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FSC's PathOne™

Rapid, Portable Pathogen Testing

Industrial Design, Mechanical Engineering, Technology-Based Innovation, Product Brand Language, Engineering Analysis & Optimization

This cartridge-based portable diagnostic system enables real-time detection of pathogens, from sample to result in less than 10 minutes.

Bresslergroup developed a revolutionary analytical platform that shifts the paradigm of pathogen testing in diagnostics, food safety, and bioterror.

Prior to the FSC’s work, there had been little innovation in diagnostic testing to address the main issues facing the industry: time to result and complexity of tests.

Bresslergroup assembled a team of mechanical engineers and industrial designers to help the company develop a system with sophisticated functionality, usability, and visual brand language.  

The resulting PathOne™ Analyzer, with its main test device and two-piece, disposable test cartridge containing a live biosensor-based assay, transforms a formerly time-consuming, laborious, and complex process into a few simple steps for conducting tests on-site and within minutes. 

To minimize wasted work, Bresslergroup’s team first focused on the disposable test cartridge, which was challenging from an engineering perspective because it requires the collection, handling, and mixing of small fluid volumes.

As the biology developed, specifications such as volume of sample, shape of test chamber, and user workflow evolved. Master-modeling the project in CAD and 3D geometry facilitated in-process changes, such as accommodating a larger sensor or thickening walls.

The engineering team collaborated closely with the Fundamental Solutions Corporation’s biology engineering partner, making dozens of rapid iterations of fluidics designs with 3D prints and in-lab testing with active biology to move quickly from theories to proven cartridge and device mechanisms (fluid storage, pumping, mixing, light collection, minimization of sources of user error). Heat sealing films were developed to allow for very thin cartridge design and sealed fluid pumping channels.

Bresslergroup’s engineers worked hard upfront to design out as many problems as possible and deliver a technical proof of concept that validates FSC’s vision. In the meantime, industrial design came up with concepts for form development and a visual brand language that carries over to both components. To meet cost requirements, the disposable cartridge was designed to be manufactured as one part.

As industrial design generated and refined concepts, engineering continued to adapt to changing specifications while managing to stay true to the form development and visual brand language work. The final device rests at an angle that is ergonomically appropriate for a machine of its size. Being raised up on legs invites the user to pick it up and cradle it, signaling its portability.

FSC patented the unique, portable form.

To meet cost requirements, the disposable cartridge was designed to be manufactured as one part.

The white, polished, smooth surface expresses cleanliness and sterility, and is easy to wipe down. The cartridges (and cartridge bay) are designed to be impossible to insert incorrectly.

 

Bresslergroup continues to collaborate with FSC on development of shipping processes for PathOne™ cartridges as the company begins the marketing of its system to the medical, food safety, and bio-terrorism verticals.

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