Propellers in Medical Devices
xanatos
Posts: 1,120
Are props certified or certifiable for use in medical devices? I have a project which seems to call out for a prop, but before I move ahead, I want to be sure of this.
Thanks!
Thanks!
Comments
We have a major customer using the Propeller in a medical application, but it is a Class II device (non life-sustaining) according to the FDA rules.
If you want to submit a ticket at support.parallaxsemiconductor.com and get connected with an FAE for your project we could collaborate more closely on the issue.
Ken Gracey
The application's BASIC function can run on a stamp , but I want a GUI on a small LCD/OLED touch screen to make it incredibly user-friendly, plus a feedback loop to monitor certain parameters of the therapeutic process as they are affecting the patient's body... so I need to get to prop expert level fast...
I'll keep you posted with all I can release as I go. I'm hoping that these will make certification and be big sellers for us all!
Dave
And y'all thought that this thread had died out!!!
Yes, the FDA has some issues for sure. However, as both an imaging systems specialist (and CRES) and parent of a child with autism, my personal feeling is the FDA has come down on the conservative side of safety. Speed of approval is a function of manpower. Doesn't look like anyone is planning to approve a 50% increase in examiners and support personnel for them. Painful? Ask anyone about GMP, PGMP, Final GMP, 510K, MDDS, MQSA, etc. FDA was originally formed to provide for the public safety. Look at devices and incidents of late nineteenth and early twentieth century. The FDA needs much improvement, but going back to far could be very bad medicine indeed.
You could not believe the range of quackery that we have seen proposed to parents for use on their children. One device in particular, looked like a clone of a 19th century electroshock machine which my wife and I dubbed the "George Foreman Lean, Mean, Shocking machine". Our developmental Ped just shook his head when we showed him this one. Probably had to go change his drawers after we left. Many more get by for more or less time before they come to the attention of the FDA. Even well intentioned and approved devices have recalls. One OEM had a recall over the image being mis-labeled due to a software problem. Does not sound like much until you realize that information will be used by a radiologist to guide/inform a surgeons decisions. Someone has to manage these recalls. Again public safety.
Yeah, regulation is expensive, add to that that the cost of the design, parts stocking, system testing, clinical trials, marketing, all add to the expense. Many of us joke about the $50.00 aspirin on your hospital bill. Here it isn't so different. For $8.00 worth of parts in the worst case, I can rebuild an AMX tube rotor board; or pay $650.00 from a third party supplier, or over $1000.00 from GE. All the product costs have to be made up somewhere. As to being behind the curve, the typical development cycle runs 2-5 years. The only thing I remember as worse was in military electronics systems.
I'm not sure about how this might apply to a propeller app, but I suspect there would be similar rules.
Actually there are already a number of laptop based systems, Caldwells EEG product is one we have had for some time. It can be mobile too, though not as easily as the Ipad/ipod/android apps. In any event, the biggest problem is NOT the FDA. Pain, yeah, but still doable with a few iterations like any other product. Just additional specifications to be met for the client to meet FDA requirements. Where I would be concerned about a "mobile app" would be the clients exposure regarding ePHI. I have told just about every salesperson and peddler of electronic devices here that if they want the edge, they should design their devices so that the device could use remote SAN for actual ePHI and not have it permanently in storage on the device itself; plenty of ways to tie the remote demographics to the data in the device. Am I worried that a Venue 40 ultrasound would grow legs? Sure, but the replacement cost of the device is a fraction of the exposure if the same device walks out the door with a tone of ePHI on it. If the information is not encrypted and few are, you will get hammered under HIPAA and HITEC, and if it is encrypted, you will still get less hammered. If it does not exist on the device you will not get hammered. Sucks, but that is how I understand the consequence of HITEC.
The reason I write this rant is simple; some of us are or will eventually design some form of medical device. The propeller is just to ideal for some of the things we will need in a device. The current devices will not be modified due to the cost of going through the approval process again for little or no gain to the bottom line of the customer and so will probably not happen. If we plan for the safe handling of ePHI, we will be way ahead of the competition. And personally as an imaging equipment specialist, I would be very much leaning to the higher security device at decision time all else being equal.
Frank