Full disclosure: I do work on medical devices (although they're very different).

I'm all for bashing corporations and a lot of high-volume medical devices are outrageously priced, but without more details, this statement is entirely devoid of meaning and can be misleading:

> Consider the nebulizer, a device used to transform a liquid into a mist so that patients suffering from asthma or similar maladies can inhale vital medicines. Commercial systems can cost hundreds of dollars. But Gómez-Márquez has designed a little device that uses standard tubing, a $7-to-$10 filter and a bicycle pump for power. It does the job as well as high-end alternatives — so well that those familiar with the gadgetry now question if the American health system might take a closer look at little devices.

It projects the idea that a nebulator is something really simple and it's the big mean Big Pharma and its friends that are charging huge fees for something that, look, is just standard tubing and a 10$ filter and a bicycle pump. It's a simple matter of engineering, right? And all that paperwork and FDA legislation and crap! Surely that stifles innovation -- I mean, a single guy, working in his garage, will never be able to afford all that legal counseling and meaningless tests for compliance to useless standards.

Yeah, but:

1. Is the inventor sure that no harmful particles are scraped from the standard tubing? That no harmful materials make it into the airways through it?

2. Is everything well-secured in place so that incorrect use doesn't result in a part becoming dislodged and aspirated or swallowed? Does he have relevant tests that prove that, under controlled conditions, which one could consult?

3. I see a breadboard in there so I presume some electronics is involved. Is it safe against inadvertent use? Is it easy to recycle (read: RoHS-compliant), or is this going to be around for centuries after the humans are dead, adding to the many tons of waste that we've left up to the mutant turtles to deal with?

4. Can the components be cleaned without causing surface degradation and the such, resulting in something similar to #1?

5. Speaking of #4: how's the instruction sheet doing? Are the directions clear enough? Is every component well-labeled, and ensuring that no one ends up in hospital because they weren't operating their nebulator correctly?

There are gazillions of rules, regulations, requirements and standards that go into the development of medical devices. Respecting them all takes time, a lot of patience and a lot of money. And while I share every other programmer's disdain for bureaucracy, none of this is worthless.

That crazy rule about how you have to ABSOLUTELY have paperwork that proves you carefully considered what symbol to use to indicate how some component is going to be used and why you decided for that particular one isn't there because some white collar imbecile had a rule quota to meet for the week and invented another one. It's there because someone, somewhere, misread a symbol and choked himself or took an overdose, and now we want to make sure that 1. that doesn't happen again and 2. that if it does happen again, we have written records we can draw upon for lessons about how make sure it has even less chance of happening again.

Oh, and that stuff about why you can't use some-obscure-substance that factories in China use in tubing or bike pumps? It's not there because Corporations want to control everything. It's because there are probably like 5,000 people who are allergic to it and standard filters can't screen its dust below a certain humidity level. So 5,000 people are going to be fine as long as they don't use your product in California, or outside their grandfather's barn or whatever -- but they're going to die as soon as they do.

It's crazy and frustrating and boring sometimes but it's human lives that are at stake. It requires this kind of extraordinary measures.

All these questions are largely irrelevant when you're coming up with a DIY solution just for yourself and a dozen people. If the chances of harming someone through incorrect use (or even correct use) are 1 in 1,000 -- huge for a mass-marketed medical device! -- you could sell it for years from your garage and not encounter a single problem. But when we get to the grand dreams of making this available worldwide, it's irresponsible not to factor in these boring problems.