
PVS-Studio: The Additional Insurance of the Medical Software - DmitryNovikov
https://medium.com/@Coder_HarryLee/pvs-studio-the-additional-insurance-of-the-medical-software-879ef1538828
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spacestuff387
Static analysis tools can be used to reduce errors. Just as Software Dev,
Test, Bug tracking and Release processes are also good.

A step further is the FDA's MDR program - Medical Device Reporting -
[https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/def...](https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm)
\- where medical device manufacturers are required to report to the FDA when
there are problems with their devices. Also, users of medical devices
(doctors, hospitals, nurses, patients, etc) can file a report anytime. The FDA
then selectively investigates.

But sometimes the FDA is too slow, superbugs in Duodenum Scopes is a good
example: [https://www.reuters.com/article/us-usa-superbug-
fda/exclusiv...](https://www.reuters.com/article/us-usa-superbug-
fda/exclusive-fda-seeks-to-speed-updates-to-superbug-device-labels-
idUSKBN0LT00H20150225)

An analog to this problem is scientific researchers not publishing failed
studies. Or not publishing 100% of the raw data for successful studies for
further analysis (finding bias removing selective sampling errors, etc).
[https://blogs.scientificamerican.com/guest-blog/why-
scientis...](https://blogs.scientificamerican.com/guest-blog/why-scientists-
must-share-their-failures/)
[https://en.wikipedia.org/wiki/Open_science_data](https://en.wikipedia.org/wiki/Open_science_data)

Here's a new idea: every single product (software, hardware etc) has a way for
anyone to file bugs or design requests or upload videos of scenarios where the
design fails. The result would be rapidly accelerating cycles of product
feedback loops and with techs like 3D printing, mass customization of devices.

A concrete example is an endoscope:
[http://www.genesis.net.au/~ajs/projects/medical_physics/endo...](http://www.genesis.net.au/~ajs/projects/medical_physics/endoscopes/)
most are built to be held in the left hand as the right hand is reserved for
more dextrous work. But what about left handed people? They need a flipped
endoscopic design. Also, the button placements are for the size and spacing of
men's hands. What about women surgeons? The buttons are placed uncomfortably
far away. [https://www.amazon.com/Measure-Man-Woman-Factors-
Design/dp/0...](https://www.amazon.com/Measure-Man-Woman-Factors-
Design/dp/0471099554)

A website that collected feedback like this for endoscopes could be used to
make sub product lines for lefty's and button placements for smaller hands.
And accelerate product cycle times of feedback to new product in the market
from 24 months to 5 months.

