Activity

  • When considering the challenges between managing a project for a medical device and constructing a skyscraper, one must take into account the safety of both deliverables in the event of the worst case scenario, both of which can have dire consequences on human life. I personally believe that the safety of medical devices requires a lot more challenges to overcome simply because the field of medicine is far less developed than the field of construction. Building a skyscraper has already been done countless times and therefore has a lot more expertise that goes into it as a result of repetition, knowing material properties, and having a thorough design plan. A medical device however, lacks that knowledge and must therefore run clinical trials, but only after they have been proven safe and effective on animal models, which can only be accomplished by overcoming the FDA and ISO regulations implemented. The likelihood of completing the construction of a building is far greater than that of developing a novel medical device, simply because there are far more challenges and concerns facing something that has never been done before that interfaces with the human body. I currently work as a manufacturer at a cell-therapy company where we extract a patient’s own white blood cells, prime them with additional surface receptors that make them more aggressive towards disease, expand them, then infuse them back into the patient. Since I am working with a blood-based product that is getting sent directly into a patient’s own bloodstream, the amount of challenges my team faces in documentation, prevention of contamination, and communication across team members and clientele are tedious and burdensome, and one wrong move is all it takes to threaten a life.