Alumni search for health care answers.
The husband and wife team of Charlie Kim, BSBA ’98, and Carla (Bender) Kim, BS ’97, know the stakes when it comes to health care. They, more than most, see the equation clearly from its many sides: research and development, administration, clinical care, economics, human emotion, success, failure, resolve. Healing isn’t an easy profession. It is hard enough to help a single patient battle a disease, let alone work toward improving an entire system that affects millions, if not billions, of people.
And then there is the other side – when you find yourself within the system. The Kims know that side too, and it’s why they do what they do. That equation appears differently when you are inside – when you or someone you love is the patient. Outside, in the lab, research is a process – slow and methodical. When you are inside, it’s a miracle. In a boardroom, the business of health care is strategic – long-term growth over short-term gains. But when you are inside, and you see where profit is affecting your outcome, it’s insufferable. It’s wrong.
So what do you do when your position in the world gives you the opportunity to make things better? That question is just one of many that Charlie and Carla have asked throughout their respective careers. And they are good at finding the answers.
Is it safe to use?
Charlie Kim is an entrepreneur and CEO of Soom, a technology company built to do one thing – bring clarity to complexity. Soom is doing the kind of work that no one really sets out to do – the kind of work that is typically handled by governments, not startups. The nascent firm isn’t just wading into the world of big data, it’s trying to wrangle it into doing what it should be doing – improving lives.
Through his company, Charlie is trying to spark a global conversation using words that are up to 50 alphanumeric characters long. The words in this case are bar codes, specifically the bar codes imprinted on medical devices used by people all over the world to overcome health challenges. It is a very specific lexicon made up of a highly complex syntax, but it holds tremendous power. Charlie believes it can do for others what nothing could do for him during the worst moments of his life. Soom is going to reassure parents, home health nurses and caregivers that they are always doing the right thing in the treatment of their loved ones.
Charlie and Carla’s daughter Isabella was born with a rare airway disorder that required the ongoing use of a medical device called a tracheostomy tube. The device allowed her to breathe. In fact, it was the only thing that allowed her to breathe. As Isabella grew, she needed larger tracheostomy tubes. Over the months and years, the tubes – like many products – underwent design changes. Usually, these changes improved the product. On occasion, they did not and had to be recalled.
The idea of a product recall isn’t new, nor is it particularly rare. But the difference between a medical device recall, and say, an automobile recall, is that there is a national registry of automobile ownership. If your car’s brakes are defective, the manufacturer has the means to contact you and get you the information you need. There is no registry for medical devices. But Charlie will tell you that medical device manufacturers should be able to notify its customers if one of its products faces recall. The key is in the barcode.
“When you buy a bag of Brussels sprouts at the supermarket and it is scanned at checkout, the barcode information for that specific bag is recorded along with other information, such as store ID info, the time and date and maybe even the name of the person who scanned it. Regardless, the information is recorded, and the means exist to pull it back out if needed, such as during a recall,” he says.
In the business world, supply chain is crucial to success and, as such, companies dedicate considerable resources to it. Everything is scanned, recorded, stored and tracked electronically, and that information has never been more readily available to consumers. It’s become so ubiquitous that mobile phone manufacturers like Apple have integrated scanning technology into the cameras in their phones. But there are two large, important industries that use barcodes and return nothing when scanned.
“Two industries that we have no choice over using are medical devices and pharmaceuticals,” says Charlie. “We are told to use them by someone else, namely our doctor. So, we presume they are safe and use them on the full faith of whatever the system is that created them. However, there are many devices and pharmaceutical items that are out there in circulation that are on recall and are unsafe to use.”
For the Kims, the safety of Isabella’s tracheostomy tube was a life-sustaining issue. When her tube began causing her problems, they had no idea what was happening. After considerable time looking into it, they learned that the tube had been redesigned using a different angle and it was causing airway obstruction to patients whose bodies had grown accustomed to the previous design. No deaths were reported, but 12 cases were referred to the Food and Drug Administration, prompting the recall. However, the Kims were not notified, and Isabella continued to use the dangerous device. Not even Isabella’s doctors were notified of the recall. When Charlie asked, they became defensive. They were insistent that it wasn’t their fault. We didn’t give it to you. It came from a distributor. How were we supposed to know you had that?
“We weren’t looking to point blame. Once you step back from the tragedy that almost happened, you just want to know how this kind of thing can be prevented,” says Charlie. “It’s our daughter. She’s a child, and she looks to us to take care of her. She can’t do it herself.”
How were we supposed to know you had that? That is the question that stuck with Charlie the most. Even though it was rhetorical, he felt it should have an answer. So, he decided to take it at face value. The doctors were asking him, Charlie Kim, how they were supposed to know. He would find out, because, ultimately, he had another question he wanted to answer. One for all the families like his – the parents, caregivers and anyone not formally trained in medicine. And that question was: Is this thing safe to use?
It took years of research and development to untangle the data that did, in fact, exist for medical devices. They completed the arduous task of figuring out the intellectual property pathway so they could connect disparate databases together in order to deliver all the relevant information related to a device to an app on a mobile phone. Everything from model number, date of manufacture and country of origin, to operating instructions and, yes, recall information would be in the palm of a parent’s hand.
In the United States, Soom is partnering with the Open FDA project, an initiative within the U.S. Food and Drug Administration to “create easy access to public data, to create a new level of openness and accountability, to ensure the privacy and security of public FDA data, and ultimately to educate the public and save lives.” Soom is pioneering the incorporation of private data as well, so that public and private data is available to the end user. Charlie hopes it can serve as a model for health care at every level.
“Health care is moving out of the hospital and into the home, so it is imperative that we give confidence and clarity to people who are not primarily trained to take care of a loved one at home. The only way to do that is to give them absolute assurance of information, and for that information to not be tainted with advertising or bias. That’s why an open-source solution is so important,” says Charlie.
When Charlie speaks about what at-home caregivers need, you can believe him. He and Carla have both made emergency decisions they weren’t formally trained to make. In those situations, there isn’t time to call the manufacturer’s customer service line or look it up online.
“You have to react,” he says.
Ultimately, that’s what Soom is aimed at doing. It’s why they are breaking down the silos of public and private data, why they are collaborating with industry leaders and the FDA. They hope to work with Apple so their technology allows someone to just hold their phone up to a medical device to instantaneously know what the device is and whether it is safe to use.
In all the years Charlie and his team have been working to answer that all-important question, he has been reluctant to share his company’s genesis. Even though, thankfully, Isabella is fine now, he and Carla have a tough time telling people about what they went through as a family for five years. The truth is, they almost lost Isabella several times.
Charlie didn’t name his company. He left that to the company’s dedicated employees and marketing folks. But his imprint is as indelible as it is undeniable, and that is why, even though his company was not named by him, it is named for him. Just as it is named for Carla and Isabella and her big sister Madeline. It is named for what started them down this path, how they got through the hard times and the relief they felt when things finally turned around.
You see, soom, in Korean, means breathe.
What causes diseases?
Cancer researchers get asked one question more than any other. Have you found a cure yet? Dr. Carla Kim is one of the leading lung cancer researchers in the world. She holds a joint appointment at Boston Children’s Hospital and Harvard Medical School, a global nexus of medical research, so she definitely gets asked. She doesn’t mind though. She knows the power in asking questions. She asks them all the time.
There is a bit of folly in thinking that there will ever be a cure for cancer. Cancer, after all, is not one disease, but many – more than 100. Carla’s work focuses on the lungs, but it does not focus on lung cancer, singular. She is advancing our understanding of lung cancers, plural, along with other diseases of the lung through groundbreaking research at the Carla Kim Laboratory in Boston, Mass., where she pioneered the use of stem cell biology approaches for the study of adult lung stem cells and lung cancer.
As a young girl growing up in Fremont, Ohio, Carla loved school, and she loved to read. And the lessons didn’t end when the school day ended or when she was dismissed for the summer. Her family provided her with workbooks full of exercises in math and science that she would dutifully complete page-by-page, step-by-step until they were finished. She consumed it all, and the more she learned, the more she wanted to know. She enjoyed all subjects, but biology captivated her interest the most. As she got older, she started thinking about careers in biology. Did such a job exist in which the learning never had to end?
“I had no clue that you could have a research lab, that running a lab was even a job people did,” she says. “But I was interested in knowing what careers were out there. I actually wrote a letter to the National Institutes of Health and asked for information on careers in biology. This was pre-internet and you couldn’t just Google that kind of thing. They sent me a pamphlet with all these jobs in biology, and it changed everything.”
So now Carla knew that jobs in biology existed. And true to form, when she learned something, she immediately asked the next question. For the teenager, that question was how?
Carla enrolled at Ohio Northern to study biology in the mid-1990s, a time when the burgeoning field of genetics was all the rage. Only a few years earlier, the international scientific community set out to map the human genome. Michael Crichton’s Jurassic Park turned genetic engineering into entertainment. In Scotland, scientists cloned a sheep named Dolly. Since taking an AP biology course in high school, Carla was fascinated by genetics, specifically the field of gene therapy, which was gaining momentum in medical research.
Following her freshman year, Carla went home to Fremont for the summer and got a job at a local grocery store. It was the last job she ever held outside of research. But it was also that summer when she took the next step toward her goal of having a career in genetics.
“I had the opportunity to shadow a genetic counselor. At that time, genetic counselors mostly helped people make decisions about the chances of having a child with a genetic disorder. And it was frustrating, because what I saw was that the counselor ultimately couldn’t intervene. They had no effect on the outcome. In fact, they couldn’t really do anything. It was the physician who was ultimately in charge of making the decisions for the patient,” she says.
Carla didn’t want to be a physician, but she did want to help people. She was quickly learning at Northern that she really loved doing research, and, under the mentorship of Drs. Linda Young and Rodney Anderson, she built a foundation of knowledge strong enough to support any career. Years later, when her daughter Isabella dealt with severe health challenges of her own, that knowledge-base was there to help her and her husband, Charlie, come closer to being doctors for their own daughter than they ever could have imagined.
The following summer, Carla was a full-time research assistant to Anderson using yeast cells and learning how to prepare DNA. Most of what she did that summer didn’t work, but that didn’t daunt her; those rare times that an experiment worked and she could learn more, she loved enough to continue. From there, Carla’s educational journey ramped up to warp speed. She spent the following summer at the University of North Carolina, where she learned how to culture mammalian cells and experimented with gene sequencing as a summer research fellow. Graduate school followed, and Carla earned her Ph.D. in genetics from the University of Wisconsin in 2002.
By now, Carla had a new interest: stem cells. At Wisconsin, she was using models in mice and cells grown in the lab to study the ways human DNA repairs itself when it is damaged. She discovered that a group of mice had deficiencies in all of their blood, indicating that perhaps something was wrong with their blood stem cells. Adult stem cells (not the embryonic kind) are present throughout the body and are responsible for the formation of certain cells. Researchers believe there might be stem cells for all the organs of the body. Carla quickly realized that, if she could better understand stem cell behavior, then perhaps it could lead to a better understanding of how diseases, specifically cancers that target particular organs, form.
Based on the strength of her doctoral research, she was accepted into a post-doctoral training program at the Massachusetts Institute of Technology (MIT) working in the lab of renowned cancer researcher Dr. Tyler Jacks. There she began concentrating on the lung, the area that remains the focus of her laboratory today.
“We study lung cancer, but we also study many other lung diseases using technologies and methods we developed around these cells we think are lung stem cells. Our biggest breakthrough was inventing a way to culture these cells in the lab to form what we call organoids,” Carla says. “Organoids are little structures that we can grow in the lab that mimic the different parts of the lung. We can create tiny versions of windpipe or an airway or even the little alveolar sacs where the gas exchange occurs. And we are applying what we’ve learned to many different lung diseases, including diseases that affect premature infants when their lungs are not formed or cystic fibrosis.”
Carla never wanted to be a doctor. Doctors treat patients once a disease takes hold inside them. They focus on what a disease does to a person, not how the disease, itself, works.
“What I realized was that I was more interested in learning how to figure out what causes a disease, and what we can do about those causes. I don’t look at what I do as finding a cure for cancer. I look at it as how can we enhance people’s lives and make their lives better if they have cancer or a lung disease like emphysema. And we can do that by better understanding these diseases.”
Think of it this way: What if a person has a malignant tumor, and researchers find a way to “turn it off,” to alter it at the cellular level so that it just stops? That person would still have cancer, but she would be living unimpeded by it. And that is the perspective of researchers like Carla Kim. Modern medicine currently has all kinds of ways to treat cancer, but some of them have terrible side effects that negatively impact the quality of life for the patient. Finding treatments that actually improve lives is what is really important. For some things, maybe there won’t be a cure. But what if treatments could be developed that allow patients to live and enjoy life to the fullest?
Carla would call that a win.