Proposal for a Novel Gastrostomy Button for Sensing Overfeeding; From Developer to Patient: Individualized and Community-Centered Medical Technology Design in a Fragmented Healthcare System

Medical devices are critical aspects of treatment for millions of Americans, yet there are many barriers to their accessibility and adoption. These barriers are posed both by the efficacy of the design, cost, regulatory hurdles, and insurance coverage. The goal of my research was to examine how device design can facilitate better patient care both in early development and downstream implementation. My technical capstone addresses complications associated with enteral nutrition, tube feeding for people who cannot receive enough nutrition by mouth. Complications arise when the stomach is overfilled, leading to discomfort, reflux, and more severe risks like pneumonia. There is no objective measurement of stomach fullness; we aimed to devise a physiological proxy for stomach fullness and a sensor to measure it. This would integrate with a gastrostomy button, the existing medical device for enteral nutrition. By modeling the sensor mechanism, we demonstrated proof-of-concept for continuous monitoring of stomach fullness during enteral feeding. Further work will require prototyping and improving the design to meet the needs of patients, anticipating requirements posed by regulatory agents. The STS research explores the trajectories of medical devices and drugs downstream of early development when they are brought to market and subject to various levels of regulation. My work focuses on the impact of insurance coverage and related policy on access to care, evaluating different layers of regulation as actors within a complex healthcare network. Overlapping regulation creates highly variable conditions across geographic and demographic groups such that a “one size fits all” solution is not possible. Current research also fails to address the specific role of medical product developers, mainly emphasizing large-scale reform rather than leveraging the current system. I argue that medical products can be made more effective and accessible through individualization, such as precision medicine, and the facilitation of community-centered care during design and implementation. The technical capstone and STS research provide a general frame and a specific case of product design, and describe both the early stages and downstream trajectory of a medical device. Both the technical and STS work emphasize the transition from theory to practice at different stages. The technical work accomplished this through a computational model of our sensor, establishing proof-of-concept for an alternative to volume estimation of enteral feeding. The device allows patients and caregivers together to tailor and improve feeding schedules and quantities to account for interpersonal and day-to-day variation. The STS work explores transitioning from concept to practice by analyzing regulatory and monetary barriers to medical device use. I argue that individualized and community-centered design help address the disparities created by overlapping levels of regulation. Together, this research establishes strategies for translation of early conceptual design to practical use for medical devices, enhancing the adoption and effectiveness of these essential devices for healthcare.