Robert Cooper painfully remembers watching a medical team try to perform a spinal tap on his infant son. A nurse had to physically restrain his newborn baby, holding him in place while a doctor inserted a needle into his son’s back. The needle slowly collected cerebrospinal fluid for testing, which is a process that could require more than one nurse holding an infant in place to ensure they don’t fuss.
For Cooper, the procedure — also called a lumbar puncture — is painful for everyone involved: The doctor, the nursing team holding the child, and the parents watching intently. From the medical team’s perspective, it’s also incredibly challenging. According to some studies, about 30 percent of all infant spinal taps fail.
Years later, Cooper was considering joining an angel investment fund. He was sitting with his wife, a now retired pediatric anesthesiologist from Hasbro Children’s Hospital, when Dr. Brian Alverson pitched to a room of investors about a new medical device that was designed to help hospitals easily perform spinal taps on infants.
“My wife elbowed me and said, ‘I can’t believe they came out with this after I retired,’” he said in a recent interview. “She hated performing spinal taps. And I’ll never forget watching one.”
An entrepreneurial executive who has worked on the business side of the life sciences for three decades, Cooper approached Alverson that day. By early 2022, SmolTap founders Alverson and Dr. Ravi D’Cruz asked Cooper to run the company.
Q: Why do so many infant spinal taps fail, and why does it matter?
Cooper: Most doctors will tell you that the most important person in the room during an infant spinal tap is the holder. If the baby is wiggling around and their shoulders or hips are not squared to the spine, then it will compress the space in between the vertebrae, making it much harder for the needle to go in. So you really look to a holder, who is typically a nurse, with really strong hands. So the entire procedure is holder-dependent. When the tap does fail, then infants are typically admitted, given antibiotics, and it becomes unnecessarily expensive [for patients].
How does the SmolTap device work?
The SmolTap helps redirect a medical team’s focus from the holding of the infant to tap accuracy. The SmolTap is almost like a cradle or seat that positions the infant by making the process more consistent. It has a floor so the baby can’t tip back, a seat to hold them in place, and arm guards that go along the shoulder to keep them from wiggling around. While the infant is buckled in, they are facing a massage table-like opening where they can be offered a pacifier and a nurse or parent can be seen.
Do you have any data on how the device has reduced mistakes or tap failures?
The whole point of this device is to get success on the first try so a tap does not have to be done two or three times. We want to reduce risk, stress on the medical team, but also hospital admissions. We worked on prototypes and our designs for three years, constantly getting feedback from the market. We did conduct tests with Toronto SickKids and we reduced the failure rate by more than 30 percent.
While this is not a validated study, and he is a co-founder, Dr. Alvarez has performed dozens of taps with this device. He said he has not yet failed with it.
Is this device expensive for a hospital or other provider to purchase?
No, we did a lot of work with a number of hospitals and a medical device pricing expert. In an eight-month effort to really see the value and our cost, there was a thought to price this around $5,000 to $7,000, but that the bottom range should be around $2,500 given the cost of the product. We made the choice to make it as easy as we could so we price them out at $2,500 across the board.
And there is a demand. We received our inventory from our manufacturer and every unit was out the door.
Does the company have any investors?
The founders initially received $100,000 from Brown University’s Innovation Fund. In a Series C round, we then raised $544,000 from some local-to-Rhode Island investors like Cherrystone Angel Group, Magpie X, and others. The Charles H. Hood Foundation (which Cooper said is known to invest in pediatric innovation) also put up funds.
We’ve applied for three patents, and were granted one this past December. (Cooper said there aren’t any similar devices on the market for infants.)
What are you looking forward to with SmolTap in the next year?
Overcoming one challenge, which is much smaller than I could have ever expected, is there are some doctors who have been trained to perform the spinal tap one way and they feel comfortable with it. But the overwhelming majority of providers who perform taps on infants want to try this device. We are also in discussions with a number of medical schools to bring the device into the classroom.
The Boston Globe’s weekly Ocean State Innovators column features a Q&A with Rhode Island innovators who are starting new businesses and nonprofits, conducting groundbreaking research, and reshaping the state’s economy. Send tips and suggestions to reporter Alexa Gagosz at email@example.com.