Actually, thats not true. I have experience with telemed having worked on a telemed project for the last 4.5 years. Telemed actually decreases response time and improves costs. One group that I'm familiar with, makes it a requirement for their doctors to check the telemed case queue when they have down time. This particular clinic when from having a waiting list 4 months long to get an appointment, to now its typically less than 1 week. And telemed is responsible for this because the doctors can take and review cases when they have a few moments free, instead of the patients having to travel in to the clinic and occupy an exam room.
Kind of, not really. We are in a really weird position. Our device is a kiosk with metal brackets for hanging other devices on. At the root of it, we are a class I, but because we talk to class II and III (12-lead ECG) and because we shuttle data around, we are a class II. Although there is the risk the FDA could come back and say we are a class III given that we talk to a class III.
Sadly, your wrong. I work for a medical device manufacturer. The two big things that drive the cost of a device up are the FDA and lawyers. The amount of documentation we have to produce for the FDA is mind-numbing. We sent a hold box of paper when we submitted out 510k.
I can't make a single change in the code base without having a signed-off requirement. I can't fix a defect without having the defect entered as a bug, and then tracing that bug back to a requirement. All because of the FDA.
Some of this is good, and a good part of GMP, but a lot of it is overkill.
Thats not 100% true. You can get a 16 PIDs from FTDI for free and use their programmer tool to replace their PID with yours. I did this for a biomedical device manufacturer we purchase equipment from. You still have to use their VID, and it takes a tiny bit of work to make the FTDI serial driver work with the new PID but its entirely doable.
I can honestly tell you that you have no idea of what you are speaking. I work for a small medical device manufacture as a software architect/engineer. There are many reasons why a medical device is expensive. I'll enumerate the two that I have experience with. The first, and biggest is the FDA. We are a class 2 medical device, much like the piece of equipment mentioned in the article.
So what does this mean? It means reams and reams of paperwork. Not nearly as much paperwork his required for a class 2 as a class 3 (pace maker and other implantable devices) device, but still reams of paper. We sent almost a WHOLE box of paper to the FDA when we submitted our paperwork. If I had to add up the cost to produce the paperwork, given the cost of lawyers, and staff time, my guess would be >$250k. Thats just the initial cost. We now have to get ready for an FDA compliance audit in the next few months. We have also have to overhaul how we develop the software. We have to be able to trace every line of code back to reams of paperwork, that adds an additional burden to the bottom line.
Next are lawyers. We spent a TON of money on lawyers while doing our FDA 510K. Competent lawyers who are also knowledgable about the FDA 510K process are NOT cheap. ONE of the lawyers we used cost $600/hr.
You also have to remember that the medical market is quiet limited. How is a small medical device company supposed to survive if they sell the device for a couple of hundred dollars into a very limited market?
When you see our product, you might be tempted to think $5000? I'm not paying that much for a metal frame, a hardened PC w/ a touch screen and some software. Its not worth that much. And when you do, I want you to tell that to me personally, to my face. I also want you to tell me that my family doesn't deserve to eat.
This is from an email from Jessie Off on the TS-7200 mailing list:
We don't have the bandwidth for that so our web site is pretty much down right now.
FWIW, we're not being limited by the TS-7200 CPU or RAM. Only 2% of the CPU is actually being utilized currently. I have Apache configured for up to 30 maximum simultaneous connections (of which all 30 are full) and we're satisfying about 10 page loads per second.
We also got linked from http://www.theinquirer.net/?article=25321
which has been generating a lot of hits all morning so we weren't really in a position to receive the "slashdot effect"//Jesse Off
Actually, according to Jessie Off (or was it Eddie Dawydiuk) from Technologic Systems, there website does indeed run on a TS-7200. Which works quiet well to serve there site, except when the slashdot hoards hit.
I've got you beat. . . In all the projects I've worked on, I've always found something good to salvage, be it good code, good artitecture, good design, or good implimentation. . . On the project I'm now; it's the people. And I hate people:-)
try working on a VB3 project thats been migrated from vb3 to vb4, to vb5, to vb6. And along the way, the code hasn't been entirely updated. . . Man, you have to love bad code, keeps me employeed:-)
I don't block ads anymore. With the exception of the extreamly annoying ones. I don't care to have something flash constantly on the screen. Are they trying to make me have a seizure?
I've driven on the section of road this happened on 20-30 times. That section of road, hell that whole highway from the time you pass Potter's Marsh to when you enter the main drag in Seward, Ak is hard enough to drive without a cellphone glued to your ear; or worse yet a dvd taking all your up attention.
I think the 10 years per life the prosecutor wants is appropriate.
Slashdot Mirror
Actually, thats not true. I have experience with telemed having worked on a telemed project for the last 4.5 years. Telemed actually decreases response time and improves costs. One group that I'm familiar with, makes it a requirement for their doctors to check the telemed case queue when they have down time. This particular clinic when from having a waiting list 4 months long to get an appointment, to now its typically less than 1 week. And telemed is responsible for this because the doctors can take and review cases when they have a few moments free, instead of the patients having to travel in to the clinic and occupy an exam room.
Kind of, not really. We are in a really weird position. Our device is a kiosk with metal brackets for hanging other devices on. At the root of it, we are a class I, but because we talk to class II and III (12-lead ECG) and because we shuttle data around, we are a class II. Although there is the risk the FDA could come back and say we are a class III given that we talk to a class III.
:) http://afhcan.org/cart.aspx
The project is a lot of fun in spite of the FDA
Sadly, your wrong. I work for a medical device manufacturer. The two big things that drive the cost of a device up are the FDA and lawyers. The amount of documentation we have to produce for the FDA is mind-numbing. We sent a hold box of paper when we submitted out 510k. I can't make a single change in the code base without having a signed-off requirement. I can't fix a defect without having the defect entered as a bug, and then tracing that bug back to a requirement. All because of the FDA. Some of this is good, and a good part of GMP, but a lot of it is overkill.
Thats not 100% true. You can get a 16 PIDs from FTDI for free and use their programmer tool to replace their PID with yours. I did this for a biomedical device manufacturer we purchase equipment from. You still have to use their VID, and it takes a tiny bit of work to make the FTDI serial driver work with the new PID but its entirely doable.
I can honestly tell you that you have no idea of what you are speaking. I work for a small medical device manufacture as a software architect/engineer. There are many reasons why a medical device is expensive. I'll enumerate the two that I have experience with. The first, and biggest is the FDA. We are a class 2 medical device, much like the piece of equipment mentioned in the article. So what does this mean? It means reams and reams of paperwork. Not nearly as much paperwork his required for a class 2 as a class 3 (pace maker and other implantable devices) device, but still reams of paper. We sent almost a WHOLE box of paper to the FDA when we submitted our paperwork. If I had to add up the cost to produce the paperwork, given the cost of lawyers, and staff time, my guess would be >$250k. Thats just the initial cost. We now have to get ready for an FDA compliance audit in the next few months. We have also have to overhaul how we develop the software. We have to be able to trace every line of code back to reams of paperwork, that adds an additional burden to the bottom line. Next are lawyers. We spent a TON of money on lawyers while doing our FDA 510K. Competent lawyers who are also knowledgable about the FDA 510K process are NOT cheap. ONE of the lawyers we used cost $600/hr. You also have to remember that the medical market is quiet limited. How is a small medical device company supposed to survive if they sell the device for a couple of hundred dollars into a very limited market? When you see our product, you might be tempted to think $5000? I'm not paying that much for a metal frame, a hardened PC w/ a touch screen and some software. Its not worth that much. And when you do, I want you to tell that to me personally, to my face. I also want you to tell me that my family doesn't deserve to eat.
This is from an email from Jessie Off on the TS-7200 mailing list: We don't have the bandwidth for that so our web site is pretty much down right now. FWIW, we're not being limited by the TS-7200 CPU or RAM. Only 2% of the CPU is actually being utilized currently. I have Apache configured for up to 30 maximum simultaneous connections (of which all 30 are full) and we're satisfying about 10 page loads per second. We also got linked from http://www.theinquirer.net/?article=25321 which has been generating a lot of hits all morning so we weren't really in a position to receive the "slashdot effect" //Jesse Off
Actually, according to Jessie Off (or was it Eddie Dawydiuk) from Technologic Systems, there website does indeed run on a TS-7200. Which works quiet well to serve there site, except when the slashdot hoards hit.
I'm glad I viewed the write up last night. . .
How long before this is hacked ala the digital "disposable" cameras?
This one is indeed real. http://news.com.com/Intel+to+stop+using+open-sourc e+license/2100-7344_3-5648518.html
I've got you beat. . . In all the projects I've worked on, I've always found something good to salvage, be it good code, good artitecture, good design, or good implimentation. . . On the project I'm now; it's the people. And I hate people :-)
try working on a VB3 project thats been migrated from vb3 to vb4, to vb5, to vb6. And along the way, the code hasn't been entirely updated. . . Man, you have to love bad code, keeps me employeed :-)
I don't block ads anymore. With the exception of the extreamly annoying ones. I don't care to have something flash constantly on the screen. Are they trying to make me have a seizure?
I've driven on the section of road this happened on 20-30 times. That section of road, hell that whole highway from the time you pass Potter's Marsh to when you enter the main drag in Seward, Ak is hard enough to drive without a cellphone glued to your ear; or worse yet a dvd taking all your up attention.
I think the 10 years per life the prosecutor wants is appropriate.