Development of a Novel Fetal Heart Rate Monitor for Multiple Gestation Pregnancies; An Analysis of the Fall of Theranos Through a Virtue Ethics Framework

Thede, Andrew, School of Engineering and Applied Science, University of Virginia
Naegle, Kristen, EN-Biomed Engr Dept, University of Virginia
Sheybani, Natasha, EN-Biomed Engr Dept, University of Virginia
Laugelli, Benjamin, Engineering and Society, University of Virginia

My technical work and my STS research are related primarily through each topic’s focus on biotechnology or “biotech”. More specifically, these projects explore diagnostics and the ethical implications of the success and failure of biotech inventions. Diagnosis as a medical concept is the process of identifying a particular disease, condition, or injury using a variety of methods to better understand a person’s body. My technical work and STS research differ in the specific diagnostic method used and the broader ethical implications of each technology. My technical work focuses on developing a novel fetal heart rate monitor specifically designed for twin pregnancies. Conversely, my STS research focuses on the ethical considerations for a proposed revolutionary blood-based diagnostic tool to identify an abundance of conditions and diseases. Although these two works differ in the specific topics they address, they are still centered around diagnostics as a medical technology.
As mentioned above, my technical work focuses on a diagnostic tool to asses the general health and wellbeing of multiple fetuses in utero. My capstone team and I developed both a phantom gel to mimic twin fetuses in the womb, and a device that simultaneously monitors the two phantom fetal heart rates. We purchased the phantom gel material from a manufacturer, but designed and built the electrical components that established a working multiple gestation pregnancy model (speakers and electrical circuit) from scratch. We also designed and built the fetal heart rate monitoring device by scratch. After testing our device using our phantom model, we concluded that the device was able to accurately measure heart rates of the phantom fetuses when both fetuses had identical heart rates. However, we also concluded that the device lacked desired accuracy in heart rate measurement when the phantom fetuses had vastly different heart rates (>30 BPM). The primary goal of our project this year was to establish a paradigm for which future iterations of this device could be build upon to eventually create a marketable and clinically usable device. I believe we accomplished in this goal due to successfully designing and building both a phantom model and monitoring device that monitors multiple sources of sound.
My STS research also focuses on a diagnostic tool, but instead of fetal heart rates, my thesis explored the ethical implications of Elizabeth Holmes, founder and former CEO of Thernaos, a company that marketed a fake revolutionary blood-based diagnostic tool. I look at this case through a virtue ethics lens, particularly focusing on Pritchard’s list of “Virtues for Morally Responsible Engineers”. In the paper, I claim that Holmes did not act in an ethically sound manner during her time as founder and CEO of Theranos due to her lack of professionalism, cooperativeness, and commitment to quality. The goal of my research was to propose a previously unexplored angle of Holmes’ actions, promoting ideals of what not to do as an engineer in the biotech field.
Working on these projects simultaneously greatly helped me succeed in completing both works. My technical work awarded me a better understanding of the development of biotech, and specifically diagnostic, devices. This understanding allowed me to considerably appreciate the viewpoint of Holmes as an engineer, opening my eyes to her ethical failures. Moreover, my STS research helped me carefully consider my actions to ensure their ethical nature. When creating a technology that involves fetuses, an already ethically complex topic in society today, being able to learn from another’s ethical failures allowed me to design and communicate my device in a more effective manner.

BS (Bachelor of Science)
Virtue Ethics, Theranos, Multiple Gestation Pregnancy, Fetal Heart Rate, Gel Phantom

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Biomedical Engineering
Technical Advisor: Kristen Naegle, Natasha Sheybani
STS Advisor: Benjamin Laugelli
Technical Team Members: Roman Ramirez, Andrew Thede

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