Bulsai Will Use Portable Ultrasound to Improve Insulin Delivery
When Bill Ervin faced a diabetes management challenge it led to a groundbreaking idea that could transform insulin injections for millions of people with diabetes. Like a stud finder in construction, Bulsai’s device will use ultrasound technology to locate optimal areas on the body to inject insulin, preventing under- or over-dosing.
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The Challenge
On Thanksgiving day 2021, Bill Ervin did what many of us do: drove to a relative’s home to share a family meal. However, eating that Thanksgiving dinner was a little more complicated thanks to his Type 1 diabetes. He needed to make sure he got enough insulin to process the sugars from the meal but not so much that he had a hypoglycemic event. After 37 years living with Type 1, Bill was a veteran at administering the insulin needed and didn’t anticipate any problems.
But on this Thanksgiving day, when he changed his insulin pump before the meal, he couldn’t find a good site. It flat out just didn’t work. So while the rest of his family sat down to enjoy the spread, he drove home to deal with his pump failure, missing both rare time with relatives and the entire meal. He’d had enough.
Five years earlier, he told his endocrinologist that one of his biggest frustrations with his diabetes care was locating healthy tissue to inject his infusion set. Past injections had led to a buildup of scar tissue, cysts, and fatty tissue, a condition known as lipohypertrophy or LH, preventing proper absorption of insulin and causing high blood sugar (hyperglycemia).
“I asked my doctor if there was some way to scan my abdomen to find a good injection site. When she said she didn’t know of anything, it really got my wheels turning.”
Bill imagined a tool that used the advancements in portable ultrasound technology and artificial intelligence to locate healthy tissue for injection sites. Like a builder uses a stud finder in construction, such a device would locate optimal areas on the body to inject into when inserting a pump, using a syringe or insulin pen. Together with a cousin who holds a PhD in mechanical engineering, Ervin wrote a provisional patent for his idea, but wasn’t sure if he was ready to launch himself into the medical device field.
That is until he missed Thanksgiving dinner and decided that enough’s enough and launched his new company Bulsai™.
The Right Idea at the Right Time
Once he decided to run with his idea, he knew just where to turn. He had a connection at Genesis Innovation Group, which specializes in medical device development and commercialization. They invest in early-stage companies, turning ideas into innovations and those innovations into assets. Genesis vets around 300 ideas a year and chooses only a handful to work with. Bulsai made the cut.
Matt Miller, Genesis Innovation Group’s Senior Director of Technology and Software Development, as well as Bulsai’s interim CTO stated, “His idea addressed a totally unmet need. As we worked through the market research, we recognized the problem and the size of the market. It was also an opportunity to get in early on a unique solution.”
After years developing software in the automotive and consumer electronics industry, Miller welcomed the chance to move into the healthcare space and create a device with meaningful impact for people living with diabetes. The timing was also right for taking advantage of the innovations in ultrasound technology to create a very specific application.
Miller, Ervin, and the Genesis team conceptualized a handheld, portable device about the size of a large magic marker, with the singular purpose of scanning the body to locate healthy tissue for injection sites. The focus for the Bulsai device is on ease of use, incorporating a red light/green light indicator marking the good area with either an erasable ink stamp or some sort of small imprint. They’ve patented this concept along with secondary uses for the device such as using it as a depth finder to locate muscle on leaner patients, to scan the injection site after a dose to know if insulin has been successfully absorbed, or using ultrasound frequencies to help the insulin absorb.
Early market research has shown great promise. “People with diabetes get it — if you have a good injection site, you’re fine, and if you don’t, you’re not.” explains Ervin. “We’ve seen all of these incredible ideas and new technologies in the diabetes space come along including insulin pumps, wearables, smart pens, and CGMs, but at the end of the day, a CGM won’t work if it’s in a bad site. You won’t get the insulin you need if the pump isn’t in healthy tissue.”
The Road Ahead
With 8.3 million insulin dependent diabetics living in the US, and over 16 million ER visits by people with diabetes a year, the Bulsai team is pushing forward to get their tool into patients’ hands as quickly as they can. To that end, they are working towards a prototype in the next six to nine months and seeking to partner with universities or other research institutions to accelerate clinical trials and testing.
Besides their collaboration with Genesis, they’re also expediting their commercialization process through partnerships with a highly experienced global electronics manufacturing company that specializes in prototype design and commercialization and with A Wright Path, industry experts in FDA regulatory processes and devices, including biocompatibility, artificial intelligence, and machine learning.
Although the market is stronger for people between 40 to 70 — those who have been living with diabetes for years and have developed scar tissue or lipohypertrophy from repeated trauma to the same injection sites, younger patients with diabetes are leaner and inject into muscle which is painful and doesn’t absorb insulin very well. With a tool like Bulsai in their hands from the start, they can prevent injection-related complications from occurring and decrease the risk of hospitalizations because the body absorbed too little insulin at a site or unintentional overdoses because of insulin pooling in the body.
“I really wanted this for myself, and I know it will help the many people who deal with the frustrations I experience on a daily basis,” says Ervin.
Our Take
It’s a golden era for portable ultrasound technology and Bulsai taps into these advancements with a specific, user-friendly application for people with insulin-dependent diabetes. The concept is clear, simple, and unique — there are no known competitors in the market. And it’s easy for patients to add to their existing routine, providing peace of mind and preventing over- and under-dosing insulin and injection site complications.
37.3 million Americans have diabetes, which is projected to grow to 54.9 million by the year 2030. The Mayo Clinic estimates that 70% of insulin-dependent patients inject into LH daily or weekly, with 61% of them doing so out of habit or because they simply don’t know. Injecting into LH reduces absorption, raises glucose, and greatly increases insulin uptake variability — if insulin isn’t absorbing fast enough, a patient might inject a second dose, only to have the first dose finally kick in. Bulsai takes the mystery out of dosing and through proper placement ensures patients that their insulin will work for them when they need it. StartUp Health is proud to support Bulsai on this mission.
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Published: Oct 19, 2023