The Butterfly Effect

Butterfly’s revolutionary chip technology could disrupt the portable ultrasound market by creating a device consumers can afford.

It still rings in my ears. “If you can’t take care of the equipment appropriately, maybe you shouldn’t be allowed to use it at all!” As a newly minted 4th year, I had just tangled the ultrasound transducer cord under the wheel of the machine while preparing to do a FAST exam. “Damaging that cord will cost us a new probe to the tune of 7 to10 thousand dollars!” added the trauma attending.

I fixed the cord issue, finished the exam, and reported positive free fluid in the abdomen. Then it hit me. “Seven thousand dollars just because the cord was run over by a 100-pound machine? That’s ridiculous!  Clearly he’s exaggerating.” He wasn’t. Across the country emergency departments spend $25,000 to $250,000 to purchase and maintain sophisticated and cumbersome ‘portable’ ultrasound machines. Often the greatest costs for expensive imaging equipment come in the form of contracts for maintenance, repairs, updates, and training. But all of that appears about to change, thanks to a disruptive new technology pioneered by Butterfly Network.

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Butterfly’s new smartphone-based ultrasound device replaces expensive transducer crystals with computer chip technology, resulting in a device that costs less than $2,000–affordable enough to potentially address the two thirds of the world’s population that has no access to medical imaging, as well as put one in the pockets of plenty of medical students.

THE BUTTERFLY EFFECT

Butterfly Network was born as a startup out of the imagination of the enigmatic Jonathan Rothberg. Previously, Rothberg was known for his ambitious 24-hour whole genome sequencing efforts and personalized cancer medications that capitalized on artificial intelligence systems to determine the optimal medication for each cancer patient.

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With 100 million in startup funds, early on Rothberg made it clear that he wasn’t interested in just another cool ultrasound machine. He poured early capital into R&D to rethink the fundamental physics of how ultrasound works.

An early team of just three began the grueling work of making ultrasound transducers out of microchips. Some of the early victories were nothing more than successfully scanning an orange. Butterfly officially moved from concept to reality this fall when it debuted The Butterfly iQ at the American College of Emergency Physicians annual Scientific Assembly.

This handheld ultrasound probe operates off an iPhone, works as three transducers in one, and can ‘Airplay’ to a computer screen for group viewing. It utilizes DICOM to store and upload images to various repositories. Additionally, it stores all images to a cloud ecosystem were an AI deep learning system evaluates and studies each image to improve “guidance” for a future where anybody can pick up an ultrasound probe and diagnose common diseases.

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For Chief Medical Officer John Martin, Butterfly IQ isn’t just another entrant into a crowded ultrasound market. It’s a lifesaver on a personal level. He had a stiff neck while testing the device at a Denver hospital, so he decided to smear some gel on his throat. The device showed a small dark mass, which he knew was not a lymph node. A few days later, the mass was confirmed as throat cancer, and Martin has since undergone surgery and radiation therapy.

The device literally saved his life. Martin was initially hesitant about sharing his story publicly but later realized just how much it brought Butterfly’s bigger mission into focus. With its extremely affordable cost and FDA clearance of 13 unique probe uses, Butterfly IQ will have the broadest application of any portable ultrasound probe to date. For Martin, this means that Butterfly takes portable ultrasound and makes it personal.

“I think we are creating our own space,” says Martin. “While I think there are portable ultrasound devices [in the market], I don’t think they are personal ultrasound devices. There is a difference. They’re not really at a price point where an individual can actually carry this around in their pocket. We’ve got the price to a point where every individual physician can hold it in their pocket.”

And those prices will get even lower, says Martin – as low as $500 – once Butterfly is able to scale up production. That means the possibility of going right to consumers in their homes, potentially detecting disease sooner. The Butterfly team quickly expanded their staff after ACEP as the activity surrounding the device was well beyond their expectations. While unable to share the exact number of reservations for the Butterfly iQ, Martin described the response as “insane.”

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THE CONSUMERIZATION OF ULTRASOUND

One of the radical results of Butterfly’s lower price point and smartphone integration is the potential for building a consumer market for the product. Martin is bullish on this potential. “We think we can ultimately get this in the hands of consumers,” says Martin. He acknowledges that there has been some heavy pushback to this idea, but argues there is precedence. “If you think about defibrillators, that’s a device that has to read a rhythm and deliver a shock at just the right time. If it’s delivered in the wrong time or in the wrong rhythm, you can kill [a patient], and that has gotten to the point where it’s in the hands of consumers who have absolutely no medical knowledge and no medical ability.”

In 2018, Martin says that researchers around the globe will be studying the use of Butterfly iQ to test if patients can utilize ultrasound themselves with Butterfly AI guidance. The goal is to shift ultrasound to the front of the care delivery pathway.

The question remains: Is Butterfly iQ with its chip technology just another med tech fad that will be surpassed by the next hot new gadget or is it a disruptive technology that will forever change ultrasound? To answer that, we have to look under the hood to see what makes Butterfly iQ unique.

THE MAGIC IN THE CHIP

While smartphone-based ultrasound devices have existed for years, Butterfly is the first to completely re-engineer the technology behind acquiring images. The goal? Increase quality and efficiency while decreasing costs. To accomplish this, Butterfly engineers had to figure out how to replace the very core element of the ultrasound probe – the piezoelectric crystals. Using sophisticated physics and fancy math, these piezoelectric crystals are used to ‘transduce’ sound energy into electrical energy and vice versa.

This allows a traditional ultrasound probe to both send soundwaves and receive sound waves as they reflect off different body materials. However, the production and commercialization of these crystal materials (usually lithium niobate, quartz or ceramic based crystals) can be expensive and labor intensive.

In order to disrupt this industry, Butterfly iQ cut the crystals entirely, attempting to do the same work using semiconductor chip technology. This technology is the backbone of the consumer electronics industry and benefits from a sophisticated and robust supply chain that is already in place.

Here’s how it works. Butterfly iQ has over 9000 little drums filled with silicate called CMUTs (capacitive micro-machined ultrasound transducer) that are molded to a CMOS (complementary metal-oxide semiconductor). These CMUTs ‘wobble’ to both receive and produce sound waves. The CMUT is engineered for a broader bandwidth than is possible for traditional piezoelectric crystals, allowing the combination of three transducer bandwidths and directionality to exist in a single probe.

There is so much computational power on this chip that signal processing is also done right inside the probe, allowing for sophisticated imaging like color doppler without the burden of a bulky machine.

TAKING FLIGHT

There are arguably three other major competitors to Butterfly iQ in the handheld ultrasound market: GE Vscan Extend, Philips Lumify, and the Clarius Wireless Scanner. Each of these devices are FDA approved for most of the major uses of POC (Point-of-Care) ultrasound. No other device on the market has a 3-in-1 transducer, which leads to doubling and tripling of cost for each additional probe. Additionally, only the Philips Lumify and Clarius are smartphone based. From a cost perspective, there is no comparison.

Butterfly iQ drastically reduces the upfront cost, and there is no extra charge for their cloud computing and storage. Not to mention, the iQ is the only probe pushing the limits of AI and deep learning. This leads us to the next obvious question. If the device will be this cheap, where are they going to find enough customers to stay in business?

“[We] live in a medical world where we have the benefit of seeing some of the most amazing technology on the planet but the evolution of technology has not been evenly distributed around the globe,” says Martin. “Two-thirds of the world have no access to medical imaging, and it’s going to take something incredibly disruptive to change that.”

Since ACEP, Martin and the Butterfly team have been bombarded with interest from all over the globe. “We have received requests from countries I didn’t even know existed,” says Martin. Which makes sense, given that the developing world wants ultrasound badly. One survey of 138 healthcare professionals representing 44 low resource countries reported that the major barriers to ultrasound access included lack of training (60%), lack of equipment (45%), ultrasound machine malfunction and maintenance (42%).

Amazingly, 75% of all respondents desired further training and access to ultrasound. A study in rural Rwanda showed a change in clinical management in 43% of all cases where ultrasound was utilized. So with 9.2 million doctors worldwide and double that number in nurses, midwives and other mid-level providers, the market for an efficient, portable, and inexpensive ultrasound device is massive.

“By removing the barrier of price, I expect Butterfly to ultimately replace the stethoscope in the daily practice of medicine,” said Martin. “We can now provide a diagnostic system to address the millions of children that die of pneumonia each year and the hundreds of thousands of women that die in childbirth, and these are just two examples of the impact this technology will have.”

While the long-term goal is a globally accessible ultrasound product, Martin says the near-term goal is medical education. Studies have already shown that medical students with only 18 hours of ultrasound training correctly diagnosed 75% of cardiac pathology while auscultation by cardiologists identified only 49% of disease. Similarly, after a pilot program at Harvard last year they are now creating a longitudinal ultrasound curriculum in all four years of training.

While nobody knows if the Butterfly iQ will actually take the point-of-care ultrasound world by storm, the Butterfly iQ is an impressive triple threat. The combination of 1) efficiency of a 3-in-1 handheld probe, 2) extremely low cost per unit and 3) the possibility of a consumer/professional oriented ultrasound device has plenty of potential.

For the first time, a financially feasible personal ultrasound device could be put into the hands of every first-year medical student. This will elevate the role of point-of-care ultrasound in many fields as the next generation of physicians think about the physical exam in terms of ejection fraction and pulmonary “b” lines rather than murmurs and crackles. For the nervous med student in the trauma bay, those days can’t come soon enough.