This report originally appeared in the November 2011 issue of DOTmed Business News

With health care reform, reimbursement shake-ups, the challenge of an aging (and under-insured) patient-base and public and professional scrutiny over all things involving dose, medical equipment insiders are scrambling to make sense of it all and doing their best to make business decisions that will keep their business profitable. In some cases, those challenges may become opportunities for those with the ability to take advantage.

X-ray takes it to the bank
The United States’ X-ray system market—including general radiography, fluoroscopy, surgical, cardiovascular and mobile X-ray systems—will be valued at approximately $2.5 billion by the end of 2015, according to the summary of a Millennium Research Group market report titled, “US Markets for X-ray Systems 2011.” Driving the sector’s growth is an increase in geriatric procedures and digital flat-panel detector systems. But the report, written by Isuru Silva and published in November 2010, said the industry also faces limits: namely, market saturation.

New releases
Although the radiography and fluoroscopy market experiences uncertainty due to the current economic climate, manufacturers continue to introduce advanced technology that they say will help improve both safety and efficiency.

Over the past year, Philips Healthcare has launched two new radiographic products, according to Shawl Lobree, vice president of marketing for the company’s diagnostic X-ray business.
These include the MobileDiagnost wDR, a digital mobile radiography system with a wireless portable detector; and the DigitalDiagnost, a suite of digital radiography room solutions. “We’ve installed the first versions of both of those in the United States. And outside of the United States,” he says.

Toshiba America Medical Systems recently introduced the Kalare Wireless X-ray system. The company originally came out with the Kalare DR, a portable detector with a tether. “Now we’ve gone from tethered to wireless,” says Aaron Ybarra, Toshiba’s XR/VL product manager.

The new product features a wireless 14x17-inch detector panel. It also has a rotating bucky tray for the table and wall stand, making it easier for technologists to handle the equipment and transition from portrait to landscape.


“That will help their productivity,” says Ybarra, who explains that it can be awkward to remove a detector in a wall stand.



In June 2011, Siemens Healthcare received Food and Drug Administration 510(k) clearance for the Luminos Agile, the first patient-side fluoroscopy system to use dynamic flat panel detector technology. According to Pierre Niepel, the company’s director of radiography and fluoroscopy product marketing in the United States, the Luminos Agile is also the first patient-side fluoroscopy system with a height-adjustable table.


“It’s a big relief for the doctor and for the hospital staff because the system adapts to them and they don’t have to adapt to the system,” he says. “It sounds like a small thing, but it makes a huge difference to the clinical environment.”

Niepel also mentions that the product features true dual-use capability, meaning that it can be used as both a fluoroscopy and radiography system.

Dave Widmann, general manager for GE Healthcare’s X-ray rad/R&F business, says the company recently launched the Discovery XR656, a new wireless version of GE’s digital radiography system. The product uses a wireless digital detector called FlashPad, which can also be used on other GE digital systems.



The company also recently received FDA clearance for the Brivo XR285amx, an analog mobile X-ray system; the Optima XR200amx, a digital-ready analog mobile X-ray system; and the Optima XR220amx, a digital mobile X-ray system that uses FlashPad.

According to Boris Geyzer, senior product specialist for Canon USA, the company has released numerous radiographic products over the past year, including four digital detectors: the CXDI-401C, CXDI-401G, CXDI-401C COMPACT and the CXDI-401G COMPACT. Canon also recently received 510(k) clearance for the CXDI-501C and CXDI-501G digital radiography systems, with 14x17-inch imaging areas; and the CXDI-80C, a compact wireless DR system.


“We’re the first company that has a 510(k) on a small format wireless detector,” says Geyzer.

From a fluoroscopic perspective, the company introduced the D-250RF at the Radiological Society of North America’s annual meeting in 2010. The product, whose official name is in the process of being finalized, is a dynamic radiographic system that uses an RF panel and has a fixed, integrated table.


Sales in the sector
Philips’ Lobree reports that the company’s sales have been very good over the past year. He has noticed that more customers in the United States seem to be interested in replacing several radiographic and fluoroscopic products simultaneously.

“I think customers have gotten more savvy and realize that they have more purchasing power if they buy multiple pieces of equipment at once,” he says.
“This has been a great year for us, we really picked up after the 2008 recession,” says Frank Serrao, marketing manager of Shimadzu Medical Systems USA.

He feels the growth has been due to a combination of newer technology and the need for facilities to replace equipment. Similarly, GE’s Widmann mentions that sales have been “very robust,” and Canon’s Geyzer says that his company has had a “banner year” thanks to the introduction of their new products.

For Toshiba, sales over the past year have been a bit slow. “We are seeing a lot of hospitals are hanging onto their RF system, like a Kalare, and they’re just waiting for it to die,” says Ybarra.

“Overall we see that the market seems to be quite stable,” observes Niepel. Referring to radiographic and fluoroscopic equipment, he says, “everyone needs it, everyone has it and it continues to be a replacement market.”

According to Leon Gugel, president of Metropolis International, a vendor of used and refurbished diagnostic imaging equipment, sales have been improving over the past year.

“It’s a cycle where every three, four years there’s a lot of straight rad rooms on the market that are sold,” he says.

He went on to note that approximately 60 percent of Metropolis’ radiography and fluoroscopy business is international, and that most of his customers are from smaller, rural hospitals located in developing countries.

Major trends
One of the biggest trends in the sector has been the growing demand for digital products. “Customers see the value of digital,” says Widmann. “The trend is not only to go to full direct digital across the product line . . . but to also leverage the digital image for other workflow and clinical enhancements.”

Widmann estimates that nearly half of the radiography and fluoroscopy market has gone digital.

“Certainly today the request for digital equipment far out pays—in terms of tender—that of any analog equipment,” he says, emphasizing the fact that the complete transition to digital will be a gradual process. “Radiology is a piece of equipment that is held on to for 10, 15, sometimes 20 years, so customers make that investment in a very determined manner and it will take a long time for the market to fully convert.”

On the refurb side of the spectrum, Metropolis’ Gugel notes that while more customers are shopping around for used digital equipment, only about 10 percent of them actually purchase it due to the high cost and low reimbursement rate. “When they see what the prices are, they get gun shy and they realize, ‘OK, we’re going to have to make do with what we have as far as an analog rad room goes,’” he says. “Think of it this way, if you’re going to buy a car and [the price of] gasoline keeps going up, why would you buy a gas guzzler if you don’t get pay increases?”

Another ongoing trend has been the rising prevalence of wireless equipment.

“There’s a huge boom going towards the wireless product,” says Geyzer, who explains that in the past, facilities would typically only have a single DR panel fixed to one room. “Now they have the ability to take four or five detectors, use them throughout their entire department—more or less depending on the size—and not have to worry about having one detector tied to one room,” he says.

The sector has also been moving towards the uniformity of dose documentation.

“All the vendors have a different name of this number that represents a DR exposure that was done correctly,” says Ybarra. “Every vendor has different numbers and different names, so there are a lot of organizations that are pushing to standardize this and they’re going to call it the Exposure Index.”

Siemens’ Niepel has noticed that more radiographic and fluoroscopic products are adapting to accommodate the nation’s shift in demographics, such as the increased presence of obese and elderly patients. One example of this would be the implementation of height-adjustable tables, which makes it both easier and safer for bariatric and geriatric patients to get on and off the table.

Tableside versus remote-controlled
Despite the fact that the majority of the world uses remote-controlled fluoroscopy systems, conventional tableside units are still dominant in the United States.

“Many of the doctors we speak to say they just like having their hand on the patient while they’re doing fluoro,” says Lobree.

Shimadzu’s Serrao suggests that this trend began decades ago because our country is a litigious society that has a higher occurrence of medical malpractice lawsuits.

The benefit of a tableside system is that many patients feel safer knowing that a medical professional is in the room in case something goes wrong. The downside, however, is that the technologist is being exposed to ionizing radiation.

While some experts believe that tableside systems will always be around, others feel they are slowly beginning to disappear. “We’re seeing that more and more, there’s a trend moving away from under-table conventional and toward a flat panel over-table fluoroscopic system,” says Geyzer, who suggests that this is due in part to the younger, video game-playing generation of radiologists who are accustomed to using remote-controlled technology. “With that being said, you’re not looking at a swing from 85 percent in the past to 60 percent — we’re talking little, incremental bits,” he adds.

Current challenges
One the major challenges in radiography and fluoroscopy—as well as in the rest of the medical industry—is that customers are becoming increasingly demanding.

“They’re under more and more pressure to take care of more patients with fewer resources,” explains Lobree.

Customers these days are really scrutinizing the total cost-of-ownership of their medical equipment. It’s common knowledge that new products are typically more expensive than older ones, because they use newer technology and the investment in that technology is still being paid off by the manufacturer; but in the midst of a struggling economy and a changing health care system, it’s not easy to persuade budget-conscious customers to dish out more money.

“You have a base price [for a product], you add something to it, it costs a heck of a lot more because it does a lot more, but they’re not willing to pay a lot more,” says Serrao. “People are still being discretionary so you have to give them more value for the product, and the way to do that is with these advanced applications, where now they can do so much more. In other words, versatility: one system that can do it all.”

Niepel thinks that there is not enough of an organic role in the market.

“There are not that many new hospitals, there are not that many new imaging centers, so the market is pretty stable,” he says. “It’s very much a replacement cycle and obviously it’s also quite competitive.”

Refurbishers face the challenge of trying to convince customers that it’s perfectly acceptable to purchase used equipment if they cannot afford to buy it new. The key is to conduct business with a reputable re-seller who is going to guarantee a high-quality product.

“It’s like a used car; as much as we all want a brand new, fancy Mercedes Benz, we can’t all afford it,” says Gugel. “Even if you can’t afford a brand new Toyota, you buy a used one. There are some owners that take care of their cars before they sell them used, and then there are others that beat them into the ground. As a conscious and discerning buyer, you have to be aware of what car, or in this case equipment, you’re going to spend money on.”

Changes to come
“Definitely we’re going to see more convergence of radiography and fluoroscopy systems into combined rooms,” predicts Lobree, referring to both tableside and remote-controlled rooms. He also mentions that moving forward, manufacturers will provide more of a variety of economical solutions. “Customers like to have a wide selection of configurations and versions so that they can really tailor the product to their budget,” he says.

“More and more customers will want to maximize their investment from an economic perspective,” says Niepel. “They want to see 100 percent fluoro and they want to see 100 percent radiography to make their investment pay off. They also want to be compelling to their patients, so they position themselves as a dose leader in terms that they apply the least dose to their customers and their patients.”

Widmann feels that workflow simplification is going to be a growing trend. “I think there will be a continued pressure to find methods to make a hospital department more productive, more effective in how they use equipment,” he says.

“I think it’s something that will never go away,” says Serrao. “It’s the bread and butter of all the radiology departments or clinics; whereas the higher-end stuff—like CT and MR—evolve and something else goes away, the basic stuff always remains there.”

DOTmed Registered Radiographic. Rad/Fluoro Companies

Names in boldface are Premium Listings.
Domestic
Ted Huss, Medical Imaging Resources, CA
DOTmed Certified
Nathalie Umpierrez, AMT Medical Technology and Equipment Corp, FL
David Denholtz, Integrity Medical Systems, Inc., FL
DOTmed Certified
DOTmed 100
Ed Ruth, Managed Medical Imaging, FL
DOTmed Certified
Mary Fowler, Espie Service Group, GA
DOTmed Certified
DOTmed 100
Larry Sprague, Imaging Resources, GA
Steve Layton, Steve Layton X-ray Services, Inc., GA
Glenn R. Hammerquist, Berrien X-Ray, MI
Krista Kotrla, Block Imaging International, Inc., MI
DOTmed 100
GEORGE Pardue, Imaging Affiliates, Inc, NC
Joe Brock, Troff Medical, NC
Joseph Jenkins, International Imaging Ltd., NV
Joseph A. Nelsen, JOJ-XRS, TX
DOTmed Certified

International
Mads Vittrup, AGITO Medical, Denmark
DOTmed 100
Imad Muati, IMC, Syria
DOTmed 100
Hector Araya, Araya y Cia Ltda, Chile
Tajinder Singh Bhatia, MRI Services, India