Abstract
My capstone project “Gastrostomy Button with Embedded Sensor for Reducing Complications Associated with Overfeeding” comes from a technical goal of increasing patient safety when performing enteral feeding by adding an objective, real-time sensor to current gastrostomy button usage. It is designed to track the physiological parameters (fullness) of the stomach and deliver actionable data to the user to prevent overfeeding and aspiration. This is an engineering-centered work but is embedded in a larger sociotechnical system that encompasses clinical practice, patient safety policies, and regulations. In my STS research paper, “Balancing Innovation and Oversight: A Comparative Study of Regulatory Impacts on Emerging Technologies”, I conducted a comparative analysis to examine how regulatory frameworks influence the development and adoption of artificial intelligence. In my research I examine regulatory design patterns in the US, EU and China and how they affect innovation and adoption from the perspective of a Regulatory Design Index, comprising regulatory burden, procedural flexibility, and capacity to support innovation. The results highlight that none of the regulatory systems alone is best at both innovating and adopting, but that the outcomes are dependent on how these regulatory dimensions interact. For instance, the U.S. is known for its innovation culture which is driven by low regulatory restrictions and high investment, the EU is renowned for its trusted innovations based on risk-based regulatory control, and China has established a governance framework that provides for adaptation and fast diffusion of innovations.
A key conclusion of my STS research is that a well-designed regulatory system (especially adaptive and risk-based) can be an enabler of innovation, not an impediment. The concept directly relates to my Capstone project in regards to usability, interpretability, and user trust. Even the most sophisticated sensor technology will not be of much use if clinicians, caregivers, or independent users are not confident in the accuracy of the information or how to interpret it. In my research on the European Union, I found that well-defined laws and policies around safety and accountability can lead to greater trust within the organization and more widespread technology adoption. When I applied this knowledge in the context of my technical project, it became clear that designing a system that is technically successful, but also transparent, easy to incorporate into a healthcare workflow, and user-friendly, was very important. Although my capstone project focuses on a clinical issue to be solved with innovative sensor design, the impact it will have in real-world applications will also depend on the ultimate success of integrating it into regulatory pathways, health care systems and user expectations. While my capstone project aims to address a clinical problem through innovative sensor design, its real-world impact ultimately depends on how well it aligns with regulatory pathways, healthcare systems, and user expectations. My STS research provided a framework for understanding these external influences and reinforced the idea that technological development does not occur independently of policy, institutions, or society. Together, these projects strengthened my belief that engineering does not exist in a vacuum, and that effective engineers must understand not only how technologies are developed, but also how they are regulated, adopted, and trusted within larger systems.
