Like most government bureaucracies, the FDA is a challenge to deal with. To make it easier, St. Cloud State University in Minnesota has begun a program that helps companies learn how to work with the FDA. Heading the project is Medtronic Inc. veteran Charles Swanson.

He headed the regulatory affairs department at Minnesota.-based Medtronic for about 30 years and is credited with helping develop many of the FDA's medical-device guidelines and procedures. Swanson says the masters program is badly needed because there is a shortage of regulatory experience around the U.S. Graduates would probably go into a regulatory-affairs department within medical-device companies.

It is difficult for medical firms to work with the FDA, says Swanson, because its regulations keep growing in number and complexity. Also, an enforcement mentality has arisen in recent years. The agency evaluates products more thoroughly, particularly complex ones, and before they reach the market. Stricter post-market surveillance then watches to see how medical goods perform after they have been on the market.