Technology Development to Meet Market Needs: A Conversation With Mark Silverman

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On April 14, 2011, Hitachi Medical Systems America, Inc (Twinsburg, Ohio), announced the FDA approval of its first 64-slice CT system, SCENARIA™. spoke with Mark Silverman, manager of CT marketing for Hitachi, about the company’s goals for the new product and the assessment of the current CT marketplace that drove its design. SCENARIA is Hitachi’s first 64-slice CT scanner. What made the company decide to introduce this technology now?

Silverman: Hitachi has sold and shipped more than 12,000 CT scanners, around the world, for the past 30 years, but they’ve all been in the lower-slice category. What made us decide to launch this 64-slice system, which is a higher level of technology for us in CT, is the fact that through our experience in MRI, we have a strong understanding of the needs of the radiological buyer. We felt this technology was needed to address certain needs in the marketplace better. What needs in the marketplace were you observing?

Silverman: We have included a number of advanced features in our 64-slice CT to provide the best combination of price and performance for the marketplace. In MRI, we’ve seen and understood the needs of trying to accommodate obese, claustrophobic, and anxious patients better, and we’ve proven our ability to provide a user interface that is easy to understand for the operator. These are all characteristics we’ve brought to the SCENARIA CT. Dose reduction is also critically important. CT procedures need to be safer for the patient, and they need to be easier for the physician to justify, because they have tremendous potential diagnostic benefits. How does SCENARIA address these needs?

Silverman: For obese, claustrophobic, and anxious patients (who, combined, make up a substantial number of patients in the United States), SCENARIA has the benefit of a 75-cm (30-inch) gantry aperture and the thinnest gantry for a 64-slice CT, which enhance access and reduce the claustrophobic feeling. Our standard table is a heavy table that can hold a patient weighing over 500 pounds, so that gives access to patients who were difficult to scan before because of size or anxiety.

As we all know, with an uncooperative patient, you’re generally not going to get very good results. Patients today want to be comfortable, and they want a quick exam. Being able to provide a positive experience for the patient is a very important selection criterion when choosing a CT system.

We’ve also built in a suite of advanced dose-reduction features. There are two new dose-awareness features to assist the operator and provider; one is called Dose Check, which complies with a new standard put out by NEMA last year in consultation with the FDA. If the operator selects a protocol that would result in a dose that’s higher than a reference level, the scanner will check that and alert the operator with a pop-up notice.

A second feature is the DICOM dose-structured report. SCENARIA can generate a dose report for each patient that can be sent with the images to the PACS or can be directed to a database of dose information for analysis. This enables providers to track radiological history, and in the future, there will also be regional reference databases collecting dose information from multiple institutions—to help create benchmarks, so an institution can see if it’s using the appropriate dose. Was SCENARIA developed with any particular market in mind?

Silverman: It was developed with imaging centers and medium-sized community hospitals in mind. The way we see the market is that a 64-slice CT, depending on how it’s configured, is the system that does what most providers need. A model can be configured for routine applications (which are 85% of procedures currently being performed in CT), but with 64-slice CT, you can also add cardiac and other advanced-applications capabilities, and you can perform these applications well.

Higher-slice scanners may provide some enhanced advanced-applications capability for a small percentage of patients, but SCENARIA meets the broadest need in the market (and for a half to a third of the investment of the most advanced CT models). It is the best clinical value, and value is obviously critical today, especially in the evolving health-care environment we’re facing.

In addition, most CT scanners being sold in the United States today are replacement scanners; we’re not seeing too many new