Hola!
Hope you guys had a relaxing weekend. This past week was my sixth week working at MicroVention and it was a relatively short week. The company had a maintenance shutdown from Wednesday through Friday, so I only went to the office on Monday and Tuesday and then worked remotely the other days. As I mentioned in earlier weeks, the validation process continued for the BOBBY product and thus I continued helping out in the clean room whenever I was free. While in the clean room, the engineering team was working on the process operational qualification (POQ) stage of the validation process, and I saw they were experiencing an issue. To better understand this issue, let me provide you a little bit of context. When performing final testing for the validation process there is a predetermined minimum sample size that must be tested based on several factors, including risk, variable/attribute features, and confidence level. The issue dealt with the low manufacturing yield for the low parameter lot (ironic isn’t it😬). Essentially, the manufacturing yield for this lot was so low that they were unable to produce the minimum sample size of successful units for final testing. Not enough successful units were built due to different defects and flaws occurring in the manufacturing process😭 I learned that when this happens, the team has to either start over and manufacture a whole new lot until they produce enough successful units, or they can justify a deviation to the procedure and manufacture a smaller lot size and produce the units remaining to meet the minimum sample size.
On Tuesday I was officially trained by Karthik to perform balloon testing on the BOBBY product, a balloon guide catheter. I was trained to test balloon compliance, fatigue/decay, and burst using official test methods (TMs) created and used by the engineers. This was pretty fun, and I got to test multiple units. Near the end of the week, while working remotely, I had a meeting with Karthik where he went over the risk management process for medical device companies. I learned a lot about FMEAs and the different types that exist such as dFMEA (design), pFMEA (process), sFMEA (supplier), uFMEA (usability). He also showed me a completed version of a dFMEA and pFMEA for the BOBBY product, explaining how they fill out these documents and what they are used for. Even though I had previously seen this at Rice University before, I found this extremely helpful as seeing the completed documents allowed me to better understand FMEAs and their intended use in the industry.
Finally, I was able to shadow Dr. Bogantes on Friday morning. Since my company was shut down for a few days, I took advantage and reached out to my professors and Dr. Bogantes to schedule a visit so I could have a better clinical understanding of medical devices as well as the healthcare field overall. Dr. Bogantes is a neurologist who works at the Hospital Nacional de los Niños. This was very interesting as I had never shadowed a neurologist before, especially not one who works with pediatrics. I got to see a few interesting cases and learned a TON about the brain, imaging tools, diagnostic tools, and patient interactions.
Over the weekend, my friends and I decided to have some fun and eat sushi for dinner which was really good (especially since it was on a 50% off sale🤑). We also decided to go on the Britt Coffee Tour on Sunday which was a lot of fun. We learned about the history of coffee, how it is collected and produced, and got to taste many different types of their coffee along the way. I also volunteered as a coffee taster, so I stood in front of the audience and got to drink and smell really good coffee😂☕️ Finally, we watched both the Euros and Copa America final together which was very fun, and I enjoyed seeing Spain lift the trophy after beating England 2-1⚽️⚽️ Here are a couple of pictures from this weekend for you guys to check out.
Even though it was a shorter work week, I still learned a lot about the company and the medical device industry overall. I also enjoyed shadowing Dr. Bogantes and learning about neurology, having a different experience this past week. Hope everyone has a great rest of the week!