This month, IPI had the opportunity to talk with Kezia and Mike Fitzgerald, the makers of CareAline. We discussed their journey from patient parents to device innovators - find them at www.carealine.com.
When Kezia and Mike Fitzgerald’s infant daughter was being treated for neuroblastoma her treatment required her to have a Central Line placed to administer medications. Suddenly, doctors and nurses were warning of yet another threat to her health – Central Line Associated Bloodstream Infections (CLABSI). They urged Kezia and Mike to keep these lines clean and safe, and stressed the importance of avoiding a life-threatening infection.
Kezia recalls clinicians’ warnings that the lines were going to be the hardest thing she would experience in the treatment process. These warnings were confirmed when after her daughter’s line was placed, the first thing the baby did was pull on it and try to put it in her mouth. “You need to be a watchdog to these lines, but they don’t give you any way to be a watchdog,” Kezia explained.
The nurses offered Kezia and Mike a few suggestions, but no one was able to offer a solution that kept the lines safe and their baby comfortable. Kezia felt that she could do better. Out of necessity Kezia fashioned sleeves and chest wraps to hold her daughter’s lines in place and out of the way while allowing access to them for infusions. From these initial innovations came the creation of CareAline Products.
When their daughter lost her battle with neuroblastoma, Kezia and Mike faced yet another challenge. “We could either go back to what we used to do every day before she was sick, or we could use this as an opportunity to help so many more patients,” Kezia explained. “No one else was helping parents in a way we knew they needed.” With this realization, CareAline was founded as a way to provide desperately needed products to all patients. Prior to this experience, the Fitzgeralds were both working as artists with no background in medicine or medical devices. Today they make sleeves and wraps to protect PICC and Central Lines for patients of all ages.
Kezia and Mike from CareAline offered some insight into the challenges they faced in bringing their pediatric device to market. The CareAline team knew that the pediatric market was key to getting their device used widely. Issues of Central Line maintenance and CLABSI occur much more frequently in kids. When it came time to do market research, however, they found pediatric-specific numbers nearly impossible to find. Not only was it difficult to find numbers that differentiate between pediatrics and adult patients, but Kezia found that “it’s hard to get pediatric numbers, period” because often the “overall” estimates do not include the pediatric market at all. Even more frustrating is that these numbers – on the placement of PICC and Central Lines for both children and adults – surely exist, but hospitals and manufacturers are unwilling to share the data.
Overall, the Fitzgeralds describe their journey as a positive experience and an important learning opportunity. As a small medical device company, they’re able to have a huge impact. Mike stressed the importance of letting his customer base know that CareAline does not just exist to generate profit, but to help people during a difficult situation – one that the company founders can relate too all too well.
CareAline was the winner of three first place awards at Impact Pediatric Health at SXSW 2015. Their products are available directly from their website and are also used in many children’s hospitals nationwide. They have been proven to curb and even prevent dislodgements of implanted lines, and research is being conducted to see whether they lower infection rates as well.
CareAline Products were created as “innovation out of necessity”. The Fitzgeralds were able to identify a problem area and design a simple, functional solution for their daughter. Rather than stopping there, they brought their innovation to market and continue to have a positive impact on many patients managing PICCs and Central Lines.