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Why Are Ultrasound Machines So Expensive? (maori.geek.nz)
195 points by grahar64 on Feb 24, 2016 | hide | past | favorite | 132 comments

The cost of components is often not a big part of the cost of producing an imaging device like this. Building hardware and software in a regulated market where human safety is involved requires levels of validation, verification, process control, risk analysis and documentation that can easily dwarf component cost at the sort of run sizes we are taking about.

This isn't the only thing going on, but it is naive at best to think of the price of these units as a parts list.

I agree with you but it can still be frustrating and there's a lot of entrenched interests involved.

My story is that I broke my foot about 10 years ago (in the Grand Canyon no less). Long story short, when I eventually got the doctor, she told me that this kind of fracture always took a long time to heal and the literature suggested that electromagnetic stimulation had some benefit. Of course, the insurance company wouldn't pay until it was deemed a "problem fracture" in a few months (as my doctor thought it would be) but I did eventually get my $1000 stimulator at about 50% off.

It had the most horrible interface one could imagine. If it slipped off the foot, it apparently simply shut down for that day's stimulation. In any case, my foot eventually healed.

A few years later, a friend had a similar injury. I gave her my stimulator. Apparently the allowable stimulations had expired by then. She took it into a medical supply place and they were horrified by the idea that they might simply reset the device.

I'm not a big pharma hater but this sort of story is why people get really mad.

Those ridiculous pricing policies are necessary to recover the cost of regulatory compliance which is seriously huge component of anything medical in USA.

As a side note, I know a company in India that manufactured a state of art blood test device. They tried to market it in USA and eventually gave up. Currently the company has tie up with Singapore hospitals which send blood to India for testing via flight and reports are mailed electronically automatically. There is a rig of blood testing machines in Powai-Mumbai which tests thousands of blood samples each day. This machine clearly can not be sold in USA (last time I checked was 6 years ago) because the cost of regulatory compliance is prohibitive.

If the medical device manufacturers indeed made windfall profits I would love to invest in their stock but they don't seem to be doing as well as the hatred directed towards them.

My portfolio is about 50% medical supply and machinery manufacturers, and they're incredibly steady investments which pay strong dividends even and especially when the stock price is down. Furthermore, they're often able to make biotech plays and their guaranteed revenue means they're strong candidates for acquisition: http://www.bloomberg.com/quote/HSP:US

Do you have any sources for your claim that regulatory compliance is hurting profits beyond a one-off anecdote? Because my experience has been that it's an industry rife with windfall profits.

Also, what's the name of this Indian company, and what's the brand name for the device? If it does what you say it does, you would be pretty foolish not to invest.

"More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report."[1]

I am not saying the companies aren't profitable. They aren't profitable the way people make them out to be.

And if there are indeed windfall profits to be made what is preventing smart-ass entrepreneurs from jumping in and making those profits ?

Tim Cook says that the Apple Watch won't become a regulated medical device, but Apple might make another product that is. Cook made the comments earlier today in an interview with The Telegraph, stating that putting the Apple Watch through Food and Drug Administration testing would slow its release cycle down too much and "hold [Apple] back from innovating."

[1] http://www.massdevice.com/study-fda-related-activities-cost-...

"And if there are indeed windfall profits to be made what is preventing smart-ass entrepreneurs from jumping in and making those profits?"

Incredibly high barriers to entry and very large established players who have already cornered the market? Following your logic, oil companies must not be very profitable since there aren't very many entrepreneurs buying their own offshore drilling platforms.

"They aren't profitable the way people make them out to be."

Who are these people? What is this way?

What concrete assertion are you refuting? How do you explain the P/E ratios of the biggest medical device companies?

If the cost of regulation is such a drag on profits and innovation, why are medical supply companies that primarily serve the US market so much more profitable in the long term than their counterparts in other countries?

Are you alleging that there's a bubble, or that they're cooking their books, or that they're not one of the most consistently profitable industries?

Wish there was something for medical manufacturing like pricepain.com - including a reduction in unecessary red tape. Sad, how it stifles innovation and actually harms more than it helps.

We could never have an 'open' or cheap medical device because of the extreme level of regulations and the tendency to pretend that the laws of economics shall not apply when it comes to human lives and medical devices.

i'm in the medical industry and love FOSS and I've contemplated this a lot. nearly every day.

I believe the way forward is with open, LGPL-style, reference designs, almost like the Red Hat enterprise model. individual companies must still be accountable and liable for their devices, but their real value-add is in the verifications and validations.

The auto industry doesn't share software, but the liability model is similar in that: how to build any car is mostly known, there are few important secrets. You choose your car based on features and quality and the companies provide those validated features and quality to customer expectations.

Reference designs in medical devices would especially help with the security crises we're undergoing.

So you could buy, say, an insulin pump based on a reference design from a dozen different manufacturers, but your feature set and quality of materials would be up to you and your insurance company. This is the best compromise I can find which allows competition to improve quality and spur development (competition is weak in med. devices) yet allows thousands/millions of eyeballs to improve software - and therefore life - quality.

The holy grail is a medical-grade embedded Linux. If any hardcore entrepreneurs want to talk with me about that, I have a lot to share on it.

That device practically screams, "hack me".

Are you just trolling? This is a device that isn't connected to any network. Indeed, it barely has a user interface.

That word doesn't think what you think it means.

> That device practically screams, "hack me".

As in, "That device practically screams, 'please find a way to tweak me to overcome my restrictive and unreasonable limits (embedded in what is otherwise a functional device)'"

Or in other words, "hack me".

Fair enough although "hack" in the context of medical devices is most commonly used these days to mean something like "maliciously access."

Hack in most contexts these days means maliciously access. Yet, you are not currently browsing a community of malicious accessors, but hackers.

User also didn't get the jones joke. Lost cause.

I assume they meant hack in the friendly, Hacker News-type sense instead of the malicious, my-grandpa-thinks-someone-hacked-his-Google sense.

fractured a metatarsal huh?

Jones fracture, specifically.

I also fractured my fifth metatarsal. It was a Pseudo-Jones fracture so I was up and walking in about 4 weeks(with lots of pain from the toe region and heel for some reason). I was just thankful it wasn't a full jones fracture.

J-what? That's a whole other "leg" that doesn't even have metatarsals.

I worked in R&D at Philips making ultrasounds. From my experience this is definitely what it is.

The amount of people that were employed to simply test, do documentation, and verify safety alone was staggering, let alone all the smart people it took to develop custom ASICs, FPGAs, mechanical housings, image processing etc. There are physicists who do research, there are sonographers who help achieve the best possible images for clinical scenarios.

The amount of effort it takes to make a high quality, safe, ultrasound is immense. When you add in the fact that you also need to follow a myriad of FDA regulations, even small code changes often require a huge amount of overhead in documentation and review before they get checked in, and then there will be whole teams of people to manage source control.

Ultrasound companies do an immense amount of R&D, but also put out a safe, well-regulated product, and the prices reflect that. I'm surprised the the author in the article found even a low quality ultrasound as cheap as he did.

Sometimes that's just a hangover from "the way it was always done.' Telephone switches used to be insanely expensive, and developed with fleets of coders, QA, documentation people etc. in projects costing hundreds of millions. Now any shady outfit with an Asterisk server is a phone company. Five nines? Is that a burger chain?

Not saying that's how FDA approved devices should be developed, but don't be surprised if "prosumer" grade equipment starts penetrating the medical field especially if anyone gets the cost incentives right.

Having taken courses in biomedical engineering, and done some research for a company looking to do what you describe, I can say with some certainty that it is very difficult to start a medical hardware company. You need to outsource production to an expensive certified CM with large expensive MOQs, unless you want to go through time consuming and expensive manufacturing approvals yourself (before being allowed to make or sell anything). You must also develop (easy) and have your device approved (hard), as well as not being allowed to change anything without additional time consuming and expensive approvals. Add in the fact that most diagnostic electronics require the highest level of scrutiny, paperwork, bureaucracy, and delays, and you quickly figure out that you're better off doing something else.

For what it is worth: It can be done though, completely in house, in a couple of years by a smallish group of people who know what they are doing.

I wouldn't be surprised if we see a number of modernized devices in spaces where there are established consensus standards.

Are the regulations very different in different countries? I can think of a few places where getting live-saving machines an order of magnitude cheaper with a small percentage increase in risk of causing harm might be an acceptable trade-off in some cases.

I've been to hospital in one of the places you're thinking of, and I noticed that phrases like "approved for use in the EU" were used as code for "this is not a scam".

I fear the market niche between "scam" and "not a scam" might be very narrow.

I mean, I was thinking less private-clinic of dubious standards in a city, and more "what can the national health services of developing countries reasonably deploy to most rural communities?".

For example, I am from Mexico, and cysticercosis (a brain parasite infection) is not uncommon in rural areas in Mexico. MRI scanners, which can be used to detect it, on the other hand, are quite uncommon outside of major cities. This might or might not be a good example, since I don't know the cost/safety trade-offs for MRI or all the alternative solutions, but if one could get, say, $20,000 USD MRI scanners that are close to in practice to $1 million ones, it might be worth a small safety delta. Public health in Mexico at the national level also tends to fall under "generally trustworthy enough, but critically under-resourced".

Edit: Again, not sure how realistic this particular scenario is, but I think in general getting cheaper equipment for national health services might be worth it in cases where having a lower-standard device can save an order of magnitude more lives than it harms.

This is not my area of expertise, but in speaking to Regulatory Affairs people when I was working in the field, most of the EU and some of Asia base their regulations on the US FDA, or at least have very similar regulations. In addition to FDA audits, we were also periodically audited by the regulatory bodies of other countries.

However, in many countries, enforcement is lax, so you get lots of devices that don't come close to meeting whatever regulation is in place.

They appear to take some very specialized training to operate them well also. There is all the overhead of training the operators and attempting to build something that is reasonable for them to use

I can understand the need for quality testing, but what's the medical threat they're trying to guard against from ultrasounds?

Equipment and other supplies are expensive in medicine, in part, because a lot of it is bought by insurance and by government funds. These sources of cash are milked for all they're worth by the vendors. Then the fact that the market is difficult to get into (big hoops creating an entry barrier) creates a ring of price protection.

But this article isn't proposing to make a low-cost ultrasound for regulated life safety applications. It is proposing to make a cheap ultrasound imaging device for fun or other general purposes.

So why aren't we creating some high level framework, for development of a large class of devices, validate it a single time - and enable such devices be designed with much less effort ?

Because it doesn't work that way. You can't validate the framework, you have to validate the product

Actually you have to validate the iteration of the product. So if your software changed significantly enough from version 1.0 to 2.0, enough that the results of processing data may have changed, now you have the pleasure of going back to validate the entire product to ensure it still works as expected instead of just doing a software verification.

Sucks, but it's the price of safety.

One of the stories I love to tell from my medical device days was spending about 6 weeks getting the validation procedure document for a software build machine approved and then spending all of 5 minutes actually building the product (which had to be separately validated), never to use the build machine again. Now, that's crossing the line into stupidity!

Considering the tragedies that could be avoided by having access to cheaper ultrasound equipment, the price of safety is not easily quantified here.

We're talking about two different things. Safety is the lack of Hazard that a Device presents to the Patient (or Operator). If the device doesn't exist, then there's no Safety issue.

What you are talking about is access to medical care, which is an entirely different topic

But why can't you validate the framework ?

It's not that you can't it's that it makes no difference since it's the final program that has to be validated, not just its components.

There are cases where individual elements of a system must be validated separately, but even then, the system as a whole still has to be validated.

All medical technology is insanely expensive.

My wife is an ophthalmologist in private practice, and we've spent far too much money on diagnostic equipment.

My most frustrating single experience was spending $18,000 on a refurbished visual field last year (the machine where you see flashes of light in your peripheral vision and push the button), and having it show up running a custom version of Windows 3.1 and an actual honest-to-god 3.5" floppy drive.

My current project is trying to figure out how to get digital visual testing systems (e.g., eye charts on a monitor) setup in her exam rooms. If I were to buy a system from a medical distributor, I'd be spending something like $2,000 - $4,000 per room.

With an Atom-powered mini-PC, I could get Windows hardware and a monitor setup in every room for about $300/room. I was hoping I'd be able to find some open-source visual acuity software, but it doesn't seem to exist. Most software-only solutions are still over $1,000 per-license per-room. The best-looking and most reasonably priced Windows software I've found is $400/room. Bringing my total cost to a (somewhat painful) ~$700/room.

There is one piece of good Visual Acuity software in the Mac App Store[2] that we'd be able to deploy in all 4 of our exam rooms with a single $99 license. So with 4x Mac Minis plus monitors, our per-room price would be pretty close to $700/room going that way too. But it seems like such a waste to spend $500 on a Mac Mini that will do nothing besides display some letters and symbols.

What I'd love to see is industry associations working together to produce open source software that solves problems like this. Visual testing software isn't complex. A fairly reasonable investment could get something open source developed that would lower the cost of healthcare across the country, and worldwide.

There are about 58,000 Ophthalmologists and Optometrists practicing in the United States. If we assume they average 2-lanes each, and open source software could lower the cost of visual acuity testing in each lane from $2,000 to $300, that would save $98-million.

1. http://konanmedical.com/chart2020/ 2. http://www.kybervision.com/mac/visualacuity/

Fancy that, my current project is to create a low-cost, high-quality optical coherency tomograph for private practitioners. I am planning to open-source the software and, depending on how things turn out over the next few months, possibly also the hardware designs.

This device can immediately detect around 80% of the pathologies of the posterior eye segment. It's high time we made this part of first-line diagnostic exams.

I don't know if you have an organization around you or not, but be careful. If your software is actually producing some sort of a quantitative or even qualititative "you have this visual defect or not" then the FDA may very well consider you a Medical Device and you'll have to go through submission, etc.

There are a lot of small businesses out there that are unwittingly (and illegally) producing medical devices and don't even know it (yet!).

We will be going through the long and arduous FDA and CE approval process. This is a big part of the cost.

Best of luck with that. As someone who has taken medical imaging software through both, my preference would be to get CE marking first and allow the market and the device to become establish before going for a 510K. The FDA predicate device process together with the glacial speed of the agency means making modifications to a system is unnecessarily difficult which is something you will need to do when innovating in a market. I find the CE process to be a more pragmatic approach.

On some of the darker days with the FDA - and despite their 90 day target we had over 900 days between submission and final clearance - I found it helped to remember the famous Churchill quote; "When you are going through hell, keep going."

Thanks for the advice. We already have experience with the CE process, it's painful but doable. The manufacturing company has been cleared for FDA before, so for now I remain optimistic. (Famous last words...)

That sounds amazing. What's the price point you're targeting?

I think we paid ~$13K for our Atlas OCT (Placido Disk), and ~$43K for our Cirrus OCT (Spectral domain). Both refurbished, a few years old.

I can't go into too much detail (publications pending), but the initial prototype cost roughly $6K in components. The basic idea is find the optimal balance between hardware-vs-software and speed-vs-cost-vs-quality. The device attaches to a regular slit lamp, so that shaves off a big part of the cost too (no need for a separate examination table and optical assembly).

This is spectral-domain OCT with tracking, so quality falls somewhere between Cirrus and Spectralis. However, I'm working on a few sweet mathematical tricks that actually surpass anything available on the market right now - hardware and software has advanced hugely over the past few years.

We already have a hardware manufacturer and are currently fighting to secure the necessary funding. This technology has to make it out there.

Great to hear you're helping to make that happen! So many medical devices (in clinical or research settings) are ridiculously outdated, expensive, and newer tech can often leapfrog the diagnostic capabilities. I've done research, mostly in soft tissue research, and it's crazy how much potential there is out there.

What's your system's A-Scan rate (SD-OCT, so I guess somewhere betweek 10kHz to 50kHz)? Sensitivity? Also I guess you already know, that there's a group that aims at producing a hyper low cost full field TD-OCT (they aim at far below 100USD per unit) intended to be used as a device that's given the patient for self administered diagnostics in ongoing treatment monitoring. There was a talk about this at the recent BiOS 2016 conference.

Personally, I'm working at exactly the other end: Ultra-High-Speed OCT. 1.5MHz and higher A-Scan rate (our group still holds the record of 20MHz equivalent A-Scan rate for a 60°×60° @ 1900x1900 scans posterior segment OCT system).

Awesome, high-speed OCT is amazing. The hardware is still super-expensive, but that is bound to change over the next 5-10 years. Do you have a publication on your system?

Right now I'm working with 70K ascans/s (we've also built a faster swept-source prototype, but the cost-benefit analysis doesn't work out just yet). We have higher-than-average losses due to the slit lamp, so sensitivity is slightly lower than fully-custom systems. We make up for that in post-processing.

I find amazing how far things have progressed in just 10 years. In a decade, we went from struggling to acquire and process x10^2 ascans/s, to real-time processing of x10^5-10^6 ascans/s.

> Do you have a publication on your system?


> to real-time processing of x10^5-10^6 ascans/s.

That would have been me :) (the real-time processing on the GPU part), second author on the paper:


If you want to, you can buy our systems from our university spin-off company: http://optores.com/index.php/products/18-mhz-oct-system

Ah, thanks, I'm familiar with those papers and the spinoff. Great job! :)

I just find it mindblowing how efficient GPUs are at processing this kind of data. I've written implementations for a 6-core DSP (40K ascans/s), modern 4-core CPUs (~70K), 12-core server CPUs (~180K), my laptop's AMD GPU (>120K), a desktop Nvidia 980 GPU (more ascans/s than I care to benchmark.) From a price/performance/simplicity point of view, the GPU outperforms anything else out there right now.

Right now I'm putting this extra computing power to improving quality in other ways than the regular OCT signal processing pipeline. 1M+ ascans/s OCT is great because it opens up new use-cases - I'd love to work on those one day in the future - but there's still a surprising amount of untapped potential in 100K OCT (in the sense that 100K + better processing can actually give better image quality than 1M + typical processing.)

You should contact me at ben AT theengine DOT co. I'm building an SDK for IoT app development that would be able to do what you want extremely easily on very cheap hardware. I'd love to talk with you about this. (My father in law is also a private practice opthalmologist.)

I'm sure you could find some second-hand early 4-5 year old Mac Mini computers at low prices. They're pretty robust little buggers.

But even at $500 you're buying a computer that has an excellent track record for reliability and industry-leading warranty support. It might seem like overkill but compare that to the time investment you'll sink into a hacked and unsupported solution.

(Believe me, I've played with enough of those cheap Atom PCs to know that I'd never, ever rely on them.)

A few years ago, my patellar tendon was getting sore from running, and I went to a sports medicine specialist. At that first visit, he did an ultrasound scan over the length of my patellar tendons, and it was very discouraging to see these "black" sections in the mid-core of my tendons. They were actually tissue that was a bit disrupted, but the way it scattered the sound, it appeared as "black". Kind of freaked me out that my tendon was "dead" in the middle. The actual diagnosis was patellar tendinopathy, previously referred to as patellar tendinitis, or "jumper's knee".

He gave me exercises to build up my tendons, mainly eccentric resistance exercise, but it was going to take a long time. I wondered how I could monitor the progress of the healing. The doctor visit and scan was at least $200/visit, and the healing could take a year. On AliBaba, I checked how much a low end machine would cost to use at home.

There were all sorts of machines available, and one manufacturer's rep latched onto me. I still get the occasional email checking if I'm ready to buy. I think these machines may require some doctor's approval, too, but I never went that far.

But they sure don't cost anything like the prices in this article. In 2013, for quantity 1, IIRC, I was quoted $1100/each for this SUN-806F laptop plus sensor plus software unit:


Maybe I'm missing something critical in this price difference? As the OP was explaining, you can almost build one yourself.

OP/author here, I also have patella tendinitis since I dislocated my patella when I was 17.

This is the reason I started looking at ultrasounds, I figured that I could buy one for the $160 cost to get a scan from a doctor. I have looked around for a cheap ultrasound, but $1100 is far cheaper than I was able to find (I got to about $3k but looked like a dodgy dealer so didn't link to it). But 1k is still way more expensive than I think it should be.

It should be a sensor you just plug into and iphone for a few hundred. I mean there is the http://www.thermal.com/thermal-cameras/ thermal camera for only $250, why not ultrasound? Making a photo sensor must be thousands of times more complicated than ultrasounds sensors.

I just want to know why I can't buy one cheaper than my massively more complex iphone :)

With the math on transducer costs, you've basically answered the question. However, aliexpress will get you 2MHz transducers 10x cheaper if you buy them in bulk. Then of course you have to worry about dodgy chinese website component quality.

I also think you're seriously underestimating the computational cost of converting the measured signal to a usable image. No way is an RPi fast enough to produce a live image with decent quality. There are quite a few papers in the literature about using high-end GPUs to speed up ultrasound imaging and denoising, for commercial vendors I'm guessing it's custom ASIC territory.

> I also think you're seriously underestimating the computational cost of converting the measured signal to a usable image. No way is an RPi fast enough to produce a live image with decent quality. There are quite a few papers in the literature about using high-end GPUs to speed up ultrasound imaging and denoising, for commercial vendors I'm guessing it's custom ASIC territory.

Really? Medical ultrasound has a long history predating high-end GPUs. Maybe that kind of computing power is required for modern high-resolution/low-lag devices, but my guess is you could get something usable with a computer as powerful as a RPi.


I can confirm that you can turn ultrasound data into a 2D image using a simple mid 2000's era ARM processor and an FPGA. So a RPi can even be overkill for that purpose.

But basic ultrasound machines have been with us for decades. From a quick check, since the sixties! I have no hard data yet, but I would be surprised if a Pi couldn't do it.

3D scans are another matter, but this is a thread about low cost scanners, so that's out of the picture.

>Making a photo sensor must be thousands of times more complicated than ultrasounds sensors.

Cheaper thermal imaging sensors like that usually use a very, very low resolution sensor for picking up thermal data, then use interpolation to map the low-resolution data onto a high-resolution image provided by a higher-res conventional camera sensor. Obviously, this approach won't work with ultrasound tech, as there wouldn't be a secondary high-resolution data source.

In the post there is a link to a paper where someone used a 40x40 array for 3d ultrasound imaging and there is a 64x array at 35MHz used for high resolution imaging of things like eyes. That is pretty low resolution for such interesting applications. Imagine the applications for a high resolution 3D ultrasound scanner combined with a high-resolution camera.

A 40x40 ultrasound array can scan with a much better resolution, look at prenatal imaging for example. The phased array is modulated in the time and space domains, so one cell can substitute many fixed ones. With the speed of sound, the receivers resolution of depth information extracted from a reflection's timing information would be a million times better. ...

I'm not sure I would understand my own description, let me go again: The transducer sends a modulated signal and receives the reflections. From the time difference information is gained. The signal is steered using beamforming as known from radar technology. This creates many different impulses that can be correlated from the received reflections.

The key is that the 1600 sells deliver more than one input over time, from a nonstatic signal, which is like shooting photos from different perspectives. I believe cell correlation or whatchamacallit is done in all kinds of variation for CCD data, too.

It might be helpful to elaborate on what applications a 3d ultrasound scanner would have.

> Making a photo sensor must be thousands of times more complicated than ultrasounds sensors.

What makes you think that?

Photo sensors have no moving parts, photons are the carriers of the electromagnetic force, so they readily interface with electronics given the right interface material; any semiconductor material with a matching bandgap will do, photons interacting with a bandgap produces free charge carriers; this is exactly what you're after. The rest is chipscale manufacturing, i.e. lots of sensor cells in a repetetive pattern. You can easily mass produce that in large quantities using photolithography methods, yet even if your process were to bad, that you'd get a low yield it would still be profitable.

Ultrasound on the other hand is acoustics, i.e. mechanical waves. So you're dealing with moving parts, mechanics. Transducers are discrete parts, they can't (yet) be manufactured at chip scale. They're ceramics, and there are lot of parameters that go into manufacturing ceramics which limit the amount that can be produced in a single batch. And then you've to deal with electronics that's not over waaay beyond your typical hobbist level; it's in fact so complex that it goes over the head of most professional electrical engineers and there are companies who are specialised in ultrasonics transducer electronics consulting, doing the difficult design work for the large brand names.

part of the reason thermal cameras are cheap and ultrasounds are not is that thermal cameras have consumer uses. One can use thermal cameras for hunting or determining home energy efficiency, an ultrasound can pretty much only be used for medicine. Although, consumer sonar for fishing(which operates at lower frequencies) is still fairly expensive[0].

Second, your estimate on the price of PZT elements is not necessarily realistic as the transducer is rather large(22 mm in diameter). A 10X10 array would be impractically large. One can buy PCB mount piezo elements for motors for cents per element in bulk[1]. It might even be possible to modify one of those expensive components into an array as was done in this homemade STM[2]. Although in both cases there are bound to be issues with impedance matching and potentially changes in resonant frequency.

[0] http://www.westmarine.com/sonar [1] http://pcbmotor.com/applications-and-solutions/smd-piezo-com... [2] http://dberard.com/home-built-stm/

Used ultrasounds can be had for good prices: https://www.dotmed.com/equipment/2/4/all/

> I just want to know why I can't buy one cheaper than my massively more complex iphone :)

Size of market for iPhones compared to size of market for iPhone ultrasound devices. Also, you'll need FDA approval in the US for their use.

You would also need approval in the EU and in other countries around the world. There are many standards that medical devices must meet. It takes a pretty good sized company to do all things that must be done in order to actually design, manufacture, ship, surveil, maintain and end-of-life a medical device of any complexity.

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.

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.

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.

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.

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.

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.

> 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.

If my previous comment is not enough detail I'll happily expand.

There are various ones for about 1k on ebay eg. http://www.ebay.com/itm/A-Portable-Digital-Ultrasound-Scanne...

Don't know if that'd the kind of thing or too basic?

So it was 3300 USD total for the solution?

And the interesting detail, in the article that the author links there is this opinion from the doctor who uses the portable ultrasound device:


"Other doctors often ask me if I bill for my exams. I don’t, because billing and the detailed documentation and posturing that would be necessary to prove to an insurance company that an ultrasound was necessary would take more time than I have."

The rest of the article is also insightful.

A few months ago I almost ended up with a functional one from a local maternity ward for less than $100 on publicsurplus.com. I didn't realize the thing weighed =~ 400lbs until after bidding on it. Thankfully somebody else got the auction at the last minute.

The current heavy hitter in the ultrasound industry is Zonare and the Zonare Technology page (http://www.zonare.com/technology/) indicates that they are providing state of the art ultrasound that is much faster and higher resolution than earlier systems by combining variable sets of observations. This indicates that the technology that is currently being purchased and used is substantially more complex than a mere sensor.

Additionally medical markets have very complex purchasing processes and criteria that require specific marketing strategies to market. Most startups are used to going for cheap or fast or both, but medical markets want good and are not nearly as sensitive to price or delivery time. To sell to medical markets it is necessary to convince medical equipment purchasers that an option is better and less risky than other possibilities.

Overall this thread is a shameful display of the shallowness and shortsightedness of startup engineering today. The answers to most of the questions raised here can be answered by the technology page of the dominant supplier, but no one bothered to look up any of that. Instead we get irrelevant broken foot anecdotes. Conversationally that may make sense, but realistically making the kind of ultrasound machine offering that doctors might want to use and be able to buy is a very different and more complicated problem than is suggested by most of this thread.

I designed an opthalmic ultrasound in the late '80s. The article describes "b-mode" ultrasound which actually creates an image (in some fraction of a circle like you see when someone shows you their unborn child). Back then, the electronics to electrically steer the beam were very hard to create (20MHz was a fast clock back then) and so the b-mode transducers were often mechanically steered. there was one transducer that was moved in an arc by the steering motor and coupled to an acoustically transparent housing by some gel.

Central Pennsylvania (from whence I'm writing tonight) played a key role in the creation of ultrasound systems - and Johnson and Johnson still manufacturers their transducers about 15 miles from where I'm sitting. The technology originally developed for SONAR came to the Pennsylvania State University where some of the engineers though of cool other ways to use transducers. Good thing the human body has so much water (or other components with a similar density and propagation speed.

When you get a b-mode ultrasound, you see the interface between two types of tissue (or bones) due to reflection. If you look at an image, it takes some practice to even "see" what the picture is.

So back to the cost issue - the biggest single expense in creating an ultrasound unit was getting through the FDA approval process. It was grueling - requiring a lot of testing by outside laboratories and a lot of internal engineering time for paperwork. Once you start to manufacture them, you're making (for a small company like ours) hundreds of units and even the large manufactures aren't making them like the Coca-Cola company spits out cans of soda. You're amortizing a lot more development costs into each unit.

And then, once you start selling to hospitals and doctors offices, the mark-up is huge. They in turn pass a large chunk of the cost of the machine to the insurance companies. If you were charging $500 per scan 20 times a day, you'd pay for your $8000 machine pretty quickly).

There are Chinese made 3D machines for sale on EBay for less than $1000:


I commented on the post that you can get a thermal imaging camera that plugs into your iPhone for $250 http://www.thermal.com/thermal-cameras/ . So I think that any price above that for a unit that looks like it has a CRT monitor from the 90's is a bit expensive. I just want one as a toy and to experiment with, and think the cost is out of reach of that.

There is 0 chance that a US hospital or clinician will risk using an off-label ultrasound machine from china on a single patient. It's almost guaranteed to not be FDA/CE approved. That's how you get a malpractice suit.

But the article also talks about the many other potential uses of ultrasound machines. For hobby use $1000 is still a bit steep, but for classroom use that might be doable.

For low income uninsured folks, it could find use. Especially in lower income countries. America holds its self to such a high medical bar that many simply can't afford healthcare. That is unreasonable.

Philips got a device called Lumify, starts at $199 but requires monthly subscription to use.

Cheers, that is awesome. Here is a video https://www.youtube.com/watch?v=HRLHtnza2jM

It seems very limited for purchase, but would be cool to get my hands on one. I added it to the post :)

If you're patient, you might just find old machines (in some form of working order) show up on eBay and other marketplaces for old gear.

There is a video series of a teardown/repair of an old baggage x-ray machine that was acquired this very way:


In fact, looking through the other videos by the same guy, he seems to have a fair number of xray machines..

How is that legal? :)

Our (US) legal system doesn't work that way. If something isn't explicitly prohibited, it's permitted. This is a feature, not a bug.

While it's not illegal to purchase and use an x-ray machine itself, it would be illegal to use one on human subjects without the proper training and licensing. (Unless, of course, you work for the TSA.)

I think the answer is simply NRE is amortized over a small number of units. This is the case for a lot of test equipment.

So my first job out of University was for a medical device startup, where the aim was to create a basic but inexpensive ultrasound (compared to huge "portable" ultrasound machines). They are still in business (I have friends still working there, 10+ years now) but for some reason they are not mentioned in any articles such as these, even though the product fits a lot of the requirements listed.

Startup name please?

A little company in Adelaide, Australia called Signostics (pronounced Sig - nostics).


Here are a few more reasons:

1) High touch sales process, slow sales cycles - ultrasounds take a long time to sell to hospitals/clinics so the sales process is very high touch and requires a significant number of demos and in person time. Those sales reps are usually paid on commission. Cheap products don't make sense to sell this way.

2) Lack of competition and high development cost - Ultrasound machines are a Class II medical device and so are regulated by the FDA. FDA requires compliance with most relevant ISO standards, and there would probably be a dozen relevant standards for an ultrasound machine.

3) Liability - complex medical devices that are used for critical diagnoses create big liability problems for the hospitals/clinicians. They have no incentive to choose the low-cost model sold by a startup. No one ever got sued for choosing GE/Philips/etc.

4) Lack of price transparency - its often hard to find prices for big ticket medical devices, so the natural pressure to reduce costs through competition isn't as effective, especially with a high touch/high cost sales process.

When I hear excuses about how some diagnostic test is expensive because the machines are expensive I think of airplanes and rental cars.

So you say your ten year old ultrasound costs $50k? I can rent a $50k automobile for $150 a day, not for just ten minutes. And rent a space on a 120 million dollar airplane for a few hundred. And seriously, mom was an accountant. The capital cost of a $50,000 ultrasound machine is about $20/day.

Meanwhile I have about $50,000 worth of test equipment sitting in my office. I'd never think of charging a customer a $2500 spectrum analyzer fee. Or a $400 oscilloscope diagnostic fee.


Ultrasound machines of some sort is also pretty popular startup idea. I've heard at least of 3 people through personal connection who were building some sort of "ultrasound" device based startups. All have had proof of concepts and all have failed. I am guessing failing to deal with regulation, and other such red tape.

When I was in the training business I was thinking of buying an ultrasound device. Yes, they are expensive, but the hardest part is you need a lot of training, even if you know your anatomy by heart, it's hard to make something out of the image.

I think it can be greatly improved by better software, so it get's closer to an MRI.

To answer the question, it is because OP (Graham) hasn't created a startup to solve this problem.

When my wife was pregnant we went to a lot of ultrasounds, and I observed those big Phillips machines very closely, they definitely have room to improve on multiple dimensions.

Like a "post image to Facebook" or tweet this image button on the console? /s

They could just as well be asking, "Why is Salesforce so expensive when the marginal cost of each additional user is negligible?"

The answer is that the market price reflects a lot of other costs than just parts for adding an incremental user.

10 years ago when my wife was pregnant, a dianostic ultrasound cost $800, took 15 minutes, and the machine looked ancient. A 3D "fun scan" was $150, took 1 hour, and the machine was state of the art. Go figure.

Thing I harp on is that the medical industry is used to just charging whatever they can get away with. Since they have a generally naive and captive customer base, there is generally nothing to keep things real. My small experience with business is that when you have that situation you're set up to totally lose control of your costs. Because a lot of excess expenses are hidden in high margin products and services. Example, you make something for $5600 and sell it for $15,340. Could be that with a small amount of work you could produce the thing for $4200 ea. But because the margin is 'good' no one feels the need.

Actually my experience with the medical industry is that products get "value engineered" to oblivion. They are acutely aware of their margins and are constantly trying to improve them by reducing costs where it doesn't affect performance.

In some parts of the device industry there is actual competition though.



Looks like they use one or just a few transducer and move it manually to reduce the cost.

Indeed! That was a solution used 30 years back =)

They wanted $600 to ultrasound me when I had gallstones, it's a racket.

Had to skip on that and just ate more fiber instead which thankfully solved that (pain was unbelievable).

More fiber will not help you with gallstones at all (had to deal with them, too); it's fats you've to be carefull about. The problem is not fat in itself, but which other foods you combine it with.

> They wanted $600 to ultrasound

Well, they were asking that for the procedure, not for the device. The problem you had is, that you're probably living in a country with a laughable healthcare system. Guess what I did pay for my ultrasounds? Nothing, because it's covered by our mandatory insurance system. In fact most general practitioners have ultrasound machines (quite modern ones, too, I'd like to add).

would beg to disagree with you about fiber (you are right about the healthcare, if anything the price is only higher now that more people have insurance rather than price reform)

after a few bad attacks over a couple years, it finally dawned on me to radically increase my fiber intake after reading up on it online

no attacks for years now

initially I had reduced my fat intake but now far less careful without any downsides

cannot imagine anything worse than gallstone attacks, I literally thought I was dying the first time it ever happened

> cannot imagine anything worse than gallstone attacks, I literally thought I was dying the first time it ever happened

I know that just too well. In case one ever happens to hit you again, I found out that a hot bath will give you instant relief. Don't ask me how it works exactly, I just found out, that it works.

" computer that can run a MHz frequency transducer is easy and cheap these days, e.g. a raspberry pi’s GPIO pins can run that frequency."

Yeah, but actually you need an ADC that runs at MHz frequencies and a frontend amplifier to capture the signal and put it into the ADC

Definitely this falls into the "not expensive" category, but not in the "trivially cheap" one

Agreed, for a single element one there's a project on hackaday : https://hackaday.io/project/9281-murgen =)

160$ cost for a single electronic board, not cheap, not so expensive..

This is a phenomenal article outlining how the regulatory environment essentially causes these devices to be far more expensive than they really ought to be:


Can anybody who is knowledgeable in this area tell me if it is possible to use later interference to build ultrasound transducer? Similar to how gravity wave detector works but for 2 dimensions?

Actually "Ultrasounds" are among the cheapest medical devices around. Practically "everybody" makes them and the market is oversaturated.

The processing software is actually the least problematic thing; it's all well documented and somebody with the right background (electronics, digital signal processing and computer graphics) could hack it in a single weekend (that's not an exaggeration: When I got invited to the group where I'm currently doing my PhD they were giving me a few datasets of raw, unprocessed Swept-Source OCT fringe data and said "have fun". A day later, using liberal application of NumPy I got pictures; another day and the quality was pretty good.

"Ultrasounds" cost more than consumer goods, because, at the moment, they are not consumer goods. Compare this to the cost of "personal computers" in the 1980-ies. Just about as expensive, and "Ultrasounds" are kind of the medical imaging "PC" counterpart for general practitioners.

So can "Ultrasounds" be made consumer goods? Difficult, because some parts of them must be built at very high quality standards, not to put the patient at risk. Also some of the electronics involved is challenging, even by todays standards. For example driving the transducers requires driving amplifiers capable of outputting >1kV against a highly complex and poorly matched impedance at bandwidths above 1MHz. That's a really tough problem, that, luckily, has been solved but still requires fairly complex electronics; you can buy appropriate driver amplifier ICs, but those are not cheap, often >10$ per Unit and you need several of them. But that's only half the story: You also need to receive the reflected signal. Here's the problem that the transducers tend to ring after emitting the pulse, causing signal artifacts. And the waves coming back will produce only a few µV of signal. So you've got a 180dB dynamic range between sending and receiving and TX and RX share parts of the signal path; either your RX amplifier can cope with the 1kV sending signal and quickly enough recovers, or you have to add some fairly quick, high insulation signal path switches to quickly switch between TX and RX.

And finally you need a whole array of medium speed ADCs (each with a sampling rate of about 10MHz to allow for some oversampling) one for each channel; and of course the interface to the computer. A single 10MHz ADC is cheap. But as soon as we enter the multiple channel interfaces domain things get pricey quick. Just look at audio which operates at most at nimble 96kHz, yet "pro-sumer" (enthusiast consumer) audio interfaces with 16 or more channels go over 1000$; And we need 100 times the sampling rate for ultrasound. So actually the about 3000$ you pay for the ADCs is pretty cheap, if you compare the MHz/$.

So you've solved all these essential problems. Now you have to make sure, that a mechanical failure doesn't expose the 1kV driving signal to the transducer to the patient. Here's the challenge: The transducers are separated by the thinnest possible layer of isolation material from the patient's skin, there's a pulsed >1kV amplitude AC signal right behind it, and between the probe and the patient you have conductor gel, which is essentially water jelly, that gives a nice acoustic impedance match, but also does a very good electrical match; we're talking body resistivity model in the two-digit ohms right now. Or in other words: A single manufacturing failure in your scanhead probe and you're going to electrocute the patient. Oh, you're thinking about just floating the whole transducer driver electronics. Smartass, that won't work, because you're operating with MHz AC here, so we're talking RF coupling, driving transducers with significant pulse power; you'll giving your "victim" RF burns, which are nasty.

Come to think about it: 8000$ for a ultrasound imaging unit sounds pretty cheap.

Buy it from unregulated Chinese providers for personal use?

Compared to an MRI machine it's very cheap

The funny thing about this is, that technologically an MRI is much simpler compared to an ultrasonic imager:

- Field coil - Gradient coils + coil driver - RF transceiver (essentially n SDR)

The single most expensive part is the cryostat for the field coil. If there were high temperature superconductors that would retain their properties within strong magnetic fields you could build and operate MRI scanners much cheaper.

A few years ago I did build a very crude and simplistic MRI scanner in my shack; it had a piss poor resolution of about 10mm³ took "ages" to scan a single plane and would dissipate huge amounts of heat in the (normal conducting) field coil; the gradient coils were driven by a regular HiFi audio amplifier. But it is definitely possible to build such a thing DIY and have it produce images (of poor quality).

Wow that's really amazing. The super conductors are annoying in that they self distruct. I wonder if there is a cheap way to make one and gracefully shut it down when finished with it.

I met one of the original engineers for ultrasound. The original design was 3d through mechanical scanning of the body

"Why is custom software so expensive to produce? Open-source components are free, so the final product should be, too!"

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