The fact that your have/had net downvotes for your comment demonstrates that consensus reality is not always reality. As an embedded medical devices engineer,

The fact that your have/had net downvotes for your comment demonstrates that consensus reality is not always reality. As an embedded medical devices engineer, I know you are exactly right. For safety-critical devices, control of the supply chain is beyond good practice, it's required by federal law, precisely so bad actors can't interfere with peoples' lives. The long list of requirements around approving a vendor are tiring and result in epic stories like the $500 toilet seat, etc., but they prevent stuff like this FTDI debacle from happening. You know it's going to be a toilet seat when the box arrives. The medical device industry is a massive cultural shift from the majority of the HN crowd (e.g. startups and cloud services). In the world of PCs and servers, disruption is, literally, the name of the game. In IEC62304 land though, everything has to be on the straight, narrow and predictable path. This is why medical devices are expensive, laggy and not very startup-compatible. The FDA's system is actually more secure than Europe's. Take that, socialized medicine! So it's not always wild and fun here in medical-land. It's like being a cop vs. a cowboy. You're not paid to sling your guns, but to de-escalate. But thank the conservative practices next time your elderly or congenitally defective family members found themselves in the hospital!