Abstract
Through my STS topic I answered the following questions: How do structural tensions between companies’ profit-driven motives and FDA-mandated ethical requirements shape the development, clinical testing, and regulatory approval of pediatric medical devices? And where can improvements be made within both regulatory and development sectors to increase innovation while maintaining the same safety standards? Additionally, I discuss how ethical obligations to protect children have caused a decrease in pediatric innovation and led to the “off-label” use of adult devices for pediatric procedures. Pediatric doctors in many different specialties are frequently required to use adult FDA approved medical devices as the standard method of care due to the lack of access to pediatric devices and often have no evidence of their effectiveness or safety in children (J. Espinoza et al., 2022). Throughout my STS paper, I explored three examples of medical devices that are thoroughly researched in adults but are lacking proper technological advancement for children. When these gaps are present, they often require the “off-label” use of medical technology. Off-label use can be described as “… the use of drugs or Medical Devices for indications not approved by the FDA, including different dosages, modes of administration or patient populations. Off-label uses are not included in the official indications on the product label and instructions for use (IFU)” (ufficiomarketing, 2025). This definition demonstrates that “off-label” devices have no evidence of their effectiveness or safety in children (J. Espinoza et al., 2022). One common example of an “off label” device used for a pediatric patient is an adult cardiac stent. Adult biliary stents, which are FDA approved for adult periphery blood vessels, are used as a stabilizer and expander of the aorta in pediatric patients when there is a narrowing of the aorta (aortic coarctation) (Forbes et al., 2003). This is considered “off-label” because the device is being used in a pediatric patient in an area of the body where there is no FDA approved study data to support its safety and efficacy for that specific application. In my STS paper I focus on why there is a need for medical devices to be used “off-label” and how the regulations and policies set by the FDA have led to an increase of “off-label” usage of different devices. Additionally, I delve into ways in which the FDA is currently impacting innovation in both a positive and negative manner. Finally, I explored different current and future solutions that are currently being explored to help expand innovation in the pediatric medical device space.
For my technical project, my team designed a pediatric stent crimping device for patients that can be used in interventional cardiology procedures for children throughout their growth and development from the ages of zero to twenty-one. Stent crimpers are used to decrease the diameter of interventional cardiology stents onto a balloon catheter. The catheter is used to insert the stent into the occluded blood vessel, and the balloon is expanded to reestablish the diameter of the stent providing vessel stabilization and enhancing blood flow. The current method for stent crimping includes using adult valve crimpers that are broken to achieve the smallest diameter possible which is around 5-7mm. However, smaller pediatric balloons (8mm, 12mm, and 14mm), that fit into a 10 French catheter used on infants, require a crimped diameter of around 2mm. Without a device able to crimp the stent onto the properly sized balloon, pediatric cardiologists must use their fingers to decrease the diameter. This method often causes uneven crimping and slippage of the stent on the balloon during the procedure. Unstable stent crimping causes surgical risks due to incorrect placement of the stent or uneven expansion of the stent in the vessel (Khashan et al., 2022). The goal of my technical project was to develop a handheld, 3D printed, stent crimper capable of crimping a stent to a 2mm diameter. Our project advisor, Dr. Michael Shorofsky, is a pediatric cardiologist at UVA Health. The project team includes Lindsay Ellis, Sheryl Loden, and me.
Both my technical and STS section of my thesis address pitfalls of pediatric medical devices and explore ways in which I can improve device design in relation to vulnerable populations, like pediatric patients, as a Biomedical Engineer. Both projects explore ways in which the engineering community can partner with the clinical faculty at different institutions to solve real world problems that they face in the operating room every day. I explored how outside factors like regulation often impact kids in both a positive and negative manner and how it is important to balance regulation and ethics with innovation and cutting edge design in the research and development stages of a device.
