Product Development Plan 

• 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.