의료기기 하드웨어 루프(HIL) 검증을 위한 고정밀 합성 생체 생리 신호
VitalSimulator는 임상적으로 신뢰할 수 있고 수학적으로 검증된 합성 생리 신호 스트림을 제공하여 의료기기 제조업체가 인체 위험 없이 펌웨어 스트레스 테스트, AI 알고리즘 훈련 및 인실리코(In-silico) 규제 임상시험을 수행할 수 있도록 지원합니다.
VitalSimulator In Silico Simulation Architecture
Computational Physiology Engine and Hardware Signal Generator
Central System: Physiological Physics Engine - Multi-Compartment Human Model
Clinical IoMT Nodes
- Lumped-Parameter Hemodynamic Core
- 3D Cellular Electrophysiology
- Respiratory Mechanics Twin
- Precision DAC Signal Injector
- Target Medical Device Under Test
Architectural Layers & Regulatory Standards
- Multi-Compartment Hemodynamic Modeling (Nonlinear ODE Solver / 21-Compartment Circulatory Twin): Numerical solution of Navier-Stokes and Windkessel differential equations simulating pressure drops across cardiac chambers and vascular beds.
- Cellular Cardiac Electrophysiology (Bidomain Reaction-Diffusion Solver / GPU Finite Element Acceleration): Biophysical simulations of ion channel kinetics (ten Tusscher-Panfilov model) producing authentic 12-lead ECG surface potentials.
- Synthetic Respiratory Dynamics (Two-Compartment Viscoelastic Lung Model / PaO2/PaCO2 Blood Gas Simulator): Simulation of airway resistance, lung compliance, alveolar gas exchange, and ventilator patient-asynchrony events.
- Hardware-in-the-Loop (HIL) Physical Injection (24-Bit Precision DAC / High-CMRR Bio-Impedance Synthesizer): Converting computational waveforms into calibrated microvolt biopotentials and pneumatic pressure waves for physical device inputs.
Key Metrics: < 10 µV (ECG Voltage Resolution) | 100 kHz (Waveform Synthesis Rate) | ASME V&V 40 (Verification Standard) | Zero (Human Clinical Exposure Risk)
고충실도 물리학으로 동물실험과 임상위험 대체하기
Testing life-critical medical devices against rare ventricular arrhythmias or pediatric respiratory distress in living patients is dangerous and ethically constrained. VitalSimulator provides deterministic digital twin physiology running in real time.
Core Engineering Areas
Technical Articles
Related Cluster Architecture Specifications
- HealthVigilance — Zero-Trust IoMT Architecture, SaMD Risk Engineering & Autonomous Clinical Post-Market Vigilance
- AgenticSaMD — Autonomous Agentic Software as a Medical Device, Multi-Agent Clinical Decision Support & FDA GMLP Guardrails
- AITelemonitoring — Autonomous AI Telemonitoring, Virtual Nursing Assistants & Predictive Clinical Deterioration Scoring
- BCI2IoMT — Brain-Computer Interface IoMT Gateways, Neural Decoding & Electrophysiological Streaming