orr.jpg (8823 bytes)Happy 20th birthday to the era of computers-as-business-tools, which began for mainstream business people with IBM’s introduction of the PC (OK, so Apple was first for a few years, but this was not much of a tool for business). Does anyone seriously remember the days before we all owned multiple computers and PDAs at work and home?

Yet, looking at the world of radiology 20 years ago, many things have remained the same. Despite the progress of CT, MRI, CR and PACS, the radiologist still patiently evaluates each and every imaging study that is requested.

Now, looking forward another 20 years, do we expect the same from our radiologists of the future, patiently evaluating each and every image?

Let’s look for some change here, and improve everyone’s effort to diagnose better and earlier, especially in screening for cancer. Interestingly, the major buzz at RSNA this year was CAD, which stands for computer-aided detection or computer-assisted diagnosis, at least for now. CAD is farther down the road, as I’m not ready to trust a computer’s ability to diagnose yet. It’s a simple extrapolation into the future then to move beyond CAD into CAR — computer assisted radiology. It’s your vision of what this includes and excludes that may be defining some of your present reactions to the fast-developing market for CAD products. But the market is clearly here, growing and the Genie is out of the lamp.

The focus of this column has always tried to stay on the near-term deployment of leading edge clinical tools that make a difference for patients. So let’s have a look under the hood at the CAD market today.

R2 Files for IPO
That’s probably not the preferred headline to write when discussing products and technologies that make a difference in patient care, especially in breast cancer screening. But to investors and technology watchers, it’s the significant event and may help patients more than you realize.

First, R2 Technology Inc. (Los Altos, Calif.) has pioneered the commercial development of CAD products for breast cancer screening, available for use with either digitized x-ray films or digital x-ray images (see story on page 54 for details). The basic facts of this disease are:

  • 548,000 new cases of breast cancer diagnosed annually worldwide
  • 181,000 annual deaths worldwide
  • 25,000 mammography systems installed worldwide
  • 58 million annual screening procedures (U.S. and Europe)
  • $58 million invested in R2 to date

So how well does the R2 device work? R2 research and clinical trials indicate that use of the ImageChecker results in the detection of ~20 percent more cancers. This implies that only 5 out of 6 breast cancers are detected by today’s radiologists, working alone and unaided. To patients who are already nervous about the procedure itself and the value of the annual screening mammogram, this technology strikes a very resonant chord!

As usual, the first rule of thumb is that CAD is neither free nor cheap, and if Wall Street doesn’t get behind this, you may have to write your own code at night. Sure, CAD is just software, but submitting any CAD-related device to the FDA without a series of solid clinical trials is asking for a speedy reply.

R2 now indicates the sale of 275+ ImageChecker units, and over 2 million procedures performed on the systems to date. If you are still awake at this point of the article, you should probably start seeing $$$, but in this case, these magic symbols are actually flowing both ways, not just out of your pocket for a change. R2 has actually accomplished something most companies only write about in their business plan, by obtaining CPT codes and insurance company payments for the use of this leading edge technology. These reimbursement payments are not exclusive to the use of R2 systems, they apply to CAD used for mammography by anyone, including competitors.

While R2 has the clear market lead and now begins to leverage its extensive technical ability in other CAD markets (lung cancer), the sweet smell of success has enticed other companies to the doorstep of the CAD market.

Competition Arrives
The old saying of it takes a pioneer to show the way, but two to make a trend applies here as well. An RSNA floor tour noted Deus Technologies (Rockville, Md.) has FDA clearance for lung cancer applications in chest x-rays; Intelligent Systems Software Inc. (Boca Raton, Fla.) has a newly cleared MammoReader system; CADx Medical Systems (Montreal, Canada) is awaiting full FDA clearance of the SecondLook after receiving an approvable letter last year; and Scanis Inc. (Foster City, Calif.) is working to file for FDA marketing clearance this year for the Mammex TR.

Kodak and GE Medical Systems also are working in these markets via partnerships with some of the above listed firms.

Now What
It’s like the car salesman always says — take it out for a test drive and see how you like it. You can educate yourself via the Consumer Reports method, by gathering technical details, comparisons of features, prices, warranties, etc., until you are familiar with the jargon and landscape. But then comes the test drive, and you can form a real opinion that counts — your own. Because if you don’t want to do this, you can come up with a hundred reasons not to. But if you try it and like it, you can come up with 20 percent more reasons to do it for the right reason, which just might be your patients.

Doug Orr, president of J&M Group (Ridgefield, Conn.), consults with medical device companies in strategy and business development for emerging growth markets, notably radiology and cardiology. Comments and suggestions can be sent to [email protected].