From: yaniv_vi (yaniv_vi_at_yahoo.com)
Date: 2002-01-10 19:15:30
hi jim
i'll answer you very shortly , we debated this issues very long ,
there is some option via fda , that don't require a multimillion
testing ,then it's not medical , and nfb practicioners cant use it
but common ppl can use for non medical opurposes , e.g. meditation
etc ...
doug knows more than me , but generally you just have to send pre-
market notification detailing the device, and then you get class-2
status from fda .
in order to do that i think we need to have a lawyer first .
but after much talking with a few people i got the knowldge that
it's possible without millions of dollars .and even some companies
did it without the expensive fda test .
sicnerly
yaniv
--- In buildcheapeeg_at_yahoogroups.com, "Jim Meissner" <jpmeissner_at_mindspring.com> wrote:
> Dear janiv:
>
> You wrote:
> > the issue here is :
> > how to get to a tested design ore work , time. test among a
group of 10 people
> > generally not a big problem people will send money to joerg ,
morritz ,
> > andreas ,and see...
> > after that the thougher issues come :starting NGO ,
manufacturing , legal issues .
> > on a second thought , maybe there not so tought , but they
haven't been started yet .
> > so the real thing blocking us here , is the lack of a
volunteering lawyer . i tried to find somebody from israel and
> > asked him about stuff ,he said that legal matters are not
complicated and doesn't a long time , and he said it
> > needs to be somebody from states / europe - where are markets
are .
> > so this is the most important thing for now - finding a
lawyer .if you can help in this it would be great! , also
> > steven ness is trying .
> > after we have that , we have a NGO , and then organizational
things would become quite easier .
> > the other option is contacting another NGO , or commercial
company . for this reason i'm working hard on the
> > site .
>
>
>
> I am not a lawyer, so this is not legal advise.
>
> In the USA the FDA is responsible for approving medical devices.
This has become BIG business and only the large drug companies have
the funds to get FDA approval. It takes 200 million dollars or so
to get a new drug approved and requires 10 years of studies. It is
worse to get a "device" approved.
>
> There are some "loop holes" and "grandfather clauses" that can
sometimes be used. The BrainMaster got approved as a "similar"
device. They had to prove that it was similar to something that the
FDA already approved or existed before the FDA took control. It is
still a lot of red tape and stringent requirements have to be met.
>
> The laws in the USA are very severe, and if you build and sell a
non-approved medical device you may end up in jail.
>
> The brain monitor would be classified as a medical device. The
bio-feedback field is highly regulated and you have to be licensed
to use a brain monitor.
>
> I don't know what country you are from, but these are the laws in
the USA that I am aware of. There is no way that you could build a
device in Denmark let's say, and sell it in the USA. Even a
licensed bio-feedback practitioner could not buy it and use it
unless it was approved by the FDA.
>
> The only possibility for the buildcheapeeg project that I see is
that it could be published for free like the BrainMaster was or sold
as a kit like the HAL-4.
>
> The law allows people to build things for their own
experimentation, but they cannot sell it, or use it on others.
>
>
>
> Juergen P. (Jim) Meissner
> Check out my Website at www.MeissnerResearch.com
> Read about the benefits of the Brain State Synchronizer sounds for
improving your life and health.
> ----- Original Message -----
> From: yaniv vilnai
> To: Jim Meissner
> Sent: Wednesday, January 09, 2002 7:42 AM
> Subject: Re: website v1.02
>
>
> dear jim :
>
> Jim Meissner <jpmeissner_at_mindspring.com> wrote:
>
> Dear yaniv:
>
> I just found out from Rob Sacks that you are the "organizer"
of the buildcheapeeg group. That makes more sense now as to why you
are doing your website. I could not figure out the "why" before.
>
> You should get Doug Southerland to help you with your
website. He is a wiz at finding things and has compiled lots of
stuff on his website that should be on "your" website.
>
> thanks , i'll try that .
>
> It seems like your group has 200 members, but only 2 or 3 are
doing any work. It also seems like there is "no" progress. Someone
posted that this is where things were a year ago. If you really are
the leader, "you" need to direct traffic so to speak. Take charge
and manage the group. Of course that may not be easy.
>
> i have always tried to do that .but i had limited sucsess ,
thought . but not 2-3 people , more then 2-3 i think. but it goes
somebody help for a bit then leaves .
> there are currently a few problms here :
> 1. think of little tasks that would intrest people
> 2. try to get the message to them , because i'm not sure
everybody reads every message
> 3. there's a problems in this medium in commitment of
people ,like for example steven ness , who said would help
> to find a lawyer had disappeared for some time , and then
reapeared before not 2 long, and said he's trying to
> find one. i just emailed him today and asked , when will
he meet with the lawyer.
> also when people send me email and tell i want tohelp , i
try to ask if the commited , and could spend an effort.
> but again this is quite diffrenet from running a
commercail company ( that's also a hard task indeed which could
> be nice to master one day).
> 4. so anyway , i'm trying to do so , and have some sucsesses ,
just now , i have 2 people willing to work on sw.
> 5. also people who just give advice is helpfull .
>
>
> I ran my own business for over 30 years and know what is
involved with manufacturing a product. I built a brain wave monitor
similar to the BrainMaster many years ago. I am willing to share
what I have learned. So far no one on the group seems interested
for some reason.
>
> first , i din't know you built something like brainmaster .
> and yeh , any help in pushing this project would be really
appreciated .
>
> There seems to be a sense of unreality in the goals of the
group. On one hand there is the "requirement" to build a brain wave
monitor for under $100 (absolutely impossible) and on the other hand
members of the group are building some "exotic" high
tech "www.biosemi.com" dream machine that has to be better than
anything out there. Unfortunately most of these people have never
seen a brainwave before and are designing in a vacuum. A year from
now they will still be arguing about some insignificant point that
has nothing to do with "real" brain waves.
>
> first maybe you right .
> part of this i regard as the way things done in net
communities . everybody tries to do his best . there's no way to
command . only persuasions make effect . heck it took me lots of
talking about fiber optic ,to see it done .
> about the $100 , i don't know. but at first stage , i wouldn't
mind if the price would be higher .
> about focusing :
> as i see it joerg/morritz have design quite ready (modeeg)
(still we don't have a fiber , that bothers me , but maybe i'm wrong
here)
> also tiny eeg seems real promising .
>
> the issue here is :
> how to get to a tested design ->more work , time.
> test among a group of 10 people -> generally not a big problem
people will send money to joerg , morritz , andreas ,and see...
> after that the thougher issues come :starting NGO ,
manufacturing , legal issues .
> on a second thought , maybe there not so tought , but they
haven't been started yet .
> so the real thing blocking us here , is the lack of a
volunteering lawyer . i tried to find somebody from israel and
asked him about stuff ,he said that legal matters are not
complicated and doesn't a long time , and he said it needs to be
somebody from states / europe - where are markets are .
> so this is the most important thing for now - finding a
lawyer .if you can help in this it would be great! , also steven
ness is trying .
> after we have that , we have a NGO , and then organizational
things would become quite easier .
> the other option is contacting another NGO , or commercial
company . for this reason i'm working hard on the site .
>
> sorry for the long letter , but that's the story dude .
> and by the way , i'm also impressed by your engineering
knowledge .
>
>
>
> (BTW) I am very impressed with Joerg's engineering knowledge.
>
>
> Please understand than my comments are intended to be helpful
even though they may seem like a criticism.
>
>
> Juergen P. (Jim) Meissner
> Check out my Website at www.MeissnerResearch.com
> Read about the benefits of the Brain State Synchronizer sounds
for improving your life and health.
>
> hope you can help
> yaniv
> p.s. maybe you can look at the vision section in the website .
> ----- Original Message -----
> From: yaniv vilnai
> To: Jim Meissner
> Sent: Tuesday, January 08, 2002 6:11 PM
> Subject: Re: website v1.02
>
>
> Dear jim ,
>
> o.k. i'll explain(sorry if i explain2 detailed , but just in
case) :
>
> 1. you have to open the zip file into directory , and then
you have html files of the website
>
> 2. we want to have a professional looking web site for a
few purposes :
>
> show the world our project from many reasons (both
reasons for the benefit of the project:
>
> gateway to making contact with organizations that can
help , making contact wit manufacturers , etc ..
>
> and also as credit for the people involved).
>
> way to get more people to help and be involved
>
> way to get more people interrested in buying cheapeeg .
>
>
>
> that's basicly our web site goals .
>
> a question , next time when you write something like i don't
udnerstand , please write exactly what from my message did you
understood , and what you didn't understood . that could save some
time and confusion.
>
> sincerly
>
> yaniv
>
> Jim Meissner <jpmeissner_at_mindspring.com> wrote:
>
> Dear yaniv:
>
> I am still not understanding? Do I need to train with a
brain monitor to understand this? What are you trying to do?
>
> Juergen P. (Jim) Meissner
> Check out my Website at www.MeissnerResearch.com
> Read about the benefits of the Brain State Synchronizer
sounds for improving your life and health.
> ----- Original Message -----
> From: yaniv vilnai
> To: Andreas Robinson ; Jim Meissner ; steven ness ;
morritz v buttlar ; Joerg Hansmann ; George von Hilsheimer Ph.D. ;
Doug Sutherland
> Sent: Tuesday, January 08, 2002 11:16 AM
> Subject: website v1.02
>
>
> here's website v1.02
>
> http://groups.yahoo.com/group/buildcheapeeg/files/web%
20site/openeeg_site_v1.02.zip
>
> remarks :
>
> there are only links from homepage at the moment , so
use the back button.
>
> text in red ask for your help in filling content.
>
> also there are some places without such remark tht might
reuire your help .
>
> any comments welcomed .
>
>
>
> sinceerly yaniv
>
>
>
>
>
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This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:36 BST