3 ms·

Would a US company have enough financial incentive to front the cost of FDA approval in the US? I'm guessing it is expensive to jump through all of the hoops.

Would a US company have enough financial incentive to front the cost of FDA approval in the US? I'm guessing it is expensive to jump through all of the hoops. Without a patent, why would a company pay for this?

deleted 3y ago
[deleted]
adam_arthur 3y ago
Usually with medical innovations, the idea is patented and the product is sold well above cost of production. e.g. this $5 device could be sold for $100 each... large profit margin. If there is no patent, and no in-place infrastructure already producing the device, then yes, it's unlikely to see rapid scale up by manufacturers. Though if it's really that cheap to produce, I'm sure it will come onto market in some form (whether through charitable foundations or otherwise). All assuming that the device is actually as efficacious as the study implies (with a small sample size).
zdragnar 3y ago
As a non-invasive diagnostic equipment, let us say it is akin to a pregnancy test, or a creatine in urine test. That puts it in Class 1, and may be exempt from a lot of the hoops a medicine would go through. There are a little over 6,100 hospitals in the US at any given time. That means roughly $30,000 in cost to produce to provide every hospital with one, using the cheapest of cheapest parts. Presumably, you'd want higher end components and things like a shell casing to protect from spills, static, etc. maybe the cost is $120k. You could sell these for $100 each, and maybe make $5 million. That's a decent amount of money for a tiny business, but a pittance for even a small business that needs to pay salaries, lawyers, etc. In reality, they'd probably go for much more- let's say $10k each, plus $100 for each test strip. Still easily in range for the budget of most US hospitals. The real question is, if breast cancer is suspected, is this test any better than imaging using equipment the hospital already has? Can it detect all types, or the degree that it is progressing? I suspect the utility in a clinical setting is not high enough to really change clinical practices any.
- aj7 3y ago
  Huh? The electronics is cheap and trivial. All the science is in those strips.

deleted 3y ago

[deleted]

adam_arthur 3y ago

Usually with medical innovations, the idea is patented and the product is sold well above cost of production. e.g. this $5 device could be sold for $100 each... large profit margin. If there is no patent, and no in-place infrastructure already producing the device, then yes, it's unlikely to see rapid scale up by manufacturers. Though if it's really that cheap to produce, I'm sure it will come onto market in some form (whether through charitable foundations or otherwise). All assuming that the device is actually as efficacious as the study implies (with a small sample size).

zdragnar 3y ago

As a non-invasive diagnostic equipment, let us say it is akin to a pregnancy test, or a creatine in urine test. That puts it in Class 1, and may be exempt from a lot of the hoops a medicine would go through. There are a little over 6,100 hospitals in the US at any given time. That means roughly $30,000 in cost to produce to provide every hospital with one, using the cheapest of cheapest parts. Presumably, you'd want higher end components and things like a shell casing to protect from spills, static, etc. maybe the cost is $120k. You could sell these for $100 each, and maybe make $5 million. That's a decent amount of money for a tiny business, but a pittance for even a small business that needs to pay salaries, lawyers, etc. In reality, they'd probably go for much more- let's say $10k each, plus $100 for each test strip. Still easily in range for the budget of most US hospitals. The real question is, if breast cancer is suspected, is this test any better than imaging using equipment the hospital already has? Can it detect all types, or the degree that it is progressing? I suspect the utility in a clinical setting is not high enough to really change clinical practices any.

aj7 3y ago
Huh? The electronics is cheap and trivial. All the science is in those strips.