Online Archive of University of Virginia Scholarship
From DIY to FDA: How Open-Source APS Projects Influenced Regulation80 views
Author
Giron, Carlos, School of Engineering and Applied Science, University of Virginia
Advisors
Davis, William, EN-Engineering and Society, University of Virginia
Norton, Peter, EN-Engineering and Society, University of Virginia
Abstract
In the mid-2010s, members of the diabetic community voiced dissatisfaction with their technologies and services in the form of the #WeAreNotWaiting movement. Frustrated by data inaccessibility from Continuous Glucose Monitors (CGMs) and the slow pace of Artificial Pancreas System (APS) development, users expanded from advocacy into direct hardware and software engineering. Open-source, Do-It-Yourself (DIY) projects such as Nightscout, OpenAPS, AndroidAPS, and Loop asserted user agency in technological development. This essay uses the Social Construction of Technology (SCOT) framework to examine how DIY movements influenced the development and regulation of APS technologies. The research demonstrates how organized lay expertise pressured device manufacturers and prompted the FDA to pivot towards modular, interoperable device standards. Through this analysis, this work highlights the potential of “lay experts” to challenge closed technological ecosystems, offering insights on patient-led activism and designing user-centered medical systems.
Degree
BS (Bachelor of Science)
Keywords
Regulation; DIY; Diabetes; Lay Expertise; Social Construction of Technology; SCOT
Language
English
Rights
All rights reserved by the author (no additional license for public reuse)
Giron, Carlos. From DIY to FDA: How Open-Source APS Projects Influenced Regulation. University of Virginia, School of Engineering and Applied Science, BS (Bachelor of Science), 2026-08-12, https://doi.org/10.18130/3fcn-pa91.
