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Posted On: 10/09/2017 8:58:17 AM
Post# of 15624
Gary. I actually used to work in the kidney industry for the largest dialysis company in the world and I can say that they are aware of this product but at least at my level nothing in how to address it as competition. The clinics will never go away but this will be a huge change for many. (Trust me I would love to see the clinic disappear but ESRD is typically a result of none compliance with high blood pressure, diabetes, or hypertension. The none compliance part is why the clinics will never all go away but this device will cause a major shift in the way dialysis is performed)
Regarding the FDA even earlier in my career I was a Chemist for an injection contract manufacturing site. I can't say I agree with all regulations but I will say this. Some of the products that are given out in the millions every year have risks of mercury, cyanide, even LSD. These are just a few products used to formulate or by products from the formulation that has to be removed from the finished produce. Even how things are stored once packaged is such a huge part of the quality of the product. The chemicals degrade at different tempuratures or like Johnson and Johnson found out with their Tylenol plant years ago... the new pallets treated with pesticides when stored in their warehouse was leaching the pesticide into tylenol. It took the FDA showing up twice to get them to fix it. The second time they showed up with 30 some inspectors and locked the plant down for a month... then they ultimately shut the plant down. I had moved from a Chemist to an auditor by this point which is the only reason I really remember it but if you look about about tylenol recalls in the last 10 years or so you will find it.
So long story short. I rather see the FDA get more staff and develop ways to be efficient in their oversight than to limit the oversight. The US public is a fix me now society which is part of the reason we have the opioid epidemic. We will pretty much take any pill or any shot as long as someone tells us it will help whatever we feel is currently wrong.
Really do love the portable Dialysis Machine it's going to be a game changer. Is his company public or taking private funding?
Regarding the FDA even earlier in my career I was a Chemist for an injection contract manufacturing site. I can't say I agree with all regulations but I will say this. Some of the products that are given out in the millions every year have risks of mercury, cyanide, even LSD. These are just a few products used to formulate or by products from the formulation that has to be removed from the finished produce. Even how things are stored once packaged is such a huge part of the quality of the product. The chemicals degrade at different tempuratures or like Johnson and Johnson found out with their Tylenol plant years ago... the new pallets treated with pesticides when stored in their warehouse was leaching the pesticide into tylenol. It took the FDA showing up twice to get them to fix it. The second time they showed up with 30 some inspectors and locked the plant down for a month... then they ultimately shut the plant down. I had moved from a Chemist to an auditor by this point which is the only reason I really remember it but if you look about about tylenol recalls in the last 10 years or so you will find it.
So long story short. I rather see the FDA get more staff and develop ways to be efficient in their oversight than to limit the oversight. The US public is a fix me now society which is part of the reason we have the opioid epidemic. We will pretty much take any pill or any shot as long as someone tells us it will help whatever we feel is currently wrong.
Really do love the portable Dialysis Machine it's going to be a game changer. Is his company public or taking private funding?
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