Complete Product Development Support: Proof of Concept to Product Validation for Product Launch.

We’ll create a well structured plan for product development. Address user experience issues, risks, and develop a thoughtful risk mitigation plan to move stepwise through a product development process. Develop Quality Assurance and acceptance criteria to define and focus the engineering effort.  Our support includes microfluidic cartridge design, consideration for the instrument interface, assay integration, materials selection, surface modification methods, and input from our high volume manufacturing partners. Over the next 6 – 24 months ALine will work with you to:

Phase One: Product Development Plan and Fluidic Component Optimization

We start with a comprehensive consultation to:

  • 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 material testing protocol, storage condition and instrument interface needs
  • Identify engineering risks and build the project to mitigate each risk with clearly defined outcomes that demonstrate the deliverables
  • Development process starts with verification of functions of modules, and then integrating them in a stepwise fashion with ability to benchmark performance to a standard
  • Define assay testing and material testing protocols for evaluation of the cartridge
  • Mechanical drawings of initial design and design review
  • Conduct material testing and preliminary assay evaluation to identify areas for optimization to achieve performance.

Phase Two – Component Integration and System Optimization: agile development process

  • The design, build, test cycle involves stepwise optimization of various system components: fluid cartridge, instrument interface, actuation protocol, and assay reagent storage and integration
  • Parallel material optimization, shelf life and storage studies
  • Provide phase two product design for manufacture and instrument integration solutions
  • In this phase two, client will collect a lot of data on assay performance and have achieved integration of all fluid functions
  • Data with statistically significant reporting of the assay sensitivity, selectivity and limit of detection, with continued optimization
  • QC criteria, both in process and 100% QC procedure for final part developed
  • Product cost estimates for high volume manufacturing for various proposed manufacturing methods
  • Conduct weekly meetings with summaries, and videography as needed along with next actions to keep the process moving.

Phase Three: Production & Verification

  • Complete integrated functional testing with product reagent storage, injection molded part design optimization and integration with various cartridge components
  • Development builds to collect statistical information on performance
  • Develop Quality Assurance procedures that will assure 100% compliance with the customer requirements as well as ISO 13485
  • Continue to make small iterative design changes to reduce variability and reach target levels of sensitivity and limit of detection
  • Optimize manufacturing methods to minimize consumable cartridge cost
  • Conduct real-time and accelerated shelf life studies
  • Continue design optimization based on user feedback
  • Finalize design for initial clinical testing
  • Provide cartridges to support clinical assay testing needs
  • Provide design control, documentation control to support ISO 13485manufacturing.

Phase Four: Manufacture and Launch

  • Support manufacture of cartridges with Quality Assurance procedures that will assure 100% compliance with the customer requirements as well as ISO 13485
  • Scale up manufacturing processes, establish supply chain options
  • Provide transfer to volume partners
  • Continue to support manufacturing as needed for product launch, serving as second source for manufacture
  • Provide necessary support for product release and regulatory approval activities.

Proof of Principle to Product Launch

Contact us today to start your project.

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