CUSTOM 3D MODELED POST-OPERATIVE KNEE BRACE DEVELOPMENT; THE INFLUENCE OF ETHICAL CONTROVERSY ON NEUROLOGICAL DEVICE PROGRESSION AND EVOLUTION

Beyond the inherent complexities associated with new product development and device engineering, manufacturing, and distribution, there are many ethical concerns that must be considered to ensure patient safety, equity, and comfort. The technical report outlines the development of a novel knee joint rehabilitation aid to address the stagnant nature of the current knee brace market, the growing demand for knee joint recovery options, and the shortcomings of existing rehabilitative processes. The STS research investigates the influence of ethical concerns, societal controversy, and regulatory policies on the progress and evolution of neurological devices. More specifically, the STS research examines the effect of regulatory intervention on neurological device progression and the influence of social factors on the development of non-medical neuroengineering applications. The technical project and STS research are closely coupled, as they cover the ethical and technical nuances and obstacles faced throughout biotechnical device development both in the context of orthotics and neurological devices.
The technical project objective is to provide a novel 3D modeled post-operative knee brace design to serve as an industry-leading knee joint rehabilitation aid and functional support mechanism. This technical project encompasses all stages of the medical device development process, spanning from preliminary research to market launch strategy formulation, while touching on ethical considerations like the Institutional Review Board (IRB) approval process and insurance and health code evaluation. The initial technical project plan included six sequential phases: preliminary research, computer-aided design (CAD) and 3D prototype printing, mechanical testing and prototype iteration, design finalization, patient testing, and market launch strategy development and patient acquisition.
Preliminary research regarding biomechanical, procedural, and ethical considerations successfully informed the technical project group of essential features to be included in the final knee brace design. Using Autodesk Fusion, finite element analysis, and rapid 3D printing, an experimental and iterative process allowed multiple knee brace prototypes to be evaluated, eventually resulting in the finalization of the knee brace mechanism. An experimental protocol for patient testing was developed to validate brace efficacy in supporting knee operation recovery and to obtain quantitative data to improve future marketability. However, due to inability to receive IRB approval in time, patient testing and acquisition did not occur. Instead of patient testing, mechanical testing was conducted to assess brace strength and efficacy, but the brace design must be tested further in the future to make substantial conclusions regarding the potential rehabilitative capacity.
The STS research proves the substantial impact of social, ethical, and regulatory factors on the progression and evolution of neurological devices by achieving two central objectives: identifying how ethical dilemmas affect technical progression and application expansion within medical neuroengineering and analyzing how societal factors and social context alterations have led to the incitement of the non-medical branch of neuroengineering. The first objective is accomplished through a general policy study, and the second objective is accomplished through the application of Pacey’s Triangle of Technological Practice and the Social Construction of Technology (SCOT).
The policy study reveals current regulatory shortcomings in medical neuroengineering and the associated consequences of outdated and excessively stringent protocols. The evaluation of particular instances of clinical trial success prevention, application expansion barriers, pre-clinical or clinical testing capability limitations, and accessibility disparities provides valuable information on the frequency of disruptive policy intervention, the stages of the medical device development process that are most commonly disrupted, and the prevalence of excessive disruption that constitutes policy modification. Regarding the application of Pacey’s Triangle and SCOT to investigate the incitement of non-medical neuroengineering applications, the sociotechnical analysis highlights three major societal components that fueled the beginning of non-medical neurological device development: the prevalent desire for monetary benefit maximization by large corporations, the reliance of individuals raised in the Digital Age on widespread technology integration, and the fast-paced nature of modern society and technological innovation. The analysis of cultural, organizational, and technical elements reveals the significant impact of social context on the direction and success of technological devices.
The newness of advanced medical technology leaves the field with many unanswered questions and conflicting opinions regarding government control; proper testing and implementation timelines; medical and non-medical application limitations; patient accessibility, safety, and privacy; and long-term device efficacy. Each stage of biotechnical device development is integral to ensure product efficacy and patient safety, and the influence of the associated ethical considerations plays a fundamental role in the developmental progress and limitations placed on a given device or area of research. The rapid evolution of the medical device industry constitutes synchronous evolution of related policies, priorities, and technological applications.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Shannon Barker
STS Advisor: Catherine Baritaud
Technical Team Members: Sabrina Alessi, Tyler Burtner, Maddie Corona, Liam Kidd