Getting in the Groove

This week I have really gotten in the groove at work. I created my own system to keep track of the tasks I need to complete and when they need to be completed, and I have also enjoyed getting to mark many of those tasks as ‘complete’ this week. I have found that I tend to be more productive when I have a lot of work to do, so being involved in several projects has helped me to work hard and fast in order to reach my goals.

For my project focused on the Design Ownership Transfer (DOT) for the cardiac catheter product, we aimed to complete several parts of the Document Review section of the checklist this week, and I also had a few personal goals for the project. For the checklist, I began a Design History File (DHF) overview, which involves identifying the product and its various models. I also read the market specifications and the three product and packaging specifications associated with the three different product models, as well as a review of the bill of materials (BOM) procedure. There are a few components of the checklist for this week that I was not able to complete, because we are trying to determine how to get access to the documents needed. I will focus on completing those items next week, along with the Design Verification Master Plan (DVMP) that I will review for this product. For my personal goals, I reviewed the process flowcharts for assembly of the imaging core and for final assembly of the product. These documents are written in Spanish, and unfortunately I do not know enough Spanish to read over 30 documents (maybe someday!) so I focused on the images of the processes. This ended up working out really well, since we had already toured the manufacturing line and had seen the process in detail. Additionally, I reviewed two PowerPoints from the manufacturing engineer at the Coyol site, which gave me a better understanding of the technical details of the product, as well as an overview of intravascular ultrasound, which is incorporated in the product.

To break up some of this reading, I have also continued to work on the project for a product that requires clarification in its FMEA in order to update portions of the Directions for Use (DFU) that are no longer necessary to include. Last week, I compared the FMEA for this product to a similar product, in order to see what modifications could be made. On Tuesday, I met with coworkers from DA, R&D, and Packaging in order to discuss how we should move forward. This meeting was really enjoyable for me, because I got to see my work making an impact on the project and helping the team make progress. On Friday, I made modifications to the product’s FMEA based on the comparison I completed earlier. Next week, we will discuss the modifications and determine our next steps. Additionally, I recently found a website through BSC that has a bunch of product demonstration videos, so I was able to watch a demo for this product. This helped me understand the purpose of the device and get a better feel for the project. I really like that BSC provides this resource, especially because I enjoy learning by watching and doing rather than only reading.

For my project involving a project scoping draft, I also watched a product demo video for the predicate device of the proposed new device, which is really similar to the already marketed device with only minor changes to the dimensions and intended use. I had already seen a brief demonstration of this product in person, but it was interesting to watch it with a model of a human body to see the application. Additionally, I learned more about this project by reading the Design Verification Master Plan (DVMP) and the Product Specification for the previous iteration of the device. This provided me with a good understanding of the differences between the already marketed device and the proposed new device. On Wednesday, I met with coworkers in DA and R&D and the Project Manager (PM) to discuss the project scope with other members of the project from different sites. The purpose of this meeting was to discuss some of the concerns with the project, including the potential need for a new supplier and any disruptions that might arise from extending the manufacturing line for the already marketed version of the device. Because of these concerns and waiting for confirmation to move forward, we may not have a completed project scope draft by the end of my internship, but I am hoping that I will still be able to contribute to the project before we leave Costa Rica.

Despite the possibility of not completing that goal, I have almost completed all of my goals for the Onboarding project! This week, I finished rereading the DA Onboarding guide and was able to provide some feedback to the project lead. I also finished checking off the items that I have completed in the Onboarding checklist, which is broken down into sections for the first week, first month, and second month. Since we are only here for six weeks, my onboarding process was a little different than the normal process, but I was still able to complete all of the tasks necessary for my job. Additionally, the team was looking into implementing a mentor evaluation for new hires to fill out, so I created a first draft that included some traits that I felt were important for a good mentor to have. My last task for this project will be to view the various links available for new hires within the guide and estimate the time of my onboarding process. I really like this project, because it gave me the opportunity to use my unique situation with such a short time period at BSC to give the team quick feedback that may have otherwise had to wait several months for a new hire.

After discussing four projects, you would think I am almost out of material to talk about, right? Well, stay tuned, because I still have some good topics to cover!

One of the best parts about being part of the DA team is that there is so much that I get to learn and experience. They have included me in so many projects that have covered all kinds of topics. This week, I also made progress on the Usability Engineering Plan for the family of guidewires that require a change to the packaging, as well as the Innovation Culture Project. On Monday, I read the Usability Engineering plan and updated it with Guiselle. This plan is being updated, because the family of guidewires being discussed needs an additional form of identification added to the packaging in order to make it easier for clinicians to identify each guidewire once removed from the carton and pouch. With this plan, we had to consider what questions need to be answered during evaluation in order to determine if the solution is effective. For the Innovation Culture Project, I created a presentation draft for the needs finding lecture using the Biodesign book and the presentation from the beginning of this summer with Paul Fearis, the brilliant English man I described in one of my first blogs. I enjoyed this task, because needs finding is something that I enjoy doing and talking about with others.

To complete my goal of learning everything I can about the different departments within the company, Chandler, Callie, and I met with the R&D Neuromodulation Manager and a Software Developer from Neuromodulation this week to learn more about what they do. We all know that the brain and spinal cord are very complex and magnificent components of the human body (OK—maybe not everyone finds it as cool as I do; I suppose that’s the nerd in me), but the extent to which we can incorporate technology within this complicated network of neurons is astounding. Neuromodulation can be used to treat Parkinson’s disease symptoms, chronic pain, phantom limb syndrome, epilepsy, bowel disease, urinary incontinence, certain types of depression, epilepsy, obesity, and even testicular cancer patients experiencing phantom pain. I didn’t realize how widespread this treatment could be, so I really enjoyed learning more about this field and the technology being developed.

Lastly, on Monday afternoon, I got to participate in the hands-on portion of a urology clinical training, where I got to practice inserting a scope into a model of human kidneys. This was a lot of fun, but it made me realize how difficult it is to maneuver these scopes inside the body. I have to give a hand to the physicians that make it look so easy.

To wrap up, I wanted to list some of the key takeaways from this week:

  • If you can’t keep a device on the market, you can’t do new product development
  • It’s important to never rush a product to please the market—the patient’s safety always comes first

Since we are working in sustaining engineering, the projects tend to incorporate a lot of reading, which can become tiresome, but it is extremely important for sustaining the products throughout their lifecycles. The only way to continue to develop new products within the company is to show that those products will survive once on the market. Additionally, while it is important to produce results in a timely manner, it is more important to provide quality results that ensure patient safety. The focus on patient safety at BSC is one of the aspects that I find very admirable about the company.

This weekend, we took an overnight trip to La Fortuna, and we went hiking at Arenal Volcano, swam in Lake Arenal, relaxed at the Baldi hot springs, and found a natural geothermal river that many Costa Ricans use as a hangout spot.

We only have three weeks left here in Costa Rica. Here’s to making the most of it!

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