Flexible Engagement Process

Working with MiniFAB means getting started fast

Our flexible engagement model, strong team and cutting-edge facilities mean that no project is too small or too big. MiniFAB welcomes projects of all sizes and can provide clients with micro-parts and micro-tooling for design evaluation, one-off projects, feasibility studies, and prototype production, through to high-volume OEM and ODM manufacturing.

By quickly building a strong understanding of your specific needs and requirements, our team of experts can develop a detailed Cost of Goods and Services (COGS) Analysis, create prototypes, and generate manufacturing strategies. Based on client needs, we can manufacture as many or as few of your product as required. Alternatively we can transfer manufacturing processes to you or your partners.

We routinely work with other partners from around the world to bring in additional technologies or expertise to complement our own, ensuring that the solution we provide creates unique value.

Our flexible engagement model is designed to allow you to engage with us at any point, depending on your development and commercialisation progress.

MiniFAB's Advantages

  • Flexible fee-for-service model or joint development partnership
  • Developed product IP is owned by our clients
  • Unique and customised designs and solutions through strong collaboration
  • In-house manufacturing of your product
  • Flexible business model with a team that is easy to work with and very open
  • Seamlessly coordinate instrument and cartridge development

MiniFAB Staged Development

Staged Development bt MiniFAB

Rigorous Project Management

MiniFAB's five-step development model is tuned to efficient delivery of microfluid products. By working through a process of technical risk reduction we move from concepts to manufactured products in a stage-gated process that delivers investor value at each step. Our clients collaborate with us through the entire process, or you can pick and choose the modules that best fit your needs and budget. We provide the required regulatory documentation as per ISO 13485 or 21 CFR 820.30 at each stage of development.

Stage 0 Product definition and concept design

Diligent product definition and pre-development planning are key to cost & time efficient product development

  • Analysis of system requirements
  • Identification of user requirements & product specifications
  • Analysis of market environment, development of a product roadmap
  • Analysis of regulatory environment (e.g. FDA 510(k), CLIA waiver)
  • Analysis of product use case(s)
  • Functional design of system and assay using ourMicrofluidic ToolBox
  • Cartridge and instrument concept generation (including rapid prototype fabrication)
  • System interface definition
  • Technical input for intellectual property assessment
  • Design & development risk watch list
  • Development schedule & expenditure planning
  • Technical feasibilities document

Stage 1 Proof of Principle for Critical Process Steps

Rigorously isolate and test all functional elements

  • Investigate potential process simplifications
  • Identify & test candidate materials for cartridge, select suitable materials
  • Identify critical process steps
  • Preliminary interface specifications between cartridge & test beds/instruments
  • Design & manufacture microfluidic chips for proof-of-principle, test critical process steps
  • Set up microfluidic test bed & test proof-of-principle chips
  • Design & manufacture proof-of-principle test beds for critical instrument functions
  • Proof-of-principle for instrument functions
  • Cartridge manufacturing strategy & COGS Analysis
  • Risk and harm assessment

Stage 2 Concept demonstration

Test integrated system functionality

  • Integration of all elements from proof-of-principle stage into cartridge design (resembles product)
  • Design interface between instrument and cartridge
  • Manufacture & test of prototype cartridge(s) with prototyping techniques
  • Initial performance variation testing, test interfaces (electrical, fluidic, mechanical, thermal, optical)
  • Design iteration of cartridge (if required)
  • Design freeze for cartridge-instrument interface with further changes handled under change control processes
  • Manufacture 10s-100s of concept demonstration prototype units using prototyping techniques (e.g. milling, laser cutting, molding and others)
  • Build concept demonstration prototype instrument
  • Test Concept Demonstration Prototype (CDP) cartridges in CDP instrument

Stage 3 Establishment of manufacturing processes

Alpha pre-production units for preclinical tests

  • Design & establish manufacturing process
  • Repeatably Manufacture 1000s of alpha units using volume manufacturing (replication) techniques
  • Statistically significant performance variation testing (C.V. testing)
  • Eliminate manufacturing process variation (e.g. polymer shrinkage, warpage, component misalignment)
  • Manufacture alpha devices for pre-clinical tests
  • Develop manufacturing run sheets and standard operating procedures
  • Assemble Design History File

Stage 4 Ramp up of manufacturing processes

Beta production units for clinical trials, transferring to full manufacture

  • Manufacturing process optimisation and qualification
  • Capacity ramp-up
  • Establish & implement in-line quality control
  • Assembly automation as required
  • Yield improvement
  • Update Design History File
  • Manufacture of product for clinical trials with manufacturing techniques capable of cost-effective ramp-up
  • Preparation of Device Master Record

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