Many doctors have visualized devices to solve medical problems. The founder and CEO of Noleus Technologies has devised one to address prolonged hospital stays after abdominal surgery.
As a practicing surgeon specializing in surgical oncology, colon and rectal surgery, Dr. Swarna Balasubramaniam had an idea over 20 years ago that she thought could make surgeons’ jobs a little easier. She talked to other physicians and some engineers and had some drawings made, but decided not to proceed.
“I didn’t do anything, even though people said it could be done,” Balasubramaniam, founder and CEO of Houston, Texas-based Noleus Technologies, told Medical Design & Outsourcing. “Fast-forward 12 years and a sales rep walks into my office with a device and it was pretty much my idea from 12 years before. I was like, ‘What?!?’”
So, in 2016 when she thought of a device to help patients heal faster after stomach surgery, Balasubramaniam took a different approach. Instead of throwing out her sketches, she consulted patent attorneys who were enthusiastic about the device’s potential. They guided her through the process of making her device idea a reality.
“I wanted to see if the idea was any good,” Balasubramaniam said. “As a surgeon, I had no idea. I guess I was kind of thinking someone’s thought of this idea before. I didn’t know the startup community at all.”
But she knew there was a problem that needed a solution. Balasubramaniam has performed numerous cancer surgeries in which she removed parts of the colon and small intestine. These patients’ intestines “go to sleep” after surgery, she explained, forcing them to lie still for 5-7 days in the hospital until they can eat and eliminate the food.
The problem is widespread. Colorectal cancer is the third most common cancer in the U.S., according to the American Cancer Society, and surgery is the most common treatment for resectable colorectal cancer. In 2020, there have been 104,610 new cases of colon cancer and 43,340 new cases of rectal cancer as of August 31.
“As long as we’ve been doing abdominal surgery, this problem has been there,” Balasubramaniam told MDO. “People have looked into this and they’ve done nerve stimulation things and doctors always assumed it was all the drugs from anesthesia. So, people investigated all of that and nothing really helped.”
Balasubramaniam wondered if all the fluid patients get during anesthesia cause the problem.
“We never really understood what happens in the abdomen because it’s kind of like a black box. But, thanks to CT scanning, we now can see intestines swell like fingers swell,” she said. “What we’re doing is we’re treating the swelling and bringing the intestinal function back more quickly.”
Reducing ileus with Noleus Technologies’ device
Noleus stands for “no ileus,” the medical term for lack of movement in the intestines. The company’s leaf-like device is temporarily inserted next to the intestines to lower swelling by removing tissue fluid through a tube, aided by a suction pump. Once finished, the device folds up like a small fan and is removed from the patient’s side like a drain. The patient should be able to eat and drink once the device is removed, shortening their hospital stay, according to Balasubramaniam.
She self-funded the patent stage and colleagues pitched in toward developing the prototype. The company has had the device tested on animals to show that it works, but she is looking toward its next steps.
“Now we’re waiting to get into humans to show that it really solves the ileus problem because animals can’t tell us if intestines are working or not working,” Balasubramaniam said. “That is the next step. Doctors really believe in this because we know that this is a huge problem. They also believe the solution will work because they see the fluid bogs down the patients and they see when the fluid leaves the patient. When we see the swelling go down, that’s when we see the bowel function typically return.”
When doctors launch startups
Startups play an important role in addressing the unmet needs of the patient population, and it’s common for physicians and surgeons to become entrepreneurs, according to Brian Johnson, president of MassMedic. There’s even an organization, the Society of Physician Entrepreneurs (SoPE) that seeks to make it easier for doctors, nurses, dentists and other healthcare professionals to work on innovation and commercialization of medical devices. SoPE has over 300 members across 28 chapters in the U.S. and six international chapters.
“Doctors have a lot of good ideas. A lot of the tools used in surgery have surgeons’ names on them. So, they’ve always been the ones to invent it,” Balasubramaniam said. “Now medicine and devices are getting way more complicated, but I think surgeons have always had the ideas and, in the past, have quickly licensed the idea to a company or someone developed it.”
These days, more doctors are earning Master of Business Administration degrees and are trying to develop devices and companies themselves to make sure the insights into the problem aren’t lost, she added.
“Medicine is really complicated, and the problem has a lot of nuances,” Balasubramaniam concluded. “You really do have to understand the problem in order to come up with the correct solution.”