The research and development project comprised several key stages, carried out in an iterative cycle following the PDCA (Plan-Do-Check-Act) model. Each stage was subjected to thorough analysis and testing, which allowed for the gradual optimization of the solution.
1. Technological analysis and market research.
The team conducted an analysis of the current state of the art in the measurement of carbon monoxide in exhaled air and assessed available technologies and standards. Based on this, the assumptions for the target technology and device architecture were defined.
2. Mechanical design and injection molding technology research.
A detailed mechanical design of the device was created using CAD tools, taking into account ergonomic aspects and mass production requirements. The feasibility of using injection molding technology was examined to optimize the production process.
3. Electronics design (PCB) with precision analog circuits. The team developed an electronic design, including precision analog circuits for the CO sensor, ensuring high measurement accuracy. Circuits resistant to interference, crucial in a medical environment, were also designed.
4. Development of DSP algorithms. Signal processing (DSP) algorithms were developed to convert CO measurements into data useful for medical analysis. These algorithms included noise filtering and result interpretation in the context of patient health.
5. Cloud system for data aggregation and analysis. A cloud architecture was designed and implemented to collect data from multiple devices. The system ensures secure data storage and presentation in a form understandable to doctors and specialists. Data tokenization and encryption maintained a high level of security.
6. Prototype production and Release Candidate units. Prototypes and three Release Candidate (RC) units were produced and subjected to rigorous testing. Long-term calibration tests were performed, simulating the exhalation of gases with specific parameters, allowing for precise calibration of the devices.
7. Medical certification. EMC (Pre-Compliance) studies and tests for conformity with CE medical standards were conducted. Mechanical resistance was tested, and optimizations were made to reduce energy consumption and extend battery life.
8. Finalization of production documentation. Complete technical documentation (ECAD, 2D schematics, technical drawings, CAD model), research reports, production documentation, and assembly and user manuals were prepared. All elements were aligned with the planned production volumes of 250 units per month.
The project was successfully completed, resulting in the development of a technologically advanced medical device that:
Thanks to these solutions, modern therapy for treating chronic smokers gained a tool that supports both diagnosis and patient monitoring, while also preparing the system for integration with artificial intelligence algorithms, which in the future will accelerate and optimize the treatment process