Design for Manufacture
Through a Phased Engineering Development Program
Right-Sizing Design for Manufacture
Complexity = High Cost of Quality = High Cost of Goods
While every design must fulfill functional requirements, getting there at the price-point needed to go to market requires an intimate knowledge of the manufacturing processes considered.
When the channels in the device do not confer functionality, but serve as fluid conduits from one part of the device to another, stick to dimensions that are easy to process with standard, high volume processes.
An objective of DFM is to make the best device design suited to the manufacturing process, minimizing the requirement for exotic, high cost processes and complex assemblies.
ALine's Phased Microfluidic Engineering Process
ALine implements a phased engineering development process for microfluidic design that provides transparency and clarity, ensuring key milestones are met, while providing clients easy access to all program documentation.
Our facility supports all aspects of the microfluidic device engineering effort: modeling software, engineering maker space, breadboard instrumentation, wet lab testing, dedicated production equipment, quality assurance tools, and cleanroom assembly.
Phase O: Feasibility
Feasibility is a consultative effort where design options are explored and tested as individual components. Starting with a schematic of a design that shows the workflow, fluidic components are proposed to meet requirements. Once design inputs are memorialized in a design control table to address technical risks, design elements are fabricated and tested. Results from testing lead to decisions to integrate the desired fluidic modules into the proposed product cartridge architecture.
Phase 0 provides the design inputs for Proof of Concept, the alpha product that integrates the complete workflow with data collection for the target assay using a breadboard instrument.
DFM for this phase includes consideration of feature sizes, potential manufacturing processes, method to integrate membranes, reagents, as well as the instrument interface. Materials and processes are chosen both for fluidic function and compatibility with the biology. With guidance from the literature as well as direct experience, material sets are chosen to consider performance, cost, and suitability for likely manufacturing processes.
Phase 1: Proof of Concept
This phase’s goal is to achieve a functioning alpha prototype. The biggest drivers of the program are speed and quality. The result of this phase is a “product-like” device that produces good quality data.
It’s meant to work in limited volumes of hundreds to understand the analytical limit of detection and sensitivity. The data produced using the Proof of Concept design provides the benchmark for performance to which future design iterations must meet and exceed.
Phase 2: Proof of Principle
Proof of Principle is a system integration effort. Results from the Phase 1 serve as the design inputs for the Proof of Principle product; ultimately achieving a soft design lock with manufacture in volumes of 10k to 100k units as the system achieves robust performance.
DFM for this phase includes a manufacture and assembly process that scales to 1MM units per year. COGs is still more than the ultimate high volume costs with complete automation, but allows market entry and profitability. Results from clinicals may require further minor changes to the design or materials.
Phase 3: Product Launch
Results from clinical trials verify product performance, and may lead to minor modifications to improve performance. After these final modifications are validated, the product is ready for product transfer to high volume production.
Manufacturing processes and assembly will change with increasing automation, but information in the product transfer package will include critical QA and performance validation parameters to benchmark performance and assure product compliance.