PVS-Studio: The Additional Insurance of the Medical Software

https://medium.com/@Coder_HarryLee/pvs-studio-the-additional-insurance-of-the-medical-software-879ef1538828

by DmitryNovikov • 8 years ago

1 1 8 years ago

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... - 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...

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://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... 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...

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.

PVS-Studio: The Additional Insurance of the Medical Software

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