Handheld ultrasound excites vendor and customer imagination

Handheld ultrasound requires a leap of faith as much as it does technology. Intuitively, the idea seems brilliant: Shrink an ultrasound scanner so it can be worn on your belt, strapped to your shoulder, or carried by hand into places where ultrasound should go but hasn't, or has gone but not very effectively-the OR, ambulances, remote clinics, labor and delivery rooms. Put it in the hands of general practitioners, cardiologists, and specialists of internal medicine. Make it part of the physical examination.

"It will be a natural evolution for the physician," said Cam Pollock, SonoSite director of marketing. "If you're going to touch the patient, listen to the (insides) of that patient, why not look inside the patient?"

Ultrasound could be the medical equivalent of the digital camera or cellular phone. Cut down the size and weight, get the data quality at least close to what can be achieved conventionally, and proponents of the technology believe sales will take off.

"We feel that ultrasound will become like a home appliance," said Teo Han, vice president of Medison America. "Everybody will want to have their own ultrasound."

Condense the system down further, as Terason has done-to a combination chipset and transducer that plugs into a PC-and diagnostic ultrasound could go anywhere there is a computing platform, to any PC-based medical device or laptop.

"The PC has changed our world and we are probably the first company to truly take advantage of PC applications," said Alice M. Chiang, Ph.D., president of Terason. "We have made ultrasound into something doctors can carry in their pockets."

Ultrasound could even become a fashion statement. MIT has been experimenting with wearable computing devices for almost a decade. IBM has a prototype. Other companies are developing similar models. They could all be options for Terason.

Completing the ensemble might be any of a number of different kinds of head-mounted displays. IBM's Almaden Research Center has come up with a very small display monitor embedded in transparent plastic. Other companies have developed visors in which LCD screens are mounted. Toshiba America has one such system designed specifically for the ultrasound market. The product, called i-View, is being groomed for use during intraoperative imaging or obstetric exams.

"The OR is usually very cramped and the physician must look over his or her shoulder or across the room to see the screen," said Phil Acker, associate product manager of ultrasound at Toshiba. "This puts the display right there."

In the obstetrician's office, the display unit might be worn by the expectant mother. Some obstetricians, according to Acker, have mounted monitors on the ceiling or wall. A heads-up display device would be a more elegant solution.

On the exhibit floor of the American Institute of Ultrasound in Medicine annual show in Orlando, FL, in mid-March, Terason, Medison, SonoSite, and Toshiba inspired booth visitors with a vision of this brave new world of high-tech medicine. Because their products excite the imagination, it was easy to succumb to the enthusiasm. SonoSite knows the risk of doing so all too well.

Publicly held SonoSite, which was a division of ATL Ultrasound before being spun off, has spent much of the past two years trying to change the practice of medicine. Now the company just wants to tweak the workflow. Its two products-the dedicated echo system SonoHeart and general purpose SonoSite 180-are being framed as the means for extending current practices, allowing the radiologist to quickly do an exam anywhere in the hospital or clinic without dragging around a cumbersome conventional system. They can provide the ob/gyn with a quick means of seeing whether the head of an unborn child is up or down or the interventionalist with positioning information.

"The system is really designed to answer a yes or no question," Pollock said.

General practitioners and emergency medical technicians, especially those on ambulances, were the highest sales targets when SonoSite started out. They are now near the bottom of the list.

"New users represent much bigger hurdles in politics and reimbursement and in education and training," Pollock said. "Frankly a company like ours can't do it on our own."

And there have been other revelations. Initially, corporate strategy called for the sale of the company's two products through distributors. But SonoSite executives soon learned that a sales force dedicated to the mission of SonoSite was essential.

"The biggest mistake we made was believing the product would sell itself," Pollock said.

SonoSite has since recovered its corporate balance, adjusting its business model to more closely reflect the harsh realities of selling handheld ultrasound. The company has established and continues to expand its own direct sales force.

In some ways, Terason is just now getting to the point where SonoSite was a couple years ago. The company has begun manufacturing and shipping its SmartProbe, which is designed to plug into PC-based computers. Only one such computer has yet been qualified for use with SmartProbe-the Gateway 9300 with Pentium 3 and 256 megabytes of RAM-but more will be added soon, according to J. Kerr Spencer, senior vice president of Terason marketing and sales.

Terason is signing up distributors around the world, while at the same time courting officials in the federal government who might be interested in such a portable device. NASA has bought several to examine their possibilities for use on International Space Station, although the agency can't seem to figure out what to do with the HDI 5000 it has up there now (see accompanying story and commentary). A better bet may be the military, whose seed grants in the early 1990s helped fuel the current surge in handheld ultrasound, including early R&D by SonoSite and Terason engineers. Military strategists opined that battlefield ultrasound could be just the ticket for infantry medics, and Terason has bought into the idea.

"They basically want to triage the soldiers, and if they see the heart beating they take the next step," Spencer said.

The company's SmartProbe is a direct descendant of a handheld sonar device used by frogmen to spot land mines and other harbor obstructions. Last year Terason was recognized by the military for developing dual-purpose technology, a swords-to-plowshares recognition shared by only five other companies.

"We have made a lot of the program managers very happy and successful in the DoD (Department of Defense) and that certainly is to our benefit as we explore medical ultrasound imaging for the military," Spencer said.

Terason's system comes equipped with two transducers: a curved linear array and a phased-array. Two others are in prototype; an endovaginal probe and a high-frequency linear array. The price of the product is at the high end of the handheld marketplace at $26,000, which is both list and street price, according to Spencer. SonoSite charges only about half that price for a sparsely configured unit. With a single probe, the SonoSite 180 goes for about $14,000. Fully configured with a complement of up to five probes, cart, and monitor, the product jumps to around $28,000. Medison whips them all in price, selling its MySono 201 over the Internet for $7500. But the gray-scale system offers few extras and probably will not be expanded.

"(Our) major sales point is having a good price," Han said.

The Korean company expects to sell 1000 of its handheld units in the U.S. and 5000 worldwide this year. But, since the product was launched at the RSNA meeting three months ago, sales have been slow to materialize. Only 20 have changed hands in the U.S. and "more than 100" worldwide, according to Han, who nevertheless remains optimistic, as do most of his competitors.

Handheld ultrasound is the latest expression of a long-term trend toward miniaturization, executives at the three companies agree. And the use of these products will expand, not contract, they say. Pollock bridles at the suggestion that SonoSite products are suited only to niches.

"A niche product is one designed, for example, just for neurological surgeons," Pollock said. "When we sell our products, we talk to surgeons and radiologists and ob/gyns. Just about everybody who uses ultrasound has a use for a product like this."

Time will tell.

© 2001 Miller Freeman Inc.
3/28/01, Issue # 1506, page 1.