Establishing the Credibility of Computational Models of Blood Pumps Through Verification, Validation, and Uncertainty Quantification | Technical Chapter

Chapter Summary

Computational modeling can provide valuable insight into blood-pump performance, but simulation results must be supported by a clear and defensible assessment of model credibility before they can be relied upon for engineering or regulatory decision-making.

This technical chapter* examines how verification, validation, and uncertainty quantification can be applied to computational models of blood pumps to evaluate whether simulation results are sufficiently accurate and reliable for their intended use. It discusses the practical challenges associated with establishing confidence in complex cardiovascular-device models, including numerical error, experimental comparison, model assumptions, and sources of uncertainty.

By connecting established VVUQ principles with blood-pump modeling applications, the chapter provides a structured framework for assessing computational credibility and strengthening the technical evidence behind simulation-based conclusions.

*Originally published as Chapter 18 in Computational Modeling and Simulation of Medical Devices: Verification, Validation, and Uncertainty Quantification.

What This Chapter Covers

• The role of verification, validation, and uncertainty quantification in computational model credibility
• Approaches for assessing numerical and modeling errors in blood-pump simulations
• Methods for comparing computational predictions with experimental measurements
• Identification and evaluation of key sources of uncertainty
• Considerations for determining whether a model is credible for its intended use
• Application of credibility-assessment principles to blood-pump and cardiovascular-device development
• The relationship between computational evidence, engineering decision-making, and regulatory expectations

Why Model Credibility Matters in Blood-Pump Development

Computational fluid dynamics and other simulation methods allow engineers to investigate complex flow behavior inside blood pumps before committing to extensive physical testing or design changes. These models can support decisions involving hydraulic performance, flow patterns, regions of recirculation, shear exposure, and other factors that may influence device performance and safety.

However, simulation results are only useful when engineers can demonstrate that the underlying model is sufficiently trustworthy for the decision being made. Numerical discretization, modeling assumptions, boundary conditions, material properties, experimental variability, and other sources of uncertainty can all affect predicted results. A model that appears physically realistic may still produce misleading conclusions if those uncertainties are not properly evaluated.

A structured verification, validation, and uncertainty-quantification process provides a defensible way to assess those limitations. Establishing model credibility helps engineering teams determine where simulation results can be relied upon, where additional evidence may be necessary, and how computational modeling can contribute to design evaluation, risk assessment, and regulatory documentation.

Who Should Read This Chapter

This technical chapter is intended for professionals involved in the simulation, development, evaluation, and verification of blood pumps and other cardiovascular medical devices, including:

• Medical-device simulation engineers
• CFD engineers and analysts
• Blood-pump and cardiovascular-device developers
• Verification and validation engineers
• R&D and product-development teams
• Engineers supporting computational-model credibility assessments and regulatory submissions