

The next generation of medical tools may be home brewed - steven
https://medium.com/backchannel/the-next-generation-of-medical-tools-may-be-home-brewed-830a753a1c58

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pdxgene
I agree with the skeptical comments leveled here, and am certainly cognizant
of the (mostly necessary) regulatory overhead that goes along with the
creation of medical devices.

Everything is on a spectrum, though, and there are plenty of opportunities for
genuine disruption. The e-nable project that's putting prosthetic hands within
financial reach (ugh, sorry, no pun intended) by bringing costs down via
3D-print-at-home is pretty impressive.

From a long-view-technology perspective, I can foresee a day when the
"replication room" \-- that makes parts and supplies on demand using additive
manufacturing -- is as common to hospitals as the copy room. That would
certainly bring down costs.

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cratermoon
Medical tools have been home-brewed for decades. The first artificial arteries
for cardiac bypass surgery made of Dacron sewn at home on a standard sewing
machine. [https://www.bcm.edu/about-us/debakey-museum/legacy-of-
excell...](https://www.bcm.edu/about-us/debakey-museum/legacy-of-
excellence/contributions-to-medicine)

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weland
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.

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ArekDymalski
Thanks for an insightful comment. Do you know if similar restrictions and
requirements apply to the medical software? Reading your comment reminded me
about this story: [https://medium.com/tragic-design/how-bad-ux-killed-jenny-
ef9...](https://medium.com/tragic-design/how-bad-ux-killed-jenny-ef915419879e)

