Hi All
thanks for all the information everyone posts on the site - exremely helpful.
I have developed a small device to help prevent CLABSI and was wondering if anyone can suggest how I could get this developed and into the market place?
many thanks
Kerin L
This is an enormous question. First you will need to determine if your device is Class I, II or III. Then make the appropriate application to the FDA based on that class. You will need a consultant experienced with working with the FDA and writing and submitting these applications. It will either be a simple product listing and registration for Class 1 or a 510(k) for most Class II, and a premarket notification for Class III. You will probably need a patent on your device, then decide the best way to bring this to market by either selling this to healthcare clients either through a direct sales force or through local distributors. You will need to set up a business, business plan, all the legal stuff for local business license, etc. Lynn
Lynn Hadaway, M.Ed., RN, BC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861