By Renee DiIulio

  “Make it easier for me to get my work done,” cry clinical laboratory managers who today find themselves in need of more time, more budget, and more staff. Unable to produce these items from thin air, these busy professionals turn to their suppliers for more efficient and productive products that can do more with greater ease. Those companies that respond can hope to maintain and even increase their market share.

Ortho-Clinical Diagnostics, a Johnson and Johnson company, has been keeping the lines of communication open with its customers and, as a result, has developed the first product in its new VITROS® Fusion Series, an idea born in May 2000. “We wanted to develop a concept for our systems that would improve and leverage upon the features our customers already like and add those they’ve been demanding,” says Bob Geen, marketing director for Clinical Chemistry at Ortho-Clinical Diagnostics.

The company knew, from both its own and third-party research, that users of its products value their ease of use, but it also knew that these customers wanted these same products to feature a larger test menu. In addition, those who had “not yet experienced VITROS” often held back because they considered the smaller test menu a barrier.

Subsequently, a new system that would combine a broader test menu with the ease-of-use Ortho-Clinical Diagnostics was known for would not only help the company expand its market share but would also help customers perform their jobs.

Factors in the Lab
According to Geen, Ortho-Clinical Diagnostics’ development team kept in mind four specific issues that affect labs:

1) Personnel shortages: “The market is facing severe labor constraints with vacancy rates in the single-high to double digits. The average age of lab technologists is now over 50, meaning that the problem will only get worse,” says Geen. “Ultimately, labs will seek systems to reduce the labor strain, first through improved labor efficiencies and consolidation of test menus on to easy-to-use systems, and then through automation and improved data integration.”

2) Budget constraints: Nearly every health care facility today must constantly look for ways to do more with the same or less funding. Labor represents approximately 50% of a laboratory’s operating budget. Easy-to-use systems allow customers the opportunity to allocate precious labor resources to value-added activities.

3) Error reduction: “Hospital administrators are focused on reporting, monitoring, and decreasing errors, so a system that can minimize the potential for laboratory errors without human intervention would be a boon in the lab,” says Geen.

4) The need for improved service to doctors: As the general public, with the aid of the Internet, takes a more active interest in personal health and as the demographics of an aging population continue to impact the system, demands on medical institutions and their personnel increase. Doctors depend on laboratory test results to effectively triage and admit patients. As a result, laboratories are working to provide faster and better information for decision-making.

Targeting Customer Needs
Ortho-Clinical Diagnostics’ current laboratory customers generally perform more than 300,000 tests annually and are generally located within hospital facilities.

The company’s new VITROS Fusion Series is being designed to integrate many of these tests, including chemistry, special chemistry, immunoassay, and infectious disease assays, into single systems. The VITROS 5,1 FS Chemistry System allows lab personnel to run up to 80 tests, double the previous capacity. “Competitive systems are able to boast a large test menu; however, at most, the systems can run only 40 to 50 tests at once,” says Geen.

This positive comparison is not due to chance. Ortho-Clinical Diagnostics evaluated customer needs before beginning development of the first product in the new series. “We wanted to determine how we could add more value and differentiate ourselves,” notes Geen.

Redesigning “Wet” Chemistry to Provide the Benefits of Slide Technology
One way the company already sets itself apart is with its MicroSlide™ technology, which, through the use of disposable tips and chemical reagents that are layered in a dry thin-film format, avoids problems inherent to traditional fixed-probe liquid chemistry systems. This technology eliminates the need many systems have for high-quality water, often in quantities of up to 50 L per hour, and the water system, maintenance, and contamination potential that go with it. MicroSlide technology also provides improved accuracy in diverse hospitalized-patient settings. An example of this is direct ion-specific electrodes.

The challenge, according to Dave Tomasso, engineering fellow, System Architecture Group for Research and Development, Ortho-Clinical Diagnostics, was to broaden the test menu without requiring the water, plumbing, fixed probes, and mixing assemblies required for today’s liquid systems. “We wanted to balance the system functionality while further improving ease-of-use and minimizing cost.”

“Our biggest challenge was to utilize liquid reagents without requiring the compromises required of a traditional liquid chemistry system,” says Tomasso. The answer was MicroTip™ technology, which uses disposable tips to dispense and mix reagents and samples. A new MicroTip was developed specifically for the system to provide the necessary metering precision and eliminate the need for typical liquid chemistry system fluids.

Merging two different technologies was another challenge. “Integrating on a traditional liquid chemistry approach would have been an easy solution for us, but not for the customer. We wanted the integration to be seamless, improving upon our VITROS ease-of-use tradition,” says Tomasso.

As part of assessing customer needs, another opportunity arose in the area of sample interferences, emphasized by customers’ increasing concern about errors. The VITROS 5,1 FS utilizes new MicroSensor™ technology, which allows the system to run interference checks without using additional samples, reagents, and disposables or slowing system throughput.

“We knew through previous development work with near infrared technology that we could run interference checks directly on the sample in the disposable tip. Using this knowledge, we developed the MicroSensor™ technology. The analysis is run in 11/4 seconds, eliminating the impact on throughput while improving confidence in test results,” says Tomasso. The sample in the tip is then used for any additional MicroTip assays.”

Throughput is also improved by utilizing parallel processing. This enables the system to run specialty tests without impacting throughput of the general chemistry tests.

The new system will also introduce V-DOCS, or onboard documentation, and e-Connectivity™. V-DOCS supplies all documentation on the system, such as Ortho-Clinical Diagnostics methodology sheets, so users can access and print at any time. In addition, it features animated help for troubleshooting and problem solving, reducing the need to turn to the manual or the customer support hotline for help. “The ultimate goal is to improve uptime and productivity in the lab,” says Geen.

Similarly, e-Connectivity can reduce time spent on maintenance. “E-Connectivity allows real-time diagnostics on the system to occur remotely, enabling a service engineer to identify the problem before he arrives on site and therefore to arrive bearing the needed parts,” says Tomasso.

“The ability to have bidirectional communication means we can also push information that we normally have mailed, such as control sheets and software updates, directly to the system in real-time,” adds Geen.

In addition, the VITROS 5,1 FS will allow users to request self-diagnosis and provide a report assuring that the key subsystems are working effectively.

Capacities and Capabilities
The need to increase capacity and improve capabilities on the new generation of clinical laboratory systems is a result of the increasing volume of patient specimens and test requests from physicians. The VITROS 5,1 FS can handle 160 samples at a time. In addition, a separate STAT lane will give priority of up to 10 samples. The reagent capacity has been increased to accommodate walkaway time.

A tip loader is now integrated into the system and, if desired, can handle a second system. “The automated tip loading capability offers significant productivity benefits,” says Tomasso.

The new system will offer a test menu that features serum proteins, therapeutic drugs, drugs of abuse, and miscellaneous tests to the general chemistry menu. “We found that customers consistently asked for these four categories,” says Geen.

The system can handle both spectrophotometric and turbidimetric assays and can perform open-channel or user-defined testing. “Just in case we weren’t able to meet all of a particular customer’s needs, we made it possible for customers to develop specific assays for the system,” says Tomasso.

Thinking Ahead
These features are just some of the many that the company has considered while looking ahead. “The VITROS 5,1 FS Chemistry System is the first in the series, but we knew that we would need to utilize what we learned here in future products,” says Tomasso. Therefore, research and development were undertaken with an eye toward not only the first system to be launched but those to follow. The new technologies, including the MicroTip, MicroSensor, e-Connectivity, and even the integrated automatic tip loader, were developed with that vision in mind. The interface and commonality will be standard across all the systems in the series.

In addition, the company employed customer input, independent consultants, and third-party analysis to refine the product through the development process.

The VITROS 5,1 FS achieved Food and Drug Administration (FDA) clearance in 45 days, a much shorter time frame than the industry average. “We work with our regulatory group throughout the product development cycle so that documentation and detail is clear when we arrive at the point of application,” says Tomasso. FDA 510(k) clearance was granted in August 2003; the system is expected to be available in the second half of 2004.

For additional information, contact Bob Geen, marketing director for Clinical Chemistry, Ortho-Clinical Diagnostics; Dave Tomasso, engineering fellow, System Architecture Group for Research and Development, Ortho-Clinical Diagnostics; Mary Richardson, Public Relations, Ortho-Clinical Diagnostics (908) 704-3652; fax: (908) 218-4640; email: [email protected].

Renee DiIulio is a contributing writer for Clinical Lab Products.