We know where the hazards are...for example, most hazards from an iceberg are below the water. You cannot see them. Experience can keep you from a wreck. We are experienced in navigating through the FDA regulatory maze. Developing new inventions for FDA "approval" has special issues. We address those issues through good science and regulatory engineering. We speed your product to market.

Most inventors believe their idea is so wonderful that if they simply declare it, someone will write them a check! Not so! We are simply - realistic. We have been through this process 100 times in ten years. We love developing medical devices and submitting them to the FDA. We are very good at it. But, you are embarking on a tedious, difficult process that has a very low margin of success. With us as part of your team, your chances will improve.

Remember the statement ...if you build a better mouse trap, the world will beat a path to your door? Whoever said this was probably an attorney or college professor. It is unlikely that an executive at a mouse trap company ever said this. IBM dismissed the Xerox machine as a trivial novelty that would have no commercial value since the mimeographs machines were so popular. The inventor of the xerox machine (Chester Carlson) had a vision no one else saw! The cash laden railroad industry in the 1930 sought investments but not one railroad invested in the fledging airline business. Railroad executives failed to envision the future of the airline business.

You cannot simply patent an idea and license it and collect a big check. This so rarely occurs, that generally you are dreaming, if you expect this to occur. To convert a novel proof of concept device into a final device conforming to industry standards, ready for mass manufacturing, embodying all current fabrication knowledge - is a significant effort. When an inventor understands the amount of "grunt work "necessary to accomplish this, they are shocked! Most expect such work is accomplished by "magic" or elves in the basement. A German physicist remarked (after his group of Ph.D.'s had failed to move a proof of concept device to a prototype) that he had never appreciated the contribution that engineering added to an development project. Those that underestimate the development process- do so - not because of their special knowledge, but because they simply lack knowledge of the true development task.

  Copyright by Compliance Consultants, Stamford, CT 06907 USA, September 2001