Radio Cade

A Readily Accessible Device for Autotransfusions

May 05, 2021 Carolyn Yarina Season 3 Episode 36
Radio Cade
A Readily Accessible Device for Autotransfusions
Show Notes Transcript

When Carolyn Yarina, today's guest, walked into her university's Center for Entrepreneurship one day as an undergraduate, she was convinced that she would never become an entrepreneur herself. "I remember tapping my foot, being impatient," she recalls, laughing, "I couldn't wait to get out of there, thinking that entrepreneurship wasn't for me." Fast forward to a few years later, and she is now the co-founder and CEO of Sisu Global, a company that is committed to providing medical technology which enables healthcare for each person in their own community. 

In this episode, host Richard Miles sits down with Yarina to learn more about Sisu Global and more specifically, Hemafuse, the company's handheld, mechanical device for intraoperative autotransfusions, designed to replace or augment donor blood in emergency situations.

Richard Miles (00:00):

Inventors and their inventions. Welcome to Radio Cade, a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We'll introduce you to inventors and the things that motivate them, we'll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace. Blood prints, you can save lives, but what if there's a shortage of blood? A handheld auto transfusion device can now help to solve that problem, whether in low tech countries or on the battlefield. Welcome to Radio Cade, I'm your host, Richard Miles, and today I'm pleased to welcome Carolyn Yarina, the co-founder and CEO of Sisu Global, which is dedicated to bringing medical technology to each person in their own community. Welcome to Radio Cade, Carolyn.

Carolyn Yarina (01:02):

Thank you, I'm very glad to be here.

Richard Miles (01:05):

So, we usually like to start by explaining what exactly it is that invention does and how it works. But before we do that, let's take one step back and talk a little bit more about giving blood and using donated blood to give listeners a sense of perspective in terms of demand and supply in the global blood market. I'm sure there's a better term for it, but let, we'll just go with that for a moment. So for instance, can you give us an idea, Carolyn, of how many units of blood are gathered every year in the United States and is all of that used up? And then, do we have figures for a global supply and demand?

Carolyn Yarina (01:38):

Yeah, absolutely. So across the globe, we're pretty used to donor blood of when a clinician reaches for, for a blood bag. You walk in, typically it's there in a place like the United States, and something interesting is blood costs about $250 to process each unit here, and globally, it's about a hundred dollars per blood bag, and something I want to do a shout out to everyone here is that during the COVID-19 pandemic, we've seen an increasing severity of the global blood shortage. So, I encourage everyone to go donate blood. It's really important and really lifesaving to our friends, family, and community. So in terms of donor blood, there is a global blood shortage of about a hundred million units of blood each year, which means that when a clinician reaches for that blood bag, especially in emerging markets, especially within say the military, that blood bag isn't there, which means that surgeries can't even start, patients can't be treated. And so that's why it's so important that we give blood.

Richard Miles (02:31):

And so in those situations, it sounds like the prognosis would probably be pretty grim. I'm sure not all of those situations result in death, but probably complications or some real hair raising experiences, as you're trying to get blood to that person, whether it's on a battlefield or an area where there's just not availability, but what would your alternative be, right? You're just trying to wait for a helicopter to take you to a place where there was blood. I imagine, right?

Carolyn Yarina (02:55):

Well, depending on the scenario, right? So in a military situation, maybe you have a walking blood bank, and so other soldiers will donate blood on the spot, but just to a fellow soldier. Of course there is reduced reaction time for that in terms of availability and safety and possibly e-back. If there's time for that, noting that we've heard maybe about the golden hour, which is that the importance of getting treatment and care immediately. So the implications of not having bladder, one is delayed in terms of that treatment and that care. The second is, in many places, take, for example, Kenya, there's a shortage of over 50% of the blood that's needed. And so if the blood isn't there, you know, option one is a delay, especially rare blood types. They can take eight hours to get one unit of O negative blood, which is a rare blood type. Two is sending patient to a different hospital that might have blood. And three is perhaps surgery is delayed or canceled and there is the possibility and likelihood of loss of life when you don't have access to that lifesaving blood, especially in a trauma where you need that blood back immediately.

Richard Miles (03:58):

Yeah. Clearly situations in which shortage of blood is really a critical component in the outcome. Your company actually has two products. I've just talked about one of them at the top of the show, Hemafuse, for blood transfusions, but then you also have something called (r)Evolve, a blood centrifuge. So, Hemafuse. What does it do and how does it work?

Carolyn Yarina (04:16):

So at Sisu Global, we design medical devices that operate anywhere. There is a surgeon. And in fact, the name of our company, Sisu meaning persevering in the face of adversity as we designed medical devices for those that persevere. So within that space, of our first in our flagship product team is a device that operates on the idea that your own blood is better than someone else's. So this device operates where if the patient has blood that's pooled internally--that could be from planned surgery, it could be from a trauma, but it's still good blood, just not transporting oxygen and nutrients--Hemafuse can capture that blood, filter it and give it back to the same patient in the same surgery. So they don't need someone else's. And what's unique about this product is that it's a handheld mechanical device that can operate anywhere. There's a surgeon, even Medtronic has called it a technology that leapfrogs their own due to its ability to operate, regardless of infrastructure. All it requires is a surgeon and a clinical team that can operate surgery, internal bleeding, and a sterile surgical field.

Richard Miles (05:19):

Alright, talk about (r)Evolve.

Carolyn Yarina (05:20):

So, (r)Eevolve is another product in our portfolio. So we have five devices in our portfolio, kind of on the same theme of designing medical devices that can operate anywhere. There's a surgeon, our product, (r)Eevolve, is in an earlier stage but also patented just like Hemafuse, and it's a device that can separate blood with or without electricity. And this is incredibly crucial for diagnostic testing, and also with just a centrifuge, you can do an immediate cross-match it's called, which is telling if one person's blood is compatible for another.

Richard Miles (05:51):

So Carolyn these products are clearly meant for an environment in which blood is hard to get. There's an emergency, and it's like sort of the best available technology. Is this something that could be modified or are you already working on a version that could show up in any hospital, and it simply replaces the standard of care simply because it's cheaper and easier to use?

Carolyn Yarina (06:12):

That's a great question. So in regards to technologies we create, we believe in following world-class standards, and the testing for Hemafuse followed ISO standards. We follow the American Association of Blood Bank, the AABB, guidelines for auto transfusion. For those of you who don't know what auto transfusion is, it's the process of using a patient's own blood to save them, whether that's donating in advance of a surgery, or what we focus in is, is interoperative or during surgery auto transfusion, which is capturing blood from internal bleeding, filtering and giving it back to the same patient. Now we're not the only ones in this space. There are other companies that can do this process. And for anyone who's doing surgery, of having surgery done, it's something definitely to consider to get your own blood back. Hemafuse, we do see a role across the globe in regarding to providing blood access, giving a patient back their own fresh whole blood immediately during a surgery. Here in the U S there are a couple of options to do this in areas that maybe don't have wall suction that want to have a device that is faster and designed around trauma, where our device can be assembled in less than five minutes. It doesn't require a specialized perfusionist. It definitely is a tool that could be used anywhere. We're actually going through the USFDA right now, which means that Hemafuse will be available. And where we see the most important market for Hemafuse in the US is with the US military, to provide access to that blood, but also in disasters, in inner city hospitals to provide blood back to the same patient are all areas that this device can be really important to increase blood access and give patients back their own blood.

Richard Miles (07:51):

So Carolyn, like a lot of great inventions, the core concept here is relatively simple, and the device itself is relatively simple to use. And a lot of times people look at things like that and they go like, well, I could have thought of that, but they didn't. Of course, you did. And you are a chemical engineer by training, right?

Carolyn Yarina (08:08):

I am, yes.

Richard Miles (08:10):

Okay. So you're not a medical doctor, right?

Carolyn Yarina (08:11):

I am not.

Richard Miles (08:13):

So tell us about that story. How did you have this idea and what prompted you to go a step further? A lot of steps further than just thinking of a good core idea and actually developing it and taking it to market?

Carolyn Yarina (08:25):

That's a great question, and with any great story, it's not just an individual, it's a team that's behind that. And so the brains behind Hemafuse is my co-founder, Gillian. So she's mechanical engineer. We actually know each other because we founded two companies at the same time. We like to say, we entrepremiserated with these prior organizations. She founded a medical device, design firm focused on Ghana, and I founded a nonprofit working with rural mobile clinics in India. My story is that I became disillusioned with the non-profit model for medical device development and saw the opportunity to design medical devices for the growing middle class in emerging markets. And at this time I reached out to Gillian and with her medical device design firm. So she's the inventor of Hemafuse, had come up with this brilliant idea with doctors in Ghana. Hemafuse is actually the first medical device to be invented in collaboration with doctors in Ghana and then cleared by the Ghana FDA. And so that's really important. Her inspiration was combining the safety and effectiveness of global standards on auto transfusion with simplicity and innovation of what really amazing clinicians in Ghana do when blood runs out, to do different techniques, to manually perform auto transfusion, scoop blood out, filter it and give it back to the same patient, but with more rudimentary tools. Even though there is plenty of investment of top tier hospitals, there's just a gap of technology in this space, and that's what we're looking to fill and really change that statistic, that 80% of all medical devices are designed for 10% of the world's population. We want to make sure that each clinician has the tools they need to save lives.

Richard Miles (10:06):

So a couple of questions immediately jumped to mind. One, how did you meet Gillian? Did you both go to the same school or was there a personal connection, or how did you come in contact? And the second one, you mentioned that you were unhappy with the nonprofit model of sort of medical technology, medical devices. So let's start first. How did you meet Gillian?

Carolyn Yarina (10:23):

I knew each other from college. We both are engineers, alumni of the University of Michigan (go blue), and we both have some roots there. I founded my first company at the University of Michigan while getting my engineering degree, was named entrepreneur of the year. Jillian as well has roots there. We did have an entrepreneurship practice together in our university days, and we became friends, colleagues, and eventually co-founders and building this organization.

Richard Miles (10:50):

Great. So second question then, what was it about the nonprofit model in the medical device space that you did not like?

Carolyn Yarina (10:58):

So I think one of the things of building a company, it's important to understand your customer, right, and to fill the medical device, build opportunity. And when something is paid for, you really know it has value. And so within building a for-profit company focused on the growing middle class, there is a lot of money being spent in healthcare in emerging markets. Healthcare markets in Africa are growing at 10 times the rate of the healthcare and medical device markets here in the United States, and there is a large opportunity there. And so by focusing on a for-profit model, we can create a scalable business that not only reduces overall healthcare system costs, but it makes money at each phase of the supply chain to incentivize the company itself with high margins on our products that incentivizes the manufacturers, the distributors, and that ongoing supply chain. And then finally in the hospital of the businesses of saving lives, but needs a strong bottom line there too. And so with the for-profit model, we can do all this. We can create strong returns, we can create a strong business. Whereas the non-profit, there is a lot of spaces where the non-profit model is really important, but when you're talking about an intensive R&D organization that requires a lot of upfront investment and requires us to consider that customer in mind and that supply chain in mind, our incentives are best aligned when we're focused on the customer, rather than focused on what the donors might think or require. And an example of this, of my first organization I founded, we created early prototypes of the centrifuge made out of bicycle parts for use in India, which turns out is a terrible idea, but won a lot of competitions and awards for this. And it was by spending time with the patients, with the clinicians within that ecosystem that we saw the importance of in the dignity of the health care infrastructure that required a substantial investment, but also saw the opportunity for a substantial return on that investment. And we know that when we exit for Sisu, and we provide our investors that strong return back that they'll be able to invest that in the next Sisu, and the next, creating that ecosystem and changing that overall statistic of how medical devices are designed to be commercialized.

Richard Miles (13:15):

So Carolyn, the two markets that you've described so far, the military, and then also developing world, I would guess that those are not the easiest markets to break into. This is harder than just going on Amazon or eBay and listing your product for sale, right? So what was your initial pitch like, or who made the initial contact say with, assume you started with somebody at the Pentagon or somebody in that world, how did you get your foot in the door? And what was that pitch like?

Carolyn Yarina (13:39):

The biggest advocate for our product has always been the clinicians, who are performing surgeries, who see the need, who are struggling with access to blood. As an engineering background, we know that when we see duct tape and super glue or the equivalent thereof, we know we have a real problem that we're solving. And there is the equivalent to that within clinicians in the healthcare space that are trying to perform auto transfusion when there is no access to blood without having the proper tools to do so. And this is military clinicians, this is emerging market clinicians. This is even occasionally in more developed countries as well of if you need blood, you don't have blood, you don't have any other tools designed for that space, what do you do you? You improvise. And so in developing our product and launching it, we've made sure to bring clinicians along for that journey, knowing that our core expertise as an organization is the engineering side of things, the medical device, to support that. And it's the clinicians who are actually doing the life saving activities with the help of our tools. And so we've really gone from the ground up of having those clinicians advocate our product to administrators, advocate to government officials. And that's how we've gotten the endorsement and the tremendous recognition and awards that we have that built up our credibility, and then from there has allowed us to get bigger and better partnerships and contracts in further awards and building that ecosystem, that cycle to scale up what we're doing.

Richard Miles (15:01):

And I know that both you and Gillian have spent a lot of time in Kenya. Tell me what that was like. Were those all days, again, most of your time spent with clinicians or were you working with government officials or other non-profits? How did that unfold?

Carolyn Yarina (15:13):

So in launching our medical device that you heard me already say of the importance of the whole supply chain. So each of those steps and those partners are really important for scale. So we think of our scale as a three-stage model and that's something that we sell to distributors, right? And their entry, they first have sold into more early adopters within the space of more private sectors, those hospitals that can make quicker decisions. And then we've phased into more public sector, getting recognition, gotten recognition from the first family of Kenya, the first lady in particular, and we've also gotten, uh, listed under the Kenya medical supplies authority, which is the government monopoly for sales into that government system. And then the next phase is going to be where Hemafuse is adopted at a policy level. So that's the next phase of the recognition of the importance of Hemafuse in that blood ecosystem and how it can address that blood shortage to become a nationwide product. And that's the model that we're following, not only in Kenya, also our discussions in Ghana, and as we have our negotiations with distributors for new countries, that is how we'll scale. And we've built this model and built our partnerships by first doing things ourselves, working with clinicians, working with advocates, negotiating, and establishing smaller partnerships and leveraging those to establish larger and more well-connected organizations to the point where in Kenya, we're sold through the largest medical device and pharmaceutical distributor in the country. And we're in partnership with Africa's largest Africa based healthcare NGO, which is called Amref. And these partnerships are really key in terms of our expansion in Kenya. We have similar partnerships established and in negotiations for other markets as well.

Richard Miles (16:53):

That's a great and very impressive story. You've mentioned earlier, this isn't just you, it's a team. Tell us a little bit more about what it's like to grow your own company, because again, you're trained as an engineer, but starting companies, obviously a lot more than just coming up with a great idea and watching it succeed. You have to hire good employees, you have to manage good employees, you have to attract investors and so on and so on. What is that process been like? Has that been cold shower, so to speak in terms of an experience, or did you have any sort of business or management training before taking these companies on?

Carolyn Yarina (17:28):

It's an interesting question. So we've developed this, you noticed as a team. So I've been really fortunate of the leadership of Sisu is myself, Gillian, and then also Sajju Jain is the third counterpart to that, our COO. To give a little bit of background with him is I've known him for about a decade. We worked together in India at a company called Embrace, which is a medical device company in India, and he was on our advisory board. And then we recruited him for a six month project. And then four years later, he's still our COO and still is stuck with us. And so for all of us, the big piece here is recognizing that there is no silver bullet in terms of this. There's no magical step that you achieve, and then it all becomes super easy and fast forward. You've heard with entrepreneurship, I'm sure of jumping out of the airplane and building the parachute on the way down, where we're building, as soon as we've grown and learned how to take our idea through 3D printing and testing and design for manufacturing and manufacturing it, and then going through testing and regulatory, and then launching that into sales, or even before that clinical study type or clinical pilot in our case type work into sales and partnerships and expansion. It's a lot of steps, a lot of different skills along each way, which is where it's been really important to us, where we have a core lean team. And then we find the best in class partners who are already doing these steps to partner with us for each phase, so that we are not learning everything ourselves. We're relying on experts at each stage, and then making sure we have great team members, and our team spans continents. At this point, we have our headquarters here in Baltimore, in the United States. We have team members and partners over in Kenya, and also more recently Ghana. And our COO has roots within India, opening doors and connections on the operation side, but also preparing us when we're ready for launch in that market as well. And we're also looking into this for our further expansion establishing further, who are the right partners who are going to help us scale faster and more effectively as we grow and recognize that we don't need to do everything ourselves, because we know that where our core expertise is, is on this technology.

Richard Miles (19:41):

So Carolyn, our listeners are always fascinated or interested in the origin stories of the entrepreneur and the inventors themselves. And you've described yourself as having had a busy and wonderful childhood. You were involved in all sorts of sports, you were involved in 4H, you were president of the Wooly Cow 4H club, which has gotten quite an achievement. One of our earlier guests last year was the president of the national 4H council. And so I learned a lot about 4H and the 4H system in the United States. Tell us what it was like growing up in your home. What point did you know instinctively or were you told that you were a born entrepreneur and that's kind of how you wanted to spend your life?

Carolyn Yarina (20:18):

I grew up on a sheep farm in the middle of nowhere in the upper peninsula of Michigan. And I've always been really great at selling things, whether that's my family members or related to a farm. And I didn't know I wanted to be entrepreneur. I knew I wanted to be an engineer, and I had a chance to have a global perspective before college. I took a gap year. I lived in Turkey for a year, and I also now speak Turkish after living with a family that didn't speak any English. And when I went into engineering school with some of that global perspective, I had an engineering class project where we designed a centrifuge that could work without electricity. It was actually my freshmen engineering class project. And at the end of that with one of my group partners, so we did create first a club and then a company around that idea of a centrifuge that could work without electricity, to separate blood for diagnostic testing. And that was sort of the route. I actually remember the University of Michigan, going into the Center for Entrepreneurship. I remember tapping my foot, being impatient. I couldn't wait to get out of there, thinking that entrepreneurship wasn't for me, but fast forward now where I've founded my own company out of college, I'm on to company number two, I've received plenty of recognition and awards ranging from Business Insider Entrepreneur Magazine, I was in Forbes 30 Under 30 as well for the work that we've done. And I'm really proud of all of my own and my team's accomplishments in this journey, and I'm really glad the circumstances that made me realize that entrepreneurship is how you really make things happen, and you change the status quo.

Richard Miles (21:55):

Carolyn, do you remember some of your earliest influences, obviously you were very active were either of your parents, entrepreneurs or engineers or doctors. And did you have a teacher or coach that gave you some really good advice early on that you still remember?

Carolyn Yarina (22:09):

I would say my parents were entrepreneurs, not in the typical, full startup sense, but in charting their own paths and what they did. My mom founded the local audiology practice in my home community, kind of built that from the ground up. My dad, computer engineer turned paramedic, and had some roots working with a number of startup companies, so we can talk about that as well. But for the entrepreneurship path, really, I give a lot of credit, I'm also a product of the University of Michigan entrepreneurial ecosystem, because I didn't realize that was a path or an opportunity for me until I went through a lot of those programs, classes, coaching, realized that this was what I wanted to do and give me the opportunity to take MBA classes when I was going through my engineering program on top of probably working 40 plus hours a week on this company that I founded at the same time of getting my chemical engineering degree and those awards and competitions, including being named Entrepreneur of the Year at the University of Michigan, helped give me that encouragement and a bit of seed capital that allowed me to launch my company full time, learn those lessons, learn by my successes and my failures to get to the really exciting and successful point that we are now.

Richard Miles (23:23):

So one final question you've been doing this long enough to where you probably, as you said, you've had successes, maybe some failures, is there one piece of core advice that older Carolyn would give younger Carolyn in terms of any regrets or things you wish you'd known say when you were 20 that you know now, what would you tell your younger version of yourself?

Carolyn Yarina (23:42):

A hard question, because I think that the important lessons are those you learn through the journey and learn by doing, but if I were to talk back to myself, the knowledge that it takes tenacity and grit and perseverance to go through these stages of entrepreneurship, but that with the right team members, with the right mentors and with those people surrounding me, that success is just around the corner. And there is a lot of opportunity to change the world if you just stick to it and make sure to continue and realize that vision,

Richard Miles (24:16):

Great answer. And Carolyn congratulations to you and your co-founder Jillian and your whole team. And I suspect this probably won't be the only company that you found or you're associated with. It sounds like you've got a lot of ideas that are yet to come out. Congratulations on your success so far. And once you've hit the big time and started your Fortune 100 company, we'll have you back on the show. Thanks for joining us, Carolyn.

Carolyn Yarina (24:37):

Thank you for having me.

Outro (24:40):

Radio Cade is produced by the Cade museum for Creativity and Innovation located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Hardwood, soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.