GE fills MR product gap in record time to market

GE Medical Systems further segmented its MRI product line thisspring with overseas introduction of the 1-tesla Signa Advantage1T system. The unit offers most 1.5-tesla Signa features but ata reduced price. GE's product strategy acknowledges growing userdemand--particularly in developing markets--for more price-pointoptions in MR.

While the success of competitor Siemens' 1-tesla Impact system(SCAN 12/16/92) may not have driven GE to offer both 1- and 1.5-teslahigh-field MRI products, Siemens' experience did signal growingU.S. MRI cost-consciousness. Sluggishness in U.S. purchasing hasalso increased the importance of emerging, price-sensitive nationalmarkets, particularly in Asia and Latin America.

Declining reimbursement, tight vendor competition and growingstate restrictions on MRI installations in the U.S. have combinedto lower new system prices 10% to 12% a year and reduce the U.S.share of worldwide MRI revenues. At the same time, problems atthe Food and Drug Administration have dramatically slowed theintroduction of new technology in the U.S., said Paul J. Mirabella,general manager of GE's global MR business.

"We are increasing our development speed, but (delaysat the FDA) mean that the diffusion of new technology will happenfaster outside the U.S.," he said.

The development of the Signa 1T took a matter of months, comparedto previous GE development cycles of 18 months to two years, Mirabellasaid.

GE surveyed 1-tesla MRI users in the U.S., Europe and Asiaprior to venturing into the 1-tesla segment, according to MichaelR. Mainelli, product manager for the new system. In addition toSiemens, Picker International and Shimadzu offer 1-tesla systems.

The vendor decided that most high-field MRI users still wantthe types of performance features offered on its 1.5-tesla Signa.GE determined, therefore, not to build a completely new platformthat might have reduced purchase and operating costs further,Mainelli said.

Some applications limited by field strength, such as MR spectroscopy,will not likely be offered on the Signa 1T. While the 1.5-teslaSigna system comes with the option of either a passive- or active-shieldedmagnet, active shielding will be standard on the 1T, he said.

For the most part, however, the same features available onthe 1.5-tesla Signa--including fast spin echo, MRA with magnetizationtransfer and ramped radio-frequency, and endorectal and phased-arraysurface coils--will be available with the 1T.

The price of the 1T will vary between $1.3 million and $1.6million, depending on the features included, Mainelli said. Siting,service and cryogen costs should run about the same as for anactively shielded 1.5-tesla Signa, since the systems share mostof the same specifications.

GE REVEALED THE SIGNA ADVANTAGE 1T at the May meeting of the EuropeanSociety of Magnetic Resonance in Medicine and Biology in Rome.The system is commercially available in most markets except theU.S. and Japan. GE applied to the FDA for 510(k) clearance inMarch but is caught in the growing device review traffic jam atthat agency (SCAN 7/14/93). Applications to regulatory agenciesin Japan will be filed later this year, Mainelli said.

Growing demand for 1-tesla MRI systems represent a $350 millionglobal market, according to GE estimates. Between 60% to 70% ofthis market lies outside the U.S.

Markets in Asia and Latin America are booming, Mirabella said.While price concerns are strong in these emerging MRI markets,initial system sales flow--as they did in earlier markets--toteaching institutions with rigorous performance and image qualitydemands. This strengthens demand for 1-tesla systems that balancehigh-field performance with lower cost.

National reimbursement systems in Europe also provide incentivesfor vendors to expand their MRI product portfolios, Mirabellasaid.

In France, for instance, MRI reimbursement rates vary dependingon different field strengths, and caps are placed on the numberof patients who can be scanned at particular reimbursement levels,he said. When the French government deems that there are too manyinstallations of a particular type of scanner, procedure capsmay be altered to discourage purchases of that type of system.

Introduction of the 1-tesla Signa is not the first time GEhas expanded that MRI platform to a different field strength.The vendor brought out a mid-field, 0.5-tesla version of Signaa year and a half ago (SCAN 8/28/91). The 0.5-tesla Signa is nowoffered along with another, lower priced mid-field unit, the Vectra.GE has ceased new sales of its original mid-field system, theMR Max.

Development of the MRI market is moving in sync with the evolutionof CT, although with a lag of about six years, Mainelli said.

CT systems were initially offered as premium medical imagingproducts in the late 1970s. The CT market started to segment aboutfive years later, and CT scanners sell today at virtually everyprice point. The MRI market should continue to segment in thesame manner and expand both at the high and low ends, he said.

The 1-tesla Signa system comes equipped with GE's latest 5Xupgrade package. Out of the approximately 1500 Signa users worldwide,about 350 systems operate with the 5X upgrade, 250 of those unitsat 1.5-tesla and 100 units at 0.5-tesla, Mainelli said.

"5X is the latest vintage architecture that we're shipping,and that's what we've based the 1T on," he said. "Itis a mature platform."

Given the accumulated experience with the 5X platform, the1T will forgo traditional multilevel beta-site testing prior tomarket, Mainelli said. The first clinical installation will beas a works-in-progress at a location close to the company's Milwaukeeheadquarters. Orders are beginning to come in, with about fivereceived in the 30 days since the system's European introduction,Mainelli said.

"There's been a surprising level of interest from centralEurope, in Austria, Switzerland and Germany in particular,"Mainelli said.