It probably was inevitable that Esra Roan would find a job doing what she does in what she calls "no man's land."
Roan admits that while earning a PhD she was especially interested in learning about soft tissue structures in the human body. It was something that fascinated her throughout her academic and professional careers in both mechanical and biomedical engineering.
As a result, two years ago - after almost a decade in academia - Roan left the lecture halls behind, taking with her the skills she honed both as a professor and a mechanical engineer and began to pursue a career in post-operative drain recovery. It was an area she felt had been ignored by the medical device profession for almost half a century.
"I want to make a difference in post-op drain recovery," said Roan, co-founder and CEO of SOMAVAC Medical Solutions, a medical device startup company that designs and manufactures a device that drains fluid from incision sites in patients recovering from flap-forming surgeries such as mastectomies.
"It's an untapped area, and I see many ways we can improve potential patient issues during the recovery period. I want to create products that are easier for patients to use and that will lead to better outcomes in healthcare."
Three years ago, Roan, who was a tenured professor specializing in biomedical engineering at the University of Memphis, decided she wanted to transition out of academia and search for a new career path.
Every year she received applications from Memphis Bioworks' Zeroto510 medical device accelerator, which helps entrepreneurs launch a start-up process, refine business models and achieve the Food and Drug Administration's $510,000 pre-market notification filing.
Josh Herwig, her student at the time and now her business partner, wanted to pursue a new biomedical project. Roan encouraged him to apply to the program.
"It's all a blur how it happened, but I became interested in the project," Roan said. "I was leaving the university and was searching for something new. I liked the idea of helping post-operative patients. As engineers, we have the potential to solve unmet needs for both physicians and patients. I wanted a chance to solve something and make things to help make the lives of individuals better. I felt Josh and I could offer our skills to solve a problem, and we applied together."
Roan worked with physicians as a professor and was drawn slowly into the field of healthcare, so working on a new medical device project was a good fit.
She and Herwig met with surgeons and post-operative patients and discovered that the current device used most frequently to drain bodily fluids from incision sites, known as a Jackson-Pratt (JP) Drain, had been in use with few design modifications for 40 or 50 years. Additionally, surgeons said one of their main challenges was seroma, which is a buildup of fluid under a patient's skin after a large flap-forming surgery. If not treated properly, it can lead to hospital readmissions or additional surgeries.
JP Drains are attached to clear suction bulbs that are often pinned to the patient. Once the fluid reaches a certain level, the patient must empty the bulb and recharge it. Roan said patients complained that the bulbs were bulky, cumbersome and smelled. Additionally, a risk of infection can be high if they are not managed properly.
"We felt that the current drainage system didn't meet the needs of surgeons or patients," Roan said. "This type of drainage device was initially designed to work in a hospital environment. With patients being discharged earlier and earlier, this type of device hasn't been adapted for home use.
"We had an idea that gives special attention to the acute post-operative phase for patients. We wanted to create a device that would draw fluid out effectively and was light, low profile and compact. Currently, there isn't a standard of care for drains. There are lots of variations with how drainage devices are used. This was our chance to simplify that."
Roan and Herwig designed the SOMAVAC Sustained Vacuum System, which is a battery-operated, light and compact drainage device that draws out fluid from an incision site continuously. The device can be hidden under a patient's clothing and contains a disposable bag that collects fluid, which can be detached easily from the device. According to Roan, the patient doesn't have to interact with any bodily fluids because the drain is attached separately from where the fluid is collected. The device can be used up to six weeks.
SOMAVAC received FDA approval in May after a two-year journey of designing the device, creating a working business model and achieving the proper funding to produce it.
The company began manufacturing the product this summer and plans to distribute it in Memphis first.
"The product is funded from Memphis," she said. "Memphis is our home, and we plan to release it regionally here."
She acknowledges the road to starting a business and achieving an FDA-approved device hasn't been easy.
"The biggest challenge for me is making quick decisions without second guessing myself," she said. "I've learned that there are no small decisions in medical device. My business partner and I are a good balance. We've learned to troubleshoot a problem and optimize for the best solution."
Originally from Istanbul, Roan traveled to the United States to attend Tennessee Tech University on a tennis scholarship 25 years ago. She said she adapts to new situations easily but has learned to do it while relying on a supportive team to assist in making each strategy successful.
"I'm a person who was used to working alone," she said. "I traveled to the U.S. alone, had to rely on myself to perform in tennis and my studies, as well as in academia. It takes a good, solid group of supporters to make this venture work, from vendors to regulatory specialists. We have a good working environment and we have built trust, which is extremely important."
Roan advises others with ideas or prototypes in the healthcare field to pursue them and not give up, no matter how long the process takes.
"I've learned that people are supportive, especially if you have a passionate idea, a decent business model and work hard," she said. "For those who see an unmet opportunity, there are people out there who will fund it. Even though there were times when things slowed down more than we liked, we kept going."
Roan said she made the right decision to pursue a new career. She has found happiness both professionally and personally with her husband and two children in Memphis.
"I'm in a place where we can impact clinical outcomes," Roan said. "I was searching for something where I could to make a difference, and I've found it."
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