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