Development Stages

We have found that customers need different levels of support based on how far they are in the development process.   We characterize these as Custom Design and Fabrication,  Optimization & Semi-Automated Instrument Control,  and product development with Instrument integration.

Please click on each for additional details. As always, you can contact us directly if you prefer, and we’ll help you choose the best path forward for your project.

Custom Design and Fabrication: Reliable microfluidic devices operated manually. Require higher volumes and higher quality devices for data collection.

If you are a biologist and need a more reliable microfluidic to test your assay, or a biomedical engineer making home brew devices, we can take a drawing or even a schematic or sketch of what you need, and turn it into a reliable, easy to use manually operated device that will move your experiments forward.

Over 1-2 weeks, we would provide you with:

  • Up to 3 consulting sessions of 1 to 2 hours each to help you finalize your design to optimize for materials and fabrication
  • Complete mechanical drawing with revision and item list with tolerance specifications
  • Batches of 20 to 100 cartridges for testing
  • After completing testing of the first batch of devices, revisions and/or quotes for higher volume will be provided
  • This stage can continue with multiple iterations until the client is ready for further integration with instrumentation.

Optimization and Semi-Automated Instrument Control: optimize the assay protocols with semi-automated instrument control

If your assay protocols are working manually and need optimization, you are ready for semi-automated control with instrumentation support to further optimize and de-risk the assay workflow in an integrated fluidic cartridge.

In this stage over a 2- to 6-month period, we would provide:

  • Definition of product specifications including cartridge functional requirements, material and surface requirements, consumable product target cost, and storage condition and instrument interface needs, evaluate target cost, strategy for assay protocol integration, material testing protocol and instrument interface needs
  • Mechanical drawing of initial design and design review
  • Conduct material evaluation and preliminary testing in close coordination with client
  • Develop instrumentation support for semi-automated testing of devices along with an actuation protocol and training as needed to provide independent testing capability in the client’s facility
  • Videography, weekly meetings, and meeting summaries as part of routine communication and program management
  • Batches of 20 to 100 cartridges for assay optimization and data collection
  • Further design revision to eliminate failure modes and to optimize assay performance
  • Additional batches of 50 to 100 cartridges for further data collection and uncovering and correcting new failure modes
  • Development of QC criteria done both in process and for 100% final QC inspection
  • Pricing for higher volumes to support continued testing
    • Some products may not need more than this to be transferred to higher volume production
  • Provide quotes and cost models for scale up from 100s to 100,000 devices, and show you at what volumes, a transition to injection molding becomes cost effective.

Product Development with Instrument Integration: Proof of Concept to Product Verification for 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 through the following steps:

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 QC procedures with 100% inspection
  • 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 100% QC and 100% pass criteria to be used for assay validation with clinical samples
  • 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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