There is no question that medical devices and durable medical equipment are big business. There is also a lot of competition and these medical device firms are trying to get as many new products on the market as possible to maximize profits. While that can result in a lot of good for patients in need of new treatments, The rush to market can also result in shortcuts being taken, and these shortcuts are often taken at the expense of patients’ health and safety.
One of the reasons they are able to get these new devices on the market so quickly is because of a loophole of sorts in the medical device regulations governed by the U.S. Food and Drug Administration (FDA). If there is a similar device already on the market, and there often is, the company may be able to skip certain testing and then go back and do post-market testing. Continue reading