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A Process for Design, Verification, Validation, and Manufacture of Medical Devices using Immersive VR Environments

Journal Article

A Process for Design, Verification, Validation, and Manufacture of Medical Devices using Immersive VR Environments. Daniel F. Keefe, Fotis Sotiropoulos, Victoria Interrante, Birali H. Runesha, Dane Coffey, Molly Staker, Chi-Lun Lin, Yi Sun, Iman Borazani, Nancy Row, Art Erdman. ASME Journal of Medical Devices (2010) Volume 4, Number 4 pp.

Abstract

This paper presents a framework and detailed vision for using immersive VR environments to improve the design, verification, validation, and manufacture of medical devices. Major advances in medical device design and manufacture currently require extensive and expensive product cycles that include animal and clinical trials. The current design process limits opportunities to thoroughly understand and refine current designs and to explore new highrisk, high-payoff designs. For the past four years, our interdisciplinary research group has been working toward developing strategies to dramatically increase the role of simulation in medical device engineering, including linking simulations with visualization and interactive design. Although this vision aligns nicely with the stated goals of the FDA and the increasingly important role that simulation plays in engineering, manufacturing, and science today; the interdisciplinary expertise needed to realize a simulation-based visual design environment for real-world medical device design problems makes implementing (and even generating a systemslevel design for) such a system extremely challenging. In this paper, we present our vision for a new process of simulation-based medical device engineering and the impact it can have within the field. We also present our experiences developing the initial components of a framework to realize this vision and applying them to improve the design of replacement mechanical heart valves. Relative to commercial software packages and other systems used in engineering research, the vision and framework described are unique in the combined emphasis on 3D user interfaces, ensemble visualization, and incorporating state-of-the-art custom CFD codes. We believe this holistic conception of simulation-based engineering, including abilities to not just simulate with unprecedented accuracy but also to visualize and interact with simulation results, is critical to making simulation-based engineering practical as a tool for major innovation in medical devices. Beyond the medical device arena, the framework and strategies described may well generalize to simulation-based engineering processes in other domains that also involve simulating, visualizing, and interacting with data that describe spatially complex time-varying phenomena.

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