Immigrant, Inventor, Lifesaver: Rany Busold Talks Biofoam and More

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Breaking BarriersUnsung Women's Project

Welcome back to the third installment of our newest blog series: the Unsung Women’s Project! We’ll be highlighting amazing women in STEM, sharing the stories of all of the incredible, meaningful things women have done in their STEM careers that haven’t gotten the recognition they deserve.

Rany Huynh Busold is the Senior Director of Clinical & Regulatory Affairs and Research & Development at Transmural Systems in Andover, MA. She holds a degree in Biomedical Engineering from Boston University, and has worked in the medical device field for 18 years developing breakthrough technology for unmet clinical needs. Throughout her years of work on medical device technology, she has been granted patents for over a dozen new technologies. Along with “bio foam,” a foam that is injected into the body to slow internal bleeding, she has also helped with developing a minimally invasive transcatheter device for children with congenital heart disease. These technologies can help patients who previously have had no other option for a positive outcome. Before working for Transmural Systems, she held the role of Senior R&D Engineer at Medtronic CardioVascular and Arsenal Medical. She is a Chinese Cambodian and first-generation immigrant, who grew up in New York City and now lives in Winchester, MA with her two children and husband. She spends her spare time renovating homes and traveling around the world with her family.     

In your own words, what is your job, and what do you do?

I am a medical device engineer, and I’ve worked at a small start-up called Transmural Systems for almost three years now. The most straight-forward way to describe what I do is just to say that I make medical devices and then I try to somehow get them to patients. Before I started work at Transmural Systems, I worked at a large company and then another start-up, but now, I’m part of the original members of this company, and we all do everything. We do everything from taking out the garbage, to building the medical devices, to business development, to meeting with multibillion dollar companies.

It seems like the medical device you’re best known for is the “biofoam”.

Yes, but that was a huge team effort, so it was a project that I worked on, but it wasn’t just “my thing.” There were a group of chemists and engineers that worked together to make a foam that we can inject into the body. Technically, it’s not very different from spray foam insulation, except that it’s biocompatible. So in order to make it biocompatible, we had to produce the polymer that was biocompatible– so the magic really all comes in the chemistry, and we just had to find a way to deliver it. Because it was a two-part chemistry, though, this was actually rather difficult, because it wasn’t just something that you could inject with a syringe. It was a very viscous material and a very low viscosity material, and so to mix the two together was difficult, which is where I came in to work with the chemists to understand how to increase the chemical reactions and how to make the materials mix together properly, and then to have it injected into the body at a speed that allows it to essentially expand and do what it needs to do with respect to attacking the surfaces that have bleeding.

In this sense, it definitely was a collaboration between a group of chemists and a group of engineers in order to get the project through. When you think about it, it isn’t something that didn’t exist, right? It existed in a different format, we just needed to make it usable in the human body.

I get that there’s a team involved, but I’m assuming that you were a pretty integral part of that, because you’re listed for a lot of the patents and in many cases, you’re listed first. What was your role in the team specifically?

I led the engineering team for the delivery system, and that included an internal team of engineers as well as an outsourced team. We used a medical device firm at the time called Ximedica, and they were great in the manufacturing injection molding portion of the device, and what we really had to understand was the mixing theory side of things. From our end, we determined how we would mix it, and what the parameters would be. We did a lot of experiments in house with prototype devices and so I created those prototype devices, and then when it came to making a product that could be used and looked like a viable medical device, we went further in manufacturing and went with this company Ximedica to use an injection molded component that would be easier to use. These components had better usability indicators for the user, like colors and ergonomics.

The first mixer we made was really big, and you could probably hold it on your shoulder, but if you ever really thought of using it as a medical device, you’d probably be like, “Woah, what is that?” It was really large. It required pneumatics– we had to use a 128 horsepower pump from Home Depot that was basically an air compressor to get it to start running and working. At the time, though, that’s just what we needed to do; we just needed to get a prototype together to make sure that we could mix the two components. Eventually, that all got whittled down from a design perspective to something that was four parts, and that a soldier could put together kind of like a jigsaw puzzle on the field. A medic soldier already carries about 85 pounds in their backpack, and now in order to carry a lifesaving device, they can’t carry another gun, basically. They had to be able to carry something that was about eight by six inches in size, and that could fit in their backpack. It had to be able to withstand extreme temperatures, like extreme cold and sand, all these conditions where they’re in a far-forward environment. Once we proved the concept, we had to redesign it, and Ximedica helped us to actually produce the parts that they’re using in clinical testing right now.

Could you talk a little bit about what the “biofoam” is actually for, or the situations that you envision it being used in?

Yes. This is project funded by DARPA, which is the Defense Department. What they were seeing was that soldiers that had either IED blast or a gunshot wound had about an hour before they bled out– what they call the golden hour. If you can get a soldier to a medical facility within an hour, there’s a 95 percent chance that they will survive. But if you’re outside of that hour range, the casualty rate is very high. So what they were trying to do is save these soldiers in more remote areas– a lot of these soldiers are in the mountains of Afghanistan, where there’s nowhere to park a helicopter or a med vac. Usually, it’s a day’s trek up mountainous terrains to get to these people, so what DARPA wanted us to do was to create a foam that would stop bleeding.

Originally, the proposal and the contract which our chemists and I wrote together intended for us to create a liquid that had a molecule that would attach itself to wounded tissue. When a cell bursts, there are matrices that are released and chemically you could find them, attach to them, and then once you attach to them, bind something to them. For instance, you can bind a hemostatic drug; that’s something that causes blood to clot in that area. We tried to do that for about a year, and we really couldn’t find any differentiation between injured tissue and just blood-covered tissue. In the process of doing that, though, we thought, “Okay, well, what’s the best way to get the material to the site?” And we thought that if you want to stop bleeding, what you really need is to have compression. The only way you can get compression internally is to push down as hard as you can, but if you did that, the person would still bleed out, because there’s just too many fluid pathways for the blood to travel in the abdomen.

From there, we thought that if you could actually seal all of those pathways by filling the entire compartment of your abdomen such that there is no displacement of blood, then you could stop internal bleeding deaths. So when we did the chemistry for the two-part foam, we noticed that it would penetrate pretty nicely, and it would have an adhesion to the tissue surface that was similar to a post-it note, so it wouldn’t be difficult for a surgeon later to sort of peel off, and then we also have to control how much thermal damage there would be to the tissue. So a lot of it was the chemistry and the delivery. We ended up not having to use any sort of special drug; it is really just a foam. The foam finds its way to the hole, closes it, and then the patient can survive up to three hours before getting to a hospital. When the patient gets to the hospital, they have to get all of the bullets out anyway so they have to be opened up, then the foam can be taken out and they’re able to have surgery.

So, that’s how the project was born. It was born out of the need to help soldiers that would normally not survive, but who could survive if they could get to a medical facility.

There must be other applications for it outside of just military, too.

It’s kind of funny because there’s this game called Halo, which my husband used to play all the time. The game has a rescue foam, and it’s called biofoam, and if you get injured in the game, someone on your team can revive you with the biofoam and you’d get medevaced. So I told my husband that this was the project that we were working on, and he was like, “Oh, you just copied that from the video game!”

The first time Arsenal Medical posted a video animation of the procedure actually, all of the comments from men were just like, “Dude, they just created biofoam!”

Haha! That’s incredible. Life imitating ‘art’? I’d love to circle back to the discussion about patents– less than 20 percent of patent holders are women, and only 8% are primary patent holders, which makes it really amazing that you hold so many patents, including being primary on some. What was the patent process like?

Wow, I’m really surprised by that number, actually! That’s really amazing. It was kind of interesting because not very many engineers get to be a part of the patent process. What they do is that most companies will say, “Okay, what’s your disclosure?” or “What is it that you think you’ve discovered?” and you’ll write a quick paragraph that they’ll send to the lawyers, who will decide whether or not it’s something that patentable or if it’s something they want to add to their portfolio. Even if it is patentable, they may not want to add it, because every patent that you file you have to pay yearly fees on. I have been really lucky in my career because I’ve worked in advanced technology groups, where I get to participate a little bit more in the patent filing process.

When I was at Medtronic, there would be a group that would meet on all the disclosures that were submitted for the month, and then we would say, “Oh, if you combine these two, that would be a good patent,” or, “The aspects of these two inventions would be great to put to strengthen our own portfolio,” and other things like that. This is not something that I think is normally in engineering training in school; it just ends up being like an “on-the-job” sort of thing, because the only people who can file for patents are people who have money, which ends up being corporations. I was just lucky enough to be able to do that. When we were at Arsenal Medical, I was also involved in their patent portfolio, mostly for the delivery system aspects of things. Most of Arsenal Medical’s IP is in the biocomposition of materials, and then usually along with it is a sister component that describes how to deliver it, because that’s equally important. You can make the product, but if you can’t actually deliver it, what’s the point?

Generally, you work with counsel to do this, so there’s a lawyer on the other end. Usually, you describe everything in a very detailed document and then what they’ll do is write the background and the claims for the patent, and then you get the chance to review it. Really, the nuances are in the claims, so even if you write a beautiful patent with beautiful pictures and everything else, the meat of the patent is the claims. Claims are really important because you can have a really broad claim, where you basically exclude other people from practicing, which is called a foundational claim, or you can have a really narrow claim, that makes sure someone doesn’t copy your exact device, but doesn’t exclude them from making a similar device as long as it doesn’t use exact components of your device.

Because of that, what you generally want to do when you write a patent, especially for something new like bio foam or if it’s a new chemistry, is that you want to make sure it becomes a foundational patent. You want to make sure that it’s a patent that other people have to license in order to practice in that field.  I’ll give you an example– the patent for the biofoam is really difficult so explain, so I’ll talk about our sinus stent. The sinus stent has to go through a very specific cavity in your nose, called your sinus ostia. So basically, a company has patented the fact that you can take a catheter and put it through the ostia of your nose– now, no one can practice delivering anything through the nose without going through that patent.

That seems really annoying for other people, but really great for the company that got the patent!

Yeah, it really is! You’ll see medical device companies like Boston Scientific, Medtronic, and Cordis just spending billions of dollars suing each other for the right to use these different devices and components. Because of that, we put a lot of money and time into things that we feel could be foundational patents, or just broader patents in general, that we want people to have to license, although we do have narrow patents as well where other companies can make similar devices.

It really is just a lot of nitty gritty details, and then on the other side you have the patent examiner– where again, you can write a great claim, but you have to convince the patent examiner on the other end that the patent is viable, that it can be upheld if you go to court, and that it’s unique in some way from other things on the market. Usually, the patents come back, because they really try not to give you very broad claims because they just end in a lot of lawsuits. The patent examiners will try really hard to get you to accept a smaller portion of the pie– a more narrow claim– and you have to fight for the bigger portion. It’s kind of interesting and fun.

Do you have any patents in the wings currently?

We do, actually. I have two more that were filed recently, but I don’t actually own any of my patents– all my patents are logged to a company even though I’m logged as the primary on them. You have to have money to file for a patent, and even a small company like us at Transmural Systems has to pay between $50,000-$200,000 a year just to maintain and prosecute our patents, which is obviously a bill you don’t want to front as just one person!

That’s so interesting. So how did you become this person– how did your childhood and academic experiences shape who you are today?

I’m a first-generation American, and I think that a big part of where I am today is about how hard I worked, which definitely comes from coming from a refugee family. My family was persecuted in Cambodia and placed into a concentration camp, which is actually where I was born. I was about a month old when my parents fled, and we then spent a couple years roaming at refugee camps in Thailand and the Philippines before we were sponsored to come to America when I was 4. And I think that that has a lot to do with my drive to want to do better, and to set my kids up for something better.

Was it just you and your parents?

It was actually a lot of my extended family that was there– my parents, my grandparents, my four other siblings, and my aunts and uncles. My parents each had five siblings, and the majority of them were killed by the Khmer Rouge, so I had a couple aunts and uncles that made it, and then as a family unit, we all fled the concentration camp together. We fled in the middle of the night through Angkor Wat, which is really just a big jungle. Then, we ended up crossing the border into Thailand, and the Red Cross was there who received us as refugees. We stayed there for two years, and then we ended up in a refugee camp in the Philippines, where we stayed for another two years before we were sponsored by a couple in San Francisco, it was a doctor and his partner.

My aunt at the time was the only one who spoke English, and she actually ended up helping him as a nurse, so then he sponsored our family to come to America. We ended up in New York, which is where a lot of the Cambodian community was, and my parents wanted us to be by people we knew.

Wow, I am so sorry that your family had to go through that. That’s a part of history that many Americans unfortunately don’t even know about. It just isn’t taught in many schools, so it’s largely forgotten about in the US.

Yeah, we hear a lot about the Holocaust, but the Cambodian genocide had such a high death count as well and no one talks about it. It’s so recent, too. Up until when Pol Pot died, there was still a lot of guerrilla forces in Cambodia trying to make an uprising.

Have you been back? What was that like?

I did go back in 2008. I left so young, so it was just like visiting a foreign country for me, but for my parents, they were returning to their home country, and it was so different. It’s modernized a lot. A lot of people who were living in America went back to retire in Cambodia and they built homes. It’s still really corrupt, though, and you just see children hanging around. There’s no education for kids, so they just hang out all day, at least in the parts where I was, in the Angkor Wat area. There’s more education in the cities, but it’s not mandatory, and it’s not a right like it is here.

Did your parents ever tell you the story of how you fled in the middle of the night?

My mom had told me that a couple of nights before they left the concentration camp, they actually dug up my grandfather, who had died a couple months earlier in the concentration camp. In Chinese culture, you usually take someone with you, so they dug up his bones and burned them into ashes to take with us. That was two days before we were going to flee, so that we would have my grandfather with us. The concentration camp is in the jungle, and there are armed guards, but in the middle of the night the whole family just took the clothes they had on their backs, and we snuck out into the jungle and just kept walking. My mom said we walked, and walked, and walked for days, until we got to the border of Thailand.

Wow, I can’t imagine how terrifying that must have been.

Can you believe my mom, though? I was one month old screaming and crying and giving away their location. She’s like, “Well, at least when you were one month old you were sleeping; if you were six months old, it wouldn’t have happened!”

Wow, they probably felt like they had to do it at that point or they would have been stuck there.  When did your parents start telling you about your history?

My siblings are much older than me– my oldest brother is 12 years older than me– so they had almost like a teenager at the time to handle as well. From as young as I can remember, we always talked about it. My parents would talk about the escape, and then the years in the Philippines in the refugee camp. Once we were there, it was a good family community to them. My father was a principal, he was an educator, which is why he was specifically persecuted. They persecuted anyone who had anything to do with education or culture, since they were trying to eradicate culture from Cambodia. At the camp, my dad set up a school and had a sort of leadership role there, where he was educating children and all of that. Having that community was one of the reasons they decided to come to New York.

Did he teach in New York, too?

No, because teaching in Cambodian is one thing, but he didn’t speak English. The only person who spoke English was my aunt.

How was it for them, then, moving to a country where they didn’t speak the language?

It was very challenging. For the first three or four years we were on welfare. We were refugees with nothing. On the plane ride from the Philippines to America, my mom didn’t even have a diaper for my brother, so by the time the plane landed, she was soaked with urine– literally we had nothing. We’re always so grateful for America taking us in and giving us housing and food stamps, etc. So, for those first years, we really survived on public assistance. Then, afterwards, my dad got a job as a dishwasher and stayed at a Japanese restaurant in Chinatown where he worked his way up from there to being a sous chef, but he worked at all hours.

My mom made little bows, like you see at Target, on clips or headbands for kids. We would all sit in the living room making these together, my mom and my brothers and sisters, and make these bows by the dozen– it was like a factory in our apartment. There were fifteen of us in a three-bedroom apartment in Brooklyn. Then people would come the next day and ask how many bows we had, and we’d package them all up, give it to them, and they’d give us money for it. The next week they’d come back with all the raw materials and we’d do it over again, and that was how we made money. My parents were really big savers, so we just kept saving, and luckily we went to public school during the day so we had a place to go.

Eventually, my dad ended up opening his own catering business, so that was what we did from when I was eight, up until I left for college.

So then you left New York for college and decided to study engineering?

Yes, sort of! I went to Boston University, and I started out pre-med, because my parents always wanted me to be a doctor. I never really liked the people, though, and I ended up being right. Everyone was really out for themselves and it was so competitive. I just happened to be stationed on an engineering floor my first year, and I ended up making a lot of friends in the engineering department. They were working on homework, one time, and it was all together, like everything was a group project or something. And I remember thinking, “Why am I pre-med? Why am I hanging out with these people who never want to collaborate or help each other?” And so my second semester freshman year I switched to biomedical engineering.

Obviously, it’s still in the medical field, but I felt that I got to have a higher impact. If you’re a doctor, you get to touch how many patients in a day, in a year, in a lifetime… it can’t be that many. But if you make medical devices, just one medical device can help millions of people, and I felt that that it was more important for me to have that bigger impact.

Do you have anyone today who inspires you professionally?

My parents have always been my inspiration. There are definitely people I work with who make me think, “Wow, they’re brilliant!” but I think at the end of the day, everything comes from my parents and all of the things they instilled in me early on. And then the other thing is my kids, because I have to say, being a mom is the hardest job ever. Trying to balance getting your company to be successful, and trying to be there and present for your children, is super difficult. I’m usually torn between the two pretty badly, but I think my children definitely inspire me to set them up to have a good life. Also, it’s good for them to see what I do as an example for hard work.

If you had three more hours in a day, how would you spend it?

I would probably sleep a little bit, because I don’t sleep very much– probably only three to six hours a night– but I would definitely spend most of it with my kids.

What does a normal day look like for you?

Typically, my kids get up around 6:30, I get them out the door by 8, and then I’m at work by 8:30. I spend usually up until 6:30 or so at work, and then I come home and make dinner. Then, I spend that time from 7:00-8:30 or so with my kids, and then I put them to bed. Sometimes I take a little nap. After that, I usually work until around 2:00 am or so; that’s probably my average day. And then I wake up and do it all again.

What’s one of the biggest lessons that you’ve learned in your career?

One of the most important things I’ve learned is that a lot of stuff gets done based on being able to establish connections with other people. I’ve learned that relationship-building and fostering those relationships really makes your life a lot easier in all aspects, whether it’s PTO or other children’s parents or another company or vendor that we work with, being able to connect with people is so important. I think that I get a lot of stuff done and that a lot of people are willing to do things for me because I take the time to establish those personal connections from early on, and it’s so simple. Sometimes it’s just asking people how they are and where they’re from or something simple like that. Usually, they’ll tell you something about themselves, and you can sort of file that away to mention later to show people that you really do care about them as people, not just as a potential business partner or whatever else, and it makes them realize that you’re also a real person on the other end of that email or text or phone call. I feel like I get a lot of things done by thinking of things in that way.

What does success mean for you?

In terms of my career and my work,  bringing products to patients that don’t have another option– “breakthrough technology for unmet clinical needs”– is definitely my definition of being successful, and that’s mostly what I’ve focused on in my career. And then, on a personal note, if I’ve raised happy children that aren’t a ward to society then I think I would be happy!

So, what’s next for you?

I keep telling my boss here that we have two more years before we need to sell this company. We have several products going into clinical trials, and part of being a startup is being able to either sell your company or your product to a much bigger company. After that, I’m not sure– my boss thinks that I’m going to help him sort of take over the company and he can go retire, but I think I might want to retire!

Ha! I love it. What would you do if you retired?

My husband and I actually flip homes! We buy a house that’s usually pretty run-down, and we work on it on our weekends and when we have free time, and then we sell the home. I love fixing and restoring old homes, and I think at some point, that will be my retirement plan– construction, working on homes, designing homes, and then getting them sold.

Is that what you geek out about outside of your work life?

Absolutely. I love it, it’s just so fun. It’s a huge profit margin actually if you do it right, and I think the interesting thing about it is that if you just pay a little bit into real estate, you can make money. It’s not a gambling sort of thing, you can always forecast what your profit is going to be if you make a conservative estimate. So at least from the way we look at it, there are a lot of spreadsheets! It’s definitely from an engineering perspective, where we think about the growth of the area in the coming years, how long it’s going to take us to renovate the house, how many bedrooms… so many factors, but if you account for them, it can be really worth it.

We also really like to travel– I love to take my kids traveling and I think it really opens up their minds and their experiences. I really geek out about going to historic places that have a lot of meaning and history, and to stand somewhere and know that that’s where something important happened is awesome. We went to the Galapagos, and to know that that’s where Charles Darwin was, and that he landed in the same port as us and walked some of the same trails– to get to sort of live a part of history– is just so cool to me. I seek out these places to travel and I hope that eventually my children will really appreciate it. I think that now they’re young so it’s sort of just “Oh, that was this place we got ice cream and had fun with our parents,” which is fine, but I hope that someday it helps them understand why these places are important in history.