Application of Computational Modeling and Simulation (CM&S) in the medical device product development life cycle continues to grow rapidly. Additive Manufacturing (3D printing) is also being adopted and applied as a technology helping designers and engineers fathom creative and innovative designs not possible through traditional manufacturing solutions. The enthusiasm for its potential is tempered by the reality of the variability and uncertainties in the current technological state. CMS can be used to explore the impacts of uncertainty and has the potential to be an essential tool for realistic device assessment and viability, particularly those with performance requirements. In this presentation, an ASME V&V40 framework (verification, validation, and uncertainty quantification) is used to explore ways to manage uncertainties in the design development decision process.