Since the beginning of my sophomore year, I have been a part of a Bass Connections team working closely to continue development of a low-cost laparoscope (an intra-abdominal camera) for use in low- and middle-income countries (LMICs). During a laparoscopic procedure, surgeons make two to four small incisions and operate using a laparoscope and surgical instruments. Benefits of laparoscopic surgeries include shorter lengths of stay, lower risk of infection and minimal scarring. However, current commercial laparoscopic suites have a market price of ~$215,000. Reducing the cost of a laparoscope would make this technology accessible to those in LMICs, enabling patients to return home and work more quickly, thereby helping to mitigate the impoverishing effects of health expenditures.

Work on this project had begun before I became a member of the team, resulting in separate camera-only and light-only prototypes. In Fall 2019, my primary responsibility was to complete rigorous testing of the prototype and make necessary changes to the prototype. I was also responsible for determining how to waterproof the seals between outer components of the prototype (to ensure the inner electronics would be safe and function normally once inside of a human body). In Spring 2020, our focus shifted to being able to integrate both prototypes into one prototype which had both the camera and light.

I spent most of my first semester on the team acclimating to the project. This included learning prototype assembly, learning testing methods, and collecting data on the newest prototype. In addition to determining how to waterproof seals on the prototype, I was also responsible for determining whether the seals were actually waterproof once the waterproofing method had been performed. This was the most challenging part of my semester because my previous work involved using established testing methods.

However, I now had to devise my own testing method. I finally decided to complete testing by submerging the different seals between shortened tubes and varying components in a dish of water. I placed strips of paper that change color when in contact with water inside the stainless steel tube on the other side. Similar strips are found within technological devices to determine the presence of water. I ended up succeeding in creating waterproof seals and demonstrating that they were waterproof.

The real challenge came in the spring semester when working with my teammates to integrate the two prototypes. I was in charge of completing the final assembly of the first integrated prototype. This included creating the waterproof seals and attaching the handle. When I was completing my final check, just after having placed the glass window, I realized that when both the LEDs and the camera were on. The resulting image had so much glare that the actual image could barely be seen. My first thought was that the sealant had reached the camera. I immediately removed the glass window and began to look for sealant dripping down the tube and into the camera. Since I did not notice any sealant in the camera (resulting image was clear), I thoroughly cleaned off the glass window in case any sealant was on the glass window and attempted to reattach it. However, the glare was still there.

At this point, I let my teammates know what was happening. I attempted to remove the glass window and reattach one more to time but was still unsuccessful in removing the glare. After consulting with our mentor, we realized that the light from the LEDs was reflecting off of the stainless steel tubing and needed to prevent that. Further testing and manufacturing efforts have been put on hold at this moment due to the coronavirus pandemic.

I have already learned a great deal about the process for obtaining regulatory approval for medical devices. My teammates and I have begun to rigorously document the assembly and testing of the prototype in preparation for submission to the FDA. We have started feasibility studies in an animal model which have shown promising results so far. Next year, I will be staying on with the team to help design a clinical trial and continue supporting the engineering team as needed.

This project allowed me to further my interest in the intersection of engineering design and healthcare. I hope to work on similar projects in the future.

Spring 2021; excerpted from Arushi Biswas's I&E Certificate e-Portfolio