Kezia and Mike Fitzgerald, owners of CareAline Products were the recipients of a Pre-Seed Award and a 2017 Target Challenge award for solutions addressing the unintended removal or dislodgement of catheters or tubing. George Price of NEPDC caught up with Kezia this month to learn more about CareAline’s start, the company’s latest efforts, and advice Kezia has for other parent innovators or first-time entrepreneurs.
Kezia and Saiorse. (Photo courtesy of CareAline)
George Price: Tell me about where the idea for the CareAline products came from and how that has helped shape CareAline as a medical device company?
Kezia Fitzgerald: CareAline was created from our family’s personal experience with cancer. In 2011, I was diagnosed with Hodgkin’s Lymphoma, and our infant daughter, Saoirse, was diagnosed with Neuroblastoma a few months later. Her PICC and central lines were a constant worry for us, since you can’t tell an 11-month-old not to pull something. They were everything from a teether to a drumstick, and the tape that the nurses put on to hold it gave her a rash and caused more issues. I made the simple sleeve for her arm, and later the chest wrap for her body, initially as my own way of keeping her safe, and letting us relax a little. They worked so well, that other patients, parents, nurses and doctors were asking me to make more for other kids at the hospital. That’s when we realized that we weren’t the only ones who needed a better solution than what was available from the hospital. We sadly lost Saoirse to her disease in December 2011, but we decided that it was important for us to help other patients that were experiencing the same troubles and challenges that we had experienced with our daughter. This is one of the reasons that we have focused on pediatric hospitals and patients as our first users and adopters. While we know that adult patients use and need our products (which is why we have adult sizes as well), we have primarily been pushing into the pediatric space as those patients and families have a special place in our hearts.
GP: What has been the most rewarding aspect of working to provide a solution to line dislodgements for pediatric patients?
KF: There are a lot of rewarding experiences for us working on CareAline. I think the most rewarding has been the stories from patients and families who have used our products. We often get emails, calls and messages about how our products have helped patients live more safely with lines, and how we have given families back some normalcy to their lives. From letting them sleep through the night, to making it so that their child can safely go to school, to being able to get a new puppy, we have heard many stories that keep us going and reassure us that its worth fighting to get CareAline more widely used by hospitals and clinics.
CareAline torso wrap (Photo courtesy of CareAline)
KF: We haven’t had a lot of variation in business approach behind the two products; however, we did have a few surprises. We thought the sleeves would be the thing that would take off much faster – especially since PICCs are used far more frequently than central lines. However, what we found was that the Central Line Wraps have been a much higher demand, and have been much more versatile than we expected them to be. We found out by customer use that they work not only for central lines themselves, but also for implanted feeding tubes like G-Tubes and PEG Tubes, and we’ve even had patients use them to manage peritoneal dialysis catheters. This versatility has allowed us to have avenues into different hospitals, departments, and even home care settings. We love when our customers find a new use for one of our products and shares that with us. It just gives us even more people to help along their journey.
GP: Are there hopes for company or product expansion over the next year beyond the scope of the Central Line Wrap and the PICC Line Sleeve?
KF: This year we have a few big things that we are working on. We will be piloting our newest versions of our PICC Sleeve and Central Line Wraps in at least 3 different pediatric hospitals. These were developed while working closely with pediatric vascular access nurses to learn how they work with patients, and how protocols have changed over the years. We are planning to launch them this year to all hospitals. After those are launched, we have a few other products in the development pipeline that will manage different kinds of lines and tubes. We are also working to grow our team, and will be doing at least one hire this year. We are really excited to get these new sleeves and wraps out there, as we know they are going to allow so many more patients access to the safety and comfort they need to live more normal lives.
GP: What would you say was the single most helpful thing that NEPDC has offered to CareAline’s commercialization efforts?
KF: My husband, Mike, and I jumped into starting CareAline with no experience in medicine or medical devices other than our own experience as patients (we are both artists by education and work history). We made a lot of mistakes along the way. NEPDC was definitely a huge help for us understanding some of the integral pieces of having hospitals as our primary customers – what we always knew we wanted. From regulatory advice, to reimbursement strategy, to pilot study design and organization. These things have really helped us to formulate our trajectory over the past two years, and have allowed us to increase our sales, grow our product line, and get on our way to scaling our growth.
GP: What advice would you give to first-time entrepreneurs or parent innovators attempting to enter the pediatric medical device market?
PICC Line Sleeve (Photo courtesy of CareAline)
KF: I think my biggest piece of advice to other parent innovators is to ask way more questions than you think you should. We found that when we started asking for feedback and asking questions of the users we met and other people in the medical device field, we learned a lot about how we could make changes and pivots that led to further development of our products. Secondly, I would tell innovators to find mentors and advisers and early investors that are deeply involved in the medical device space as early as possible. As we’ve found more mentors that are heavily involved in medicine and medical devices, we’ve been able to make more progress faster than before. This has really helped us – but would have been even more helpful, and would have staved off some of the mistakes, if it had happened earlier in the process.
Thank you to Kezia for sharing your inspiring story with us!
If you would like to learn more about CareAline Products, visit https://carealine.com/ or follow Kezia and Mike on Twitter @CareAlineTweet.
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