Home / Applications / IVD & Point-of-Care Diagnostic Components
APPLICATION
IVD & Point-of-Care Diagnostic Components
IVD and point-of-care components translate fluid paths, assay strips, reagents, and reader interfaces into molded geometry. Typical parts include cassettes, cartridges, pipette tips, microfluidic components, tube caps, and holders. The manufacturing review centers on strip alignment, flash, sealing, optical or reading areas, small channels, automated handling, cavity balance, and dimensional consistency across production lots.
Suitable Projects
- Lateral-flow cassette and holder programs
- Diagnostic cartridges and microfluidic plastic parts
- Pipette tips and tube-cap components
- Non-sterile IVD hardware with controlled assembly interfaces
Engineering Risks to Resolve
- Flash or mismatch near fluid and strip paths
- Window, channel, and alignment variation
- Seal surfaces and closure consistency
- High-cavity balance, ejection, and part handling
How MedMoldPro Approaches the Work
The assay or instrument interfaces are identified before part geometry is frozen.
DFM, gate, venting, shrinkage, cavity strategy, and inspection points are then reviewed around the functional path rather than only the outer dimensions.
Expected Project Deliverables
- Application-specific DFM questions
- Tooling and cavity strategy
- Functional-interface inspection plan
- Project documents defined before tooling
Scope and Responsibility Boundary
Molded-component controls do not establish diagnostic sensitivity, specificity, shelf life, biocompatibility, or regulatory clearance. Those require final-system validation by the legal manufacturer.
IVD & Point-of-Care Diagnostic Components: Frequently Asked Questions
Strip channels, reading windows, fluid paths, seal areas, snap fits, datum features, and automated handling surfaces.
No. Demand, design maturity, balance risk, inspection strategy, and change cost must justify the cavity count.
A concept can start discussion, but controlled 3D geometry, material, channel requirements, and joining method are needed for a reliable quote.
No. MedMoldPro supports the molded component; the legal manufacturer validates the diagnostic system.
Technical review: Jerry Zou | Last updated: August 28, 2026
Manufacturing statements are limited to available capability information. Regulatory references are informational and do not replace the legal manufacturer’s qualified review.
Discuss the Drawing, Material, Volume, and Documentation Scope
Send the controlled files and project requirements needed for an engineering review and quotation.