Prototyping and functional trials of artificial valve software focus on several key areas to ensure the valve's performance, safety, and reliability.

Simulation and Modeling

• Fluid-Structure Interaction (FSI): Simulating how the valve interacts with blood flow to ensure optimal performance and minimal turbulence.
• Mechanical Stress Testing: Assessing how the valve materials withstand repetitive mechanical stress to ensure durability and longevity.

Design Optimization

• Iterative Design: Continuously refining the valve design based on simulation results to improve performance and reduce potential issues.
• Generative Design: Using algorithms to explore various design configurations and identify the most efficient and effective solutions.

Regulatory Compliance

• Testing Protocols: Ensuring that the valve meets all regulatory requirements for medical devices, including extensive testing and validation.
• Documentation: Maintaining thorough documentation of all design, testing, and trial processes to support regulatory submissions.

By focusing on these areas, prototyping and functional trials aim to develop a reliable, effective, and safe artificial heart valve that meets clinical needs and improves patient outcomes.