On Wednesday, February 9th, 2011 the NY Times ran an article that questioned the role and efficacy of the FDA as the gatekeeper for approving the commercialization of various products intended to enhance and improve the publics quality of life. Many industry executives and investors believe the time has come to revamp this regulators role. Yet, before the public lynching of the FDA ramps up, understanding the bodies role is integral in delivering safety first when it comes to medical devices.
As the gatekeeper for public health their job is to assure the safety and efficacy of human drugs, biological products, medical devices, and our nations food supply in addition to a few other areas. In addition there role becomes more difficult when one considers that they are also responsible for advancing public health, assist in bringing innovation to the marketplace, ensure safety, and make the delivery of healthcare safe. Essentially, those are two very different responsibilities. Assuring safety and bringing innovation to the market are two very different roles.
For the obvious reasons, investors continue to shout from their financial mountain tops that the FDA is not doing their job, inhibiting innovation, denying Americans supposed state-of-the art devices, and most of all not allowing them to capitalize on their investment in real time so that they could cash out and move on to their next venture. Many entrepreneurs would love less scrutiny in the process. Yet, without entrepreneurs our industry would not grow. So the entire process must be reevaluated. Is the process too slow, or do some of these investors fail to understand the true nature of our business, meaning the patient comes first? As investment capital permeated the device industry the focus centered on financial results rather than the process. There're many examples in our industry that have placed the cart before the horse. Are we willing to compromise safety first for the good of the almighty dollar? TSB is not attacking the investor, but what happens when your mother's hip fails, or your child dies of salmonella poisoning because there is a failure by the FDA to monitor and regulate properly. And what about the many people that have initiated a venture only to fail because of their own inadequacies? It is easier to point fingers at one another instead of sitting down and attempting to work out a mutually agreed upon solution. But then for all the complaining about Obama he has slowly evolved into every entrepreneurs best friend, I guess it's time to start gearing up for the 2012 election. TSB wants to know, how do we fix the system while we protect the patient, and even if we resolve these concerns will U.S. Companies continue to export manufacturing and jobs overseas all for the love of a maximum return on investment?