You need a realistic plan, not consultants' poetry that ignores the reality that in a medical development, seldom do things go the way expected. Those who have never been through this process are like the innocents swimming unknowingly among sharks. What is your greatest risk: technology, regulatory issues, budgetary limitations, schedule or competition?

We understand these risks and can create a plan to achieve FDA approval to support your plan to "rush to market" and break even. Our plan is 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. There are any hazards. Most of which - you will not anticipate. We know those hazards and how to avoid them.We direct the regulatory development that drives the engineering development of new medical inventions to ensure money, at risk is not spent in efforts which will not benefit your ultimate goals. We participate in the engineering development as part of a feed back system to ensure progress. 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.