The exhaustion has finally set in. I found myself feeling exceptionally tired the last several days this week, which made it difficult to concentrate on my work. Luckily, I was able to continue plowing through my tasks and complete all of my goals for the week. Having a lot of tasks that can be completed in small amounts of time has helped a lot with keeping my motivation high and my progress on track.
For the DOT checklist project I am working on, I completed all of the sections of the Document Review that we aimed to finish this week. I read Design Verification Master Plans (DVMPs) for two of the product models, as well as the Design Validation (DV) Plans and Reports for those models. DVMPs are documents that describe the methods that the company will use to verify that the design of the product meets the requirements that were previously outlined in the design inputs. DV Plans and Reports are documents that outline the tests that the company will use to validate that the device meets the user needs and intended uses and then documents that these tests have been completed and whether or not certain specifications are met. I also spent some time this week summarizing my notes on these documents, so that they are more organized and easier to read. Next week, I will complete this project after reading the Design Change Logs, Use and Design Failure Modes and Effects Analyses (FMEAs), and the Usability Engineering Plan and Reports for the different models of this catheter product. This project has really taught me the importance of documenting your work. In a large company like BSC, there are thousands of employees all over the world that need to be able to understand all of the components of the projects they are working on, so having good documentation is crucial to company success. Documentation is also important for traceability of a project and being able to sustain products on the market. Although paperwork may be the least exciting part of the process, I am glad that I have had the opportunity to see its importance and learn to appreciate it.
Along the lines of documentation, BSC recently switched to a new system for storing their documents, and the DA team has a Value Improvement Project (VIP) open to help organize this system. They are creating Design History File (DHF) summaries in order to make it easier to find documents for specific products. Guiselle gave me the task of completing these summaries for five different products while she is on vacation. So far, I started the summaries for four of these devices (all of which are guidewires), and I finished the summary for one of the products that I discussed last week, which is the device that requires changes be made to the Directions for Use (DFU). In addition to the DHF summary for this product, I got to do a manufacturing line tour at the Coyol site this week to see how it is made. This was definitely the best part of the week for me, because the device is really neat and extremely beneficial to patients. It is used during interventional cardiology procedures to catch plaque and clots in the arteries to prevent them from traveling into the bloodstream and potentially the brain.
Another new task that I was assigned this week is to help get feedback from the DA team about working at BSC. A few months ago, the team took a survey in order to give the company feedback from their employees. My manager wants to get additional feedback about some of the answers to the survey in order to make improvements within the department and potentially within the company. I will be conducting one-on-one meetings with each member of the team in order to learn more about what BSC offers its employees and what aspects of their work life could be changed in order to make them happier. Once I have conducted these meetings, I will present what I hear to the entire team so that we can brainstorm solutions to improve the aspects of the job that the team feels are lacking. Guiselle and I are hoping that the team will be more willing to tell me some of the things they would like to see changed, since I am impartial in this situation and can present the findings anonymously. This is another project that I am excited to be a part of, because I get to use my unique situation of short time here at BSC as a benefit to the team and hopefully help make an impact and help my coworkers. They have been so wonderful to me, so I am glad that I have a chance to do something for them.
Last week, Guiselle taught me the basics on how to conduct a complaints analysis for a product already on the market. This is important for sustaining, because if your users are complaining about one of your products, you need to find out why and how it will affect the product’s life cycle and, more importantly, the patients. Complaints analysis utilizes a scale for severity and occurrence of a potential harm to the patient in order to determine a risk index that is then compared to the risk index indicated in the FMEA. If the indices match, there is no need for the company to do anything, but if they don’t, the company will have to take action. I will get the chance to practice what I was taught by doing a complaints analysis for one of the guidewires produced by BSC.
While I am excited that I have gotten to do all of these new tasks, I am a little bummed about two of my projects that have hit a standstill. For the Innovation Culture project, I completed a presentation for the Needs Finding lecture that I planned to present with Guiselle, but unfortunately, our goals were set back because of meeting rooms being completely booked. It seems that I won’t be able to give this presentation with Guiselle before I leave Costa Rica, but hopefully she and Jorge can use the presentation that I started to give the lecture. Additionally, my project focused on writing a scoping draft has not made any new progress this week. On Monday, I will be meeting with the project lead to determine the status of the project and will hopefully get some new tasks to complete. After discussing the project with my boss, she wants me to come up with a list of concerns and questions that I have about what this project could require, especially in terms of time and money. One of the biggest concerns is not knowing whether or not the project will require a clinical trial, which is expensive and takes a long time. I will also be looking into any predicate devices that the company may have that we could leverage for the new proposed device. Hopefully the project will start to gain some momentum next week, but regardless, I have learned that goals aren’t always met and that’s OK. The important part is that I am still learning.
On the bright side, I finished my portion of the onboarding project this week! Now, I can say that one of my projects is complete, and that is a great feeling. This week, I reviewed the website links that are provided to new hires to learn more about the company and the resources they have as an employee at BSC. I also estimated the time it took me to complete different portions of the onboarding process and gave more feedback about the process to the project lead. Hopefully the team will be able to use my work to continue to make improvements. I have noticed that the DA team is really proactive about improving their department, which is something that I find inspiring.
Lastly, on Thursday, Chandler, Callie, and I met with one of the engineers from the Neuromodulation Hardware team. He showed us the circuit boards they use inside their devices, as well as the machines they use to test the circuits before they put them in the casing. It is amazing how much information can be controlled in such a small amount of space.
Tuesday of this week was a Costa Rican holiday, so we got the day off to relax and catch up on some sleep (although, “sleeping in” now refers to waking up at 6:30am instead of 5:30am). In the evening, we had a BBQ out by the pool at our place, and some of our Costa Rican friends joined us.
On Saturday, we traveled to Manuel Antonio to kayak through mangrove trees and relax on the beautiful beaches in the national park.
With only two weeks left in Costa Rica, I am excited to go home to visit with my family and friends, but at the same time, I am sad that the summer is coming to a close. I look forward to making the most out of the next two weeks. Pura Vida!