With 3-D printed bone. Faster, please. Why should it wait five years for human trials?
3 thoughts on “Fixing Fractures”
To give a sense for how this works with the current FDA system, a company I know will need 3 years and $ 6 million, minimum, to get 510K approval for a plastic component in a bone screw. And this is using material already approved for in-body use, with no moving parts or drug element, in a well-established medical procedure.
So 5 years to get to human trials for this newer therapy seems optimistic. And then figure at least another 2-3 before approval.
Not knowing anything else about it I’d SWAG the cost at $20 million before human trials start, and another $100 million minimum for approval.
With the “democratization” of 3D printing, and the rise of the body-modification community, hopefully this is one of those treatments that “mad scientist”/”rogue” doctors begin to test on themselves rather than wait for full FDA approval for trials.
I’m still not clear from the article how this helps fractures heal, however. Most fractures that I’m aware of (note: not a doctor) consist of two pieces that have matching ends. The current treatment is to use a splint or screw or other method to bring those pieces back in contact and allow the body to rebuild the gap between the pieces.
How does 3D printing aid in this? If I snap my femur, why would I want to put a piece of artificial bone in between the pieces to heal it? Wouldn’t that make one of my legs slightly longer than the other?
And if the material is designed to mimic bone and/or be put in place of bone, it doesn’t sound like something you would want to use as a splint between the two broken pieces; it would make my femur larger in that spot.
Because of that lack of understanding on how this is designed to work, I also don’t understand how 3D printing is useful or necessary; it seems like a doctor would just shave a chunk off of a block of material and slip it in between the ends of the fracture, without much need for the custom shaping afforded by rapid prototyping.
For cleft palates and other major reconstruction, I can see the aid of 3D printing, but not for simple fractures.
” Most fractures that I’m aware of (note: not a doctor) consist of two pieces that have matching ends. ”
Crushing fractures leave even large bones in too many pieces to heal. Bones embrittled by osteoporosis are often too weak to heal on their own, and can collapse after the fracture seems to have healed. The advantage of 3d printing is that the insert can be custom-made for each individual. Human bones grow under the unique strains each individual puts on them, and each is unique. The 3d printing also allows building in the porosity mentioned, which allows growing bone to integrate withe the insert by growth rather than by pins or other attaching systems that can break, or not bond to bone.
To give a sense for how this works with the current FDA system, a company I know will need 3 years and $ 6 million, minimum, to get 510K approval for a plastic component in a bone screw. And this is using material already approved for in-body use, with no moving parts or drug element, in a well-established medical procedure.
So 5 years to get to human trials for this newer therapy seems optimistic. And then figure at least another 2-3 before approval.
Not knowing anything else about it I’d SWAG the cost at $20 million before human trials start, and another $100 million minimum for approval.
With the “democratization” of 3D printing, and the rise of the body-modification community, hopefully this is one of those treatments that “mad scientist”/”rogue” doctors begin to test on themselves rather than wait for full FDA approval for trials.
I’m still not clear from the article how this helps fractures heal, however. Most fractures that I’m aware of (note: not a doctor) consist of two pieces that have matching ends. The current treatment is to use a splint or screw or other method to bring those pieces back in contact and allow the body to rebuild the gap between the pieces.
How does 3D printing aid in this? If I snap my femur, why would I want to put a piece of artificial bone in between the pieces to heal it? Wouldn’t that make one of my legs slightly longer than the other?
And if the material is designed to mimic bone and/or be put in place of bone, it doesn’t sound like something you would want to use as a splint between the two broken pieces; it would make my femur larger in that spot.
Because of that lack of understanding on how this is designed to work, I also don’t understand how 3D printing is useful or necessary; it seems like a doctor would just shave a chunk off of a block of material and slip it in between the ends of the fracture, without much need for the custom shaping afforded by rapid prototyping.
For cleft palates and other major reconstruction, I can see the aid of 3D printing, but not for simple fractures.
” Most fractures that I’m aware of (note: not a doctor) consist of two pieces that have matching ends. ”
Crushing fractures leave even large bones in too many pieces to heal. Bones embrittled by osteoporosis are often too weak to heal on their own, and can collapse after the fracture seems to have healed. The advantage of 3d printing is that the insert can be custom-made for each individual. Human bones grow under the unique strains each individual puts on them, and each is unique. The 3d printing also allows building in the porosity mentioned, which allows growing bone to integrate withe the insert by growth rather than by pins or other attaching systems that can break, or not bond to bone.