Your medical device must have "approval" from the U.S. Food & Drug Administration to sell a medical device in America. To accomplish this requires a real plan, a plan based on reality not idealism. The most compelling reality will always be the FDA. How will you deal with those issues? What issues apply to you invention? So many issues exist that there are few straightforward answers. You will be negotiating in torturous unknown waters.

We deal in new medical devices. New means not the same thing. Most of our clients are start-ups who have something totally new. Due to the numerous projects that we have done, we have developed experience in the early efforts to develop alliances and partners to bring new medical devices into the U.S. marketplace.

In the commercialization of innovative medical devices, we offer the ability to:

• Guide early development to ensure your invention is on track.
• Define issues to ensure your invention meets FDA requirements.
• Identify potential partners to share in the expertise and risks in distribution.