Steps
Step 1
Experiment 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 2
Data Acquisition
This step performs biomedical experiment design and implementation, obtaining reliable data and conclusions through scientific experiments. Biomedical experiments must strictly follow scientific methods and ethical norms, ensuring objectivity and reproducibility of experimental results. Full-process quality control from experimental design, sample preparation, data collection to statistical analysis.
• Design experimental protocol, determine sample size, grouping method, control setting and evaluation indicators, pass ethical review
• Prepare experimental samples and reagents, debug experimental equipment, establish standard operating procedures (SOP)
• Conduct data collection according to experimental protocol, perform statistical analysis using SPSS or GraphPad Prism
Deliverable: Experimental report (including experimental protocol, raw data, statistical analysis, result charts, conclusion discussion) | Quality standard: Scientific experimental design, reliable data, correct statistical methods, evidence-based conclusions
Step 3
Kinematic 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 4
Kinetic Modeling
This step establishes mathematical models of biomedical systems, providing theoretical foundation for simulation analysis and parameter optimization. Biological systems are characterized by complexity and nonlinearity, requiring reasonable mathematical descriptions based on physiological mechanisms combined with experimental data. The model must balance accuracy and complexity, ensuring computability and interpretability.
• Build differential equation or finite element models using MATLAB or COMSOL based on physiological mechanisms and anatomical data
• Perform parameter sensitivity analysis, identify key parameters, provide direction for subsequent parameter identification and optimization
• Calibrate model with experimental or clinical data, identify parameters using least squares or Bayesian methods
Deliverable: Mathematical model report (including governing equations, parameter list, sensitivity analysis, calibration results, validation comparison) | Quality standard: Clear model mechanism, identifiable parameters, fitting error <15%, sufficient validation
Step 5
Result Analysis and Report
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