Automating processes to streamline the clinical lab workflow
Awards: 2010 Medical Design Excellence Awards, IVD
Regulatory Requirements: EN 61010-1, IEC 61010-2-81, UL 61010A-1 & UL 61010-2-010, EN 61326, EN 55011, RoHS
Leveraged Expertise: Fluidics, Motion, Industrial Design, Usability/HFE, Connectivity & Systems Integration, Consumable Design, Contract Manufacturing
Conventional clinical microbiology involves specimen collection, registration, inoculation, isolation, identification and testing of pathogenic microbes from clinical specimens. Traditionally, this process has used minimal automation. The isolation of bacterial colonies for identification and antibiotic susceptibility testing is performed manually using handheld spreading devices called “loops” to streak a specimen onto one or more agar plates for incubation. This process is highly labor intensive, produces results of variable quality, and ties up highly skilled and valuable microbiologists by performing routine work in an environment where their skills are in increasing demand.
LabTech Systems developed a revolutionary concept for mechanically streaking microbiological specimens on to conventional agar plates for diagnostic microbiology.
They approached us to develop a concept for high-throughput automation of this core process in clinical laboratories, and then to design and manufacture this instrument.
The technical challenge required us to design a highly robust system to deal with a very wide variety of sample types at high throughput while handling a wide range of agar plate types at high speed and producing reliable and consistent plate streaking.
Our team worked closely with LabTech Systems, and later with bioMérieux, to build on their critical market input to design, develop and manufacture the instrument. The goal was for it to use LabTech’s innovation to automate many of the manual tasks traditionally involved in the preparation of agar plates.
We were tasked with automating many of the manual tasks traditionally involved in the preparation of agar plates.
From Concept Development to Contract Manufacturing
During our collaboration with LabTech Systems, we provided:
- Instrument concept generation
- Basic proof of principle for the critical higher risk automation solutions
- Detailed design and development of the instrument (including electronics, fluidics and robotics)
- The instrument control and service software and GUI
- Prototype building, testing and qualification
- Formal instrument Verification to Requirements
- Transfer to manufacturing to our in-house manufacturing facilities
- Ongoing manufacturing support and sustaining engineering
Particular challenges throughout development included creating precision pipetting and positioning functions that could cope with the high variability of agar plates, and providing robustness and ease of use for field deployable applications. The technology within the Microstreak revolutionizes specimen inoculation and front-end processing tasks by: Maximizing bacterial colony isolation and quantification Standardizing plate inoculation processes and results interpretation Streamlining the lab workflow, freeing up skilled staff for high skill activities
We designed and manufactured a high-throughput automated culture plate streaking instrument to streamline the clinical lab workflow.
