I believe, with the way the FDA enforces its regulations, improvements on the design process must improve. The FDA can only do so much to prevent companies from producing medical devices that may harm users down the line. As time progresses, medical devices have grown more and more complex, which undoubtedly calls for stricter and more elaborate regulations on the FDA’s side, but also calls for more responsibility on the company’s side. In addition, it is in the companies’ best interest to produce a safe and well-tested product that does not harm their customers and image.