When Steven Schmidt worked at Vertex Pharmaceuticals (NSDQ:VRTX), Eric Olson – the man who led the development of the 1st drug to treat the underlying causes of cystic fibrosis – asked Schmidt to look into ways that families could become more engaged with managing a patient’s condition.
Olson pointed towards a publication that showed that involving caregivers added 8 years of life expectancy to children with cystic fibrosis.
Schmidt, who now serves as founder and CEO of Quvium, took that idea and began development of a wearable cough monitor that alerts patients’ caregivers when a cough is out of the ordinary.
At the Medical Sensors Design Conference earlier this month, Schmidt explained that 10 million children ages 0 to 4 went to the emergency room last year for excessive cough and 2 million children ages 0 to 4 use a nebulizer. This large patient population could use a solution that would help prevent unnecessary trips to urgent care and give their families ease of mind, Schmidt said.
Since the company’s founding in 2014, Quvium has gone through 6 prototypes to develop a wearable that kids would tolerate.
“It turns out small children will lose things – they will fiddle with buttons, they will paint the microphone holes shut,” Schmidt said.
The device also had to be cheaply made so that families could afford to buy several of them and stock up.
“It had to be inexpensive enough so the wearable button companion, you could have 4 of them,” he said. “The 1 left at school, the 1 you can find, the 1 you can’t find.”
The team finally settled on a small monitor that could be worn around the neck or ankle. The SonaSure system listens for coughs, analyzes the cough frequency and duration and can alert the patient or caregiver if a cough deviates from a patient’s baseline.
What makes Quvium’s solution unique is that it measures a patient’s cough against a personalized baseline, Schmidt said. The system uses artificial intelligence to construct a baseline that takes into account the hundreds of personal variables that can affect a person’s cough.
“Having a literature baseline to measure a change against is not useful,” he said. Instead, the company decided it was more valuable to look for coughs that are out of the ordinary for each individual patient.
“In medical, you either have to know everything, which is virtually impossible, or you should know something new has shown up,” Schmidt said.
By constantly monitoring patients and measuring against a personalized baseline, the device can warn against potentially life-threatening flare-ups. Schmidt pointed out that patients who suffer from fatal asthma attacks or COPD often have signs that could have warned them to get to a doctor.
“Half of the people who die from asthma, COPD or had a serious event in CF had a rising baseline cough for at least a week,” he said.
Quvium’s SonaSure is just getting ready to hit the market, Schmidt said, and in the future he hopes the device can evolve into a screening diagnostic device. The company’s algorithms can identify conditions like asthma, pneumonia and tuberculosis. For now, it’s a cough monitor that hopes to give caregivers a bigger role in managing a patient’s disease.
Although the data that Quvium collects for each patient can be easily read and analyzed by a doctor, Schmidt said that doctors told him they don’t want to be the 1st line of defense. Instead, they would prefer to get involved when it’s a true emergency.
Schmidt said this is at the heart of his company’s philosophy – empowering caregivers to take charge of a patient’s condition with constant monitoring and personalized data.
“What we can do is allow families to watch on the front-line. We can collect quality data that we’ve validated against gold standards in the medical community and just give it to them,” he said.
CORRECTION: An earlier version of this story incorrectly stated that Steven Schmidt helped lead the development of the first cystic fibrosis drug at Vertex. The article has been corrected to clarify that Eric Olson led that development.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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