I have been debating how to approach this subject, and after much procrastination, I guess I will just jump in. There are many challenges that medical manufacturing organization leaders face on a daily basis. However, the most frustrating part for me is the regulatory and legal red tape that exists in the process today. While I understand that regulations and legal issues are designed to protect the public (myself included) I often feel that much of what is happening today is not beneficial to the public and in actuality detrimental to our economic well being. The first challenge on every leaders list in the medical manufacturing arena is the Food and Drug Administration and the additional burden of much longer approval times for new products. At different trade shows we casually talk with friends in the industry, and a common topic is the pain felt in dealing with the FDA today. I personally rate the first subject so high on my list that I think number two is actually number three on the list.
