Engineering Case Studies

Detailed technical dossiers demonstrating problem-solving methodology, constraint management, and validated outcomes in regulated environments.

PROCESS DEVELOPMENT

Performance Qualification of Manual Terminal Crimping Process for Heart-Lung Machine Production

A cardiovascular device manufacturer required documented evidence that their manual terminal crimping process for HLM (Heart-Lung Machine) cable assemblies would consistently produce product within IPC/WHMA-A-620B specifications when operated at nominal conditions across multiple production lots. The challenge involved validating operator-dependent manual crimping across two wire gauges (14 AWG and 24 AWG) with different terminal types and crimp height specifications. Critical concerns included operator variability as the primary process parameter, preventing excessive or insufficient crimping, ensuring crimp form quality, and maintaining dimensional accuracy (crimp height) within tight tolerances (±0.002 inches).

IPC/WHMA-A-620B StandardTyco Hand Crimper 91500-1AMP Hand Crimper 90450-2+3

Outcome Verified450 Terminals

PROCESS DEVELOPMENT

Performance Qualification of Automated Terminal Crimping Process for Heart-Lung Machine Production

A cardiovascular device manufacturer required documented evidence that their automated terminal crimping process using the AMP-O-lectric Model G machine for HLM (Heart-Lung Machine) cable assemblies would consistently produce product within IPC/WHMA-A-620B specifications when operated at nominal conditions across multiple production lots. The challenge involved validating automated crimping across two wire gauges (14 AWG and 22 AWG) with different terminal types and crimp height specifications. Critical concerns included ensuring the crimp fixture (Auto Crimp Applicator) setup was correct, validating the first piece article process with Precision Adjustment Lever calibration, preventing excessive or insufficient crimping through automation, and maintaining dimensional accuracy (crimp height) within tight tolerances (±0.002 inches).

IPC/WHMA-A-620B StandardAMP-O-lectric Model G Automatic Crimping MachineAuto Crimp Applicators (Crimp Fixtures)+4

Outcome Verified450 Terminals

SOFTWARE VALIDATION

Test Method Validation for Visual Inspection of Software Setup in Heart-Lung Machine Production

A cardiovascular device manufacturer required validated evidence that production operators could reliably distinguish between acceptable and unacceptable software settings and data entry during Heart-Lung Machine (HLM) production. The challenge involved validating visual inspection methods across multiple software setup categories including function selection, general verification, manual operation, data entry, and password entry. Critical concerns included ensuring operator repeatability and reproducibility across varying software interfaces, preventing software configuration errors that could impact device safety, and maintaining compliance with medical device software validation requirements.

TMV Protocol 864367Manufacturing Review Detection (MRD) SystemAttribute Gauge R&R Analysis+3

Outcome Verified30 Samples

PROCESS VALIDATION

Test Method Validation for Visual Inspection of CDI Components in Incoming Quality Assurance

A cardiovascular device manufacturer required validated evidence that Incoming Quality Assurance (IQA) operators could reliably distinguish between acceptable and unacceptable CDI (Cardiovascular Device Incorporated) components during incoming inspection. The challenge involved validating visual inspection methods across 118 PIP (Part Inspection Plan) features categorized into 15 distinct inspection categories including adhesive placement, color verification, wire inspection, barcode labels, label printing, presence/absence checks, and surface finish. Critical concerns included ensuring operator repeatability and reproducibility across varying component types, preventing acceptance of defective incoming materials, and maintaining compliance with medical device quality requirements.

TMV Protocol 856985Manufacturing Review Detection (MRD) SystemAttribute Gage R&R Analysis+4

Outcome Verified42 Samples

PROCESS VALIDATION

Operational Qualification of Tumbling/Deburring Process for Medical Device Components

A cardiovascular medical device manufacturer required documented evidence that their tumbling/deburring process for machined CDI components would not produce unacceptable product when operated at process extremes. The challenge involved validating multiple equipment platforms (three tumblers and one centrifuge) across varying part geometries, materials (plastic and aluminum alloys), and process parameters including run time, media type, machine agitation, and batch quantities. Critical concerns included preventing under-processing (insufficient burr removal) and over-processing (part damage or dimensional changes).

Sweco FMD-4LR TumblerHammond-Roto Finish HR 5 TumblerRosler R580/1100 TE-15 Tumbler+4

Outcome Verified186 Parts

AUTOMATION & TESTING

Installation & Operational Qualification of Automated In-Circuit Test Equipment

A mid-sized medical device electronics manufacturer required documented evidence of proper installation, intended operation, and compliance with 21 CFR Part 820 and ISO 13485:2016 for a newly installed Medalist i3070 In-Circuit Test (ICT) system supporting Class II medical devices. Key challenges included validating complex hardware and software configurations, ensuring electronic data integrity, controlling system access, and demonstrating compliance with FDA and ISO requirements.

Medalist i3070 In-Circuit Test (ICT) systemInstallation Qualification (IQ) ProtocolOperational Qualification (OQ) Protocol+2

Outcome VerifiedZero Deviations

AUTOMATION & TESTING

Installation and Operational Qualification of Lumax S-Cable Automated Test Equipment

Cooper Surgical required a validated automated test system for Lumax S-Series fiber optic extension cables used in surgical catheter applications. The challenge involved designing and qualifying a custom test system that could perform comprehensive optical and pneumatic testing without requiring external optical measurement equipment or reference standards. Critical concerns included ensuring accurate optical throughput measurements for fiber optic cables, detecting optical crosstalk between fiber channels, measuring pneumatic leakage and flow rate within tight tolerances, detecting pneumatic obstructions in cable pathways, integrating with existing Lumax Catheter ATE database via Ethernet, achieving self-calibration capability without external equipment, and providing an operator-friendly touchscreen interface for production environments.

RS-485 Serial CommunicationEthernet 10/100 Database IntegrationNIST-Traceable Pressure Calibrator+4

Outcome VerifiedIQ + OQ

AUTOMATION & TESTING

Installation & Operational Qualification of Automated In-Circuit Test Equipment

A medical device manufacturer required documented evidence that the Agilent Medalist i3070 In-Circuit Test (ICT) system was properly installed, calibrated, and operating according to design specifications. The challenge involved validating a complex automated test platform incorporating hardware, software, and electrical safety testing capabilities while ensuring compliance with medical device quality system requirements and maintaining data integrity for production use.

Agilent Medalist i3070 ICTIPC-A-610 StandardsNIST-Traceable Calibration+4

Outcome VerifiedIQ + OQ

PROCESS VALIDATION

Pasteur Pipette Sterilization Oven Upgrade & Validation

The existing sterilization oven system at CooperSurgical was outdated and created multiple operational and compliance risks. The legacy Scanlink software was incompatible with modern Windows OS, hardware was limited to 12 thermocouples versus the required 20 for proper temperature mapping, manual data retrieval required cleanroom entry, and temperature overshoot and oscillation were observed (ranging from 134–140°C when setpoint was 133°C). Oven #4 specifically exceeded setpoint by up to 7°C. These issues created sterility assurance risks, process reliability concerns, regulatory exposure, and operational inefficiency. The business required improved monitoring, control logic, and regulatory compliance while enabling continuous 24/7 operation with remote monitoring capabilities.

Type-K Thermocouples (20-point)External Temperature ControllerPLC-Based Control System+8

Outcome Verified20-Point Mapping