Interested in pediatric medical devices? Learn how the U of Minnesota is making strides with cardiovascular device development for children.

Zeeshan Syedain received his PhD in Chemical Engineering from the University of Minnesota in 2009. Dr. Syedain is currently a senior research associate in the laboratory of Professor Robert Tranquillo in the Department of Biomedical Engineering at the University of Minnesota. He has worked as senior R&D engineer in the medical device industry with his work leading to multiple patents filed and two funded Small-Business Innovation Research (SBIR) Phase I awards from NIH. His current research focuses on cardiovascular tissue engineering with emphasis on vascular grafts and valves. Dr. Syedain is one of the recipients of 2016 Regenerative Medicine Minnesota Bio-Business Award.

Q: What are the main commercialization challenges in the development of pediatric medical devices?
A: Two main barriers to new pediatric medical devices are smaller market size and regulations approval cost. To date most pediatric devices in use were initially approved for adult population, and then data from the adult clinical trials was used to support approval for the pediatric devices.

Q: What’s unique and different about pediatric medical devices compared to devices for the adult population?
A: Traditionally, it is assumed that size is the main factor and smaller size would solve the issue, however that is just one factor. A simple example is the IV catheter. Most adults get an IV catheter when in the hospital, and it works well; however, adult IV catheter diameter is too large for pediatric patients, and the smaller version doesn’t work well and often gets clotted. That’s an example where scale-down just doesn’t work.

Besides the smaller size, the device must accommodate for different physiology. For example, cardiovascular device not only has to be smaller, it should also function for different hemodynamics if in contract with blood, different immunology if that’s an issue, and most importantly, a device that can last 15 years is a perfectly good option for a 70-year-old patient, but less than ideal for a 5-year-old.

Q: What resources are you aware of that are available for startups focused on pediatric medical devices?
A: At this point, there are several device consortiums focused on pediatric needs around the country. Many have healthy competition for monetary awards.  NIH has also focused on pediatric-specific grant programs for academic institutes. There has been at least one SBIR program for pediatric devices but more of these programs are needed to further develop pediatric-specific devices.

Q: What type of products are you developing for the pediatric population and how far along are you on the commercialization path?
A: We are developing vascular conduits and heart valves for pediatric patients that could provide better hemodynamics and long-term outcome. We are in pre-clinical validation phase on the project.

Q: How do you see the field evolving over the next 5 years and what changes do you anticipate?
A: I think there is a stronger recognition that pediatric patients are not smaller adults and need more specific devices. This requires a clear regulatory guideline that factors unique situations like smaller patient population to accelerate regulatory approval process for new pediatric-specific devices. 

Resources are increasingly becoming available for the development of pediatric medical devices.  The FDA has launched a site with useful links to guidance documents and pediatric consortia around the US that offer many resources, some of which are free, to companies developing medical devices for the pediatric population.