Medical patents

LUMBERJILL

I have read and heard about the long and very expensive process of getting a medical device patented.  My question for those who know, if we were to create the prototype and have it manufactured, and sell it with patent pending... can the product be covered by insurance providers?  Or can you even sell a medical device without ADA or other governance approval?  Thanks in advance for all your suggestions. 
Lumberjill

LUMBERJILL

Thanks for the wealth of information!  Its amazing how complex my ideas turn into.    I have bookmarked the fda page for reading again and again. 
Lumberjill

InactiveMember

As far as I`m aware, FDA approval is required for any medical device for which a curative or palliative treatment claim will be made. In fact, I think that every single piece of medical equipment, down to tape and gauze, has to be FDA approved. A few years back a few of those electrical abdominal muscle stimulation device manufacturers got in some very hot water. However there are a few exceptions. I`m not sure if massage chairs have to be FDA approved, or things like mouthwash and so forth. Or what about those Breathe-Right nasal strips? You might have some room depending on the type of device. But I would imagine that a patent is required ... though it`s often very very easy to engineer right around a patent.
CookieMonster2007-3-7 21:54:24

patentandtrademark

I`ve done patents for medical devices [surgical devices].  There is an absolute ton of money made on some very "simple" devices due, at least in part, to the hurdles to make it through the process.

LUMBERJILL

I was wondering about that too...being able to have it patent pending and pending fda approval to market it and sell it.  Fortunately its an improvement to an already existing medical product, and that may make things more smooth.  Thanks.
Lumberjill

LUMBERJILL

I remember the furor of "skin so soft", when its bug repelling abilities were marketed, and fda swooped in to say hey... we haven`t approved that as a bug repellant and avon had a few years of fixing that headache.  But they did continue selling it, pending approval and so forth.  Thanks for all your input and valuable information.  Lumberjill