The idea that spending ‘excess’ funds on quality engineers is a burden and that they only bring bad news has been the general consensus of the previous companies for which I have worked. Currently at my job, upper management, engineers, and technicians alike both dread missing the standards the quality team sets for a product because that means sending the immunoassay instrument back into the laboratory to repeat roughly two dozen hours laboratory testing. Inevitably, this means retesting an instrument (frustrating to begin with) in addition to logging significant overtime in order to meet the monthly quota.

Even though I am part of this cycle and have had my fair share of overtime hours, I believe that an excellent quality team is definitely a necessity when it comes to medical devices. In my case in particular, if an instrument leaves the manufacturing plant defective, that could put an entire hospital’s patient body at risk for faulty lifesaving diagnostic test results. In addition, as mentioned above, the company image would be negatively affected by frequent recalls of product. This pairs with the financial payout the medical device company would have to pay to both recall their product and in the coming civil suits. Therefore, we as employees of medical device companies owe it to our client, to ensure quality is built into every step of our medical device process to give them the most reliable device we can.