, again, I want to point out that Kate is someone who has done exactly what she said. Not only has she built an amazing network of people who support her and who are there to join her. But during Medtech Innovator, she’s reached out to people for resources. She’s been on every one of our webinars asking questions. She’s taking advantage of the opportunities, and I would encourage you to do similar things in your life. Whatever resources are out there, take Kate’s advice. You know, you’ve got to just jump out and do it. You can’t sit back. I love what you said, Kate, about, you know, the things that you would regret are the things you were too chicken to do. Don’t be chicken. Yeah. Jump out there, you know, and take advantage of those opportunities because you can’t take it back, right if you miss those opportunities. So again, that’s what being an innovator is all about and why I was really happy to feature Kate today. So thanks again, Kate.

Kate Dilligan:
Thank you so much.

Paul Grand:
All right. So for all of you who are listening, that is another one of our terrific guests here on Med Tech Innovators Outcomes Rocket Podcast. We are thrilled to be able to feature innovators, leaders, stakeholders in the industry, as I mentioned. Make sure you look for our post on LinkedIn. We’d love to hear your thoughts. Join the conversation. Get to know Kate as one of our guests. You can just look her up on LinkedIn and reach out. We’d love to hear your thoughts, so watch for this episode to be posted on LinkedIn and join the conversation and also make sure you tune back into Outcomes Rocket MedTech and just Outcomes Rocket in general. We also have our nursing discussions. We have discussions on pharma, we have discussions on health tech, we have discussions on just the general things that are affecting everybody in our industry and hearing both success stories and advice. It’s really a place that I was as a listener for many years before I joined as a host, so I hope you’ll join us and we’ll look forward to seeing you again soon. Thanks, everyone.

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