Written by Cassie Brugger, MA, Program Administrator for the New England Pediatric Device Consortium in conjunction with Johnie Rose, MD, PhD, Assistant Professor, University Hospitals Case Medical Center
Spending your days thinking about big problems in the world’s poorest places puts you in the ideal position to imagine new devices and technologies to improve pediatric care and outcomes. Dr. Johnie Rose, Preventive Medicine/Public Health physician and Epidemiologist at Case Western Reserve University School of Medicine, applied to New England Pediatric Device Consortium’s (NEPDC) grant program in February 2015 with an idea born out of his knowledge of unmet pediatric needs.
In his work on diarrheal diseases, Dr. Rose came to understand that sanitation, rotavirus vaccination, and access to oral rehydration therapy were not a complete answer to preventing the hundreds of thousands of deaths from dehydrating diarrhea that occur worldwide each year. A missing piece was a method to give fluids to the sickest of the sick in areas where personnel skilled at starting IVs are scarce. This enormous need inspired him to create a subcutaneous rehydration device that could be inserted rapidly by individuals with little to no clinical training. This device would provide accessible rehydration therapy to children who might not otherwise receive it due to lack of access to health care facilities. In the interview below, Dr. Rose explains the unique challenges for clinicians developing a medical device, as well as the NEPDC resources he was able to leverage on his pathway towards commercialization.
How did the idea for developing a subcutaneous rehydration device first come to you?
As a PhD student at Case Western Reserve University, my dissertation research focused on predicting the public health and economic outcomes of programs to vaccinate Indian infants against rotavirus. Though rotavirus infects all of us at some point, it tends to kill mainly those in parts of the world with poor access to healthcare. While my work suggested that universal vaccination using a western rotavirus vaccine could save a lot of lives, over 60,000 infants would still die of the disease each year in India alone, despite the availability of World Health Organization (WHO)-recommended oral rehydration solution (ORS). Even with ORS, the sickest of the sick will still need parenteral fluids. The problem is that kids in many parts of the world may be days away from clinical personnel skilled in starting intravenous lines. I wanted to make a user-friendly device that would empower caregivers and community health workers in remote settings to get a head start on parenteral hydration when ORS wasn’t enough and IVs are not a timely option. This could impact mortality from rotavirus as well as from other dehydrating diseases such as cholera. Before IVs were commonplace in the U.S., the subcutaneous route was used frequently in children, and it is still used commonly in the geriatric setting. While fluids cannot be bolused using this route, the fact that a vein does not need to be cannulated is a major advantage for a device intended for use by those with little or no clinical training.This could impact mortality from rotavirus as well as from other dehydrating diseases such as cholera. Click To Tweet
What was the biggest challenge you faced in the development of your device?
My primary area of research lies in using computer simulation to examine population health interventions—nothing at all to do with device development. Nor do I come from an engineering or entrepreneurship background. So, the biggest challenge for me was just figuring out where square one was and who could help get me there. It has been like learning a new language, but I’ve been fortunate to get a lot of great help along the way!
What types of resources does your institution provide for faculty, clinicians, or staff who have an idea for a medical device or technology?
As a first-year faculty member, I was fortunate to benefit from some institutional assistance when I won the University Hospital Case Medical Center’s (UHCMC) “Pediatric Innovation Day” contest with nothing more than the idea for my device. The technology transfer experts at UHCMC’s Center for Clinical Research and Technology connected me with individuals who helped me start to find my way, including colleagues in the Case Western Reserve University School of Engineering and industry contacts. They have also supported the costs associated with prototyping and intellectual property protection.
What was the most helpful assistance that New England Pediatric Device Consortium was able to provide to you?
The single biggest boost to the whole effort was the assistance I’ve received from NEPDC. Even more valuable than the grant money was the expertise that NEPDC’s network of engineers and commercialization professionals provided. They really helped me put together a strategy for finding a market for my idea and refining the design based on feedback from end users. I am still learning as I go, but I would be nowhere without the help I’ve gotten along the way. NEPDC has been, and continues to be, one of my best advocates.
Why do you think programs, such as NEPDC and the FDA’s Pediatric Device Consortia program, are important for improving pediatric medicine and care?
Ideas for solving problems often come from the people most familiar with those problems; and very often, those people don’t have expertise in device development and commercialization. It’s an intimidating arena to enter, and having these consortia programs available to nurture ideas and help move them toward something that is actually helping patients is a vital function. Without an advocate to help an inventor turn an idea into something that will attract investment, ideas like mine would wither on the vine.