BBI Contributing Writer

SAN FRANCISCO, California – This year's American Society of Anesthesiologists (ASA; Park Ridge, Illinois) meeting featured some new technology, some enhancement and refinements of previously announced technologies to make them more marketable, and much development to web-enable personal devices that host medical applications. The pain of the medical device slowdown was being felt by many on the Moscone Convention Center exhibit floor, with a few notable exceptions.

The coming year will be a challenging one for almost all suppliers, and a difficult one for companies who introduce new technologies to the market unless they are very compelling. A further shakeout in vendors can be anticipated, with several new acquisitions and some failures in the market. This is becoming a market sector in which companies with novel products in unsaturated markets are doing substantially better than the larger competitors with broad product lines in mature markets. Telemetry, resuscitation, oximetry, EEG-index monitoring and a few other segments will buck the trend, but most other segments will have difficulty until the market gets through its current recession.

The ASA conference was a bit smaller than last year's, with total attendance of nearly 12,000. The consolidation of equipment vendors was noticeable, with fewer booths and new devices being shown than in past years.

In the processed EEG sector, also known as the Bispectral Index (BIS) market in deference to Aspect Medical's (Newton, Massachusetts) industry leading technology, a new competitor has entered the market. Giant Baxter Healthcare (Deerfield, Illinois) is promoting little Physiometrix's (North Billerica, Massachusetts) new PSA 4000 processed EEG monitor and index.

Like the Aspect BIS monitor, Physiometrix has come up with a 0-100 awareness scale unit that has a narrow target range which the anesthesiologist must keep the patient in to avoid over- or under-sedating the patient. The unit features a color display, with amber/yellow showing when the patient is out of range (either too light or too deep) and a green trend when the patient is within the indicated range. While a little slicker- looking than the monochrome (amber) display of the Aspect BIS, it is questionable whether this represents a really significant difference.

Baxter also says that the PSA 4000 works better during episodes of electrocautery, and while this may be initially true, Aspect has made some recent changes that are likely to minimize this difference.

More significant will be the use of a much larger sensor array, with additional electrodes that are attached to the back of the skull. This allows for the detection of shifts in brain electrical activity that Physiometrix says are typical of the shift into and out of a state of conscious awareness. Missing, however, were the clinical research studies that support this assertion, and more significantly, the comparative studies of the Aspect and Physiometrix technologies. Company personnel said the cost of the Physiometrix unit and accessories will be competitive with what Aspect is charging.

Baxter was upbeat about the chances of gaining a significant market share in spite of its late entry into the processed EEG sector, but that will not be easy to accomplish. One sticking point for any new entrants in the sector is that Aspect has done an outstanding job of lining up OEM partners, including Spacelabs (Redmond, Washington), Nihon-Kohden (Irvine, California), Datex-Ohmeda (Tewksbury, Massachusetts), and most recently, Agilent Technologies (Andover, Massachusetts).

Indeed, one could not move from display to display within the Agilent booth without coming into contact with a monitor to which an external BIS was attached, or which used Aspect's new BIS module for its modular bedside units that has just become available. This, plus the standardization on Aspect's BIS monitor by the Premier group purchasing organization, with its 1,850 member hospitals, may make it more difficult for Baxter to find easy penetration of the operating room market, where this market share battle will ultimately be waged.

One thing that the market entry of Baxter has achieved with its new Physiometrix unit is a validation of the market by one of the bigger suppliers. This changes the market fundamentally from the perception of BIS being a unique, proprietary parameter available from only one company into a parameter with documented benefits that will now be marketed by many companies. This development may benefit Aspect Medical more than Physiometrix, particularly during the next 12 to 24 months, as Aspect dramatically leads Baxter in establishing viable distribution channels. However, one cannot dismiss the specter of the legendary marketing and distribution clout that Baxter brings to the sectors in which it is involved.

Elsewhere on the exhibit floor, Siemens (Iselin, New Jersey) was reintroducing its KION gas machine, its first entry into the U.S. gas machine market dominated by competitors Datex-Ohmeda (55% share), and Drager (40% share). Siemens will be fighting it out with four or five other gas machine suppliers who also are trying to penetrate the U.S. market. Siemens has access to Picis' (Arlington, Virginia) anesthesia computer-based patient record (A-CPR) system for the operating room, at least in Europe, but would only hint at what its new Shared Medical Systems (SMS; Malvern, Pennsylvania) division might be working up for the future. SMS, prior to being acquired by Siemens, marketed a few Carevue-type A-CPR systems to those customers that wanted them, but never really got the product out of the starting gate.

North American Drager (Telford, Pennsylvania) was showing its new Saturn A-CPR system that it has now successfully installed in 20 U.S. sites, accounting for more than 700 total workstations. This is an impressive achievement for a system that had only one beta site a year ago. The system interfaces with more than 11 popular gas machines, from which Siemens' KION was noticeably missing. Drager was displayed all over partner GE Medical's (Milwaukee, Wisconsin) booth, highlighting the level of commitment GE has gone to in making this product a commercial success. While Drager has undergone a lot of internal reorganization, by its European parent, Draegerwerk, Telford has become the information technology center of the company. There is not yet a broad family of such products, so maybe Drager has more in the works.

Cerner (Kansas City, Missouri) also was showing its A-CPR system, but, as we looked at all the vendors' systems, they began to blur together. Not a single vendor of the eight or so showing these systems offered what could be loosely described as a "complete" solution. Perhaps with some clever alliances, enhancements, additional mergers and acquisitions, some company will emerge to offer a total solution by the time the American Society of Anesthesiologists' 2001 meeting in New Orleans, Louisiana, rolls around.

In the way of new patient monitors, Criticare Systems (CSI; Waukesha, Wisconsin) was showing the new Poets 8100 and 8100 Plus monitors, a 4- and 6-trace (respectively) product that includes all CSI technologies, including its new agent ID and bench. These new monitors hit price points ranging from $8,000 to $12,000 (including agent bench), making them very aggressively priced. The weakness will be the lack of state-of-the-art pulse oximetry, because CSI units have never done that well in any of the published studies for accuracy and false alarms in low perfusion or noisy environments. Nonetheless, these monitors are likely to be popular in outpatient surgery, particularly for procedures performed in freestanding surgical centers and physicians' offices, where low cost is paramount. This may make CSI more competitive to Datascope (Mahwah, New Jersey), which currently leads in nonhospital monitoring market share with more than 30% of the U.S. market.