3 ms·

Size of market is a chicken and egg problem, if they were cheaper, the market could grow, and get more cheaper. Also FDA would only regulate for medical use, it

Size of market is a chicken and egg problem, if they were cheaper, the market could grow, and get more cheaper. Also FDA would only regulate for medical use, it could be sold for educational use to remove the regulations.

jes 11y ago
With respect, I think you're speculating here. For example, the FDA and other agencies are concerned with the effects of transmitting energy into the human body. Medical devices like ultrasound systems are not toys. I don't mean to be harsh at all, but with respect, I question your assertions here.
- grahar64 11y ago
  It would be interesting to see, I mean the argument is that my head phones don't need FDA approval and they can damage my hearing if I turn them up too loud. But some kind of limits would be important to ensure safety. And this post is a question because I don't know the answer, so I am just guessing (a lot). I hope someone with actual experience in getting FDA approval for a medical ultrasound machine actually reads it and answers, with how much it cost and what hoops they had to jump through.
  - ska 11y ago
    If my previous comment is not enough detail I'll happily expand.
  - jes 11y ago
    I have worked in the medical device industry building ultrasound systems for twenty years. In general, there are thousands of regulations that must be satisfied. Some specifications that must be met include ISO 13485, ISO 14971, IEC 60601 3rd Edition, IEC 62304, and probably ten more that I have forgotten about, such as RoHS, WEE, radiated emissions, etc. The systems I worked with involved multilayer (16 layers plus) circuit boards, custom ASICs, FPGAs, ARM SOCs, etc., mixed OS (e.g., Windows CE and WindRiver, etc.) The code base is large and complex, as you have not just ultrasound, but often, calculation packages of various kinds (cardiac, OB, etc.) These packages are expensive to develop and have to be carefully verified. If you're measuring the length of a fetal femur and translating the measured length to an estimated gestational age, you don't wish to be wrong. Same deal with cardiac output measurements, etc. Then there is the whole issue of transducers. It's a complex field, and you have to deal not only with materials (some of which contain RoHS regulated elements, such as lead), but also, dicing saws (to cut the piezo), matching layers, transmission lines (to send signals to / from the transducer and the ultrasound machine front end.) I'm not trying to be rude, or baffle you with a lot of jargon, it's just that my experience is that building a useful ultrasound machine is much more complex than it might appear from the outside of the industry, so to speak. Finally, I think building an iPhone is probably even more complex, but the incredible volume of sales tends to make amortizing the cost more palatable. I could be wrong, of course, and your comments are welcome.
    - grahar64 11y ago
      That is a great post. I quoted it in the post if that is cool and will read up on some those references. Do you think that a lot of that complexity would be reduced by opening it up to a wider development community through open source? How much open source, consumer electronics, were used? Did you source the transducers from another company, or make them in house? Cheers again for the comment.
      - jes 11y ago
        Thank you for your kind words. The post is necessarily incomplete; I don't think I can give you a full appreciation for all that is involved. And I don't wish to give the impression that ultrasound is necessarily more complex than other imaging modalities, such as MRI, PET, etc. I wouldn't rule out open source, and many open source tools are used in the engineering process (e.g., gcc, git, etc.) I don't know about including open source components in a commercial code base, though. The lawyers usually ran away screaming whenever we would suggest using any open-source code. Certainly the high-volume electronics industry makes components that are used in ultrasound systems. Some of the ARM SOCs, for example, and I suppose, some of the FPGAs, DSPs, etc. There are also a number of custom components, such as ASICs and combined analog-digital parts that show up in the so-called "front end." The companies I have worked for designed their own transducers. That really is a science as well. Making a transducer probably involves at least 100 - 150 process steps, and some very expensive equipment (dicing saws, for example.) You also often have injection-molded parts (e.g., the transducer handle itself) that are expensive to produce (the molds for the injection molding machine are done with 3D solid modeling tools, then CNC machined from steel, etc. You also have whole departments of people that work in "Regulatory Affairs" and/or "Compliance Engineering." You also need to employ people to "optimize" your ultrasound images, in each of the different modes you might support: B-mode (2D), doppler, M-mode, color power doppler, etc. You also have things like harmonic imaging, etc. Then there is sending images you have collected off to the various PACS systems that hospitals have. This usually involves a complex protocol known as DICOM. Ok, I'm out of gas for this comment. Again, not trying to drown you in jargon, just suggesting that there is a reason that new ultrasound machines tend to be pricey; that reason is that NRE (non-recurring engineering) is very expensive, actually building the boards is expensive, shipping the systems and maintaining them in the field is expensive, and maintaining all of the other systems you have to have in place to be a viable ultrasound company is really expensive. Hope this helps; thanks for letting me share a bit of my experience.

jes 11y ago

With respect, I think you're speculating here. For example, the FDA and other agencies are concerned with the effects of transmitting energy into the human body. Medical devices like ultrasound systems are not toys. I don't mean to be harsh at all, but with respect, I question your assertions here.

grahar64 11y ago
It would be interesting to see, I mean the argument is that my head phones don't need FDA approval and they can damage my hearing if I turn them up too loud. But some kind of limits would be important to ensure safety. And this post is a question because I don't know the answer, so I am just guessing (a lot). I hope someone with actual experience in getting FDA approval for a medical ultrasound machine actually reads it and answers, with how much it cost and what hoops they had to jump through.
- ska 11y ago
  If my previous comment is not enough detail I'll happily expand.
- jes 11y ago
  I have worked in the medical device industry building ultrasound systems for twenty years. In general, there are thousands of regulations that must be satisfied. Some specifications that must be met include ISO 13485, ISO 14971, IEC 60601 3rd Edition, IEC 62304, and probably ten more that I have forgotten about, such as RoHS, WEE, radiated emissions, etc. The systems I worked with involved multilayer (16 layers plus) circuit boards, custom ASICs, FPGAs, ARM SOCs, etc., mixed OS (e.g., Windows CE and WindRiver, etc.) The code base is large and complex, as you have not just ultrasound, but often, calculation packages of various kinds (cardiac, OB, etc.) These packages are expensive to develop and have to be carefully verified. If you're measuring the length of a fetal femur and translating the measured length to an estimated gestational age, you don't wish to be wrong. Same deal with cardiac output measurements, etc. Then there is the whole issue of transducers. It's a complex field, and you have to deal not only with materials (some of which contain RoHS regulated elements, such as lead), but also, dicing saws (to cut the piezo), matching layers, transmission lines (to send signals to / from the transducer and the ultrasound machine front end.) I'm not trying to be rude, or baffle you with a lot of jargon, it's just that my experience is that building a useful ultrasound machine is much more complex than it might appear from the outside of the industry, so to speak. Finally, I think building an iPhone is probably even more complex, but the incredible volume of sales tends to make amortizing the cost more palatable. I could be wrong, of course, and your comments are welcome.
  - grahar64 11y ago
    That is a great post. I quoted it in the post if that is cool and will read up on some those references. Do you think that a lot of that complexity would be reduced by opening it up to a wider development community through open source? How much open source, consumer electronics, were used? Did you source the transducers from another company, or make them in house? Cheers again for the comment.
    - jes 11y ago
      Thank you for your kind words. The post is necessarily incomplete; I don't think I can give you a full appreciation for all that is involved. And I don't wish to give the impression that ultrasound is necessarily more complex than other imaging modalities, such as MRI, PET, etc. I wouldn't rule out open source, and many open source tools are used in the engineering process (e.g., gcc, git, etc.) I don't know about including open source components in a commercial code base, though. The lawyers usually ran away screaming whenever we would suggest using any open-source code. Certainly the high-volume electronics industry makes components that are used in ultrasound systems. Some of the ARM SOCs, for example, and I suppose, some of the FPGAs, DSPs, etc. There are also a number of custom components, such as ASICs and combined analog-digital parts that show up in the so-called "front end." The companies I have worked for designed their own transducers. That really is a science as well. Making a transducer probably involves at least 100 - 150 process steps, and some very expensive equipment (dicing saws, for example.) You also often have injection-molded parts (e.g., the transducer handle itself) that are expensive to produce (the molds for the injection molding machine are done with 3D solid modeling tools, then CNC machined from steel, etc. You also have whole departments of people that work in "Regulatory Affairs" and/or "Compliance Engineering." You also need to employ people to "optimize" your ultrasound images, in each of the different modes you might support: B-mode (2D), doppler, M-mode, color power doppler, etc. You also have things like harmonic imaging, etc. Then there is sending images you have collected off to the various PACS systems that hospitals have. This usually involves a complex protocol known as DICOM. Ok, I'm out of gas for this comment. Again, not trying to drown you in jargon, just suggesting that there is a reason that new ultrasound machines tend to be pricey; that reason is that NRE (non-recurring engineering) is very expensive, actually building the boards is expensive, shipping the systems and maintaining them in the field is expensive, and maintaining all of the other systems you have to have in place to be a viable ultrasound company is really expensive. Hope this helps; thanks for letting me share a bit of my experience.