Yeaseul Park: Orange Biomed’s New Diabetes Device

Author(s): Scott Douglas Jacobsen

Publication (Outlet/Website): The Good Men Project

Publication Date (yyyy/mm/dd): 2024/11/28

*Interview edited for readability.*

Yeaseul Park, CEO of Orange Biomed, is a Forbes 30 Under 30 honoree. She holds an MBA from Duke University and co-founded Orange Biomed, a company focused on innovative diabetes management technology. The company is expanding globally, with their OBM rapid A1c test in clinical trials at Seoul Asan Medical Center.

Park discusses the development of their innovative A1C diabetes management device. Park describes the motivation to create a more accessible and affordable test, highlights the challenges of existing technology, and shares insights on clinical trials, FDA clearance, and the device’s potential global impact.

Scott Douglas Jacobsen: We’re here today with Yeaseul Park, the co-founder and CEO of Orange Biomed. I want to compare your A1C device to current tests. What inspired you to create a newer device or test in this market?

Yeaseul Park: Our vision is to make A1C testing more accessible and affordable for anyone who wants to test and manage their diabetes or prediabetes. The problem I identified, especially during the COVID-19 pandemic, was the difficulty of getting tested. In the U.S., I found it challenging to visit a doctor and get this test done every three months. Currently, the technology is only available for professional use. You must see a healthcare provider regularly to get your A1C test results and monitor your glycemic control.

However, diabetes is not a one-time issue—it’s a chronic condition that requires lifelong management, which can be burdensome. We wanted to make testing more accessible. According to statistics, 12% of the adult population in the U.S. has diabetes, and 33% has prediabetes. The American Diabetes Association recommends that these individuals regularly test their A1C levels. So that’s our vision. 

Jacobsen: Now, how does your microfluidic technology provide more accurate results?

Park: First, I want to explain the limitations of current technology and how we aim to solve those problems. Existing A1C devices use protein quantification methods, which are complicated and require trained professionals to operate. These methods involve protein reagents that require refrigeration, have a short shelf life, and need significant maintenance, making it difficult for patients or caregivers to test A1C levels independently. These devices are also expensive, especially lab machines for medical centers or hospitals start at 6 digits, and smaller professional-use devices for clinics can cost around $5,000.

Our device is different because we don’t use protein reagents, making it much easier for anyone to use, similar to a COVID-19 test kit. Have you ever used a self-administered COVID test?

Jacobsen: Yes, a couple of times. But I was working on a horse farm then, so I was pretty isolated, and it wasn’t on the front of my experience at the time.

Park: I understand. That’s why we designed our device to be like a self-administered test kit, similar to the glucose monitoring systems that diabetes patients are familiar with. This will be the first time such a device is available for home use by patients or caregivers, although it still needs to be added to the market.

Jacobsen: Hemoglobin variants are a known issue. We’ve found a higher frequency of these variants among Black, Hispanic, and Asian American populations. How does your device make testing more accessible to populations that traditional methods may have underserved?

Park: Your question has two parts. The first part is about the hemoglobin variants. With existing technology, only lab devices can accurately identify hemoglobin variants. This means point-of-care (POC) devices cannot reliably detect these variants, which significantly impacts the accuracy of A1C levels. POC devices are more likely to give inaccurate readings, especially for individuals who are not part of the white population.

The second point is that since we are not using protein reagent technology but are utilizing microfluidic technology, we rely on the physiological features of red blood cells, not proteins. So, hemoglobin variants do not impact the performance of our device. Theoretically, hemoglobin variants can’t affect our device because they don’t involve identifying proteins. This principle allows us to overcome the limitations of current devices, particularly point-of-care ones.

Jacobsen: So, how do patients typically describe their experience when looking at older technologies? With newer technologies, like the microfluidic ones, how would they also describe their experience?

Park: Currently, patients are required to visit labs or their doctors to get this test done, which poses difficulties, especially for older individuals with diabetes or those with complications. It’s often harder for them to go to the doctor alone, and they may need someone to drive them or require at-home options. However, with current devices and technologies, it’s nearly impossible to do this at home.

There are some options, like direct-to-consumer home kits by mail. You get the package by mail or at a convenience store, draw a relatively large blood sample, send it to a lab, and receive results within five days. This is an alternative for those who can’t easily access a hospital, but it still takes more time and requires more blood. I tried one of those kits once, which required 60 times more blood than our device.

Our device only required a single drop of blood, while that kit required around 300 microliters, which felt like I was almost bleeding out. It’s really hard to draw that amount of blood with just a needle. 

Jacobsen: Not to mention, how packed these labs will be with blood! It’s too much blood!

Park: Some states don’t allow human samples like that to be sent through the mail, which limits service in certain areas of the U.S. Demand was high, especially during the COVID-19 pandemic, when getting a doctor’s appointment was difficult. People looked for other options, but they were still very expensive. Depending on the condition, A1C tests should be done regularly, at least twice a year or more frequently based on condition. With our reusable device at home, patients can get cartridges for each test and see their results within minutes.

So that’s how we want to solve this unmet patient problem. 

Jacobsen: Two factors in the United States are the main points of reference. One, they have a different style of healthcare—I’m Canadian, obviously—so it’s different in Canada from the United States. I talked to an epidemiologist, Gordon Guyatt, who is well-cited and co-founded Evidence-Based Medicine.

He argues that Canada values or prefers equity, while the United States emphasizes autonomy. This affects the kind of healthcare systems that people tend to prefer. In Canada, you get more nationalized healthcare; in the United States, it’s more privatized.

So, my first question is: does that impact accessibility for these tests and devices? So, does the difference in healthcare models between Canada and the U.S. impact accessibility for A1C devices like yours? In other words, how do the approaches to healthcare in these countries affect access to your device? This device is more accessible and easier for people because it bypasses the hemoglobin variant issue by not using proteins. So that’s one factor. Another potential barrier could be the healthcare model. Does that impact accessibility for people using this type of device? I don’t know.

Park: Let me also give you an example outside the U.S., where I live. In Korea, getting an A1C test at a doctor’s office is very easy compared to the U.S. But people still need this device because if it’s just a one-time test, you can visit a doctor whenever you want to take a day off to do it. But diabetes testing is not a one-time event—you must do it every few months.

Sometimes, they don’t give you the results right at the point of care. They may send a venous blood sample to the lab, and then you must wait for the results. The doctor might even require patients to return when the results are available to plan the treatment. So, it’s about something other than the healthcare system but people’s schedules. People working or studying often can’t commit to regular checkups and miss appointments because they want to maintain their routines. So, they need an at-home option.

I’ve also observed that in the U.S. When we first focused on suburban or rural areas, where doctor’s offices are far away, we thought the issue was mostly geographic. But even in big cities, where people live near their doctors, many don’t have time to visit during the day. So, even in Canada, where the healthcare system is completely different, people with chronic diseases still want to live normal lives while managing their conditions. 

Jacobsen: The next part of the question is about FDA clearance. Despite the differences in healthcare systems, the FDA is known for being very rigorous with its multi-stage trials or phases for new products to come to market, and this has been the case since the 1970s. You aim to bring the product to market in 2025 through FDA clearance. How is that process going? What hurdles have you encountered in ensuring you’re meeting all the requirements for approving a new product, especially given that you’re using a different type of technology?

Park: We are preparing to submit a 510(k) application next year for FDA clearance of the OBM rapid A1c device, classified as a Class 2 medical device. As the device has unique technological characteristics compared to the predicate device, we are conducting clinical studies to demonstrate that these technological differences do not raise new questions regarding safety and effectiveness. We aim to complete the clinical studies by early next year and submit the application by mid-year. We are eager to obtain FDA clearance as soon as possible, to help more people manage their diabetes effectively.

Jacobsen: How does the ISO 9001 certification ensure the quality of the product?

Park: ISO 9001 is an international standard for a quality management system. However, it’s not specific to medical devices—it’s more general. We are also preparing ISO 13485, which is specifically for medical devices. We are working on that certification in addition to already having ISO 9001.

ISO 9001 is a very holistic system. It requires that the entire management system be based on quality management principles. We’re using FDA-cleared software to ensure all documents are traceable and to record the development history. Even after we get approval, this system will track customer feedback and complaints, if any, and help us resolve issues systematically. This is very important. So, our entire management team is involved in that system.

Jacobsen: You received the KHF Innovation Award—how does it feel?

Park: Yes, that was a very recent achievement. If you’re familiar with CES, it’s similar to the CES Innovation Award in the U.S. The KHF Innovation Award is from South Korea’s largest annual medical device conference. The Korean Hospital Association gives this award to innovative ventures; we were fortunate to be one of the recipients.

Jacobsen: What are some important statistics relevant to men and for complications too? 

Park: So, for prediabetes and diabetes, A1C is an incredibly important biomarker. A1C is the top biomarker for diagnosing diabetes and has well-established standardized criteria. If your A1C level is higher than 6.5%, you have diabetes. If it’s between 5.7% and 6.4%, that means you have prediabetes. With this single biomarker, you can accurately understand your risk status.

Even after diagnosis, it’s crucial to regularly test A1C levels because this biomarker predicts the risk of developing diabetes-related complications. While most people are more familiar with glucose testing, the American Diabetes Association strongly recommends A1C testing for all diabetes patients. In contrast, glucose monitoring is recommended only for certain patients. These tests serve different purposes. Extensive research has shown that regular A1C testing can reduce the long-term probability of death and improve patient outcomes. I can provide the exact statistics after the meeting if needed.

Jacobsen: Can you explain some of the complications people with high A1C levels face? What are some of the conditions they may encounter?

Park: Yes, there are many microvascular complications, but the most common is retinopathy, which affects about 40% of diabetes patients. This condition can lead to blindness if not managed. There are also diabetic foot complications, neuropathy, cardiovascular, and ulcer issues, which are very common as well.

All of these complications are related to microvascular disease. When A1C levels are high, blood viscosity increases, leading to issues in the microvessels, not just the larger blood vessels. This can result in serious conditions like heart disease. Additionally, there are some differences in how diabetes affects men and women. For instance, type 2 diabetes, which accounts for 90-95% of cases, affects men and women differently in terms of complications and disease progression.

Men tend to develop diabetes at an earlier age than women. Research has shown that men with obesity are more likely to have upper body obesity, which is strongly correlated with insulin resistance—a significant risk factor for type 2 diabetes. As a result, men with upper body obesity tend to develop type 2 diabetes at a younger age. For women, it’s different.

Women are more likely to have lower body obesity, which has a different impact on diabetes. Women tend to develop diabetes later, often in their 60s or 70s, whereas men should be more cautious starting in their 40s. Current guidelines recommend that individuals begin annual screening tests for diabetes at age 35 to detect prediabetes or diabetes early, allowing for earlier intervention and prevention of complications.

Jacobsen: Thank you very much for your time today. I appreciate it. 

Park: Perfect. Thank you so much, Scott. I appreciate the conversation.

Jacobsen: Likewise, it was nice meeting you. Thank you.

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