[lisper]

I can tell you from firsthand experience (as an investor) that the gist of this article is 100% correct: there are significant barriers to bringing a new medical device to market that have nothing to do with the merits of the product or the supply chain, but are quite simply pure protectionism for the established players. If anyone wants details, contact me privately.

[seehafer]

As a product guy who works in medical device startups, I can reinforce this statement. Even if you find a way to exit the supply game by developing something that doctors have some choice over because they believe it has an impact on patient safety/outcomes, you still run into many of the issues detailed in the article. Here's just one: if you develop something that is truly revolutionary, you'll play hell trying to get paid for it, because the payers (private insurance and Medicare for the most part) only pay out for certain codes. It takes years to get a new code.