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The AmplifiDx project, started with micro-fluidics cartridge development and an idea for an easy-to-use, point-of-care covid diagnostic test. Fusion was engaged not soon afterwards, due to the short covid-19 diagnostics window and the accelerated timeline. We immediately started industrial, systems and optics design right from the beginning of the project, while we worked with the cartridge designer to define the product requirements.

The industrial design process was accelerated in order to meet an aggressive 2-month timeline for a working prototype. It is important for the industrial design to finish with enough time for mechanical engineering to create 3D CAD files and complete their work. The final concept becomes the jumping-off point for the mechanical work, along with design for manufacturability.  Working hand-in-hand the mechanical team implements the industrial design and modifications are made to accommodate the final concept.

Mechanical design uses machine shop equipment, CNCs and 3D printing to create fast prototypes. These prototypes allow the team to envision translation of the renderings into the final commercial product. Once we have finalized the mechanical design, it is modified for manufacturing. Mechanical engineering designed the internal subsystems, auto-puncture of the lysis buffer blister, the manifold and pneumatic system, the enclosure and support structure, optical and PCBA mounting and overall mechanical structure.

Electrical engineering designed the electronics, cabling and system architecture. They interfaced with the optical system, heaters and pumps to allow for control of the system.

Software engineering created the embedded control of the system and the application software to interface the user via tablet or cell phone to the instrument. This provides reporting and remote connectivity functions.

Optical engineering was created from scratch and implemented to reduce assembly time and fit in a small enclosure.

Systems engineering designed the overall architecture, provided guidance during system integration and managed the prototypes and clinical unit builds for the client. This was all done in 2 months during the covid-19 pandemic.

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