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Medical Device Simulation

ANSYS MedTech

Accelerate medical device innovation through comprehensive virtual simulation and testing.

HIPAA compliant
ISO 13485
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Category
Software
Ideal For
Medical Device Manufacturers
Deployment
Cloud / On-premise / Hybrid
Integrations
50++ Apps
Security
HIPAA compliance, role-based access control, data encryption, audit trails
API Access
Yes - REST API for CAD and simulation data integration

About ANSYS MedTech

ANSYS MedTech is a comprehensive simulation platform designed specifically for medical device manufacturers and healthcare innovators. It provides integrated finite element analysis (FEA), computational fluid dynamics (CFD), and structural analysis tools to enable virtual testing and validation of medical devices throughout the entire product development lifecycle. The platform supports implantable devices, diagnostic equipment, surgical instruments, and therapeutic devices, helping manufacturers reduce physical prototyping costs, accelerate time-to-market, and ensure regulatory compliance. ANSYS MedTech integrates with CAD systems and PLM tools, enabling seamless workflow integration. Through AiDOOS, organizations can access managed ANSYS MedTech instances with enterprise governance, automated compliance reporting, and optimized computational infrastructure. AiDOOS enhances deployment efficiency, provides dedicated technical support for medical device validation, and ensures scalable resource allocation for complex multiphysics simulations, enabling faster innovation cycles while maintaining regulatory standards.

Challenges It Solves

  • Extended development timelines due to physical prototyping and iterative testing cycles
  • High costs associated with multiple physical iterations and regulatory validation studies
  • Risk of patient safety issues requiring redesign after clinical or market deployment
  • Difficulty meeting FDA, CE Mark, and international regulatory requirements efficiently
  • Complex multiphysics simulations requiring specialized expertise and computational resources

Proven Results

45
Reduction in physical prototype iterations required
52
Faster time-to-regulatory submission achievement
38
Lower product development and validation costs
61
Improved device safety and biocompatibility predictions

Key Features

Core capabilities at a glance

Multiphysics Simulation Engine

Integrated structural, fluid, thermal, and electrical analysis

Comprehensive device behavior prediction across all physical domains

Implant and Biocompatibility Analysis

Specialized tools for implantable device validation

Ensures device-tissue interaction safety and long-term biocompatibility

Fluid-Structure Interaction (FSI) Simulation

Advanced coupling for blood flow and device interaction

Predicts thrombosis risk and hemodynamic performance in cardiovascular devices

Regulatory Documentation Support

Automated compliance and traceability reporting

Streamlined FDA 510(k), PMA, and CE Mark submission documentation

Cloud-Based Computational Infrastructure

Scalable HPC for complex multiphysics problems

On-demand computing reduces simulation turnaround from weeks to days

Design Optimization and Parametric Studies

Automated design exploration and sensitivity analysis

Identifies optimal geometry and material configurations rapidly

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Real-World Use Cases

See how organizations drive results

Cardiovascular Device Design
Design and validate stents, heart valves, and blood pumps with fluid-structure interaction analysis to predict hemodynamics and thrombosis risk before clinical trials.
67
Reduced clinical trial failures by 40 percent
Orthopedic Implant Validation
Simulate stress distribution, bone adaptation, and implant durability for joints, spinal devices, and fracture fixation systems across realistic loading scenarios.
55
Eliminated costly redesigns after launch
Drug Delivery System Optimization
Model drug release kinetics, diffusion patterns, and device degradation for patches, inhalers, and injectable systems to ensure efficacy and safety.
48
Accelerated regulatory submission by six months
Surgical Instrument Design
Validate cutting efficiency, material fatigue, and ergonomic factors for instruments like electrodes, blades, and endoscopic tools.
62
Reduced physical testing by 50 percent
Bioelectrical Device Simulation
Analyze electrical field distribution and safety margins for pacemakers, neurostimulation devices, and diagnostic electrodes.
52
Ensured patient safety margins verified pre-launch

Integrations

Seamlessly connect with your tech ecosystem

C

CATIA

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Direct CAD model import and parametric design integration for geometry updates

S

Siemens NX

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Native CAD interoperability with associative model updates

S

SOLIDWORKS

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Seamless part and assembly import with design modification tracking

M

MATLAB/Simulink

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Co-simulation for coupled controls and device response modeling

W

Windchill PLM

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Integration with product lifecycle management for design history and traceability

D

DICOM Imaging Systems

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Import patient-specific anatomy from medical imaging for personalized device validation

E

Enterprise Data Management Systems

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Automated compliance reporting and audit trail documentation

A

ABAQUS

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Advanced material modeling and nonlinear analysis capabilities

Implementation with AiDOOS

Outcome-based delivery with expert support

Outcome-Based

Pay for results, not hours

Milestone-Driven

Clear deliverables at each phase

Expert Network

Access to certified specialists

Implementation Timeline

1
Discover
Requirements & assessment
2
Integrate
Setup & data migration
3
Validate
Testing & security audit
4
Rollout
Deployment & training
5
Optimize
Performance tuning

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Alternatives & Comparisons

Find the right fit for your needs

Capability ANSYS MedTech Epic Systems GE Healthcare Centr… Health Catalyst
Customization Excellent Excellent Good Excellent
Ease of Use Good Good Good Good
Enterprise Features Excellent Excellent Excellent Excellent
Pricing Fair Fair Fair Fair
Integration Ecosystem Excellent Excellent Excellent Excellent
Mobile Experience Fair Good Good Good
AI & Analytics Good Good Good Excellent
Quick Setup Fair Fair Fair Fair

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Frequently Asked Questions

Does ANSYS MedTech support patient-specific modeling?
Yes. ANSYS MedTech integrates DICOM medical imaging data, enabling personalized device validation based on individual patient anatomy. This is critical for implant sizing and surgical planning applications.
How does ANSYS MedTech assist with regulatory submissions?
The platform generates comprehensive simulation reports with automated traceability, sensitivity analyses, and design justifications. AiDOOS provides managed compliance templates for FDA 510(k), PMA, and CE Mark submissions, reducing regulatory review cycles.
What computational resources does ANSYS MedTech require?
ANSYS MedTech can run on local workstations or cloud infrastructure. Through AiDOOS, users access scalable HPC clusters on-demand, enabling complex multiphysics simulations to complete in days rather than weeks.
Can ANSYS MedTech model biocompatibility and material degradation?
Yes. The platform includes specialized material models for bioresorbable polymers, metals, and drug-eluting coatings, with kinetic degradation and release behavior simulation for regulatory submission.
Is training and support available for medical device teams?
Yes. ANSYS and AiDOOS provide comprehensive training, including FDA guidance interpretation, design validation best practices, and platform certification for engineering teams.
How does AiDOOS enhance ANSYS MedTech deployment?
AiDOOS provides managed cloud infrastructure, automated software updates, enterprise governance, dedicated medical device expertise, and integrated compliance tracking, eliminating IT overhead and ensuring regulatory standards are continuously met.