Torque-Based Bone Density Estimation; An Investigation of the FDA Approval Process for Bone Fixation Hardware

Technical Project Abstract
For my technical project, my team and I designed a device and procedure with the goal of determining local bone density based on the torque required to drill pilot holes in bones. Our main considerations for our design included making a product that is compatible with existing surgical drills, easy to use for surgeons in the operating room, and reasonably affordable for hospitals. The current methods for determining bone density before a surgical procedure rely on external scans and do not provide precise data on bone density at the surgical hardware site. While these scans generally give a good measurement of average bone density for a cross section, the local bone density would be more helpful for surgeons. With this device, we hope to provide much more precise data to surgeons so that they are able to create a higher quality surgical plan.
We designed and constructed our own load cell using strain gauges, and found a relationship between strain and torque. The data obtained using this relationship can then be utilized to determine if a specific location is suitable for bone fixation hardware. Surgeons can use this to determine the best course of action in terms of what types of hardware to use to repair fractures. Our main research question for this project was how can we measure the torque required for drilling pilot holes in bones, and how can this data be used to provide a better outcome for patients undergoing surgery?

STS Project Abstract
In my paper, I investigate the general approval processes of the Food and Drug Administration, as well as the specific processes for how bone fixation hardware and similar technologies get approved. The main research question that I address is to what extent are the FDA approval processes problematic, specifically for bone fixation hardware? In addition, I use the STS Framework Actor-Network Theory to discuss the effects of the approval process on relevant parties such as patients, manufacturers, surgeons, and other healthcare professionals, as well as discuss how these parties are uniquely intertwined. The importance of this research question is quite clear; anything related to healthcare and the field of medicine as a whole is extremely important, as any decision can have extreme consequences. While not every medical decision involves a life-or-death situation, each decision can significantly impact one’s quality of life. For example, if a broken tibia is unable to be properly repaired during surgery, that person could experience symptoms that have massive negative effects on their quality of life such as pain and difficulty walking.
In this paper, I provide evidence for why I believe that the FDA needs to make certain changes. My primary belief is that the FDA should limit their reliance on the 510(k) process for medical devices such as bone fixation hardware. Furthermore, I think the FDA needs to create greater emphasis on the postmarket surveillance process, including a better reporting system for product issues after approval. To accomplish this, the FDA will have to obtain larger amounts of funding, which is a massive hurdle in and of itself.

Synthesis
My STS Research Paper pairs uniquely with my technical project, as my STS paper investigates the processes in which the device we designed would go through in order to reach the market. If the design that we created were to be pursued further than in this capstone project, we would effectively be joining the network discussed in my STS paper. We would most closely be linked with medical device manufacturers, but we would also be closely linked with other actors such as insurance companies and the FDA itself. Regulatory policy is another area in which my projects are linked together. In my thesis, I investigate regulatory policy and how it relates to bone fixation hardware. If we were to pursue this design further to the point where it would actually be manufactured and used, regulatory policy would play an extreme role in the shaping of our design.
Additionally, the technology at the center of both projects overlap in the fields of biomedical and mechanical engineering. They are tied together in their fields, and also through their specific uses. The device we designed would be used in the operating room to apply the specific technology at the center of my STS Research Paper, bone fixation hardware. For both of my projects, medical, ethical, financial, administrative, logistical, and a countless number of other factors were considered throughout the process of creating both.

School of Engineering and Applied Science

Bachelor of Science in Mechanical Engineering

Technical Advisor: Jason Forman

STS Advisor: Joshua Earle

Technical Team Members: Grant Garland, Jackson Green, Joseph Liberatore, Matthew McEwen, Logan Wasserman.