Stratos
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Response
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RESPONSE RAMP 200
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Stratos Services:
Industrial design and GUI
> Mechanical & electronic hardware  
> Embedded software development
> Patient EMR interface
> IQC & LQC
Quality engineering & verification
> 21 CFR 820 design controls
Project management

Rapid point-of-care diagnostics with international deployment

“Throughout the development life cycle, Stratos has provided excellent design control and creative
solutions to complex development challenges.”

– Senior Director, Operations, Response Biomedical

Rapid, accurate test results generated at the point of care are key to improving the physician’s ability to quickly diagnose and initiate treatments that can improve clinical outcomes and save lives.

To address this need, Response Biomedical developed its Rapid Analyte Measurement Platform (RAMP). RAMP is a breakthrough in diagnostics that provides reliable information in minutes for both point-of-care testing and on-site laboratory use. However, the company’s earlier RAMP 3.2 Reader could only conduct one test at a time and its 2-line/20-character monochrome display severely limited its functionality. To fully meet the needs of the emergency room and busy healthcare facilities, Response Biomedical needed a higher throughput instrument with a more sophisticated user interface and improved assay result handling capability.

Response Biomedical chose Stratos to design the new device.

Stratos leveraged its deep understanding of instrument architectures and proven point-of-care diagnostic device design to develop a new reader that would acquire and manage more patient results for clinicians, accept multiple assay types, be easy to use, and allow for configuration flexibility at the point of care. The project included more than 500 new product requirements and called for an exceptionally quick development cycle.

The Stratos team developed the RAMP 200 Reader: a multi-port, high-throughput reader that can process up to 36 tests per hour and features a color touch screen that includes a full virtual keyboard. To provide real-time integration of patient data across multiple systems, Stratos software engineers designed the reader to be fully networkable, HIPAA-compliant and compliant with the industry standard POCT1A protocol. The instrument also features an automated Instrument Quality Control and Liquid Quality Control tests that verify assays are running correctly, ensuring accurate results every time. The RAMP 200 is deployed in the U.S. through licensing arrangements with 3M for infectious disease diagnostics and with Roche for cardiac panel diagnostics.

Since initial release of the product, Stratos has added localization features to support distribution in Europe and Asia. Supported languages include English, Chinese, German, French, Italian, Spanish, Swedish and Portuguese.