College of American Pathologists
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  Vendors' views on the function and future of middleware


CAP Today


March 2008 System Review Series

CAP TODAY asked middleware vendors to define the term middleware and the role such systems will play in the laboratory in years to come. Here's what they had to say.

CAP TODAY: How do you define middleware? How does it differ from a pure interface product?

Jacques Baudin, executive vice president and general manager, Technidata, Tucson, Ariz.: Middleware is a concentrate of new technologies and software solutions dedicated to enhan­cing laboratory information systems, regardless of which LIS, lab automation system, or instrument vendors' products are being used. It is designed to handle all tech­nical aspects of a specific section of the lab or the complete laboratory work­flow, from dispatching specimens, to verifying results, to generating reports. In other words, middleware is the ultimate laboratory production manager.

Middleware is much more than an interface between two devices-it is a scalable connectivity solution that can handle multiple instruments, multiple LISs, multiple users, and possibly multiple sites. It can ­provide added-value functionality in its use of the information being exchanged between devices, such as instrument flags and status messages. It automatically triggers relevant actions in real time upon receiving test orders or test results. And it can be used as a powerful, user-definable, rule-based system for autoverification or as a comprehensive specimen-management system.

Middleware helps the laboratory by ensuring productivity, optimizing the use of resources, and minimizing turnaround times without compromising the quality and accuracy of the information supplied.

John Selmyer, president, Dawn­ing Technologies, Fort Myers, Fla.: Middleware is a suite of applications that fit between devices and systems or systems and systems in any combination and that adds value and functionality to the integrated pieces. It is not limited to the connection between laboratory instruments and lab information systems. An interface, on the other hand, historically would connect an instrument and an LIS, providing a bidirectional exchange of orders and results, often translating one end into a standard protocol, such as HL7 or ASTM. Middle­ware is a next-generation approach that adds considerable intelligence and user control to that process.

While a number of features differentiate middleware from interface products, it is primarily rules capabilities that set middleware apart from simple interfaces. A rule may lead to a standardized comment being added to a result message, information that would cause errors being filtered, a reflex test being triggered, or many other actions.

At the extreme, a complex set of rules filters can provide autoverification of results or review by exception. However, there is considerable difference across middleware products in how rules are created, applied, and managed.

Gregory Vail, CEO, Data Innovations, South Burlington, Vt.: Middleware is software residing in the middle of lab operations. The common definition—software that facilitates communication between two applications—may have fit when middleware first served as a protocol translator between a labora­tory information system and analyzer, but it is too simplistic to depict what the soft­ware has become.

Reimbursement caps, budget cuts, and staff shortages have forced laboratories to undergo rapid changes in relatively short order. Many have turned to automation and outreach programs while trying to handle more, and increasingly complex, data. Some have adopted the business model of manufacturing and engaged in exercises traditional to that model, such as Lean Six Sigma. Middleware is a critical tool for supporting these changes in labora­tory workflow, having expanded into pre-analytics, analytics, post-analytics, and even ancillary activities that have nothing to do with interfacing, such as scheduling and tracking maintenance activities.

Eric Olson, senior director of infor­matics, Siemens Healthcare Diagnostics, Tarrytown, NY: Middleware is the layer of software that connects clinical and departmental information technology systems to diagnostics instrumentation. The right middleware system fills the gaps between a laboratory's LIS and the unique data-management needs of that laboratory. Consequently, laboratories look to middleware for more than basic interfacing capability. They use it to handle results management, rules engines, sample management, quality control, and test order entry.

CAP TODAY: Is the trend for middleware to be the "go-to" solution for needed lab computing enhancements getting stronger? Or have traditional LIS companies become more likely to offer such enhancements in their offerings?

John Selmyer (Dawning Technologies): I believe middleware products will remain in demand for some time. Good middleware allows clients to add considerable functionality to an LIS at a very reasonable cost. This can extend the useful life of the LIS, or even several LISs when the application involves multiple clients sharing resources, such as expensive automated instrument systems. Middleware may be the only way to gain new functionality since few vendors are making noteworthy research-and-development investments in their LIS products these days.

Middleware has become a hot topic in recent years, triggering a flurry of activity, ranging from some smaller LIS vendors presenting their lab systems as middleware to larger LIS vendors and in vitro diagnostics manufacturers developing their own middleware products. Where these will fit in the evolving spectrum of middleware products remains to be seen.

There are a very small number of true middleware vendors, whose products have been refined by years of competition and continuous development. But these vendors' products will continue to offer cutting-edge features and benefits well ahead of repackaged systems and lab information systems posing as middleware.

Jacques Baudin (Technidata): Middleware is not the only go-to solution available for lab computing enhancements-similar functionality may be available from more traditional LIS companies. However, middleware is one of the newer delivery mechanisms for value-added features. It can fill functionality gaps in an aging LIS, providing affordable access to new technology and functionality, and thereby giving the aging LIS a new lease on life.

Laboratories need to be able to access best-of-breed functionality or enhancements and take advantage of new technology as much as they need to be able to address the operational issues they face on a daily basis. The main issues for laboratories are how best to access and implement enhanced functionality, the cost of ownership for such functionality, and the associated return on investment.

Gregory Vail (Data Innovations): I don't think these two questions should necessarily be separated by an "or." Not only has middleware become a go-to solution, but traditional LIS companies are beginning to embrace it as such.

Because middleware has been poorly defined, LIS companies initially did not know what to make of it, some even perceiving it as competition. After doing a make/buy analysis of the functionality offered by middleware, Data Innovations' LIS partners are coming to the conclusion that it is an inexpensive and time-saving way to augment their total solution.

Eric Olson (Siemens Healthcare Diagnostics): Rather than choosing between middleware and an LIS, the trend is toward simplifying laboratory management-one system, one integrated workflow. IVD and LIS companies will continue to focus on software solutions that enhance data management and process management.

The next big breakthrough in information technology will come from integrating the workflow that spans LISs, middleware, and analytical instruments. Diagnostics companies will need to have strength in information technology and systems design to lead in this area.