KELSEY FORKER
Exalt Model B Suction Testing Development
Exalt Model B
Exalt Model B is a single-use bronchoscope that comes in three sizes, slim, regular, and large. A bronchoscope is inserted through a patient's mouth and into the lungs. A camera is attached to the end of the scope, relaying live image to a connected tablet. This allows physicians to view the airways of the lungs. Bronchoscopes are commonly used for visualization/ diagnosis, biopsies, and the removal of foreign objects. Exalt Model B delivers superior suction to other scopes on the market.
Problem
During my first co-op at Boston Scientific, the team was tasked with developing a suite of test methods to be used to evaluate our device and its performance compared to FDA-approved competitors. Since the company had never developed a bronchoscope, there was little applicable test methods available to adapt. I was tasked with developing a method to quantify our device's suction rate. Since a key feature of our scope is its superior suction, this test method had to be applicable to our device as well as competitors. This test method also had to be reliable and easily repeatable by any operator with any of our scopes.
Test Fixture Development
My first step in creating this test method was designing and releasing a test fixture. This fixture had to securely hold the device in place vertically. Suction is activated by holding down a button on the handle of the scope. Therefore an actuator connected to a timer was used to reliably engage suction for the desired amount of time. Finally, suction pump, collection container, tubing, etc. had to be designed into the system. I worked in conjunction with the manufacturing team in Spencer, Indiana as well as several engineers in Marlborough to develop this fixture using a combination of existing components and machined parts. I was responsible for designing and releasing the CAD of all the individual parts (over 60) and the assembly. This constituted of developing engineering drawings (CAD) for all manufactured parts and assembly, along with a BOM. These drawings had to adhere to BSC internal guidelines. These drawings were ultimately reviewed and approved by several internal quality personnel before its release. All test fixtures must be released prior to being used in official testing.
Test Method Development
While the fixture was in the process of being released, I also developed and released the corresponding test method. Previous engineers had been using a rough method to evaluate initial prototypes and baseline competitors. I adapted this test method to make it more repeatable and adjusted the parameters to achieve meaningful results. I then helped run a Gage R&R and subsequent analysis to release the test method. With both the fixture and test method released our team now had a way to officially test the suction rate of our scope and prove our claim of superior suction.
Skills Learned
The test fixture development and release gave me an opportunity to improve my CAD skills and gain experience creating engineering drawings in adherence to certain standards. I interacted with our machine shop to have our custom parts made which gave me exposure to the machining process as well as best practices for designing machined parts. Finally, assembling and disassembling the fixture gave me hands-on engineering experience with hand tools and tubing schematics.
Developing and validating the test method helped me improve my technical writing skills. It also forced me to think through each step of a process in order to ensure all steps were clear and repeatable. I also learned data analysis skills using Minitab through the data analysis and validation testing.
Anatomy Path Followed in a Bronchoscopy
Exalt Model B Regular Scope
Exalt Model B Suction Claims