Medical Device Simulation for Cardiovascular Medical Device Development: Capabilities and Methods
Standards-oriented benchtop testing and patient-specific simulations on validated cardiovascular anatomies shorten design iterations from months to weeks and deliver regulatory-grade evidence.
v-Patients is an in silico simulation platform developed specifically for the development of cardiovascular medical devices. Unlike generic engineering platforms, it was not retrofitted for medical applications after the fact. This is simulation for product development, not a clinical training simulator: v-Patients investigates how a medical device performs under defined anatomical and physical conditions.
The platform combines computational fluid dynamics (CFD), computational solid mechanics (CSM) , and fluid-structure interaction (FSI) in a shared workflow. This makes it possible to model the behavior of a medical device in the anatomy it was developed for.
This page covers the two central simulation categories of v-Patients: virtual benchtop testing for ISO-oriented, regulatory-relevant evidence, and patient-specific implant simulations for deployment, anatomical fit, and the assessment of device performance across different patient populations.
Virtual Benchtop Testing for Cardiovascular Medical Devices
Virtual benchtop testing reproduces physical tests on digital models of cardiovascular medical devices and can generate regulatory-relevant evidence without requiring a new physical test setup for each design iteration.
Fatigue testing
Fatigue testing simulates the cyclic loading a medical device is exposed to over years of use—such as a heart valve that opens and closes, or a stent that deforms with the movement of the vessel wall. v-Patients assesses more than 10 years of service life, corresponding to up to 400 million cycles, without carrying out a full physical durability test for each design variant.
The aortic valve benchtop testing use case shows how v-Patients can be used for an ISO 5840-aligned durability assessment.
Hemodynamic performance
Simulation of hemodynamic performance assesses blood flow through and around a medical device, including pressure gradients, wall shear stress, and thrombosis risk. For valve devices, regurgitation and hemolysis risk can additionally be investigated—two performance parameters relevant to cardiovascular device development.
Our TTVR simulation use case shows how hemodynamic performance can be assessed for a tricuspid valve replacement (TTVR).
Worst-case scenario analysis
Worst-case scenario analysis tests a medical device against anatomical extreme cases that it must nonetheless withstand, even if these occur rarely. These include, for example, rare anatomical variations, heavily calcified valves, or extreme vessel angulations.
Such edge cases are often difficult to reproduce deliberately in physical studies. Simulation makes it possible to systematically investigate device performance at anatomical limits and to account for such constellations during development.
Patient-Specific Implant Simulations for Cardiovascular Medical Devices
Patient-specific implant simulations investigate how a medical device can be deployed in an individual patient anatomy and how it behaves there. The basis is digital patient twins from real imaging data rather than exclusively generic reference geometries.
Deployment simulation
Deployment simulation reproduces how a medical device is crimped, navigated through the vascular anatomy, and expanded or released in the target anatomy. This includes, among others, TAVI/TAVR (transcatheter aortic valve implantation or replacement), stent expansion, and the positioning of LAA occluders (left atrial appendage occluders).
You can work with your own CAD model of the medical device and provide it as an STL file for the simulation. This means the calculation is based on the actual device geometry rather than on a generic template.
Our cardiac catheter design optimization use case shows in detail how the modeling of catheter navigation works.
Interactions Between Device, Tissue, and Flow
Simulation of the interaction between device, tissue, and flow captures strains, stresses, displacements, and fluid-mechanical effects where a medical device interacts with tissue and blood flow. This includes, for example, the dynamics of heart valve leaflets, stent-vessel interaction, and the outflow performance of a ventricular assist device (VAD).
Fluid-structure interaction (FSI) combines the structural and fluid-mechanical effects within the same coupled simulation.
Population simulation
Population simulation tests a medical device on hundreds of virtual cardiovascular patients. The cohorts can cover different severity grades, sexes, age groups, and rare anatomies that are difficult to recruit deliberately in physical form.
Customers can also provide their own DICOM (Digital Imaging and Communications in Medicine) CT data. Virtonomy’s Data & AI team applies proprietary segmentation algorithms, verifies the results, and converts the source data into digital twins that can be used in the same simulation workflow.
The methodology behind digital patient cohorts is described in detail in the digital patient twins overview.
Simulations Across Your Entire Cardiovascular Development Cycle
v-Patients supports cardiovascular medical device simulation from the early design concept through study and regulatory preparation to later development and monitoring phases.
Early design validation
Test concepts for structural heart and vascular devices such as valves, stents, or catheters on digital anatomies before further physical prototypes are manufactured.
Clinical Trial Planning
Use digital patient cohorts to account for anatomical variability, severity grades, and demographic differences as early as the study planning stage.
Regulatory submissions
Generate simulation-based evidence that can be aligned with relevant standards and model credibility frameworks such as ISO 5840 and ASME V&V 40.
Post-market surveillance
Continue to investigate design changes, anatomical edge cases, or observed device behavior on the basis of virtual patient models.
Trusted by Leading Medical Device Companies
Understanding patient anatomies and optimizing anatomical fit directly impacts the fate of development projects. Virtonomy’s combined expertise in specific pathologies, device/patient interactions and state of the art therapy options is tremendously valuable for anyone looking to create or optimize cardiovascular technologies.
Dr. Maximilian Kütting
Director R&D New Valve Technology
The SPH Method: A Simulation Technique for Cardiovascular Medical Device Development
SPH (smoothed particle hydrodynamics) is a mesh-free simulation technique that represents complex physical systems using particles instead of classical grids. v-Patients uses SPH for, among other things, fluid-structure interactions, in which fluids and structures influence one another.
This is especially relevant for cardiovascular applications in which geometries change or move substantially during the simulation. Examples include opening and closing heart valves, expanding stents, and catheters in moving anatomical structures.
We explain in detail how SPH lends itself to modeling complex interactions between device, tissue, and blood flow in our article on the SPH method in medical simulations.
SPH simulations of cardiovascular applications: catheter navigation, heart valve dynamics, and flow behavior in a cannula.
SPH method: What is it and how is it used for medical simulations?
Smoothed Particle Hydrodynamics (SPH) is a revolutionary method in computational modeling, particulary known for its use in medical simulations. This particle-based approach excels in handling dynamic interfaces and changing geometries, making it a powerful tool for various applications, especially in the healthcare technology.
Frequently Asked Questions (FAQ)
Which medical device simulation methods does v-Patients support?
v-Patients supports two main categories of simulation: virtual benchtop testing with fatigue testing, hemodynamic performance assessment, and worst-case scenario analysis, as well as patient-specific implant simulations with deployment simulation, device-tissue-flow interactions, and population simulations.
The methods used include computational fluid dynamics (CFD), finite element analysis (FEA), and SPH for certain fluid-structure interaction problems. SPH is one of several simulation techniques used.
Are v-Patients simulations ISO-compliant?
Yes, simulations with v-Patients can be aligned with the requirements of relevant standards such as DIN EN ISO 5840 for heart valve substitutes. The simulation results are structured so that they can support regulatory submissions.
Which standards and evidence are relevant in a specific case depends on the medical device, its regulatory pathway, and the defined Context of Use.
Which cardiovascular device categories can I simulate with v-Patients?
v-Patients supports applications for structural heart and vascular medical devices, including TTVR, TAVI/TAVR, aortic valves, catheters, and stents. Beyond this, further device classes and applications can be integrated depending on the development project.
You can find concrete examples from different cardiovascular device categories in our overview of digital twin use cases.
Do the FDA and EU Notified Bodies accept in silico evidence generated on v-Patients?
Yes, in silico evidence can support regulatory submissions in the US and the EU. Its acceptance, however, depends on the respective use case, the model credibility, and the regulatory embedding.
The FDA publishes guidance on assessing computational modeling and simulation. In the EU MDR context as well, simulation-based data can be part of the evidence base. What matters includes the defined Context of Use as well as verification, validation, and model credibility following frameworks such as ASME V&V 40.
More on this in the article on in silico clinical trials.
Can I upload my own CAD model and my own patient data for the simulation?
Yes, both are possible. You can provide your own CAD model of the medical device as an STL file for deployment and fit simulations, so that the results reflect your actual device geometry.
For patient data, you can upload your own DICOM CT scans. Virtonomy’s Data & AI team applies proprietary segmentation algorithms, verifies the results, and anonymizes the data before it is integrated into the workflow as digital twins.
Does v-Patients fully replace physical benchtop testing?
No. Simulation complements the physical testing pathway rather than fully replacing it. Virtual benchtop testing can reduce the number of physical prototypes needed and shorten design iterations from months to weeks.
Certain physical and in vivo endpoints remain required, depending on the device class and regulatory pathway. You can read about the role of the different methods in the direct comparison.
Is there a free trial or self-service access to v-Patients?
No, v-Patients does not offer a self-service trial. Access begins with an initial conversation and a demo tailored to the specific medical device and the respective use case.
This way, the demo can be aligned with relevant target anatomies, device geometries, and simulation requirements from the start, rather than showing a generic sandbox environment.
v-Patients in Your Application
A demo tailored to your medical device shows how v-Patients can be used for your specific development task. The focus is on relevant patient anatomies, simulation methods, and possible workflows for your cardiovascular medical device.