A love to create and a chance conversation led Daniel Mendez on a journey to build a device that will reshape the medical industry and help newborns around the world.
It’s called “the soft spot.” Every baby is born with one at the top of its head. The plates of the skull eventually fuse and it disappears within months after birth. It’s as natural as nervous parents. But, sometimes, nature needs a helping hand.
If an unborn child’s head rests against its mother’s pelvic bone for too long it can become distorted, a condition known as plagiocephaly. The same thing can happen when a child born prematurely rests in the same position for too long; soft bones flatten under their own weight and fuse together in an asymmetrical shape.
The occurrence of plagiocephaly increased in the 1980s and 90s as parents desperately sought a way of preventing Sudden Infant Death Syndrome (SIDS). In 1994 the American Academy of Pediatrics (AAP) went so far as to implement the “Back to Sleep” campaign to educate parents, caregivers, and healthcare providers on ways to reduce the risk of SIDS. The AAP recommended placing newborns on their backs while sleeping. And while this led to an 80 percent decrease in SIDS, it also led to a 600 percent increase in plagiocephaly.
Today’s treatments range from labor-intensive repositioning of infants in neonatal intensive care units (NICUs) to cranial remolding orthoses, restrictive helmets used to reshape the skulls of toddlers. In 2009, UTSA engineering students Daniel Mendez, Israel Cruz and Nick Flores thought there had to be a better way, and they used their senior design project to find it.
“It seemed like a relatively simple problem that could be solved easily and cheaply,” Mendez says. “Having just finished an internship at Kinetic Concepts (a San Antonio-based wound care development and manufacturing company) and having gone through the whole FDA 510(k) process, coming up with a way of preventing plagiocephaly seemed like almost a no-brainer. I felt like I could do that.”
Every nurse and neotologist Mendez and his team interviewed loved the idea of finding some way to prevent plagiocephaly instead of just treating it once it had occurred. They also agreed there was nothing effective currently on the market. The solution the UTSA team developed, the Aqua Bonnet was, like most inventions, born of necessity.
Rather than create some intricate mechanical device that would move a baby’s head periodically or make a clumsy padded helmet, Mendez addressed the root cause of the problem: pressure against pliable plates in a baby’s skull. He and his team designed an elegantly simple cotton hat, padded with gel inserts, which distributes external pressures equally around the skull and reduces the stress on the contact point.
The concept was so simple and practical, Mendez and his team entered it in UTSA’s biannual $100K Student Technology Venture Competition sponsored by the Center for Innovation and Technology Entrepreneurship (CITE). Created to give students hands-on experience as early stage entrepreneurs, the CITE program teams senior business and engineering students to work throughout the semester to develop a technology demonstrator and business plan to successfully develop a new company.
Even though he was an engineer, Mendez was eager to be involved in the business planning portion of the project, so eager in fact, his team entered the competition without a business major.
“We decided to enter the competition on our own,” he explains. “My teammates and I felt that, as long as we had the guidelines of the competition, we could do everything required. We wrote our own business plan. We did everything on our own. We entered the competition at the end of our second semester of senior design.”
Even without a business specialist in their corner, Mendez and his team won the competition. The result was not only a new product, but a new career for Mendez. With a bachelor’s degree in engineering in hand, he’s now working on his master’s in business administration.
A Chicago native who went to high school in The Woodlands, Texas, Mendez demonstrated some of his business savvy when he chose UTSA. “It’s like an investment. The value of a degree from UTSA is going to increase over time. You put something in and, at the end, you’ll get something even better.”
But it’s not all about business. The San Antonio lifestyle has had an impact on Mendez as well.
“There is a big mash-up of culture here. You have Texas culture, and you have a strong Hispanic presence, and you have your typical American culture, especially here around the university. So you get to see everything. It’s like a miniature Austin without the congestion and the high prices.”
“I loved engineering. I’ve always been interested in how things work. The main reason I decided to go for an M.B.A. is because I think it will help me in running my own business.
“I’ve had the opportunity to see good management and bad management. I can always spot a problem, and I can usually create a solution for that problem. So instead of going the engineering route, I wanted to not only create a company, but run it as well. And in order to do that, I think it would add a lot of legitimacy if I got an M.B.A.
“After the competition I was able to meet some entrepreneurs here in San Antonio and they were able to connect me with some excellent resources; business resources, technology resources, capital resources.”
Those resources were instrumental in Mendez’ creation of Invictus Medical, the company he launched to bring the Aqua Bonnet to market. As chief technology officer, Mendez is conducting bench tests which have shown the device can potentially reduce the occurrence of head molding by 92 percent. The company is currently raising a half million dollars to manufacture prototypes, complete clinical studies, and submit its product to the FDA for 510(k) clearance.
But, in the end, Mendez isn’t creating just a product. He’s also creating opportunities some children never had. “This isn’t just a cosmetic issue,” he says. “It’s also a neurodevelopment issue. A lot of children undergo motor skill development therapy because of plagiocephaly. Even when they’re young, they have trouble tracking things with their hands and their eyes. Something had to be done.”