Wednesday, December 26, 2007

Medical Device Myth Busters: Can Linux meet the cut with FDA?

[Click on Post Title for Link to External Article]

Disclaimer: I am not a Linux hater. However, like Will Smith in iRobot, I am allergic to "BS".

The credit goes to slashdot for showing me where the original link is:

[This is an interesting project. Nothing against them either. Ah, to enter the magical world of incessant disclaimers..]

Linux users usually piss me off with something or the other. This time, it is by spreading this vague notion that the FDA would like to side with devices based on Microsoft (who else?) For all the brouhaha, Linux adoption has been slower than that of handicapped snails....not because Bill Gates and Steve Balmer double up as "thugs of the night" going around slashing electrical wires and smashing monitors wherever Linux is used....

It is mostly because people who work with Linux have this ad obnoxium problem with using Linux for what it is. Instead, they always have to somehow make it a Windows problem...always fighting the "man".

A very simple "Google" search produced "Merlin"

-a device that is used in CRM.

(That's a real medical device by the way. I am constantly nagged by people posting monitors as "medical devices just because they will be used in hospitals. I don't have a problem with someone marketing their product as strong and ready for use in hospital environments - but equipments and devices that directly aid a person's treatment are different...a helmet helps you keep your head working(class I device), a monitor helps the doctor(usually does not require approval). A doctor who drops a monitor is... here is a link to this ignominous monitor: )

'Tis the season to rant, but Merlin seems to have done fine with FDA approvals. And I am sure if I dug deeper, I would find enough software and OS based on Linux that are probably being routinely used in medical devices.

Validated Software and Operating Systems

It is not that there will be a witch-hunt when devices fail, but medical devices need to be "validated" to be "approved". So, a disciplined development approach is needed. While it may be great to think of downloading an entire operating system and making whatever the heck we want of it, a disciplined approach is needed for use in medical devices.

Imagine lying on the OR table while the OS or software springs a little "surprise". No one would like that now, would they?

Validated Linux OS, Software, and Unix Software are commonly used in medical devices. Here is another reinforcing link:

Here is a paragraph stolen directly from that link:

"In short terms, medical device manufacturers can usesoftware from third parties as long as they validatethat the software behave as intended in the medicaldevice. The degree of validation required for a packageis relative to the confidence that such package mayhave developed in the industry."

What will it take, anyway?

In short here are the ways in which Linux can see increased adoption in the medical devices industry:

1. No negative, Windows is the all consuming evil - marketing, please (and that's not just for medical devices). Thing is, it always feels great to think all corporations are out to get your goat, but so is every honest-to-salt business man. You have to compete. It's not Microsoft's fault that at some point they were really good at it. Linux developers, for the most part still haven't left their teenage rage behind..

Practicing physicians and surgeons do not care about your phantom wars.

2. Adoption breeds on adoption. There are Linux based devices out there. Use these as examples when you plan to design software for your medical devices and definitely reinforce these when seeking approvals from the FDA. Learn and understand how medical device validation works. It is not unlike software validation in general, its just more procedural. (After all, you don't want your CEO in prison for your coding or commenting shortcomings, now do you?)

That's it! Get set go! And don't blame the FDA for poor Linux adoption. (That note is for our anonymous friend at Slashdot who tries to peg the wrong reason for the "extremely rare" adoption of Linux for medical devices). There are several hundred other real problems among which you can pick and choose - to blame the FDA :).

Happy Developing!

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