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Thread: X-Laser's New Variance Process

  1. #1
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    Default X-Laser's New Variance Process

    Hey all -

    For some time we have had a new variance process in the works which really redefines, and IMHO enhances, the entire variance experience as it has existed.

    I wanted to post this here for two reasons:

    First - and least importantly - I knew that word would soon get around and questions/speculation/criticism would arise in the absence of definitive information. So I wanted to head that off at the pass by being totally upfront especially with this community who cares so deeply about these sorts of issues.

    Secondly and much more importantly I have really grown to respect this community of laserists and I wanted to share it with you before it hit the PR wires. I could not think of a better place to roll out such a significant series of developments - at least for those of us working and doing business in the US.

    Moving on, I want to continue the pre-amble by making two points:

    1) I am happy to answer many questions BUT there are things that I am just not going to post. This new process gives us a significant competitive advantage over other manufacturers, some of whom are members here, and frankly we both worked our butt's off to get this done and set a very, very high bar for anyone else who may give it a go so I am not going to be going into certain specifics which would make it easier for someone to replicate the program.

    2) Maybe I have overestimated the significance of all of this in my own head but I suspect that there are going to be some people who are irritated if not angry that these developments were allowed... especially with me not answering certain questions about why and how they were allowed. I will just say that we did the work, blazed the trail and there is nothing in the world stopping anyone else from doing the same if they are willing to put in the year worth of time, tens of thousands of dollars and creativity that we did. As such there is really no reason to be bent out of shape - if that would in fact be anyone's reaction.

    Ok - so enough of that.

    Here is the new deal:

    Part I: Under a complex and comprehensive process which includes literally every aspect of our business as well as several new ones, we sought and subsequently received approval including modifications to our manufacturer's variance to be able to sell high powered laser projectors to individuals and firms who do not hold variances at the time of the sale.

    A requirement of every manufacturer's variance is that purchasers must have an active FDA variance at the time of the sale, prior to product being delivered. Under our process, users will still need a variance eventually, but this makes it much easier to compete with the illegal Chinese product thereby tackling the problem of non-compliant product from the demand side.

    One of the things I will not go into at present is the robust series of safeguards we have put in place to make this possible from both a manufacturing and distribution perspective. However, it is important to note that we have established a supra-compliant series of procedures - most of which are invisible or wholly unremarkable to the user - that in virtually every scenario will make this new process SAFER than that which presently exists. That is not just my opinion, it is also the opinion of the CDRH.

    Part II: X-Laser variances can now be applied for fully and accepted directly on our website. Using some custom software, two commercial solutions and leveraging existing Federal law we have made the entire variance process paperless, highly secure, fully traceable, encrypted and completely legally binding without ever touching pen to paper. User variances are now submitted instantly... which leads me to the last development.

    Part III: Because of the security measures built into this system which make it virtually impossible to forge, copy, or otherwise make use of the variance package except within the context of this system, our new 16 page stock variance package has been reviewed and approved by CDRH. Because the FDA is guaranteed to receive identical encrypted submissions with zero deviation and because of one other major factor, our EZ Variance Kit will now virtually eliminate the many months of review time that has become the norm due to the CDRH's workload. I must note that a user still has to receive their approval letter as per usual but that should happen dramatically faster than ever before.

    For what it is worth the CDRH put a lot of very reasonable requirements on us even with this system detailed as it was. They are hugely overworked and are genuinely, IMHO, doing their best to keep the industry safe, compliant and free from unnecessary intervention. There is a lot going on behind the scenes and some changes taking place which will make this a better industry for us all and for all of the griping that we ALL do about the turnaround speed and accessibility we really do collectively owe them some thanks for what is otherwise a pretty thankless job. It takes a lot of fortitude to show up for work everyday when you know that hundreds of people are at least irritated with you - whether right, wrong or debatable - and stick to your guns to do what you think it right. This was not a gimmie for us, we had to push the boulder up the hill and while I would really love to share all that was involved I hope that everyone can appreciate if not respect why I cannot.

    As I said before, I am happy if not eager to answer questions or respond to comments and in the coming months we will be taking a look at how we can make this system, or some variation of it, available to any domestic manufacturer of compliant high power laser products. That will be a challenge but at the end of the day the more compliant systems we all get into the market in a responsible fashion, the lower the chances of a major incident occurring ( ala Russia) which taints the industry as a whole.

    Remember, you heard it here first!

  2. #2
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    you know I have nothing against you guys but it sounds to me like the CDRH's inability to do their job and their eagerness to get you guys to stop harassing them has lead the CDRH to give you an unfair business advantage with it comes to granting variances vs other manufacturers?...

    or maybe I am just misreading what your trying to communicate... its possible, its like 1:30am lol

  3. #3
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    Dan-

    It sounds like a great thing to be totally honest. But it has also come to the point where *MANY* if not *ALL* projector manufacturers just dont care anymore. I have talked to many companies (and "influential" people) that just "do what they gotta do" to make it in this industry. At this point, the rules and regulations are there to simply say, "Hey look, we got rules and regulations."

    The government and rules and regulations have not changed with this industry. So therefore, the industry is changing the rules and regulations. And if someone is going to tell me otherwise, i'll have a field day defending my right to run my business.

    You and i have talked in great length, and i think youre a cool guy a great business man and have a great market for your lasers. But you have a proverbial "leg up" on me. You are 7 minutes away from the CDRH, you have high priced fancy lawyers, and you are paying (what i assume to be some serious money) to re-invent the wheel to streamline a process (variance, product reports) with fancy schmancy software and high tech text messaging product reports (whatever...lol...).

    No where in 21 CFR does it say, hey suckers...thanks for following all of our rules and regulations, please sit back and enjoy the ride for the next 1 year while we decide when and *IF* we would like to respond to your requests. BUT WAIT....if you act now with fancy schmancy software and websites, you can get in the VIP line to our exclusive club.

    Sorry bro, but that aint gonna happen.

    Dan, i applaud what you are doing. I think your process and the idea of it is great. and i am glad that it will probably work great for you. But here is the bottom line...(and this is coming from small companies like me to enormous companies 100X the size of me)

    I build 100% compliant machines. i file my paperwork whether it is for me, or for a client. i wait my 30 or so days and if, at that time i get no responses, sorry...but its business as usual. I WILL NOT lose business because someone doesnt have the "time" or the man power to do what they are supposed to do.

    *I* do not have the time and the man power to chase the govrnment around to do the job i am paying them to do in the first place.

    -Marc
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  4. #4
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    No I don't think you are misreading it so much as misinterpreting it. Jumping through hoops is not the right expression but as I wrote this was not a gimmie to get us to go away or out of apathy. The proposal went through a number of rounds of revisions and the CDRH expected us to meet a very high standard to make this work. We did and even went a some ways beyond it. More to the point, I don't think anyone who lives in the DC area would tell you that harassing a federal agency is a productive idea. We pitched an idea, they were receptive to the general outline but had a number of concerns, we addressed them in several drafts, went through a second major round of concerns, addressed them in a couple more drafts, submitted a half dozen documents and finally got approval.

    When getting into issues of fairness I don't think this is unfair at all... I think that if we had indefinite exclusivity THAT would be unfair. Just because we did it first does not make it unfair.

    CDRH cannot be capricious about granting some things to some and not to others and they made it very clear that if someone walks in tomorrow with the same proposal that they would need to put it through the same scrutiny but that they would probably need to grant it. To that end we had a choice to make: keep it under the radar thereby keeping it exclusive longer, or put it out there in the light of day to keep everyone informed and keep everything above board. We chose the latter mainly because while it was inherently disadvantageous in some ways, our natural inclination is to be upfront and clear.

    I know that it is a big change and I know that it could be irritating to those who have been sorting through regulatory issues for so long, but at the end of the day businesses thrive on innovation and it was either that or just keep getting buried by non-compliant imports.

    I would also mention again that we are beginning to explore ways to make this system available to others. However, for the time being our year or so of hard work has paid off and more generally we have definitively proven that changing the existing variance process is possible if you are willing to devise and religiously implement an alternative process that meets or exceed the same regulatory goals.

    I will leave you with two more big picture thoughts: If I were on the other side of this I would, in some small way, see this as a good thing for US laserists at large because there is now a precedent for industry fixing regulatory problems which I don't think has really happened before - at least not to my knowledge outside of perhaps the Pangolin PASS or something- in the laser community.

    Second, there is a plain reality that X-Laser has dramatically increased the CDRH's workload and thus contributed to the slowdown of processing for everyone. In 2008 we increased the CDRH's variance workload by about 70% relative to the year before and the 2009 numbers are even more dramatic. Simplifying the process for us should speed everything up for everyone else... at least that is the plan and hope.

  5. #5
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    Quote Originally Posted by X-Laser View Post
    I must note that a user still has to receive their approval letter as per usual but that should happen dramatically faster than ever before.
    "should happen"????

    Buy our product. Its legal we swear. (1 year later)... Oh, sorry we don't know whats taking the CDRH so long.

    Sorry man, sounds like marketing hype.

  6. #6
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    if its a marketing gimmick or not its irrelevant... I think for the sake of this thread we should assume that basically the CDRH is giving them the ability to do the entire process themselves as long as they promise to comply with whatever it is they promised to comply with... at least thats what I gather from their statement...

    Quote Originally Posted by X-Laser View Post
    We pitched an idea, they were receptive to the general outline but had a number of concerns, we addressed them in several drafts, went through a second major round of concerns, addressed them in a couple more drafts, submitted a half dozen documents and finally got approval.

    When getting into issues of fairness I don't think this is unfair at all... I think that if we had indefinite exclusivity THAT would be unfair. Just because we did it first does not make it unfair.
    yes but thats not something you or I could do... it probably required a lot of attorneys fees, consultant fees, blood sweat and tears...

    that might be in the realm of possibility for a company selling a LOT of projectors, but someone like say Marc... not so realistic from a business perspective

  7. #7
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    Quote Originally Posted by flecom View Post
    if its a marketing gimmick or not its irrelevant... I think for the sake of this thread we should assume that basically the CDRH is giving them the ability to do the entire process themselves as long as they promise to comply with whatever it is they promised to comply with... at least thats what I gather from their statement...


    I guess my point was that this really doesn't help anyone here on this board. Its great for x-laser (if its true). And it really may not help the consumer. Filling out the paperwork for a varianced projector is easy. So, easy a caveman could do it. Its the wait for the CDRH to reply that is the real problem. I guess I don't take x-laser's word for it. Their use of the word "should" exemplifies my point. Personally I don't think we should assume anything from a second party about the CDRH. For example.... If I said I talked to someone at the CDRH yesterday that said "it is now legal to crowd scan with a laserscope" Unfortunately I can't reveal that persons name. Would you take that as truth?

    Just my opinion.

  8. #8
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    Quote Originally Posted by logsquared View Post
    I guess my point was that this really doesn't help anyone here on this board. Its great for x-laser (if its true). And it really may not help the consumer. Filling out the paperwork for a varianced projector is easy. So, easy a caveman could do it. Its the wait for the CDRH to reply that is the real problem. I guess I don't take x-laser's word for it. Their use of the word "should" exemplifies my point. Personally I don't think we should assume anything from a second party about the CDRH. For example.... If I said I talked to someone at the CDRH yesterday that said "it is now legal to crowd scan with a laserscope" Unfortunately I can't reveal that persons name. Would you take that as truth?

    Just my opinion.
    absolutely agreed. This information should be provided along with some official gov't documentation that proves that things really are the way they are described as being, and that the advertised benefits will actually happen.

  9. #9
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    Quote Originally Posted by logsquared View Post
    I guess my point was that this really doesn't help anyone here on this board. Its great for x-laser (if its true). And it really may not help the consumer. Filling out the paperwork for a varianced projector is easy. So, easy a caveman could do it. Its the wait for the CDRH to reply that is the real problem. I guess I don't take x-laser's word for it. Their use of the word "should" exemplifies my point. Personally I don't think we should assume anything from a second party about the CDRH. For example.... If I said I talked to someone at the CDRH yesterday that said "it is now legal to crowd scan with a laserscope" Unfortunately I can't reveal that persons name. Would you take that as truth?

    Just my opinion.
    well considering this is a company that would be liable for those statements I sincerely doubt they would just make it up out of thin air

  10. #10
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    I don't think it's as simple as someone making things up.. often in business things are embellished or exaggerated for marketing purposes.

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