IVD Executive Discusses Three Developing Trends

Published interview describes existing flaws in analyzers, automation, and software

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CEO SUMMARY: In a refreshingly candid assessment of current technology published in IVD Technology magazine, one lab industry executive describes both the successes and the failings of analyzers, automation, and software. He offers three trends he expects will address the deficiencies of the current generation of products. Help appears to be on the way, even if it will take a few years to reach the market.

SERENDIPITY IS THE WORD that describes the unplanned and fortuitous conjunction of events. It aptly describes the May publication of an interview with a top executive at one of the leading IVD companies, discussing laboratory automation and lab software, even as early adopter laboratories at the Executive War College in Miami last month were sharing their lessons learned.

In the May 2006 issue of IVD Technology magazine, David P. Herzog, Ph.D., who is Senior Vice President, Instrument Systems Division at Diagnostic Products Corporation (DPC) in Los Angeles, California, wrote a story in which he described “three emerging trends that may improve automation and take lab efficiency to the next level.”

THE DARK REPORT now offers an edited selection of his specific comments on the problems caused by today’s level of instrument, automation, and software technologies. It confirms the assessments presented in June 12, 2006 issue of THE DARK REPORT, and adds understanding to the reasons why many forward-looking laboratories are implementing pieces of automation, looking for third-party middleware sources, and deploying quality management methods in their laboratories.

Today’s Large Analyzers

Early in his story, Herzog addresses the problems of today’s large analyzers and instrument systems. Herzog recognizes that IVD (in vitro diagnostics) manufacturers have designed their products to save labor. He writes, “By looking for solutions to minimize labor further, today’s total lab automation (TLA) systems integrate multiple analyzers, automate specimen preparation, and facilitate sample retrieval when additional testing is required.

“The resulting systems often require labs to spend more than $1 million on complex, rigid automation systems to achieve the much needed productivity improvements. Manufacturers are reaching the limits of current analysis technologies as high-volume instruments become too large to fit into some labs.

“In addition, the growth in complexity and physical size of analyzers and automation systems has required IVD manufacturers to design higher levels of embedded instrument intelligence for performance monitoring. Many analyzers contain sophisticated sensors and software that manage every step of sample processing, ensuring that it is carried out with quality and precision. Such systems give labs and manufacturers new opportunities to access a wealth of real-time sample and instrument data that the automation software may use to efficiently manage the testing process.”

Describing Some Problems

Following this summary of the current state of IVD technology, Herzog then describes some of the problems, many of which will be familiar to clients and regular readers of THE DARK REPORT. (The use of italics in Herzog’s statements is done by us to draw emphasis to certain points.)

Herzog describes several problems, saying, “However, due to legacy systems and limited efforts in system integration, most of the automation software on the market today is complex and difficult to use. Lab technologists must use multiple screens and workstations to access test and instrument data. Software commands are complex and multi-step, even for the basic lab processes such as the review and release of test results. While today’s analyzers can deliver growing amounts of real-time instrument and test data, automation software has not caught up to translate data into effective lab management tools.

“Instrumentation bloat and software complexity have limited the gains that labs have seen from automation,” he wrote. “These issues, though, are undergoing change.”

Herzog has more to say on the subject of software, “Automation software limitations slow down lab processes and do not allow labs to realize the analyzer’s test volume potential. For example, automation software that does not allow any test results to be released until the slowest test has been completed limits productivity gains from a multi-million-dollar investment. Staff savings are constrained by software that requires lab personnel to walk around the lab and view screens on multiple workstations in order to manage an automation system.

“Instrumentation bloat and software complexity have limited the gains that labs have seen from automation,” he wrote. “These issues, though, are undergoing change.”

“The next generation of lab automation software will move away from today’s fragmented, complex systems by integrating all aspects of lab management, from sample logistics to results management, archiving, and retrieval. Access to the laboratory information system (LIS) and all lab processes will go through a centralized control function. Labs will achieve productivity gains by consolidating data and instrument management, and not requiring lab personnel to monitor and manage various data feeds on multiple screens. This emerging functionality may enable a staff of fewer than five technologists to manage a lab delivering millions of tests per year.

Demand For Solutions

“Laboratory demands will drive this software trend. Lab managers and their personnel are increasingly frustrated by automation software that has not caught up with the capabilities of the analyzers, and cannot provide access to and management of the lab data. A survey by Diagnostic Products Corp. (DPC) found that many labs believe their automation software is several generations behind the functionality of the instruments.”

Herzog summarizes his view by predicting three trends which, as he puts it, “will drive laboratory automation’s future.” First will be “smaller, more flexible analyzers and automation based on next-generation technologies, including microfluidics.”

Herzog foresees that developing microtechnologies will create smaller instruments, which use smaller amounts of sample (he predicts 100 nl–50 µl), as well as reagents.

The second trend identified by Herzog is “easy-to-use, powerful software for centralized lab management.” After noting that, in today’s laboratory, techs must view multiple screens on multiple workstations around the laboratory in order to manage the automated system, Herzog observes that the solution will be in simple-to-use software that integrates and controls all the management functions, and can be accessed from any single workstation in the laboratory.

The third trend reflects the IVD executive’s enthusiasm for the potential of developing technologies to address the QA/QC challenges resulting from today’s “big box,” high-volume automated systems. Herzog predicts that “Internet-based real-time service for better uptime” performance of the laboratory’s instrument systems will become common.

Remote Monitoring Via Web

He explains that IVD manufacturers are learning how to tap into the “analyzer’s built-in intelligence to monitor and diagnose instruments remotely,” including via the Web. Not only can this allow the vendor to spot impending failures of the analyzer’s parts and systems, but it opens the door to added value services.

In particular, Herzog notes that DPC is already using Internet connections with its installed analyzers to collect quality control information and provide this information back to the laboratories. With enthusiasm, he notes that, “This technology can generate quality control reports for the labs in real time and can download composite peer information to a Web browser at any time, anywhere in the world. Labs will no longer need to wait for the next monthly summary of quality control results to find out how their performance compares with their peers.”

Herzog’s comments show that the IVD industry recognizes that, in creating large, high-volume analzyers and automated systems, it has contributed to increased labor productivity in laboratories. At the same time, Herzog offers candid comments on the weaknesses of these systems and the operational problems they create for laboratories.

Unlocking Productivity

This is why THE DARK REPORT has repeatedly pointed out that, even as laboratories enjoy the benefits that accrue from using some of these large analyzers and automation solutions, they still have a compelling need to continuously attack existing bottle-necks and unlock additional productivity gains.

Progressive labs are emphasizing operational efficiency. They are redesigning deficient or inadequate work processes in pre-analytical, analytical, and post-analytical work flow. Middleware and quality management methods are proving to be effective tools to accomplish these goals.

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