Abstract
This thesis combines the characterization of the Adonis knee brace with an analysis of gender bias in musculoskeletal data to understand how biomedical devices may produce unequal outcomes across patient populations. Knee osteoarthritis (OA) is a degenerative condition whose disease progression is driven largely by biomechanical loading imbalances. A non-surgical brace called the Adonis, produced by Icarus Medical, aims to address these mechanical issues. However, the data and models designed to evaluate such biomedical technologies are often derived from male-dominated datasets which raises concerns about whether these devices perform equitably across different genders. By combining a technical evaluation of brace performance with a sociotechnical analysis of bias in biomedical data, this work examines how engineering solutions interact with broader social structures to shape patient outcomes.
The technical component of this thesis focuses on characterizing the Adonis, a novel knee brace that utilizes three-point unloading and joint distraction to redistribute forces within the knee. The study approached this characterization using three methods: a clinical study to understand patient-reported outcomes, a computational simulation, and a market analysis of existing knee brace technologies. Preliminary clinical findings from patient interviews suggested that brace use reduces pain, while computational modeling showed that varus knee alignment leads to significant medial compartment overloading. These findings support the biomechanical rationale for load redistribution and joint distraction through braces. Additionally, the market analysis revealed that current brace technologies are limited by poor patient compliance, insufficient validation, and barriers related to cost and reimbursement. Overall, this work highlights the potential of the Adonis brace to improve non-surgical treatment options for OA while also identifying key areas for design improvement.
The sociotechnical portion of this thesis examined how gender bias is embedded within musculoskeletal research and biomedical engineering practices. The central question addressed was how reliance on male-dominated datasets influences the development of biomechanical models and medical devices. Using Donna Haraway’s situated knowledges framework, this research analyzed how scientific knowledge is shaped by social and institutional contexts rather than being purely objective. The analysis identified key mechanisms through which bias is reinforced, including skewed data collection practices, modeling assumptions that treat the male body as the default, and institutional structures within biomedical research. These biases can lead to devices and/or models that are optimized for male physiology while not accounting for known differences in joint structure, ligament behavior, and injury risk in female populations. This can lead to unequal treatment outcomes, reduced device effectiveness for women, and systemic inequities in healthcare delivery. This research emphasizes that gender bias is not simply a technical oversight but a reflection of deeper structural issues within scientific data collection.
The technical analysis demonstrates that the brace can redistribute joint loads and reduce pain; however, its real-world performance depends on whether it accurately reflects the biomechanics of diverse patient populations. If the computational models and clinical validation processes are based primarily on male-centered data, the brace may not perform equally well for female patients, whose joint mechanics and anatomical structures differ. This highlights the enormity of engineering solutions shaped by the datasets, research practices, and institutional norms that produce them. As a result, even well-designed technologies can perpetuate inequities if the underlying knowledge systems are biased. To address these challenges, changes are needed at multiple levels, including the incorporation of sex-specific data in biomechanical modeling, more inclusive clinical study designs, and improved regulatory and reimbursement frameworks that prioritize patient-centered outcomes. By addressing both technical limitations and systemic inequities, biomedical engineers can develop more effective and inclusive solutions for treating conditions such as knee osteoarthritis.
This work emphasizes the importance of being a conscientious engineer who looks beyond the functionality of a device to understand its broader societal impact. While technical innovation is essential for advancing medical care, it is equally important to recognize how social factors shape the effectiveness and accessibility of these technologies. By integrating technical expertise with an awareness of social context, engineers can contribute to the development of more equitable and responsible healthcare solutions. Ultimately, this approach not only improves the quality of engineering outcomes but also ensures that technological advancements serve the needs of diverse patient populations.
