CASE STUDIES

bioMérieux: NucliSENS® EasyMAG Sample Preparation Instrument

Evolved existing technology into a highly usable, robust, market-ready general-purpose sample preparation instrument in just 20 months.

Client: bioMérieux

Product: NucliSENS® EasyMAG

Regulatory Requirements

UL 61010, EN 61326, FDA Class II

Expertise Used

Fluidics, Thermal Control, Motion, Industrial Design, Usability/HFE, Connectivity & System Integration, Design to Regulatory Standards

From instrument concept to manufacture ramp-up in 20 months

When bioMérieux, a world leader in the field of in vitro diagnostics (IVD), approached us to partner on this project, they had already developed a concept demonstration prototype in-house. The main challenge was to evolve the technology into a highly usable, robust, market-ready instrument in a short amount of time, and we were able to deliver it to them in just 20 months.

Key aspects of our development included:

  • Instrument concept generation and industrial design
  • Significant usability studies to perfect workflows
  • All hardware development including fluidics, robotics and heating 
  • Instrument control and service software
  • Prototype build, test and qualification
  • Seamless manufacturing ramp-up and volume manufacturing at our Melbourne manufacturing facility

The resulting bioMérieux NucliSENS® EasyMAG is a general-purpose sample preparation instrument that extracts nucleic acid from a variety of biological samples, such as blood, CSF, stool and sputum. By using the proven bioMérieux magnetic extraction design, it removes waste and leaves only purified nucleic acid in the sample vessels. It can be used as a front-end for bioMérieux’s molecular diagnostic systems and for stand-alone assays, including “home brews” and competitor’s assays.

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