Microfluidics Cartridge Development: Starting with System Architecture

Developing fluidic consumable cartridges for in-vitro diagnostics (IVD) or life science research tools requires balancing performance, manufacturability, and cost. At Wainamics, we begin most projects with a strong focus on system architecture, ensuring efficient and reliable fluidic cartridge product development.

There are many possible design approaches, but simplification and design for manufacturing (DfM) are essential for achieving reliability, competitive cost-of-goods (COGs), and accelerated timelines. Early system architecture discussions allow us to align on user requirements, assay workflows, and instrument interface expectations before detailed cartridge engineering begins.

Key Considerations in Fluidic Cartridge Design

When approaching microfluidics design, we evaluate several critical factors:

• User requirements
  For diagnostic cartridges, ease of use, throughput, and consistent performance are essential. Understanding the end user—clinicians, lab technicians, or patients—drives usability-focused design.
• Reagent storage strategy
  Deciding whether reagents should be stored on the cartridge or delivered through the instrument significantly impacts usability and COGs. On-cartridge storage simplifies workflows but may require stability studies, packaging, and shelf-life validation. Instrument-delivered reagents can lower cartridge cost but often increase system complexity and maintenance.
• Cost-of-goods targets
  Preliminary COGs are shaped by expected production volume, the complexity of interfaces (e.g., connectors, seals, gaskets), and requirements for dimensional precision, assembly, and quality control.
• Simplification of bioassay workflows
  Bench-top steps such as pipetting, dilution, mixing, and filtration often translate into complex fluidic operations on a cartridge. Eliminating unnecessary steps—or pre-mixing and co-storing reagents—reduces both design complexity and manufacturing risks.

At Wainamics, we guide clients through these decisions early, ensuring cartridge designs meet usability, cost, and manufacturability goals.

Microfluidics Cartridge Metering Precision

One of the most critical aspects of consumable cartridge design is metering precision. Workflows requiring strict volumetric control (e.g., 1 µL ± 0.1 µL) often demand high-precision molding and tight tolerance control, which increase manufacturing costs.

To reduce risk, bench-top experiments can be performed to determine how assay performance tolerates over- or under-metering. These insights can support relaxed tolerance requirements, resulting in more cost-effective cartridge designs without compromising assay reliability.

At Wainamics, we work closely with clients during prototyping to balance assay performance requirements with manufacturability and cost targets.

Example: Point-of-Care Cartridge Development

Figure 1. Wainamics development of a point-of-care molecular testing cartridge using a commercial 96-well isothermal amplification assay. (a) Assay workflow diagram. (b) System architecture integrating all assay steps. (c) Injection-molded cartridge (front and back views). The cartridge supported clinical testing and EUA submission, achieving a high-volume COGs of less than $6 while delivering performance comparable to current clinical standards.

Learn more in our COVID-19 point-of-care diagnostic test case study

Wainamics Expertise in Fluidic Cartridge Development

With over a decade of experience in microfluidics cartridge development, prototyping, and manufacturing, Wainamics helps teams reduce risks and accelerate commercialization. Our expertise spans:

• System architecture and bioassay integration
• Design for manufacturing and assembly (DfM/DfA)
• Rapid prototyping of microfluidics systems
• Scalable cartridge manufacturing partnerships

Looking to streamline your Microfluidics Cartridge Development? Contact Wainamics at https://wainamics.com/#wainmamics-contact.