Brigham Buhler

Yeah. And then there's all sorts of things like in medical, in surgical, you know, people make the assumption that if something came through the FDA, that it's safe. Even bigger than pharmaceutical, 92% of the products in the operating room never had a human safety study. In the operating room.

Yeah. And then there's all sorts of things like in medical, in surgical, you know, people make the assumption that if something came through the FDA, that it's safe. Even bigger than pharmaceutical, 92% of the products in the operating room never had a human safety study. In the operating room.

Yeah. And then there's all sorts of things like in medical, in surgical, you know, people make the assumption that if something came through the FDA, that it's safe. Even bigger than pharmaceutical, 92% of the products in the operating room never had a human safety study. In the operating room.

So any implant, any knee, any shoulder, any joint, scopes that go into your body, anything, pacemakers, all of it, most of that has never had a human safety study, which sounds mind-boggling. The FDA couldn't get to all these things, so they created an exemption in the 80s called the 510K approval process, which says if you can find a like product in the market today, we'll give you a daisy chain.

So any implant, any knee, any shoulder, any joint, scopes that go into your body, anything, pacemakers, all of it, most of that has never had a human safety study, which sounds mind-boggling. The FDA couldn't get to all these things, so they created an exemption in the 80s called the 510K approval process, which says if you can find a like product in the market today, we'll give you a daisy chain.

So any implant, any knee, any shoulder, any joint, scopes that go into your body, anything, pacemakers, all of it, most of that has never had a human safety study, which sounds mind-boggling. The FDA couldn't get to all these things, so they created an exemption in the 80s called the 510K approval process, which says if you can find a like product in the market today, we'll give you a daisy chain.

So like take a ring rotary phone at your house as a kid, like in the early 80s, you know, probably before even your time. But like that was a phone. If that phone had an FDA approval and you grandfather in a cell phone and then you grandfather in an iPhone and now you got an iPhone 17 or whatever we're at with AI. The study was done in 1982 and now we're 30 generations away with a product.

So like take a ring rotary phone at your house as a kid, like in the early 80s, you know, probably before even your time. But like that was a phone. If that phone had an FDA approval and you grandfather in a cell phone and then you grandfather in an iPhone and now you got an iPhone 17 or whatever we're at with AI. The study was done in 1982 and now we're 30 generations away with a product.

So like take a ring rotary phone at your house as a kid, like in the early 80s, you know, probably before even your time. But like that was a phone. If that phone had an FDA approval and you grandfather in a cell phone and then you grandfather in an iPhone and now you got an iPhone 17 or whatever we're at with AI. The study was done in 1982 and now we're 30 generations away with a product.

What are the...

What are the...

What are the...

elements of that are in the operating room that are the highest concern for you uh i mean obviously anything that's implanted in the body because there's some implants that are better than others oh for sure there always are and then there's like there there were in like i can give you example in women's health they had a device that was put into the uterus to stop pregnancy and that device what they didn't ever do was a study on how to take it out and it was absorbing into the uterine lining so

elements of that are in the operating room that are the highest concern for you uh i mean obviously anything that's implanted in the body because there's some implants that are better than others oh for sure there always are and then there's like there there were in like i can give you example in women's health they had a device that was put into the uterus to stop pregnancy and that device what they didn't ever do was a study on how to take it out and it was absorbing into the uterine lining so

elements of that are in the operating room that are the highest concern for you uh i mean obviously anything that's implanted in the body because there's some implants that are better than others oh for sure there always are and then there's like there there were in like i can give you example in women's health they had a device that was put into the uterus to stop pregnancy and that device what they didn't ever do was a study on how to take it out and it was absorbing into the uterine lining so

So when a woman... Copper IUD? Yeah, not a copper IUD. This preceded all that. An e-sure procedure, and when women were deciding to take these various things out, it absorbed into their uterus, and they had to take out the whole uterus. People were having all sorts of side effects. There's a big class action lawsuit. There were... literally like surgical procedures.

So when a woman... Copper IUD? Yeah, not a copper IUD. This preceded all that. An e-sure procedure, and when women were deciding to take these various things out, it absorbed into their uterus, and they had to take out the whole uterus. People were having all sorts of side effects. There's a big class action lawsuit. There were... literally like surgical procedures.

So when a woman... Copper IUD? Yeah, not a copper IUD. This preceded all that. An e-sure procedure, and when women were deciding to take these various things out, it absorbed into their uterus, and they had to take out the whole uterus. People were having all sorts of side effects. There's a big class action lawsuit. There were... literally like surgical procedures.

I'm in at crucial points in heart surgeries, even where they're using high def cameras. And when they would hit the ablation device, they never taste tested it with all the other equipment that's in the OR. So you're at a crucial part of a heart surgery. You go hit an ablation device to burn or cauterize a piece of a heart tissue or whatever and piece of anatomy you're working on.

I'm in at crucial points in heart surgeries, even where they're using high def cameras. And when they would hit the ablation device, they never taste tested it with all the other equipment that's in the OR. So you're at a crucial part of a heart surgery. You go hit an ablation device to burn or cauterize a piece of a heart tissue or whatever and piece of anatomy you're working on.