Pura Vida! How have you guys been? My second week working at MicroVention I completed some company trainings and learned A LOT about the manufacturing process from my cool supervisor Karthik. I started the week by attending the mandatory employee training with the other new guys starting to work for MicroVention. I learned more about the company, their products, as well as their documentation system. After completing my training, I spent worked with the interns in the clean room and took pictures under a microscope of specific manufacturing process defects that the team needed to add to the inspection protocol. This was very interesting as I saw first-hand each step in the manufacturing process for one of their products, and how each operator worked through a detailed procedure created by the engineers. Later in the week I met one-on-one with my supervisor Karthik who explained the entire medical device product lifecycle and validations. The lifecycle begins with research and development (R&D) engineers, who first identify the need from clinical observations and research. They then move on to research and test the feasibility of the project, and proceed to design and develop a solution. The design phase includes design specifications product drawings, build records, test methods, and design failure mode and effect analysis just to name a few components. After design verification and validation, there is a design freeze and only minimal changes can be made to the device. Then the manufacturing stage begins, which is where I come in 🙂 I learned so much from Karthik about the manufacturing process, so I will try to give you guys a quick overview. First the building processes are improved to allow for mass production, and then these processes have to be validated. Rather than validating each individual product at each manufacturing stage, the process by which these products are built is validated through testing by the engineers, therefore proving that each product is being built correctly. There are several factors that play a role in process validation including equipment / tooling installation and operational qualification, verification qualification, and process operational / performance qualification. I have included a picture down below that visually demonstrates an overview of the product lifecycle.
Medical Device Product Lifecycle Overview
To end with fun news, I went to Hacienda La Chimba with some friends here and did the 5 km mountain hike through the coffee plantation. It took us a little under 3 hours to complete the hike, as we took some breaks in between to take fun pictures and rest from all the uphill and downhill walking we did. The hike was tiring but rewarding at the same time, as we got an incredible view from the top of the mountain. We took a picture at the famous “La Mano del Mantra“, and had a lot of fun even though we were all muddy by the end of it haha. I have included some cool pictures we took this past weekend below!
Hope you guys enjoyed this past week as well, and see you next week!