Sleep apnea devices are engineered to deliver safe, stable airflow that keeps a patient’s airway open throughout the night. Because these systems combine advanced airflow mechanics, precision sensors, electronics, and patient-facing ergonomics, manufacturing them requires a disciplined, highly controlled process.
From airflow control to PCB integration and final QA, here is a detailed look at how modern sleep apnea devices are manufactured, and how Sanbor Medical supports OEMs across the respiratory device market.
The airflow generator is the core of every sleep apnea device. It must deliver consistent, adjustable air pressure with exceptional accuracy.
Dynamic balancing of impeller assemblies to minimize vibration and ensure stable, continuous airflow.
Micro-sensor calibration that detects changes in airway pressure and breathing patterns in real time.
Brushless DC motors designed for ultra-quiet operation, often <28 dB(A).
High-efficiency airflow channels, injection-molded from ABS or polycarbonate to reduce turbulence and noise.
Because the patient directly inhales airflow from the device, every component in the air pathway must meet strict biocompatibility and cleanliness requirements.
Medical-grade polycarbonate or PEEK used for injection-molded air chambers.
Modular filtration housings incorporating HEPA and hypoallergenic filters.
Ultrasonic or laser welding for airtight, leak-free housing seams.
Leak-rate testing under ISO 80601-2-70, ensuring respiratory therapy compliance.
To improve patient comfort, many CPAP/BiPAP systems include heated humidifiers and temperature-regulated tubing.
Thermoformed water chambers using corrosion-resistant stainless-steel plates.
PTC heating elements for precise, safe temperature control.
Heated tubing assemblies incorporating embedded resistance wires.
Closed-loop temperature sensors integrated with the device’s main control board.
The electronics define how the device regulates air pressure, logs data, and interfaces with the user.
Surface-mount PCB assembly (SMT) performed in ISO 13485 cleanroom conditions.
Firmware flashing and verification using automated test benches.
Functional testing of sensors, displays, and user interfaces.
Serialized traceability for each PCB and subassembly.
Patients sleep beside these devices, making noise reduction and usability critical.
Precision-cut acoustic foam placed around pump assemblies.
CFD simulations to optimize airflow paths and reduce turbulence.
Ergonomic injection-molded enclosures designed for compact size and low vibration.
Sound-absorbing materials integrated without compromising airflow efficiency.
Sleep apnea devices fall under FDA Class II and EU MDR respiratory classifications, requiring rigorous testing and process validation.
100% leak and airflow calibration testing using automated systems.
Electrical safety testing to IEC 60601 standards.
Endurance testing simulating 10,000+ hours of continuous operation.
Final packaging in ISO 7 cleanrooms using validated sterilization protocols.
Sanbor Medical provides end-to-end box-build manufacturing for respiratory and diagnostic devices, including CPAP and BiPAP systems.
Our capabilities include:
We maintain certified processes, controlled environments, and full device traceability to support global regulatory compliance.
Our teams handle:
Respiratory device assembly
Integrated PCB installation
Functional and endurance testing
Airflow calibration
Final-pack cleanroom operations
Medical-grade plastics, filtration housings, humidifier components, and subassemblies are produced or integrated within validated workflows.
With Southeast Asian manufacturing hubs, we deliver high-quality, scalable production with competitive pricing and reliable lead times.
Whether you are launching a new sleep apnea device, transferring production, or scaling an existing production line, Sanbor Medical offers the technical expertise, quality control, and regulatory alignment to bring your product to market safely and efficiently. Contact Sanbor Medical to discuss your next project.