f03a.jpg (10046 bytes)It’s not what we expected.
The mammography market boom that many industry observers and participants predicted would sweep the industry into the 21st century so far has been a bit of a let down. The holdup? Full-field digital mammography systems didn’t hit the market as expected after the former Trex Medical Corp. (Danbury, Conn.), at the time an industry leader, stumbled in the FDA’s clearance process. (Today, Trex is gone, having been acquired by Hologic Inc. (Bedford, Mass.) in September, which promptly purged the Trex name.) Only GE Medical Systems (GEMS of Waukesha, Wis.) has released a full-field digital mammography unit, the Senographe 2000D. Industry watchers say the market is in a temporary lull, waiting until digital mammography systems enter in force within the next two years and the next round of Mammography Quality Standards Act (MQSA) regulations take effect in 2002.

Holding Pattern

In 1998, market research firm Frost & Sullivan predicted the world mammography market would more than double between 1998 and 2004, from about $240 million in 1998 to $535 million six years later. Just two years into that prediction, it is clear the market will not perform as expected. Frost & Sullivan’s forecast was based largely on the assumptions that digital mammography systems would be on the market by 2000 and that early adopters would drive up sales for the more expensive equipment.

“The market’s still growing,” says Ryan Goulding, senior analyst at Frost & Sullivan, “but a lot of things have not come to fruition like I thought they would.”

Goulding adds that the regulatory process has been a steeper climb than many companies expected. Trex, which many assumed would be the first to release a full-field digital mammography system, was surprised by the FDA’s decision to return to the company its submission for its charged-coupler device (CCD) system.

“A lot of these companies, especially Trex, had a lot invested in digital mammography,” says Goulding. “And it has all been deflated by regulatory barriers.”

The market, which had been growing the last four years, saw a bubble of activity in 1999, when a number of mammography centers upgraded their equipment to meet a regulatory deadline in the MQSA.

John W. Cumming, president of Lorad, the former Trex’s mammography division says sales rose from 1996 to 1999, with volume topping at 1,800 units in 1999.

“I think that we’ll find in 2001 that there is going to be another increase based on the interest in digital, especially for companies that have products that can have an upgrade path to digital, like our M-IV,” Cumming says. “Also, because the MQSA compliant rules in 2002 are going to affect the numbers of mobile mammography systems — which probably total in the hundreds and hundreds of units out there — there will be another spike. I think we’ll see a 2001 year.”

Others agree that the market is just catching its breath this year and will pick up again in 2001. In addition to digital systems entering the marketplace and MQSA compliance — which some say may affect 20 percent to 25 percent of the installed base — other factors that may positively impact the market in the future include aging baby boomers and increasing awareness of mammography exam benefits.

According to the U.S. Census Bureau, the population of women aged 45 to 64 years is expected to grow nearly 30 percent in the next 10 years. The population of women over 65 years will grow nearly 12 percent.

Despite the increasing number of mammograms done each year, its effect on mammography equipment sales is expected to be minimal.

“I think it is still going to be primarily a replacement market in that the new equipment coming out is far more productive than the equipment that exists in the installed base today,” says Samantha Allison, GEMS general manager of Women’s HealthCare Business.

Reimbursement issue

Another limiting factor in the market is the low rate of Medicare reimbursement for a mammogram. At approximately $66 per exam, vendors say it is difficult for imaging centers to make a profit, let alone invest in new equipment. Allison says a labor shortage adds to the financial crunch, because centers have to increase wages and benefits to attract and retain good employees.

“Given that the population is aging and more women are going to need this procedure, it is an interesting dilemma for providers where they need to balance meeting the needs of their community with trying to have a profitable entity,” she says.

Allison says the result is that, instead of trying to expand services, such as to rural populations, clinics are centralizing their efforts to maximize efficiency and constrain costs.

Don Blomstrom, vice president of U.S. mammography at Instrumentarium Imaging Inc. (Milwaukee, Wis.), a division of Instrumentarium Corp. (Helsinki, Finland), agrees that reimbursement is the “thousand-pound gorilla in the room.” But Blomstrom adds that because the initial cost of a digital mammography system is so high, the industry must prove that digital can do a better job than film before reimbursement rates will increase.

“We have not yet proven — nobody has — that we can do something with digital that we can’t do with film,” Blomstrom adds. “We haven’t dramatically improved sensitivity. How can we justify improving reimbursements, if we can’t prove improved outcomes?”

Is digital there yet?

Blomstrom believes the early drive to release digital mammography systems came not from a patient — care perspective, but for marketing reasons. “Someone just simply wanted to be first, whether they had the details worked out or not,” he says, adding that “the devil is in the details.”

The details include the higher resolution required for digital mammography vs. other digital systems, such as chest imaging. But digital mammography shares additional problems, such as large file sizes, monitor requirements, high initial costs and learning to read digital images.

Blomstrom says Instrumentarium Imaging’s approach is to let the digital technologies — such as high-resolution selenium detectors, imaging handling techniques and display quality — mature so that when they do enter the digital market, their products will be of the highest quality available.

Instrumentarium Imaging’s Diamond breast imaging system, a full-field, 3D imaging platform, is awaiting FDA approval. The Diamond can use film and switch to an amorphous selenium direct digital flat-panel detector. Initially, a mid-field 3D diagnostic system will be offered. Blomstrom says benefits to the company’s system include an automatic digital full-breast phototiming system, the ability to park the tube head out of the way and a bidirectional compression system that makes the exam less painful for the patient and may help increase women’s willingness to undergo the procedure.

With fewer than 50 percent of women receiving mammograms, Blomstrom says taking the stress and pain out of undergoing the procedure should be a higher priority. “We spend all of this money on absolutely beautiful women’s imaging centers trying to make the experience as pleasant and positive as possible, but when you take the patient back into the mammography suite, the compression system on everybody else’s machine is the same as it has been for the last 15 years,” he says.

While Instrumentarium Imaging plans to enter the full-field digital market, Blomstrom says the company wants everything in place. “We want to make sure that we don’t let the hype get in front of the actual clinical advances,” he says. “We want to take the long view of this and that we don’t do something just because it is available. Does it make a clinical difference? In many respects we haven’t proven this in digital mammography.”

Hologic Chief Technology Officer Jay Stein asserts that today’s digital mammography technology may not be good enough to drive the market forward. He says three things must happen before digital will succeed. First, it must be proven to be superior to film; second, the cost must come down, given the current reimbursement rate; and third, the system must be approved to read soft-copy.

(GEMS’ Senographe 2000D — the only digital mammography system cleared by the FDA — has been approved to read only hard copy.)

Stein maintains that Hologic’s newly acquired system, Trex’s Lorad mammography line, will perform all three functions within the next two years. Hologic plans to resubmit the CCD-based digital mammography system to the FDA for approval soon.

Despite Trex’s results in the last go-around, Stein says Hologic is not worried about receiving FDA clearance this time. The problem was not with the product, he says. The FDA decided to send the product through the more rigorous premarket approval process rather than the 510(k) process.

Instead of scrapping Trex’s digital mammography system, Hologic — whose own products are flat-panel based — has wrapped it into its long-range plan.

“The short-term transition is to get the customer base from analog to digital,” says Stein. “For that, we’re going to use the existing technology, which is the CCD technology developed by Trex. Then we are going to upgrade all of those systems with the superior selenium imaging plate.”

The highest quality digital system of the future will use a selenium detector, Stein asserts. “Selenium will provide either two to three times more image quality information in mammography than screen film or current digital systems. Alternatively, it will provide the same capability as current systems, but with half the radiation dose,” he says.

In June 1999, Hologic acquired Direct Radiology Corp. (Newark, Del.), which makes selenium detector arrays.

GEMS’ system, which has been on the market since February, uses a cesium-based flat panel detector. As of early October, GEMS had sold approximately 50 systems in the United States and anticipates having 80 to 90 units installed by the end of the year. The company has filed for FDA clearance for soft-copy reading on the Senographe 2000D. GEMS had not requested soft-copy clearance initially so that the company could expedite the initial PMA process, GEMS says.

Healthcare providers in Canada currently are using the Senographe 2000D for soft-copy reads and have reported increased throughput and productivity, says GEMS’s Allison, maintaining that clinics can obtain two times the exam volume over film.

GEMS had sold approximately six systems in Canada and Latin America as of early October. The company estimates that it will sell approximately a dozen in the two markets by the end of this year.

In addition, patient satisfaction is higher because the technologist does not have to leave the room to process and check the film. With the digital system, the tech stays with the patient and can check the positioning on a workstation in the room, resulting in less patient anxiety and fewer callbacks.

But what about the $400,000 price tag? Is a digital system still economical compared to analog? According to Allison, it is.

“When we look at the incremental [patient] volume, patient satisfaction and the taking out the processing of film and storing film, then yes, you can still purchase the equipment and pay for it and get a return on your investment,” she says.

Ulana Supran, M.D., of Medical Imaging of Manhattan (New York City), says it is too early to tell if the two Senograph 2000D systems the facility purchased in June and July of 2000 will work out economically. The increased throughput has allowed the imaging center to replace three analog systems with the two digital machines, eliminating some technologist positions. Eventually, the cost of printing and storing films will be eliminated once monitor resolutions are enhanced and soft-copy reads are approved. The center has increased the cost of mammograms to make up some of the initial equipment expense. Although patient volume has not increased, patient visits are quicker.

“So far everything has worked out well for us,” says Supran. “However, it is pretty early. We’re going to have to see in a year or so whether it has worked out economically for us. In the long run, I think it will economically be a good idea.”

Other companies also are creating full-field digital mammography systems. Fischer Imaging Corp. (Denver) has developed the SenoScan, a CCD-based system that has a wide field-of-view at 22 cm by 30 cm. Ken Crocker, Fischer’s director of marketing, says the company anticipates releasing the SenoScan in late 2000 or early 2001. Fischer is awaiting FDA approval.

Siemens Medical Systems Inc. (Iselin, N.J) also is working on a full-field digital mammography system based on the company’s Mammomat 3000 analog system. Both the Mammomat 3000 and the 3000 Nova are upgradeable to digital. Siemens’ digital system will use an amorphous silicon flat-panel detector. The company would not speculate on the availability of their digital system.

Although Siemens is actively pursuing the digital market, Joanne Scott-Santos, Siemens’ Women’s Health manager, says the growth in the mammography market will not be due just to digital.

“I think that as we educate more and more of the population, more women will become compliant with having annual mammograms,” she says. “Right now, nothing detects breast cancer better than film screen mammography.”

Analog and Stereotactic Remain Steady

Although the highly anticipated digital mammography systems are receiving much of the attention, analog equipment will continue to comprise most of the market for at least the next several years. No major advances have been made in analog systems, but some enhancements have been made to existing products, and companies will tout improvements to their current analog systems at this month’s Radiological Society of North America’s (RSNA) annual meeting in Chicago.

One area that has gone digital is stereotactic and spot imaging systems for minimally invasive biopsy procedures. Although physicians are turning more and more toward ultrasound imaging to perform biopsy procedures, vendors say the need for stereotactic

X-ray-based imaging remains strong. The market for prone stereotactic tables has leveled off since its initial release in the early 1990s.

“Both ultrasound and X-ray-based imaging for biopsy have its place,” says Fischer’s Crocker. “Ultrasound is certainly a good and useful technique for larger, well-defined masses. But, if you want to perform a biopsy on early-stage cancers and indicated only by microcalcifications, you need a device like a stereotactic table in order to properly make those biopsies happen.”

Stereotactic and spot imaging core biopsy procedures offer a minimally invasive alternative to open surgical biopsies, which are judged benign about 80 percent of the time, and physicians are becoming more comfortable performing the core biopsy procedure. Digital spot imaging, offered by many stereotactic and mammography equipment vendors, has made biopsy procedures, which are frequently arduous and time-consuming, much faster, easier and more accurate, say vendors.

Because ultrasound is used more frequently in the procedure, some companies have or are considering integrating X-ray and ultrasound imaging into their stereotactic biopsy tables. Fischer, for example, has developed an integrated table into its Mammotest Plus and Mammotest Plus/S stereotactic biopsy tables.

Siemens’s Mammomat 3000 analog system can accommodate a stereotactic biopsy table and the company’s Opdima product for digital spot imaging. Avail-able since 1997, the Opdima uses a CCD detector and a large field-of-view of 49 cm by 85 cm.

“Our system can be integrated [and] utilized 100 percent of the time, as opposed to a prone biopsy table that can only be used for one function. You get a quicker return on your investment,” says Siemens’ Scott-Santos.

GEMS also offers a digital spot and stereotactic device as an add-on to the company’s Senographe DMR+ analog system.

Like the analog mammography systems, companies continue to make enhancements to their digital stereotactic and spot imaging biopsy systems, many of which will be displayed at this month’s RSNA conference in Chicago.