Comment by jes | Hacker News Reader

Comment by jes | Hacker News Reader

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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.

Hey Jes, would be glad to get your insights on echopen.org 's project still =)

Electronics wise, we are using a single element, mechanically translated (similar to the atl access pv10 probe) - then with a single element you can cut on the price (so far our prototype parts costs 250$/300$) while still giving a basic image for the user, who doesn't all the time need all the feature of a high-end ultrasound scanner =)

What do you think?

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.

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.

One more warning... Two years ago I was on a project that spec'd inexpensive transducers from China. We bought samples from multiple factories and they were all terrible. Datasheets were vague, and a lot of the transducers didn't even meet those weak specs.

Ultimately it didn't matter much for our beauty product but it would be a big problem if we tried to use them for imaging.

Yup. Yet one more cost: Supply Chain control is vital.

Again, valid point.

At one point in time, I had a number of people in incoming receiving working for me. We had to do all kinds of quality control on incoming components, such as castings, PCBs, etc. We had automated measuring machines, etc. It's all very expensive to set this stuff up and staff it.

We also had to use an XRF gun on parts, to make sure we weren't being shipped non-RoHS parts.

As I remember, one of the add-ins for our Agile PLM system (Agile is an Oracle product) was on the order of a few hundred thousand dollars for licensing fees and setup, not counting the months of consulting time necessary to load bills of materials, etc., into the system.

On the topic of Open Source, our IP attorney was primarily concerned with licensing, but that's because he's an IP lawyer. Our Regulatory and Quality Assurance people would be far, far more concerned with the Design History of any open source code we tried to bring into a medical device product. How was it developed? Where are the requirements? How was the output validated against the requirements? Our process mandates Design and Code inspections, can we show that they were performed on this Open Source product, etc, etc, etc.

Once you see the uphill road, you realize you're better off starting from scratch and writing the product yourself instead of depending on OSS. For some noncritical aspects, it's fine, but then you get into the definition of "noncritical" :-)

That's an excellent observation. IEC 62304 speaks to these issues, although not in the context of open source per se.

It also depends on the class of your device (A, B or C in 62304 parlance) how much rigor you must put into your software process.

> 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.

Just to point out injection molding, 3D solid modelling, and CNC machining don't have to be super expensive these days.

Large volumes, and especially high end stuff... sure that takes a lot of up-front cost. But for smaller volumes (eg prototyping, short run) the costs are very reasonable now.

It seems due to continuing development of Open Source hardware and software in these fields, which created good virtous cycles for them. Hopefully this continues... :)

Note - saying the above as someone who's into 3D solid modelling and CNC machining already. Haven't gotten into injection molding yet, but it's on my personal ToDo list for not far off. :D

Building anything is much more complex than it might appear from the outside. Yet, except on a few areas, people get ways to make stuff cheaply.

The fact that this company has to work with very low level components and that it had no spin-off on other areas is a market flaw, not something inherent on their devices.

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