"Let's say the regulatory costs add up to $100,000,000 and the valve has a marginal cost of $1.00 to make and distribute." That's two numbers relating to the c

"Let's say the regulatory costs add up to $100,000,000 and the valve has a marginal cost of $1.00 to make and distribute." That's two numbers relating to the cost of production. The second is the cost that a 3D printer doing one off prints actually costs (it's in the article, as a rough estimate.) The first number is a deliberately chosen "insane" example figure to show the absurdity of an $11,000 part. A medical test n license for a single part of a device does not cost anything like $100M. Now as to the market for these things - the third number. Nearly 8,000 people have died so far. I can't be arsed to extrapolate further but I recall reading that these are single use devices.