Phase 1 Engineering Development - Fully Functional Assay with Instrument Control

Over the course of 6-24 months, depending on the complexity of the Assay, the program proceeds as follows:

Product Development PlanĀ 

  • Define cartridge functional requirements and specifications
  • Develop design control document, which:
    • Collects development risks and the methods used to mitigate them
    • Defines the user experience
    • Evaluates target cost
    • Develops the assay protocol integration strategy, storage condition and instrument interface needs
  • Identify technical risks and mitigate each risk with clearly defined outcomes that demonstrate resolution
  • Verification of functions of modules, integration and benchmark performance of integrated components
  • Define assay testing and material testing protocols for evaluation of the cartridge
  • Mechanical drawings of initial design and design review

Component Integration and System Optimization

  • The design, build, test cycle involves step-wise optimization of various system components: sample interface, instrument interface, actuation protocol, liquid reagent storage and dry down.
  • Parallel material optimization, shelf life and storage studies
  • Provide design for manufacture and instrument integration solutions
  • Assay optimization and Sample interface engineered, tested and integrated
  • Data with statistically significant reporting of the assay sensitivity, selectivity and limit of detection, with continued optimization and trials with a variety of sample in range of likely matrices
  • Product cost estimates for high volume manufacturing for various proposed manufacturing methods
  • Conduct weekly meetings with written summaries, action items, and videography as needed.
  • support preparation and execution of live demos with real samples to demonstrate milestones

End of Research and Transition to Development

  • All components of the cartridge work at least 90% of the time with real samples.
  • Injection molding design optimization, blister integration
  • Optimize reagent dry-down
  • Begin to create product transfer package to include assembly of various cartridge components.

Proof of Principle to Product Launch

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