Scaling Medical Device PCB Assembly with Custom Developed Automated Test Fixtures

Background

A U.S.-based innovator in orthopedic recovery solutions partnered with Syrma Johari MedTech to scale up manufacturing of their Class II FDA 510(k)-cleared cold and compression therapy system. The collaboration focused on mass manufacturing of the device’s printed circuit board assembly (PCBA), sourcing of critical components, and comprehensive testing and validation. The innovative therapy system combines motorized cooling with adjustable compression to deliver effective and controlled treatment for post-surgical and musculoskeletal conditions. Its compact, portable design makes it ideal for use in both, clinical and home care settings.

Objectives

• Manage sourcing of all off-the-shelf and custom mechanical components, ensuring high quality and cost-efficiency
• Mass manufacture the PCBAs based on the client-provided design, as per regulatory standards
• Integrate plasma coating on PCBAs and validate coating effectiveness for environmental durability
• Conduct end-to-end PCBA testing and validation

Challenges

• Identify, evaluate, and qualify alternative vendors for key components
• Design and develop customized automated test fixtures for accurate and rapid functional testing of PCBAs

Solution

Supply Chain Management

• Integrated SAP-based ERP system for real-time inventory tracking, shelf-life monitoring, and batch-level traceability.
• Leveraged our robust ecosystem of global suppliers to multi-source power supplies, gear drives, and membrane keypads of high quality and at optimized cost.

PCBA Manufacturing, Testing, & Documentation

• Manufactured multi-layer, double-sided PCBAs with tight tolerances, adhering to IPC standards.
• Executed multi-stage inspection: solder paste inspection, 3D automated optical inspection, and BGA X-ray inspection.
• Conducted board-level testing, in-circuit testing, and end-of-line functional testing.
• Ensured end-to-end traceability and documentation according to ISO 13485, FDA 21 CFR Part 820, and IPC Class 3 standards.

Plasma Coating of PCBAs

• Integrated plasma coating on PCBAs, enhancing durability in high-humidity and high-usage conditions.
• Performed environmental protection qualification (IPX7 and brine tests) for coated PCBAs.

PCBA Validation Using Custom-Designed Automated Test Fixtures

• Designed, manufactured, and validated customized functional test fixtures in-house, integrated with the Fluke pressure calibrator.
• Developed in-circuit fixtures with high-density bed-of-nails setups and precisely aligned pogo pins for consistent and accurate testing.
• Integrated mechanical, pneumatic, and customized automation modules supporting high pin-count and fine-pitch PCBAs.
• Executed programming, calibration, and testing for each PCBA.
• Achieved typical test cycle time ranging from 30 sec to 3 min per unit, with automated test reports generation.

VALUE DELIVERED

~50,000-

PCBAs manufactured annually with full traceability and documentation

~3x

Faster test cycle time (30 sec to 3 min per unit) achieved using custom-developed test fixtures

Impact Created by Syrma Johari MedTech

• Established a robust and agile supply chain ecosystem for on-time delivery of high-quality components at optimized cost.
• Scaled medical device PCBA production to meet increasing market demand while maintaining regulatory compliance.
• Improved device reliability and environmental resilience through plasma-coated PCBAs.
• Significantly enhanced PCBA test throughput and accuracy using automated functional test fixtures.