Forums: Discussions for entrepreneurs and small business.

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

Oh BIG no no, do not bring a Medical Device to market without having followed the proper procedures, if you do, insurance will be the least of your worries. For basic information on what you need to do check this page.

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

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.

What makes any medical device a "Medical Device" are the claims the manufacturer makes. For instance if you manufacture a machine that aids in the prevention of pollen or air-born allergies and claim it as such it then "becomes" a Medical Device, however, if you simple market it as a clean air machine making no medical claims it does not need to be FDA approved as a Medical Device. Same product, same results, different (read no medical) claims.

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.

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James Lindon, Ph.D. Patent Attorney
Lindon & Lindon, LLC
Cleveland, Ohio
Patents, Trademarks, Copyrights, Pharmacy Law, Litigation
[this is not legal advice - provided for discussion only]
Intellectual Property for the Individual and Small Business: Identify, Protect, Enforce, Defend.
"Fools rush in where angels fear to tread."
http://www.LindonLaw.com

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

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

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