In Vitro Diagnostics Case Studies

Sustaining Engineering Breathes New Life into Existing Clinical Chemistry System

Software for Multiple-Assay Clinical Laboratory Analyzer

Verification and Validation Leadership for New Product Development

Architecture for a Complete Remote Diagnostics System

Verification Utility for Immunodiagnostic Instruments

Fluid Analyzer Throughput Upgrade Using Direct HDL

HIPAA Compliance, Throughput Improvement and Cost Avoidance for Clinical Chemistry Analyzer

Integration of Analyzer into Laboratory Automation System

Sustaining Engineering Breathes New Life into Existing Clinical Chemistry System

RTEmd’s sustaining engineering team helped a leading diagnostic systems manufacturer launch a new FDA-approved product without the usual cost of new product development. Software enhancements to an existing clinical chemistry system improved throughput 10% to 25% and time-to-first-result up to 12%. These dramatic improvements allowed the manufacturer to launch the improved system as a new model—creating new revenue fast, and boosting customer satisfaction. Get the full story.

Software for Multiple-Assay Clinical Laboratory Analyzer

RTEmd developed the operational software for a new multiple-assay clinical laboratory analyzer. This automated laboratory test system uses nuclear magnetic resonance (NMR) spectroscopy to analyze plasma and serum samples and to diagnose patient risk for cardiovascular disease and related maladies. It integrates an automated sample handling system and a server with software to analyze digitized spectral data from the NMR spectrometer.

RTEmd designed, developed, documented, and tested the operational software for the new product. Key aspects of the project included:

• completing the software requirements specification
• defining the software architecture and high-level design
• developing and implementing software for overall instrument control, sample handling, fluidics control, and interface to the NMR subsystem
• providing a flexible implementation to support multiple assays

The instrument is now operating with consistent reliability and producing repeatable results. Clinical trials are expected to begin in 2009.

Verification and Validation Leadership for New Product Development

RTEmd provided software verification and validation (V&V) in a major product development effort for a leading diagnostics systems manufacturer. The project involved combining two current products into one integrated system, providing both clinical chemistry and multiple immunoassay testing on one platform.

RTEmd provided software quality assurance leadership throughout the three-year development process. The RTEmd V&V team:

• Helped create the system verification testing strategy for the graphical user interface (GUI).
• Helped identify and document project requirements.
• Helped classify testing requirements for system and subsystem verification testing.
• Reviewed legacy test procedures to determine which could be used or modified to meet the new subsystem verification needs.
• Wrote new verification test procedures for areas that required additional testing.
• Executed test procedures and created compliant documentation.
• Produced interim and final test summary reports
• Participated in formal reviews of procedures, requirements, functional specifications, and release notes.
• Completed retests of defects and any applicable test cases as the defects were resolved.
• Finalized and delivered subsystem test notebooks in accordance with the schedule.

A subsequent review by the customer also resulted in a redesign of one of the legacy systems, with RTEmd providing V&V services for that project as well.
Our customer was able to bring these two highly complex systems to market on time. An aggressive development schedule was executed with timely completion of interim milestones as well as a successful FDA 510(K) approval. The RTEmd team responded to changes in priorities and worked effectively as part of a larger integrated team with other engineering and scientific disciplines throughout the program.

Architecture for a Complete Remote Diagnostics System

For a major provider of in vitro diagnostics systems to clinical laboratories worldwide, RTEmd architected a next-generation remote diagnostics system for one product line, with the expectation of fulfilling the remote diagnostic needs for all corporate product lines. RTEmd designed the architecture to cover the broadest range of current and future product platforms.

This remote diagnostics system features:

• Secure and immediate transmission of operational data
• Secure remote login capability for troubleshooting
• Software downloads for upgrading the IVD analyzers and the remote diagnostics system itself.

RTEmd's solution also enables easy integration into clinical facility networks, maximizing protection and security for the IVD analyzers.

Verification Utility for Immunodiagnostic Instruments

For a worldwide provider of immunodiagnostic instruments, RTEmd produced an Assay Protocol Verification Utility that compares the assay protocols used by several instrument models to the data created when assays are run. The utility facilitates instrument and assay verification as well as troubleshooting problems identified in the field. RTEmd wrote the utility, to run under Windows 2000 or XP, using VB.NET and .NET Framework Version 1.1 and interfaced it with Microsoft Access 97 and 2000 databases using ADO.NET. Outputs were several reports, and a CSV file that included all of the pertinent data used in the verification.

Fluid Analyzer Throughput Upgrade Using Direct HDL

For a major in vitro diagnostics manufacturer, RTEmd implemented software support for a direct high-density lipoprotein (HDL) chemistry on two of its analyzer platforms. The new process eliminates sample pretreatment to significantly speed time to result. No sample division is needed; all patient tests are performed from a single sample container.

HIPAA Compliance and Cost Avoidance for Clinical Chemistry Analyzer

RTEmd improved the analyzer of a major manufacturer by applying multi-faceted enhancements. RTEmd:

• To support the system's remote connectivity, ensured the system was HIPAA-compliant by encrypting patient data in analyzer log files and by adding other security features.
• Upgraded the analyzer's operating system to accommodate faster motherboard speeds while maintaining overall system timing. This permitted the customer to avoid a complete rewrite of the analyzer's application software.

Integration of Analyzer into Laboratory Automation System

To integrate the fluid analyzer of a major manufacturer into an LAS, RTEmd performed the complex analysis of analyzer movements and provided all the software that communicated with the LAS. RTEmd designed an efficient robotic pick-and-place algorithm for the analyzer's rotating well so sample cycle times were not impacted.