LEHI — For Kurt Workman, the seeds of his idea for a device to monitor a sleeping baby's vital signs were sown by trauma his wife experienced as an infant with a congenital heart defect.
"Ten days after my wife's parents brought her home from the hospital, they rushed her back for emergency heart surgery," Workman said.
She went on to have two additional cardiac operations.
During a visit to his wife's cardiologist several years ago to see if pregnancy would be a safe option, Workman's thoughts turned back to what she went through as a child, and what they could do to keep their future baby safe.
"There was a chance our child could have the same defect, and I was worried about that," he said. "How would I know if something was wrong?"
Rather than wait for the answer, Workman took it upon himself to come up with a solution. He consulted with a friend, a nurse at University Hospital. Together they began working on a method to adapt pulse oximetry — that thing surgeons attach to the end of your finger to monitor oxygen levels — technology to be wireless and effective for an infant.
What followed is a string of successes, first by winning numerous entrepreneurial competitions, and the cash prizes that come with them, which helped fund a prototype that led to eventually garnering $2 million in seed funding to launch the product in the fall of 2015.
Now, the Owlet Smart Sock — like it sounds, it's a sock that fits snugly over an infant's foot with built-in wireless monitoring — is in its second generation with more than 100,000 of the devices sold to parents all over the world.
The latest version monitors heart rate and oxygen levels, while connected to an in-home monitor that emits warnings if levels move into unsafe zones and can stream the data in real time to a smart phone app.
Over the past year, more than 120 families have contacted the company to share stories about how the device helped avoid a crisis, Workman said. And that, he said, has been the goal of the Owlet monitor since the beginning.
"Owlet is about allowing parents to be there when their child needs them the most," Workman said.
One of Owlet's stepping stones to reshaping the world of infant monitoring was a victory at the 2013 Utah Entrepreneur Challenge, hosted in part by the University of Utah's Lassonde Entrepreneur Institute.
While the $40,000 prize came at a critical time for a company trying to turn an idea into a reality, Lassonde Executive Director Troy D'Ambrosio said the competition also provides a forum to put budding businesses in front of the right people.
"For these student entrepreneurs, this competition comes at an important time for them," D'Ambrosio said. "The exposure it provides to local venture capital firms, potential angel investors, legal experts and media coverage really is invaluable."
While winning the competition was certainly a great shot in the arm, he said, what Owlet has become since that time reflects a lot of work and focused commitment.
"Seeing what Owlet has accomplished is a great credit to their team and their vision," D'Ambrosio said. "We can help provide some momentum and funding, but if they don't execute on it, it will go nowhere."
While Owlet's growth has been outstanding and has included attracting almost $24 million in outside investment, its path has not been without challenges.
In January, the Journal of the American Medical Association published an editorial on digitally connected infant monitors with a decidedly cautionary tone. The article noted that "there are no medical indications for monitoring healthy infants at home," and monitors like the one Owlet makes, which are not subject to Food and Drug Administration approval, lack "publicly available evidence supporting the safety, accuracy, effectiveness or role of these monitors in the care of well infants."
The piece does go on, however, to note that "the current market of smartphone apps integrated with sensors that monitor infants’ vital signs are innovative and have potential to improve care."
Pushing the envelope of the established regulatory realm has become a hallmark of new technology companies, and some of those conflicts, raised by companies such as Uber, Lyft and Airbnb, have played out in very public settings.
The article's authors even reference what may be construed as a disconnect needing to be addressed between the current process and techonological advances that may be outpacing it.
"Striking a balance between fostering innovation while providing appropriate and efficient regulation in the rapidly expanding mobile medical app market is challenging," the article stated.
Workman respectfully refutes the Journal of the American Medical Association's claim to a lack of efficacy for his monitor and noted the baby sock really doesn't fit into the current and limited FDA categories.
"We think it’s a misconception that monitoring doesn’t help parents know that there’s a problem happening," he said. "Right now, there's simply no regulatory pathway in place for a consumer medical device that uses pulse oximetry."
While hoping it can be a positive force for change in the work to update approval processes, Workman said Owlet also has filed the initial paperwork to seek FDA approval through the existing system. In the meantime, and unlike some other tech companies with disruptive business models, Workman and his Owlet team are playing by the rules.
And according to those who are using it, the Smart Sock monitors are an effective and popular addition to a parent's tool kit. Workman said customer feedback on the product has been overwhelmingly positive.
The cost of that peace of mind: $300. And the company has recently expanded outlets for purchase to include retailers buybuy Baby and Babies 'R' Us, in addition to the Owlet website.
Workman believes in his product and said he sees a future where the Owlet monitor could become as ubiquitous as another infant must-have.
"Just like the car seat, one day every baby will leave the hospital with a health monitor," he said. "And Owlet is going to be seen as the technology leader for infant care from pregnancy through the first few years of life."