Kezia Fitzgerald was diagnosed with Stage 3 Hodgkin’s Lymphoma while pregnant with her first child, but this was not the most devastating news she would receive that year.
Months after Kezia’s daughter Saoirse was born, her baby woke up with two mysterious black eyes. This set off a chain of hospital visits and tests that yielded no answers until a doctor thought to examine Saoirse’s belly and found a mass, which turned out to be a severe Stage 4 neuroblastoma.
Kezia and her husband Mike, who live in Boston, spent the next eight months doing everything they could to battle Saoirse’s cancer, while Kezia also underwent treatment for her own.
It was this experience that led the Fitzgeralds to found CareAline, which on Tuesday won the first ever Impact Pediatric Health pitch contest at the annual South by Southwest Music and Media Conference in Austin. The event was hosted by four of the top children’s hospitals in the U.S. and focused on innovations that address gaps in pediatric medicine.
“We were super surprised by the win because we felt like underdogs," said Fitzgerald. "We did not see ourselves as top contenders, and when we won, we really felt like the community understood what we were doing and how it was needed.”
Emcee Mark Cuban, owner of the Dallas Mavericks NBA Basketball team and judge of ABC’s entrepreneur reality show, Shark Tank, was so compelled by Kezia’s story that he offered to buy 1,000 orders of of CareAline, provided she adds the Mavericks brand to her product.
CareAline makes a simple cloth sleeve and wrap that prevents children with implanted intravenous lines from pulling and tearing them off.
During Saoirse’s chemotherapy treatment, she constantly fiddled with her catheter lines and often dislodged them. The most common way to secure lines is with tape, but this strategy is far from effective.
Tape irritates the skin and lines that are pulled can cause infections, including ones that are potentially life threatening, such as Central Line-Associated Bloodstream Infection (CLABSI).
“At 11 months old, anything that is attached to you is a toy,” Fitzgerald said. “The line was something Saoirse could chew on while teething. It constantly dangled down and caught on things, which was really dangerous and made us nervous as parents."
Kezia used a piece of pink fabric to fashion a little sleeve with a buttonhole that the IV line could go through, which prevented Saoirse from dislodging it.
The simple solution proved remarkably effective. “I saw how well my sleeve worked and thought ‘Great, problem solved,’” said Fitzgerald. “But then I realized other parents and nurses were really excited about how it was helping Saoirse and wanted one for their children or patients too.”
Saoirse passed away in December 2011, three months after Kezia went into remission and a few months after she developed the initial “prototype.” The Fitzgeralds decided to build the idea into a full-fledged company.
“When Saoirse passed away, we realized that we could either do something or not do something,” said Fitzgerald. “We had to push forward and figure out how to make these garments on a larger scale. We knew how many people it would help, and it was worth it to push through that grief.”
The Fitzgeralds founded CareAline in 2012. The company’s two products keep lines off the patient’s skin, so they remain safely, cleanly and comfortably tucked away as they deliver medication or feeding.
The $19.95 sleeve and $24.95 tubular wrap are made from a 94 percent cotton, 6 percent Spandex fabric blend. They wrap around a patient’s arm or body to keep lines in place (without tape) and protect the entryway or cap, which can easily become a source of infection.
“There are a few other devices and garments out there, but most are just decorative covers,” said Fitzgerald. “Ours are functional."
"It not only keeps the lines covered, but off the skin, which is a huge benefit to patients because the skin can harbor bacteria and if lines sit in one place on the skin, they can actually break down the skin itself. There are a lot of people who have tried to find some way to solve this issue, but not in such an elegant and simple way.”
Kezia Fitzgerald, once a photographer, has now become a businesswoman.
The Fizgerald’s made a video for an indegogo campaign to cover the costs of selling Kezia’s sleeves and wraps worldwide. (Kezia and Mike Fitzgerald)
The impact of CareAline’s products has been dramatic. A Children’s Hospital in Colorado recently conducted an informal study which found that patients wearing the sleeve or wrap didn't have anyaccidental PICC line removals.
In addition to the long list of medical benefits, said Fitzgerald, “the CareAline products improve peace of mind for patients, parents and caregivers”.
That such a pervasive problem has such a simple solution makes you wonder why no one thought of it before. Medical device companies have often overlooked pediatrics because its not as profitable as other markets.
And so it took an innovative set of parents who experienced the problem in a deep and painful way to take the extra steps needed to solve it. Today, CareAline has sold over 4,000 units and works with distributors in the United States, Canada, Australia and the European Union. About 20 percent of its sales come from hospitals, a percentage the company aims to increase over time.
“Our vision has always been that CareAline should be a hospital provider or insurance company product,” Kezia said. “We’ve lived the patient experience. We know the financial troubles parents see when they have children dealing with long term chronic care management.
Our products are not that high cost, but when you consider that over half of families with a child diagnosed with cancer go into bankruptcy, even $25 is a burden we do not want to put on parents.”
However, selling to hospitals can be a long and difficult process. It involves navigating through layers of bureaucracy and approvals, appealing to both care providers on the ground floor, as well as the executives higher up who make the decisions. Also, to date, CareAline products are not covered by health insurance.
“The nursing community is one of our biggest advocates because they deal with this on a day-to-day basis,” Kezia said. “They are the ones who see the complications and troubles patients have with lines, how nervous it makes it parents, and how damaging tape is to the skin."
"They are the ones trying to figure out how to make their patients more comfortable, but sometimes people higher up the chain don’t see the value added.”
Fitzgerald said that convincing hospitals they should spend more money on CareAline instead of using tape, which is “pretty much free,” is a challenge.
The key is to make hospitals and insurers understand that the money they spend on CareAline will quickly be recovered when the number of infections and repair procedures go down.
CareAline’s product is already resonating with members of the pediatric health community. The SXSW event is the second pediatric health competition CareAline has won in the past six months. With two wins under their belt, the couple is looking toward the future, along with their son Lochan who will soon turn two.