Steps
Step 1
System Requirements Analysis
This step conducts in-depth analysis of biomedical engineering problems, clarifying clinical requirements and technical specifications. The core of biomedical engineering is combining engineering technology with medical needs, requiring analysis of physiological mechanisms, technical feasibility and safety requirements starting from clinical application scenarios. Determine design inputs through literature review and clinical needs investigation.
• Search databases such as PubMed and IEEE Xplore, investigate domestic and international research status and technology development trends
• Analyze clinical application scenarios and user needs, clarify indications, target population and key performance indicators
• Identify technical difficulties and risk points, develop technical route and key performance parameter specifications
Deliverable: Requirements analysis report (including literature review, clinical needs, technical specifications, risk analysis, technical route) | Quality standard: Thorough investigation, clear requirements, reasonable specifications, feasible technical route
Step 2
Analog Front-End Design
This step performs biomedical system or device scheme design, translating clinical needs into specific technical solutions. Biomedical design must simultaneously consider functionality, biocompatibility, safety and regulatory compliance, seeking optimal solutions under multi-objective constraints. Adopt modular design methods to ensure system verifiability, manufacturability and maintainability.
• Perform system architecture design, divide functional modules, determine interface specifications and communication protocols for each module
• Select key components and materials, evaluate biocompatibility according to ISO 10993 or GB/T 16886
• Design circuit schematics or mechanical structures, complete detailed design using Altium Designer or SolidWorks
Deliverable: Design document (including system architecture diagram, schematic/structural diagram, BOM table, material selection description, interface specifications) | Quality standard: Reasonable design, correct parameters, compliant materials, meeting clinical needs
Step 3
Data Acquisition Design
This step performs biomedical system or device scheme design, translating clinical needs into specific technical solutions. Biomedical design must simultaneously consider functionality, biocompatibility, safety and regulatory compliance, seeking optimal solutions under multi-objective constraints. Adopt modular design methods to ensure system verifiability, manufacturability and maintainability.
• Perform system architecture design, divide functional modules, determine interface specifications and communication protocols for each module
• Select key components and materials, evaluate biocompatibility according to ISO 10993 or GB/T 16886
• Design circuit schematics or mechanical structures, complete detailed design using Altium Designer or SolidWorks
Deliverable: Design document (including system architecture diagram, schematic/structural diagram, BOM table, material selection description, interface specifications) | Quality standard: Reasonable design, correct parameters, compliant materials, meeting clinical needs
Step 4
Digital Filtering and Algorithm
This step is an important element in biomedical engineering projects, closely integrating engineering technology with medical needs to solve clinical problems. Biomedical engineering must strictly follow relevant medical device regulations and standards, ensuring safety and effectiveness. Work is carried out using interdisciplinary methods of biology, medicine and engineering.
• Work according to relevant medical device regulations (NMPA, FDA, CE) and standards (ISO, GB, YY)
• Use professional tools (MATLAB/COMSOL/SolidWorks/SPSS, etc.) for design, calculation and data analysis
• Perform biocompatibility and safety evaluation, ensuring compliance with clinical application requirements
Deliverable: Professional report (including method description, experimental data, analysis results, risk assessment, conclusions and suggestions) | Quality standard: Compliant methods, accurate data, safe and effective, compliant with medical ethics
Step 5
System Testing and Report
This step conducts comprehensive testing and verification of biomedical systems, ensuring functional performance meets design requirements and relevant standards. Testing of biomedical products must strictly follow ISO 13485 quality system and relevant medical device standards, ensuring test result repeatability and credibility. Multi-level verification through bench tests, simulation tests and animal experiments.
• Develop test plan and test cases, determine test methods and acceptance criteria according to YY/T or ISO medical device standards
• Perform functional testing, performance testing, safety testing and electromagnetic compatibility (EMC) testing
• Record test data, analyze deviation causes, conduct corrective actions and regression verification for non-conforming items
Deliverable: Test report (including test plan, test cases, raw data, result analysis, non-conformity correction records) | Quality standard: Comprehensive test coverage, standard-compliant methods, complete traceable data, all critical items qualified