We executed end-to-end redesign, DFM/DFA optimization, supply chain consolidation, and regulatory alignment to deliver a portable POC platform for quantitative hemoglobin variant analysis and ferritin measurement on a unified reader architecture.

Key Impact Metrics

• 41% reduction in BOM; 20% reduction in manufacturing cost
• 11× production scale-up (50 → 1,100 units/month) with the same team; >99% first-pass yield
• 0% PCBA failures in field deployment; 19% localization reducing lead time (6–8 weeks → 2–3 weeks)
• ~98.4% diagnostic accuracy vs laboratory gold standards for hemoglobin variants; quantitative phenotyping (~19 phenotypes)

Discuss Your POC IVD Program

Client Overview

Geography: United States; deployment across 40+ countries
Company Type: IVD OEM with protected IP and expanding test menu
Market Segment: Hemoglobinopathies, anemia workup, and point-of-care biomarkers
Device Classification: EU IVDR Class C; FDA 510(k); CDSCO Class C
Engagement Model: Exclusive design support + contract equipment manufacturing (reader and cartridges) with QARA services

The OEM sought a partner to transform a bulky prototype into a robust, manufacturable, and globally compliant point-of-care platform. The goal: deliver quantitative microchip electrophoresis for hemoglobin variants and enable expansion to fluorescence immunoassay-based biomarkers on a scalable, unified reader architecture.

Business Challenge

Strategic Challenge

Accelerate commercialization and multi-region market access, reduce total cost, mitigate supply chain risk, and enable rapid test menu expansion on a unified POC platform.

Technical Challenge

Miniaturize laboratory-grade electrophoresis into a battery-operated reader with integrated real-time optical imaging and algorithmic interpretation. Integrate FIA-based ferritin testing, ensuring optical stability, firmware reliability, and consistent performance in decentralized care environments.

Regulatory & Compliance Challenge

Establish structured ISO 13485 design controls, risk management per ISO 14971, and comprehensive verification/validation to support CE IVDR (Class C), FDA 510(k), and CDSCO submissions — including performance evaluation for analytical and clinical evidence.

Manufacturing & Scale Challenge

Stabilize yields, eliminate PCB failures, consolidate vendor base, and scale production from 50 to over 1,000 units per month while maintaining quality, accuracy, and compliance.

Our Approach

Architectural Redesign & DFM/DFA Optimization

• Complete hardware redesign: schematics, PCB layout optimization, plastics and metal components, and injection tooling refinement
• Optics alignment and thermal stabilization to preserve analytical performance
• Firmware enhancement for power management, connectivity, and algorithm-assisted interpretation
• Part-count reduction and standardization across reader and cartridge assemblies

Manufacturing System Transformation

• TAKT time reduction through line re-sequencing and parallel production lines
• Custom fixtures and jigs enabling precision optics and electronics assembly
• Implementation of SPC, AOI, ICT, and final quality control protocols
• Transition from job-shop production to scalable batch manufacturing

Supply Chain Consolidation & Localization

• Qualification of 100+ vendors with centralized procurement governance
• Dual sourcing strategy, reducing vendor dependency
• 19% component localization reduces lead time from 6–8 weeks to 2–3 weeks
• BOM optimization achieving 41% cost reduction without compromising performance

Regulatory & QMS Integration

• ISO 13485-aligned QMS implementation with full design control documentation (DHF/DMR)
• Risk management framework per ISO 14971
• Performance evaluation structure supporting IVDR Class C and FDA 510(k) pathways
• Technical dossier preparation for CDSCO compliance

Results & Business Impact

Measurable Outcomes

• 41% BOM reduction; 20% manufacturing cost reduction
• 11× production scale-up (50 → 1,100 units/month)
• 99% first-pass yield; 0% PCBA failures in the field
• ~98.4% diagnostic accuracy vs laboratory gold standards

Operational Impact

Optics-calibrated assembly processes, automated inspections, and standardized work instructions enabled reproducible performance across decentralized settings. High-throughput, scalable production supported global deployment.

Regulatory Outcome

QMS and technical documentation aligned with CE IVDR Class C, FDA 510(k), and CDSCO expectations, including performance evaluation evidence and structured post-market processes.

Market Outcome

Delivered quantitative hemoglobin phenotyping at the point of care, supporting expansion into anemia workflows and additional biomarkers through FIA on a unified platform architecture.

Design-led CDMO for scalable, compliant POC IVD from concept through country-scale deployment

We combine electrophoresis and immunoassay expertise with disciplined DFM/DFA, regulatory rigor, and localized supply chain strategy to deliver accurate, affordable, and scalable POC diagnostics for global programs.