Establishing Channels Within Fiber-Based Hydrogels for Endothelialization; Personalized Treatment to the Rescue: The Ethics of Medical Device Design

Advances in medical technology are being made everyday, offering patients an opportunity for renewed health and a better quality of life, but not all technology designs consider every potential patient. This leaves minorities who were left out of design and testing with treatment that does not address their needs, and they do not receive the care that they deserve. Health care has taken a one-size-fits all approach to treating patients for far too long; it is time we switched to personalized treatment. My technical project addresses this, proposing a new design for a microfluidic device (MFD) in which patient-specific cells can be seeded for the testing of the patient's physiological response to treatment and an appropriate adjustment of care. My STS research tackles this problem by investigating the underlying reasons technologies can be created without considering important members of society and proposing an avenue for health care to move forward with personalized treatment.
Current MFDs lack dynamic properties in their design to accurately replicate a patient's physiological conditions. This is the concept at the heart of personalized medicine, and this is the problem I aimed to address by incorporating a granular hydrogel into my MFD design as opposed to traditional bulk hydrogels to better replicate the extracellular matrix where human vasculature naturally forms through which nutrients and oxygen diffuse through the body. I conducted experiments by seeding cells within the MFD using various concentrations within the solution that promotes cell adherence to the device, monitoring them for up to 24 hours after seeding, and analyzing stained images of the cells at various time points to determine their viability. I found that keeping cells alive for longer than a few hours was much harder within the granular hydrogel than the bulk gel.
MFDs are not the only inequitable medical devices, leaving behind those in minorities who were not considered during design. It was discovered that the pulse oximeter, a medical device used to detect and administer the oxygen saturation of a patient's blood, was three times more likely to miss low oxygen levels in Black patients than White patients (Sjoding et al., 2020). In my sociotechnical research, I aimed to identify the factors that enable engineers to design medical devices in narrow-minded ways and to propose an alternative to promote inclusive technology design, testing, and regulation. I analyzed examples of medical devices that failed to promote the health of all of their users, the interactions between the Food and Drug Administration and biotechnology developers during approval of technologies, and examples of devices designed with a personalized approach to address the needs of patients on an individual basis. I discovered how easy it is for engineers to overlook minority groups during design and testing stages, as the lack of appropriate Food and Drug Administration standards for diverse testing do not provide engineers with adequate guardrails during device approval. To combat these generalized approaches to medicine, I propose a personalized approach to technology by employing additive manufacturing (AM) or three-dimensional printing.
While AM is a valuable tool for producing technology with fewer limitations than traditional subtractive approaches, it has limitations of its own. My sociotechnical research does not address contexts in which AM is not ideal such as long-term implanted electronic devices. Proposing AM as a catch-all is not a solution either, as even AM can embed biases in the data that anatomical models are trained on. Additional research can be directed toward investigating and improving the foundations of these personalized approaches to move them further towards achieving equitable health care. There are a wide range of medical devices that do not easily fit into one of the categories my sociotechnical research discusses, so these devices may require different considerations in their approach that are beyond the scope of this study. In my technical research, the ability of MFDs to replicate physiological conditions is limited to how much is known about the body and how advanced research of implementing cells into these devices is, so future research into these systems can improve the ability of MFDs to accurately model the human body.
I would like to sincerely thank my Capstone advisors Chris Highley and Emily Ferrarese for their constant guidance both inside and outside of the lab and the members of my Capstone team, Avi Brubaker, Joy Bethea, and Daniel Delgado, for their hard work and dedication to this project. Finally, I would like to thank my sociotechnical professor, Caitlin Wylie, for her counsel and encouragement throughout the thesis-writing process.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Chris Highley
STS Advisor: Caitlin Wylie
Technical Team Members: Joy Bethea, Avi Brubaker, Daniel Delgado