NC State doctoral student’s new spirometer could improve lives of asthma patients
Patients suffering from respiratory ailments such as asthma currently have limited options for measuring their breathing. They either can use peak flow meters, which tend not to be very accurate, or spirometers, which are so expensive that some physicians’ offices don’t carry them.
To address these issues, James Dieffenderfer, a North Carolina State University doctoral student, has created a new portable and inexpensive version of a spirometer, which originally began as a class project. Patients who use the VitalFlo, as it’s called, can easily record their breathing measurements using the device connected to an app on their smartphone.
The net result is patients are able to record more accurately their breathing numbers, and physicians are able to better care for them. Being able to have more accurate data available could mean physicians could alter a patient’s treatment, such as changing how often the patient uses an inhaler.
Dieffenderfer, of Apex, started working on the VitalFlo in his product innovation class at NC State that teams up engineering, design and business graduate students on projects. Dieffenderfer’s team was tasked with asthma management. John Muth, the professor of engineering who taught the class, initially suggested that the team look at making a better peak flow meter. Gradually, though, Dieffenderfer’s team saw the value in making a portable spirometer instead.
“When we looked at devices for asthma management, we saw there were more treatment-based devices than management-based,” said Dieffenderfer, who had asthma when he was a child. “People were using their inhaler to manage the symptoms, but they weren’t using devices to manage their lungs. We decided to build a spirometer that was small and easy to use to solve the problems selecting between peak flow meters with their faulty readings or spirometers, which aren’t portable.”
Dieffenderfer said patients are often asked to use their spirometers three times a day, which he said can feel tedious, since the results often had to be recorded by hand or synched with a computer. The VitalFlo automatically records data to the app.
“We use a different way of sensing while keeping the accuracy,” he said. “Normally, devices will use pressure or ultrasound. The VitalFlo uses an analog turbine – basically a small windmill that generates electricity when moved by the patient’s breath. It’s a simplified way of measuring, which allows us to make it lower cost and get it in the hands of patients, and make it smaller too.”
The team’s class project was stimulated by the National Science Foundation’s Nanosystems Engineering Research Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies, or ASSIST, Center on NC State’s campus. The center’s objective is to help create low power devices that monitor people’s health.
Muth, impressed with the design, suggested the team submit the project to the NASA Tech Briefs Create the Future competition, and the VitalFlo defeated 80 teams to win the 2013 competition for Best Medical Design.
“When they won that, I got excited, and I got them to apply to the Center for Integration of Medicine and Innovative Technology (CIMIT) in Boston, which was having a student contest for technology transitioning to patient care,” Muth said. “They won first prize for that and $150,000.”
VitalFlo won that competition in 2014, and NC State administered the prize money to be used on further development of the product.
The accolades keep on coming. In April, the team won $10,000 and took overall top honors over 21 finalists at NC State’s Lulu eGames, a competition run by the university’s Entrepreneurship Initiative.
Creating a business
With the success of VitalFlo, Dieffenderfer has formed VieMetrics Inc. to improve and ultimately market the device. VitalFlo President and CEO Luke Marshall, who met Dieffenderfer through the ASSIST program, said the company is currently raising capital to refine the device and fund clinical trials.
To take the product to market, the company will need approval from the Food and Drug Administration, which means testing the product. Dieffenderfer is conducting studies of the device with doctors from the University of North Carolina School of Medicine.
“We’re conducting clinical trials to see how it measures up against the gold-standard spirometer,” Dieffenderfer said. “We’re about to start a second clinical trial to prove the efficacy of the device.”
Marshall added that the company hopes the product could be on shelves by the end of 2018.
“VitalFlo should be a Class II medical device, which has a lower-bar FDA clearance,” he said. “We expect our clinical trials to be sufficient.”
So far, the clinical trials have yielded encouraging results, according to Dr. Michelle Hernandez, an assistant professor of pediatrics at UNC Health Care and associate medical director of the NC Children’s Allergy & Asthma Center.
“We incorporated the VitalFlo into an ongoing study I have on adolescent children with asthma,” Hernandez said. “We’re creating other clinical studies to try to deploy VitalFlo into the field and see how it does there. It’s looking very promising, very exciting. There are not devices like this on the market. It’s exquisitely easy to use.”
Hernandez said that one of the challenges of asthma is over time people adjust to not breathing well, and patients don’t realize they are having problems breathing.
“Having a device like this will help people manage their asthma better,” said Hernandez, who added that the device could also be beneficial for patients with COPD. “The whole purpose is to prevent people from going to urgent care and having asthma attacks.”
Muth said mentoring students who are creating new technology that will improve people’s lives goes to the very heart of the mission of NC State.
“It’s a pleasure to work with bright people with good ideas,” he said. “This is a good example of getting people to think as much about the technology and connect to the business aspects of that technology. It creates opportunity. I think that’s what we’re here for at the university, and James is a good example of that.”
Written by Phillip Ramati