Janet Conneely, BSN, RN, CPN, was visiting a new mother in the hospital who had just delivered a baby with a cleft palate to let her know about Boston Children’s Hospital’s Cleft Lip and Palate Program. The mother was trying, without success, to breastfeed, but because of cleft palate, her baby didn’t have an intact hard surface on the roof of her mouth, so couldn’t create enough suction to draw milk.
“I was new to seeing these moms,” Conneely recalls. “This mother was in tears, pleading for ‘some way to be able to breastfeed my baby!’” She adamantly did not want to be shown the specialty bottle typically used for babies with cleft palate.
Conneely tapped her colleague, Olivia Oppel, BSN, RN, CPN, CLC, and together, they reviewed existing breastfeeding products. The few that were available — nipple shields, bottle attachments and a sling that holds the bottle against the breast — were either awkward to use or didn’t really allow for skin-to-skin contact.
“There was nothing really hands-free where the baby has the ‘to the breast’ experience,” Oppel says. “We got to thinking there had to be some way she could hold the infant to her breast during feedings, without the baby needing to latch or apply suction.”
Solving a design problem
Around this time, Salim Afshar, DMD, MD, an oral and maxillofacial surgeon in the Department of Plastic and Oral Surgery, was working with Boston Children’s Innovation and Digital Health Accelerator to engage nurses in the innovation process. He had prior business experience, starting a software company, Clinical Box, and consulting in medical device and software design.
“When I came back to the hospital, I noticed a lot of design flaws,” he says. In the ICU, a keyboard was awkwardly positioned next to a sharps container. A cabinet was hard to access because it was above a sink.
“The nurses who deal with these design issues just tolerate them – they feel they don’t have a voice to solve the problems,” says Afshar. “I started thinking about how to empower nurses with the language and tools of the design world. Part of design is exploring what you can do differently.”
When Afshar met with nurses in his own department, Conneely and Oppel explained the breastfeeding problem they were trying to solve. He immediately became excited.
“I had just had a child and had a deep appreciation of breastfeeding issues,” he says. “My wife was trying to deal with that. They wanted something more natural, so we started to explore and sketch out what that would potentially look like.”
The three quickly realized that the need for a breastfeeding aid went far beyond the cleft lip/palate population. Babies can have trouble sucking or latching onto the breast because of muscle weakness, prematurity or tongue tie, which affects about 4 percent of babies. Mothers may be unable to nurse because of flat or inverted nipples or sore, painful nipples. Even many healthy babies have trouble latching, with anxiety and frustration escalating the problem. Overall, 60 percent of mothers who attempt to breastfeed stop earlier than intended.
Conneely, Oppel and Afshar engaged with students at Olin College of Engineering and developed a series of sketches. In 2015, they received a Boston Children’s innovation grant. With the help of engineers and 3-D printers in the hospital’s Simulator Program, they came up with a minimum viable product and began showing it to friends and family.
The product, Breast Breeze, consists of a soft pouch for milk that can be tucked into a nursing bra, over the breast. It has a screw-on opening where mothers can attach an off-the-shelf bottle nipple. Babies can then get milk without having to latch or suck, simply by compressing the nipple.
“Almost everyone we’ve brought this to sees the value immediately,” says Conneely. “Most moms would love to breastfeed if possible.”
Working with a market research firm, they used Survey Monkey to poll volunteer mothers. Their responses confirmed that breastfeeding problems are common and that many mothers would be interested in trying a product to help them (click to enlarge):
Bringing Breast Breeze to market
Conneely and Oppel have had a learning curve: “intellectual property challenges, legalities, who can we talk to when, and the business end,” says Conneely. Since both work full-time nursing jobs, the project has moved along relatively slowly since its inception in 2014. “We passionately want to push this forward, so most of our dedicated time to this project is from home,” says Oppel.
But the pace is picking up.
In April, the team filed a provisional patent application, which covers other potential features. They would also like to develop an adaptor to attach the product directly to a breast pump. Working with Boston Children’s Technology and Innovation Development Office, they’ve begun discussions with potential partner companies to co-develop, manufacture and market Breast Breeze.
Afshar has been key in these discussions. “We’re in the stage now where you need experience around negotiating partnerships and bringing relationships together,” he says. “This is where a lot of people just stop.”
Conneely and Oppel look forward to helping more mothers enjoy the breastfeeding experience.
“Breastfeeding is a big emotional experience, a quality of life improvement for mothers and babies,” says Conneely. “We want to watch the babies thrive and take away stress for the mothers.”
Companies wanting more information on Breast Breeze should email firstname.lastname@example.org.