Objectives
Our goal in researching and designing a new surgical tool is to publish a patent or a research paper with our findings. In this scenario, other people can potentially use our research and development to bring our tool to the market, as this outcome is likely out of our scope for this project. Along with our published patent and research, our goal is to develop a functioning prototype.
Focussing specifically on our mission to improve ACL reconstruction, the objectives of our project in terms of what the device should accomplish have begun to develop. Our primary objectives are to make this operation safer — reducing the likelihood and severity of complications and returning the patient to normal physical activity sooner. ACL reconstruction is a quite common operation, however drilling the necessary tunnel (and in some important cases which we will focus on, multiple tunnels) through the femur bone still comes with risks. The accuracy of the placement of these tunnels is extremely important for successful ACL reconstruction and correction operations, and we hope to design an improved device that ensures safe and proper alignment which all but eliminates those complication risks.
In order to evaluate these objectives we must come up with measurable specifications. Already the team has been comprehensively reviewing literature and studies surrounding ACL reconstruction, and is familiarizing with both the important vocabulary and measurements used to define a successful operation. Additionally, we have access to multiple orthopedic surgeons which have already been able to provide valuable input through interviews for what our device should be able to accomplish. We also plan on being able to experiment/test with prototypes of the device we create on models of a human knee.
Constraints
The FDA approval process in regards to medical tools and devices is elaborate and out of our time range. This means that within our time frame we likely will not be able to bring our device to market. Currently, we have limited knowledge on surgical tools and the human body. As this will largely change overtime with research, physiology and tool knowledge is still a constraint that must be acknowledged. As this project has a strict deadline, we are limited in the time that we have to fully develop our product.
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