This week was some tough, but rewarding, work. As you may recall, I am working at Establishment Labs to help design a design process that meets regulatory requirements. I wrapped up a preliminary design of the design process (similar to the waterfall model), from conception to prototype to iterative design to out the door. Now I must consider regulations and in which step(s) they apply in the design process. Now, you may be wondering: “regulations during the device process? Why not just have some regulations to clear at the end?” It all hinges on what compliance with FDA and ISO regulations looks like. It is maintaining a series of documentation that serve as records and checkpoints in the design process, as well as other parts of product development and implementation. Unlike college, you can’t just procrastinate and do all the paperwork at the end. A medical device company needs to maintain records throughout the product’s existence.
So why does this continual documentation matter? Documenting throughout the design process helps build the habit of masking deliberate and well thought out decisions. There are no hacked-together solutions. Every aspect of design is considered within the context of quality and function.
At the end of the week, the Consultika team met with Luis (GMI ’17 and Tico Owl extraordinaire) to discuss the next steps of the project. He and the Consultika team of the previous cohort constructed the app for secure physician communication. Now it’s time to run a clinical trial in the Costa Rican hospital system. As you can imagine, there’s a lot of paperwork to handle for that. We had a minor freakout over some documents we needed Dr. Clifton, our director, to sign off on, but thanks to continued documentation from the previous cohort, we found them in no time at all. That’s just one of the ways continued documentation and record keeping comes in handy! If that paperwork along with other regulations were kept off towards the end, we would not be ready to apply for research approval. We’ll spend the year filing for IRB approval and (hopefully) starting the clinical trial.
With such a long week, we decided to wind down and visit the town of La Fortuna, home of the Arenal volcano and a 70-meter waterfall. The hike up to see the volcano was exhausting, but the view was astounding.
The only wonder that came close to that was the waterfall. My legs are still hurting from the stairs to see the waterfall, but it was worth it.