Dr. Umar Sofi with "Hal," a patient manikin, in Carilion Clinic's Center for Simulation, Research and Patient Safety. A rough prototype of Sofi's invention, the Flow Regulated Nasal Delivery System, is attached to Hal. Photo by Randy Walker.
Dr. Umar Sofi with "Hal," a patient manikin, in Carilion Clinic's Center for Simulation, Research and Patient Safety. A rough prototype of Sofi's invention, the Flow Regulated Nasal Delivery System, is attached to Hal. Photo by Randy Walker.

In the depths of the COVID pandemic, when intensive care units were packed with patients struggling to breathe, an idea came to Dr. Umar Sofi.

Sofi is a pulmonologist at Carilion Clinic. “The respiratory therapists, they were really stressed, because there were hundreds of patients in the hospital,” Sofi said. “I would come in the morning and I would see this patient, either on too much oxygen, or too little oxygen.”

Sofi would adjust the oxygen flow manually, a process which might take five or six minutes.

“I would say, ‘there needs to be a process by which a machine can do the job.’ So that’s where the thought came from.”

The thought in Sofi’s head is now tangible, in the form of a small box sporting a bouquet of multicolored wires. This is the rough prototype of Sofi’s invention: FRNDS, Flow Regulated Nasal Delivery System.

It doesn’t take a medical degree to understand the concept behind FRNDS. The system monitors blood oxygen and the patient’s flow rate (liters of air breathed per minute) and adjusts oxygen delivery accordingly. If the patient exerts himself — for example, getting up to go to the bathroom — oxygen is automatically increased. If something is wrong, or the patient’s vitals take a turn for the worse, the system alerts a human attendant.

Why such a device hadn’t been invented already is a “million dollar question,” Sofi said.

In any case, when inspiration struck, Carilion was ready to respond. (Disclosure: Carilion is one of our donors but donors have no say in news decisions; see our policy).

In January 2020, the health system launched Carilion Clinic Innovation, a program to nurture, protect, and help bring to market products and services developed by Carilion personnel. It’s an avenue for any employee who has an on-the-job brainstorm and says, “There has to be a better way.”

With the yearslong development, testing and approval process required for medical devices, Carilion hasn’t yet commercialized a product. But if and when it does, proceeds would be returned to Carilion, said Aileen Helsel, interim director of Carilion Clinic Innovation. 

As a not-for-profit, Carilion invests monetary gains back into the system rather than issuing dividends to stockholders. 

That’s not to say that inventors don’t stand to benefit.

“We have a very generous share with our inventors because we want to incentivize people here at Carilion Clinic to be able to be inventive,” Helsel said. The percentage split is spelled out in the employee handbook.

Aileen Helsel, interim director of Carilion Clinic Innovation, with some 3D printing equipment in the “Makerspace” lab, in a corner of the Center for Simulation, Research and Patient Safety, located in the former trolley barn. Photo by Randy Walker.

The handling of intellectual property follows the state university model. The employee’s name is on the patent application, but rights are assigned to the institution. In return, Carilion assumes the costs of filing the patent applications. 

Carilion has several inventions, including FRNDS, in the patent pipeline, guided by lawyers from the region who have intellectual property expertise. Carilion is also seeking funding to build the next-stage prototype.

Sofi’s device, in addition to better serving the patient, helps address staff shortages by reducing demands on providers’ time, Helsel said. The need for oxygen is increasing due to an aging population and higher rates of asthma and chronic obstructive pulmonary disease. “So it kind of is this technology that checks a lot of boxes.”

The machine could even be used by outpatients. 

“A patient that I see in the clinic, I usually walk them for six minutes, and decide that this patient needs two liters or three liters of oxygen” per minute, Sofi says. “They go home, they do yard work, or they get excited, there’s a birthday party or there’s something going on, or the patient dances with his spouse, the flow rates increased tremendously. They go up to 10 liters, 15, they go can go up to 20 liters. But now he’s on a fixed flow of two liters. So he can’t perform his daily physiological functions that he would, if he had a machine that would match that flow.”

It is becoming more common for mid-size healthcare systems to have programs dedicated to commercializing innovations, Helsel said. Such programs help employees stay enthusiastic about their work.

“I’ve seen it be very, very fulfilling for a lot of our folks, to be able to work with Innovation in order to come up with a solution to something that’s really been bothering them for a really long time.”

The process can  help prevent burnout and serve as a recruitment and retainment tool as well, she said.

The first step for would-be inventors is a disclosure, in which the employee notifies Carilion of his or her idea via an email or an online form. Since 2020 there have been about 70 or 80 disclosures, Helsel said. Most have been from medical doctors, although Helsel has also worked with therapists, nurses and other professionals.

In addition to his hospital position, Sofi is an associate professor of medicine with the Virginia Tech Carilion School of Medicine. Also on Tech’s faculty is Dr. Andre Muelenaer, a retired pediatric pulmonologist who is a professor of practice in Tech’s Department of Biomedical Engineering and Mechanics. The two docs are just a few of the many human links between Carilion and Virginia Tech.

“Dr. Sofi had a need, had lots of ideas of how all this would go together,” Muelenaer said. “But he’s not an engineer. All the flow sensing, electronics, that has come from the engineering side.

“We have hundreds of engineers at Virginia Tech, that when we have an issue, you start looking around and saying, oh, OK, who is expert in this area, that we can tap into that expertise to meet the needs of the physicians?”

“Without Virginia Tech support, we wouldn’t have been able to do it,” Sofi said. “My expertise at what we want in a machine and how it should work, and their expertise in building that machine.”

Co-inventors with Sofi and Muelenaer are Alfred Wicks, an associate professor in the Department of Mechanical Engineering, and graduate student Hunter Mollica.

Hunter Mollica, a graduate student in Virginia Tech Department of Mechanical Engineering, attaches a cannula to a black box that models the nasal airway. Photo by Randy Walker.

Carilion Clinic Innovation’s projects bring together people from Roanoke to Blacksburg. The meeting place is the Center for Simulation, Research and Patient Safety, located in a former “trolley barn” near Dr. Pepper Park and the Walnut Avenue bridge in Roanoke. Built in 1911, the building once housed electric streetcars, cutting-edge technology of 100 years ago. 

On Nov. 28, Carilion’s “Makerspace” began operating in a corner of the building.

It’s a laboratory where inventors can meet with Helsel and work on prototypes. She described it as “a one-stop shop, where we have engineering support and expertise, as well as a lot of physical resources that can be used to go from problem all the way to solution.”

Randy Walker

Randy Walker is a musician and freelance writer in Roanoke. He received a bachelor's degree in journalism from the University of North Carolina at Chapel Hill and was formerly a staff writer on (as it...