FDA and outsourcing abroad (China)

Contraluz

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Good evening, folks. If the following has been discussed prior, please excuse. I do think, though, the issue is still current, even more so with the present "made in the US" thing...

So, while talking with a colleague about the hurdles of FDA regulations, the question came up about FDA approved materials and outsourcing to China. I am pretty sure the FDA does not have the authority to check labs abroad if they us materials, or not, that are FDA approved, for restorations sent to the US.
Now, my guess is that there is a loop hole and it is actually permitted to import dental prostheses, that are put into the Pt. mouth.

How does that compare to the hoops and loops a company has to jump trough, to get a material or device approved, they want to sell here, in the US? Every Car has to meat certain minimal criteria, imported or not, if it wants to be sold here in the US (That is the reason the US is missing out on some nice cars... o_O).

Any way, I would love to hear from you guys. Thanks in advance,

Michael
 
CoolHandLuke

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the short answer : its complicated

the long answer: its really complicated. every state abides by a different combinations of regulatory boards and commissions trying to get a handle on what can be done and what cannot be, and some of them do it for financial reasons, and some of them do it out of a sense of duty to the country... its hard to tell who is doing what and why. in some states its good that china sends work, because theres a shortage of capable, qualified, people. in some states there is a surplus. some patients drive out of state. some labs ship work out of state... its a mess of what should be regulated, who is actively regulating it, and why they actually care.

the fda controls certain aspects like who is allowed to make certain products, with what tools, and what materials. except in some states where a labour board or dental board would overturn that. the fda governs the products and such made in america; in order to qualify for that sticker you need to meet certain criterion.

canada has much the same idea but with a far simpler state of oversight, given we have only 11 conflicting provinces instead of 50 states with their own laws.

the fda requires makers of products (like medical devices) to be made with specific tools, to have a paperwork process in place that makes all the manufacturing secrets known. this is called a 510k. this must line up with the suggested manufacturing parameters laid out by a material manufacturer, such as Ivoclar, makers of e.Max who give guidelines as to the use of the material. if the two are in conflict, you do not get approval to make your product under your brand name.

so how to the chinese get away with sending cheap and inferior items? i urge you to consider, they are probably actually not made of tin cans and parts of rat bones. they probably do make them of approved, quality materials. thinking they arent is assuming malice where none exists. its in china's best interest to play by the rules after all. question their craftsmanship if you care, but its not likely the material is subpar.

people often wonder, how can china make a crown for 10-20 bucks? i cant buy an ingot for less than 30! well they can buy 10 million ingots and use them in a week. they have the buying power and get the breaks. buying 5 at a time is not worth giving you a break is it?
 
JMN

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State boards cannot overturn fda regs, they can however be more strict.

The crazyness with US law and regulation is due to all 50 states retaining measures of soverienity, providing they do so within the framework of the constitution, this is in part what the 10th ammendment is about. Each state (or commonwealth) can and do make decisions for themselves regarding many things, including trade delegations that go to other countries, and accept trade delegations from other countries as well.

China has a great track record on their products being made properly and from the right materials. Who wouldn't want milk tainted with a human harming chemical to make it test as higher in protein, or wallboard/sheetrock that off-gases formaldhyde.

Not every business or lab there, by far, has inferior materials, inferior methods, inferior equipment, or undertrained staff that will result in a poor restoration or prosthetic. But I think you would agree that something outsourced to China has a greater chance of issues than were it sent to Belgium, Sweeden, Germany, France,...

As to the materials, the ones we use are certainly available, but so are pirate versions. Flexite for some time had a warning that the "flesite materials" being sold on eBay are knock-offs. Fake chips (silicon) are rampant.

It *is* insulting to think all of the Chinese labs are acting in bad faith. It's also insulting when they *do* act in bad faith.

Someone here told a story of getting an account by putting a magnet to a China outsource crown, and the crown stuck.

The part I cannot fathom is how it works out cheaper after the shipping costs. Not duties and tarrifs, just the UPS bill alone, adds a not insignificant layer of cost.

China has some amazing options ahead with enormous oppourtunities. If you are 1 in a million over there, there's 999 of you. We should stay aware.
 
Contraluz

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Thanks for the input and your thoughts!

its in china's best interest to play by the rules after all. question their craftsmanship if you care, but its not likely the material is subpar.

It *is* insulting to think all of the Chinese labs are acting in bad faith. It's also insulting when they *do* act in bad faith.

Oh, I agree! I don't imply they sell us inferior materials as their 'modus operandi'. As long as they sell a product that has a 'Brand name' attached to it, e.g. e.max, Katana etc, either it is or it isn't.

I do question their integrity, though, if there isn't a brand name attached to it. For example, there is a lot of lee way in quality if they sell 'zirconia' crowns or 'Titanium' abutments...

But, I guess that goes for a lot of labs on this side of the world, too. Even with all the regulations in place, if you want to, you still can get inferior products and sell them as 'premium'...

So, and this is rather provocative: In order to be able to compete with cheap labs abroad, should we abolish regulatory agencies like the FDA, and their rulings and let the free market regulate itself?

M
 
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they are less expensive because an average chinese tech gets paid 10 bucks a day and they are really pushed to do volume. they use a lot of copies of materials and the material supply companies have 2 level price system .for example i purchased a pack of 5 emax ingots for $70 dollars from the ivoclar stand, at the shanghi dental show a couple of years back as opposed to the normal price of $220 in oz.western countries are basically subsidising the asian manufacturers. doesnt it make you feel good to help others.personally we need these fda regs etc because there is no way any of us should self regulate and the price wouldnt change.supply companies hide behind the oh it costs so much to get fda approval all the time they use it to rip everyone off.
 
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they are less expensive because an average chinese tech gets paid 10 bucks a day and they are really pushed to do volume. they use a lot of copies of materials and the material supply companies have 2 level price system .for example i purchased a pack of 5 emax ingots for $70 dollars from the ivoclar stand, at the shanghi dental show a couple of years back as opposed to the normal price of $220 in oz.western countries are basically subsidising the asian manufacturers. doesnt it make you feel good to help others.personally we need these fda regs etc because there is no way any of us should self regulate and the price wouldnt change.supply companies hide behind the oh it costs so much to get fda approval all the time they use it to rip everyone off.
I wonder if the ingots you purchased were from a lot that didn't pass on this or that test. They need to pass different tests for different markets.
 
CoolHandLuke

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So, and this is rather provocative: In order to be able to compete with cheap labs abroad, should we abolish regulatory agencies like the FDA, and their rulings and let the free market regulate itself?

M
you can't just abolish the FDA in order to compete with china.

you have to also abolish labour laws to re-allow slavery, or have an economy SO GOOD that you can afford to pay workers in pennies, and workers will accept it as it still allows them enough money to buy food for a family.

when Tom Duck and Harry Scrotim's Dental lab can do this, it can manufacture a product at 5-10$ dollars and make 4-9$ in profit on each item.

why do u think we have adopted cadcam so quickly and brought the price down so quickly? you dont have to pay a robot.
 
JMN

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Oh, I agree! I don't imply they sell us inferior materials as their 'modus operandi'. As long as they sell a product that has a 'Brand name' attached to it, e.g. e.max, Katana etc, either it is or it isn't.

I do question their integrity, though, if there isn't a brand name attached to it. For example, there is a lot of lee way in quality if they sell 'zirconia' crowns or 'Titanium' abutments...

But, I guess that goes for a lot of labs on this side of the world, too. Even with all the regulations in place, if you want to, you still can get inferior products and sell them as 'premium'...

So, and this is rather provocative: In order to be able to compete with cheap labs abroad, should we abolish regulatory agencies like the FDA, and their rulings and let the free market regulate itself?

M
We have too many willingly stupid and unreasonably litigious people now to let caveat emptor be the sole regulation. Halloween costumes with tags that read "cape does not enable wearer to fly" should explain my ranty sentence just fine.

Brand names are not safe. There is a reason that China has less than 10% valid Windows licenses, IP and branding is not nearly as well policed.
Witness "Hitler Chicken"
http://newsfeed.time.com/2013/07/08/kfc-is-not-amused-by-hitler-fried-chicken/.

or the fake Apple stores:
http://www.bbc.co.uk/news/technology-14503724

Not all involved have to know that they are impinging on IP. That is the thing to remember.
Their boss is a jerk, but the employees may think they actually work for the legit group.

The FDA was created because of things like bottles of tiny "slimming pills" being sold with directions to take a tablespoon full a day, two a day if fast enough results are not seen. They were tapeworm eggs.

Price pressure is from a number of things, I'd rather work on those. Inflation/government overspending being one of the first places to start I'd think.
Quick fixes frequently have catastrophic failures at the time you need them most. Colored tape over a brake/turn lamp with a shattered lens is great on a sunny day, when it's night and pouring down rain, when you need someone to see you, it's not so great anymore.
 
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you dont have to pay a robot.
Which is being proven very rapidly in the places that people were wanting $15/hr to serve re-flavored, ammonia washed, warm 'burgers' as the kiosks come in and the rude 17 year old leaves.
 
CoolHandLuke

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Which is being proven very rapidly in the places that people were wanting $15/hr to serve re-flavored, ammonia washed, warm 'burgers' as the kiosks come in and the rude 17 year old leaves.
which is scary when you think about it.

if low pay jobs arent going to exist and high pay jobs are so scarce, who exactly will be left to work in the environment of AI?

 
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which is scary when you think about it.

if low pay jobs arent going to exist and high pay jobs are so scarce, who exactly will be left to work in the environment of AI?


Yep. If you don't know how to fix the machines, be ready to be a grunt work level employee. Or we could just put our shoes in them. But I'd not call $15 an hour a low paying job in most of the US. It's a very respectable wage in my area, no where near an entry level wage.
 
CoolHandLuke

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its a low paying job due to the median standard of living in populated areas.

im making 21 an hour ish, and its difficult to justify even having a car.
 
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its a low paying job due to the median standard of living in populated areas.

im making 21 an hour ish, and its difficult to justify even having a car.
You're also not a entry level employee who's main duty is to pick up a basket out of oil when you hear a beep, dump it, reload it and drop it back in the oil.
 
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all the more reason to bump those low effort jobs to better pay, or eliminate them completely. if its not worth it to work doing that, why should anyone even consider it?

if i had to pay for a home while putting myself through college, i would quickly have gone homeless given the inability to keep up.

in this way many asian factories are able to sustain. not only do they employ low wage people by the hundreds, they house and feed these workers within the factory itself AND pay pennies on top of it. its not life at a spa, but its a life free of those typical burdens as they are absorbed by the factory.

you can't qualify for a mortgage on 10 bucks an hour and don't work regular hours.
 
CoolHandLuke

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all its going to take is one company bold enough to create an Automated system (material, method, manufacture) of raw dental product satisfying 80% of all cases, and everyone's dental lab job will be threatened into oblivion.

if you can make an AI identify a margin within 95%, or any other anatomy, you an create subprocesses to build on that structure from design through to manufacture completely hands off overnight.

if you go in to a dentist office and get a scan via IOS, and someone can use that IOS to design, manufacture and ship overnight a full, working, fitting denture that needs no adjustment due to the tons of computation that went into it, what can you do better? what can you do to sell yourself? what can hands do, that machines cant?

if you can break the process down to checklist tickboxes, and account for every one, youve become a powerhouse stronger than glidewell.
 
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Entry level jobs teach people who never had a job before that it is not like going to school and hanging out. It is a job with minimal pay because it has minimal responsibility. As a person shows more abilities and adapts to the environment, they should (note should, I know it doesn't always work that way) be given higher pay and raised to a level of expecting more responsibilities as well. Nobody stays a pickup/delivery driver forever, unless they want to, or they cannot take additional responsibility well.
 
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all its going to take is one company bold enough to create an Automated system (material, method, manufacture) of raw dental product satisfying 80% of all cases, and everyone's dental lab job will be threatened into oblivion.

if you can make an AI identify a margin within 95%, or any other anatomy, you an create subprocesses to build on that structure from design through to manufacture completely hands off overnight.

if you go in to a dentist office and get a scan via IOS, and someone can use that IOS to design, manufacture and ship overnight a full, working, fitting denture that needs no adjustment due to the tons of computation that went into it, what can you do better? what can you do to sell yourself? what can hands do, that machines cant?

if you can break the process down to checklist tickboxes, and account for every one, youve become a powerhouse stronger than glidewell.
That's why I repair and reline as a priority service. Machines are good at making, not so good at fixing. Yet. Although a new one could be made overnight and shipped next day, the price required would likely be prohibitive for every fracture, etc.

I think that the idea of society in the movie 3% is not unlikely. It is already a sharp division between the technically adept with the plutocrats, and the less well, um, financed majority in some countries.
 
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Aside from paying each other to make art, or putting a heavy heavy yearly tax on automation, I think things are going to get very interesting in 100 years. Maybe we would learn to be happy with farming again. It's not unlikely that a return to a largely agrarian society could coexist with a highly advanced subset.
 
CoolHandLuke

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Entry level jobs teach people who never had a job before that it is not like going to school and hanging out. It is a job with minimal pay because it has minimal responsibility. As a person shows more abilities and adapts to the environment, they should (note should, I know it doesn't always work that way) be given higher pay and raised to a level of expecting more responsibilities as well. Nobody stays a pickup/delivery driver forever, unless they want to, or they cannot take additional responsibility well.

in an ideal world, sure, but thats not how it works in the real world. mcd's and walmart get subsidized through tax dollars and shareholders, incentivized to spend as little as possible on their workers. because of this they can afford to cut wages, hours, benefits, and standards, and still make wads of cash. it hurts nobody to raise the minimum wage to meet the standard of living. nobody. not mom and pop coffee shops. not small businesses. nobody.

https://www.washingtonpost.com/opin...6cabd0-dbed-11e5-925f-1d10062cc82d_story.html

article quote: companies can cut profit margins or top-level salaries to meet higher wage mandates. This last mechanism is one reason such policies get so much pushback from business, and it is particularly germane in an economy where income inequality stands at historically high levels.
 
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in an ideal world, sure, but thats not how it works in the real world. mcd's and walmart get subsidized through tax dollars and shareholders, incentivized to spend as little as possible on their workers. because of this they can afford to cut wages, hours, benefits, and standards, and still make wads of cash. it hurts nobody to raise the minimum wage to meet the standard of living. nobody. not mom and pop coffee shops. not small businesses. nobody.

https://www.washingtonpost.com/opin...6cabd0-dbed-11e5-925f-1d10062cc82d_story.html

article quote: companies can cut profit margins or top-level salaries to meet higher wage mandates. This last mechanism is one reason such policies get so much pushback from business, and it is particularly germane in an economy where income inequality stands at historically high levels.
Nobody? Really. I am at the cusp of hiring someone. If the minimum wage were to rise to nearly double, that would be a job that isn't available for a longer time.
Would you really rather have that person drawing unemployment, camping under a bridge, living with a family member, etc than to have a lower wage?

I know well how that works, and that's why I don't shop at Walmart unless I must, nor eat McDude food if I can help it from proper planning.

The problem with assuming that it hurts nobody, is you haven't yet had to look at the financials for most small businesses. When the Medical tax was proposed, my boss told me outright that if dental wasn't carved out with an exemption, we'd be out of business. There's not as much free money floating around at the top as you may think.
Goverments take it, but businesses create it. The huge mega-corps, oh yeah, they do have wildly uncool levels of wage discrepancy, but they are not the same as the average small business by far.
 
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