Comment Overly Simplistic (Score 1) 128
Looks like there were at least a couple of other medical device developers in this discussion, but for the rest of the readers here suggesting "open source", it's just not as simple of a solution as that. There are no standard hardware or software platforms that could be used across the board for medical devices, or should there be. The hardware and software needs of a glucometer are completely separate of those for a CAT scanner. The term "Medical Device" is much too broad and applies to many disparate systems to think in that fashion.
On another note, it is worthwhile to remember than some of the medical devices that are in use in the field (and generate these complaints) are probably quite old. Yes, there have been failures associated with software, hardware, or human factors issues, however complaints associated with devices that have been in constant use in the field for 20+ years comprise at least a portion of this. Have these devices met their goal of reliability? Absolutely. Do these devices meet the current regulator's expectations for new devices (reference IEC 60601 series for basic safety, EMC, software design, usability, home use, etc)? Not necessarily. Is the expectation that medical device companies recall these devices so that hospitals are forced to buy a newer updated version of these devices? Risk analysis (see ISO 14971) wouldn't necessarily agree with this (depending on the failure modes) as an instant recall or end of support or not selling the consumable (if there is one) would result in the hospital's (or long-term care facility, or home user) inability to use the device until it can be replaced. Yeah, there could be ways to avoid or minimize this, but I'd be willing to wager there are millions of "old" devices (20+ years old) in active use in the field and there would be a definite impact to cost and a disruption to many users if this were the approach.
Final thought: Not surprised the idea of Linux comes up on Slashdot as a solution. Linux has been discussed by many development teams that I've been a part of. However, the 'ol Validation question always comes up. Not that Linux has never or will never be used on a device, but the cost of validating it becomes a much larger question (and cost) than either designing your own simple OS built specifically for its purpose, or purchasing an off-the-shelf "validated" OS. Many devices don't even really need an OS due to the device's simplicity (in the sense of what the average Slashdotter would think of as an OS), so the idea of Linux for everything is a bit off. Note: When I say Validation, I mean meeting the expectation of the FDA 21 CFR 820 as well as ISO 13485. There are more specific requirements depending on the device type/classification, but those are the starting points.
On another note, it is worthwhile to remember than some of the medical devices that are in use in the field (and generate these complaints) are probably quite old. Yes, there have been failures associated with software, hardware, or human factors issues, however complaints associated with devices that have been in constant use in the field for 20+ years comprise at least a portion of this. Have these devices met their goal of reliability? Absolutely. Do these devices meet the current regulator's expectations for new devices (reference IEC 60601 series for basic safety, EMC, software design, usability, home use, etc)? Not necessarily. Is the expectation that medical device companies recall these devices so that hospitals are forced to buy a newer updated version of these devices? Risk analysis (see ISO 14971) wouldn't necessarily agree with this (depending on the failure modes) as an instant recall or end of support or not selling the consumable (if there is one) would result in the hospital's (or long-term care facility, or home user) inability to use the device until it can be replaced. Yeah, there could be ways to avoid or minimize this, but I'd be willing to wager there are millions of "old" devices (20+ years old) in active use in the field and there would be a definite impact to cost and a disruption to many users if this were the approach.
Final thought: Not surprised the idea of Linux comes up on Slashdot as a solution. Linux has been discussed by many development teams that I've been a part of. However, the 'ol Validation question always comes up. Not that Linux has never or will never be used on a device, but the cost of validating it becomes a much larger question (and cost) than either designing your own simple OS built specifically for its purpose, or purchasing an off-the-shelf "validated" OS. Many devices don't even really need an OS due to the device's simplicity (in the sense of what the average Slashdotter would think of as an OS), so the idea of Linux for everything is a bit off. Note: When I say Validation, I mean meeting the expectation of the FDA 21 CFR 820 as well as ISO 13485. There are more specific requirements depending on the device type/classification, but those are the starting points.
