Medical Device Link.

Originally Published MX January/February 2006

COVER STORY

Building a new medtech company to capture leadership in a market that doesn't even exist yet is a risky business move, but it certainly helps to have control over the essential technology for the field.

That's the strategy that has supported eight years of extraordinary growth by SonoSite (Bothell, WA), whose proprietary application-specific integrated circuit (ASIC) technology has enabled the company to develop high-performance ultrasound systems that are smaller, lighter, more rugged, and less expensive than cart-based systems. The company's technology leadership has essentially enabled it to create the marketplace for hand-carried ultrasound devices—and the company is also working hard to maintain its leadership in the field.

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ASICs are microchips designed to perform specific functions. SonoSite engineers invented a method of integrating multiple ultrasound functions on a single chip, thereby significantly reducing the number of chips required to run an ultrasound system. SonoSite's Chip Fusion technology replaces the 10 to 20 circuit boards typically found in cart-based ultrasound systems with a single circuit board. Such a high level of integration increases system reliability and durability, which have become hallmarks of SonoSite's products.

SonoSite has improved on its technology with each successive generation of devices. The company's first-generation system, the SonoSite 180, was introduced in 1999. Weighing just over 5 lb, it was the first product to bring digital ultrasound to the point of care. In 2002, the company released the iLook 25, which weighs only 3 lb and is used at the patient bedside to improve the accuracy of first-time vascular insertions. In 2003, the company further broadened the capabilities of hand-carried ultrasound with the release of its Titan system, a high-resolution modular ultrasound unit.

The company's latest release is the MicroMaxx system, which was launched in June 2005. Representing SonoSite's third generation of devices, MicroMaxx combines portability with enhanced performance. The unit weighs just under 8 lb, and provides high-resolution imaging and broader on-board functionality that facilitate the deployment of ultrasound in a variety of nontraditional settings.

For one application now under study, MicroMaxx systems have been fitted with embedded SonoCalc IMT software for cardiovascular disease management. This proprietary edge-detection software enables clinicians to measure the thickness of the carotid artery lining. With the availability of this capability in a portable, less-expensive device, it becomes possible for primary-care practitioners to perform carotid artery assessments during a patient's routine annual physical. SonoSite has initiated a study of office practice assessment of cartoid atherosclerosis using handheld ultrasound with clinical investigators at seven medical centers. The study is intended to determine whether adding an IMT exam to traditional risk assessment can provide a more complete indication of cardiovascular risk than offered by current diagnostic methods alone.

SonoSite expects that carotid artery assessment and similar applications of hand-carried ultrasound will soon become part of a patient's annual "imaging physical exam." As a result, the company believes that the use of such devices in office practice could grow to comprise half of the expected $1 billion market for hand-carried ultrasound in 2010.

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