It felt like the first day of school all over again: being dropped off by a bus, wearing freshly pressed clothes, and standing in front of an ominous building (that is also very energy-efficient I might add). But much like the whirlwhind of childhood academia, the first week of my internship at Establishment Labs was exciting, challenging, and fun.
Soy yo.
Establishment labs makes implants used across the world. With these implants staying in patients for the rest of their lives, there are strict regulatory and quality guidlines in place, and these requirements differ from country to country. For an international company like Establishment Labs, that means QA/RA (Quality Assurance/Regulatory Affairs) is an essential part of the company.
As a quality intern, I am verifying that internal company processes for various activities are up to code and are ensuring the highest level of patient safety. That means reviewing regulations from the countries the product is being sold. It means reviewing internal documents to make sure they provide needed information. It means reviewing big picture processes and ensuring they are up to snuff.
It means a lot of reading.
I doubt this baby can actually read.
But the importance of quality control cannot be understated. One only needs to look at history’s most serious medical device incidents to see why. The Björk-Shiley Tilting Disk valve was a heart valve replacement that seemed to offer a new lease on life for patients. However, this miracle device turned into a nightmare when stress fractures formed in the struts supporting the disk in the valve, breaking off and causing valve failure and death. Two-thirds of patients receiving this valve died. Hundreds of millions of dollars were needed to correct what could be salvaged.
The Bjork-Shiley valve.
With the delicate human body, every medical design feature must be thoroughly vetted. A broken valve in a human is far more serious than a broken valve anywhere else. And an ounce of prevention is worth a pound of cure. Quality is ensuring that the medical device performs to the highest standards before patient use. The United States, European Union, and other governments place regulations on both device and design to minimize negative effects.
With better medical devices, patients can enjoy more of life’s pleasures, such as the wonderful Irazú Volcano, which we traversed yesterday. The clouds were dense when we arrived, but they slowly peeled away to reveal the beauty of the crater. Pictures cannot do the scene justice. The sights were magnificent.
Don’t fall in.
This past week was extra special for me as Ramadan came to an end. With the end to a month of fasting comes a day of feasting. I went to the Eid prayer in San Jose. The Muslim community in Costa Rica is small, so when special holidays come around, people from all over the country come to celebrate. Some people traveled up to 200 kilometers (124 American distance units) to get to the prayer! It was a great day to meet yet more Ticos (and finally eat with them).
Om nom nom.
Another wonder of the world to be enjoyed is soccer. Ticos love la Sele. People are wearing the jersey everywhere, even to work. Lunch time World Cup viewings are not uncommon. With Costa Rica’s turn in the World Cup coming up, the spirit of the Ticos is almost tangible. Ole, Ole-Ole-Ole! Ticos! Ticos!