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The Precision Requirements of Modern Respiratory Diagnostics
According to the World Health Organization, chronic obstructive pulmonary disease (COPD) is a leading cause of death globally, responsible for more than 3 million deaths every year. Given this substantial disease burden, early and accurate diagnosis is essential for effective prevention and long-term management. The GOLD 2024/2025 reports emphasize that spirometry is required to establish the diagnosis of COPD, with a post-bronchodilator FEV1/FVC < 0.7 serving as the defining criterion for persistent airflow limitation in the appropriate clinical context.
Health awareness campaigns have also highlighted the value of lung function testing. For instance, World COPD Day 2024 adopted the theme “Know Your Lung Function”, emphasizing the importance of broad access to reliable pulmonary testing.
In addition, professional standards continue to tighten. The ATS/ERS 2022 update reduced the within-session repeatability requirement for FEV1 and FVC from 200 mL to 150 mL, raising expectations for precision and consistency in pulmonary diagnostics.
The convergence of stricter clinical standards, expanding diagnostic needs, and heightened public awareness underscores the need for respiratory diagnostic solutions that deliver exceptional accuracy, reliability, and operational efficiency to meet both current and future healthcare demands.
Cubic Enables Precision Through Advanced Gas Sensing Technologies
Meeting the demands of modern pulmonary diagnostics requires integrated systems built on proven sensing technologies and backed by comprehensive development support.
Cubic, an experienced OEM/ODM manufacturer, has leveraged its mature technology platforms, including NDIR, TDLAS, and ultrasonic, to deliver advanced sensing solutions for medical and healthcare applications, such as pulmonary function testing (PFT), cardiopulmonary exercise testing (CPET), metabolism measurement, oxygen therapy, and ventilator & anesthesia monitoring.
To demonstrate pulmonary diagnostics capabilities, Cubic has developed the OEM/ODM PFT System for spirometry and diffusion capacity assessment.
Cubic OEM/ODM PFT System: A Showcase of Advanced Gas Sensing Technologies
Cubic OEM/ODM PFT System solution integrates two complementary gas sensing technologies to deliver comprehensive respiratory assessment capabilities. Ultrasonic flow measurement captures airflow dynamics with exceptional precision, while NDIR multi-gas analysis provides real-time breath composition measurement. Together, they form the foundation for OEM partners to develop pulmonary function testing solutions that meet the highest clinical standards.
Precise Flow Measurement through Ultrasonic Technology:
Accurate spirometry depends on precise measurement of exhaled airflow and volume across a wide range of breathing maneuvers. Cubic's self-developed ultrasonic flow sensor achieves high precision utilizing ultrasonic technology and time-of-flight principle. Two transducers alternately transmit and receive ultrasound signals in opposite directions through the exhaled air stream, calculating flow velocity based on travel-time differences measured with exceptional accuracy.
The sensor’s no-contact architecture eliminates moving parts, preventing wear and drift common in mechanical flowmeters and minimizing the need for recalibration. Fast response times and wide dynamic range enable the sensor to capture both steady breathing and rapid forced expiratory maneuvers with equal precision, supporting comprehensive spirometry indices including FVC, FEV1, FEV6, PEF, and MVV.
Clinical environments demand robust, long-term reliable performance. Cubic ultrasonic sensor's solid-state design maintains measurement stability under high-frequency testing conditions, while the wide flow range accommodates diverse patients from pediatric to athletic populations.
High-Accuracy Gas Analysis through NDIR Technology:
For diffusion capacity assessment, Cubic integrates proprietary non-dispersive infrared (NDIR) sensor capable of simultaneous multi-gas analysis during pulmonary function testing. Cubic NDIR gas sensor measures CO, CH4, and CO2 concentrations in exhaled breath in real time, providing essential data for single-breath DLCO testing and alveolar-capillary function evaluation.
By detecting gas absorption at characteristic infrared wavelengths, Cubic NDIR sensor enables high precision measurements even at very low concentrations. An integrated microprocessor performs signal conditioning, automatic calibration, and BTPS correction to ensure measurement consistency under varying conditions. The optical design minimizes cross-interference, while fast modulation and high signal-to-noise detection circuits provide rapid response and robust anti-interference performance.
By integrating ultrasonic flow measurement with NDIR gas analysis, Cubic OEM/ODM PFT System solution provides a complete gas sensing foundation for advanced pulmonary function testing. The approach delivers the precision, stability, and clinical versatility required for both spirometry and diffusion capacity assessment in a single, scalable platform.
Supporting Equipment for System Validation and Calibration:
Measurement accuracy begins with sensor performance but extends throughout the entire diagnostic system. To ensure complete system validation, Cubic also offers calibration and testing equipment designed to verify performance across the entire measurement chain. The supporting tools are available as OEM modules or turnkey products to assist partners in validation, manufacturing calibration, and quality assurance.
The Breathing Simulator reproduces physiological breathing patterns to verify spirometry and diffusion measurement systems. Equipped with a servo-controlled piston driven by a precision motor, it can simulate square, sinusoidal, or trapezoidal flow waveforms, as well as user-defined patterns. The Breathing Simulator supports both positive and negative pressure cycles to mimic inhalation and exhalation, generating controlled airflows of up to 20 L/s and volumes up to 10 L.
Automatic testing sequences enable continuous operation and programmable waveform generation compliant with ATS/ISO standards, including volume-time and flow-time test protocols specified in ATS-24 and ATS-26. The device maintains gas temperature at 37 °C ± 2 °C and relative humidity at 92 % ± 5 %, replicating human respiratory conditions for BTPS correction. This ensures repeatable performance validation and supports factory calibration or R&D test environments.
For routine calibration and verification, Cubic supplies a 3 L precision syringe meeting ATS/ERS requirements. The syringe enables quick verification of spirometer flow and volume accuracy, providing a stable, reproducible standard for daily system checks.
These validation tools complement Cubic’s gas sensors and help ensure end-to-end quality from sensor performance to system integration throughout the development and production process.
Why Choose Cubic: Comprehensive OEM/ODM Partnership Solutions
As respiratory diagnostic standards continue to evolve and clinical demands intensify, medical device manufacturers require partners capable of delivering both advanced sensing technologies and complete development support. With over two decades of experience in gas sensing innovation and precision measurement solutions, Cubic has established itself as a reliable partner for healthcare providers seeking advanced respiratory assessment capabilities through OEM and ODM services that span from core sensor development to complete system integration.
Cubic’s OEM/ODM framework is built on a vertically integrated model that covers every stage of development, from sensor innovation to product realization. The foundation lies in self-developed gas sensing technologies, including NDIR, TDLAS, and ultrasonic platforms, which ensure precision, stability, and long-term reliability for high-performance medical and healthcare applications.
Complementing this expertise, Cubic maintains in-house manufacturing of core gas sensors and key components, where critical processes such as optical assembly, calibration, and electronic integration are conducted under strict quality control to maintain consistency and traceability.
Beyond core gas sensing technologies and manufacturing, Cubic provides supply chain integration that coordinates component sourcing and logistics to support scalable, cost-efficient production. Hardware and structural design teams assist partners in developing optimized mechanical layouts and compact module architectures, while software development capabilities enable data acquisition, analysis, and visualization that integrate smoothly with hospital information systems.
Through prototype testing and validation, Cubic helps partners verify measurement accuracy and system reliability under simulated operating conditions. Additional mold development services further support enclosure customization and product differentiation for diverse clinical and market applications.
By combining self-developed sensing technologies, in-house manufacturing, and full-cycle development support, Cubic delivers flexible, collaborative OEM/ODM solutions that empower partners to accelerate product development and bring advanced pulmonary diagnostic systems to market with confidence. At the same time, a global sales and service network provides responsive technical support and localized expertise throughout implementation and operational phases.
Cubic's integrated capabilities, worldwide presence, and ongoing commitment to innovation position the company as a long-term partner providing flexible, end-to-end solutions that meet the needs of medical and healthcare device manufacturers worldwide.
References:
1.https://goldcopd.org/wp-content/uploads/2024/02/GOLD-2024_v1.2-11Jan24_WMV.pdf
2.https://goldcopd.org/world-copd-day-2024/
3.https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)
4.https://www.lung.org/getmedia/d53c0e59-f3ab-435a-bcaa-a6a195b6b565/Spirometry-quick-glance-guide.pdf
