This paper presents a framework and detailed vision for using immersive virtual reality (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 high-risk, high-payoff designs. For the past 4 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 system-level 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 computational fluid dynamics codes. We believe that 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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e-mail: keefe@cs.umn.edu
e-mail: fotis@umn.edu
e-mail: interran@cs.umn.edu
e-mail: runesha@msi.umn.edu
e-mail: coff0097@umn.edu
e-mail: stake007@umn.edu
e-mail: linxx691@umn.edu
e-mail: sunxx564@umn.edu
e-mail: iman@buffalo.edu
e-mail: lebao002@umn.edu
e-mail: rowe@msi.umn.edu
e-mail: agerdman@umn.edu
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December 2010
Design Innovations
A Process for Design, Verification, Validation, and Manufacture of Medical Devices Using Immersive VR Environments
Daniel F. Keefe,
Daniel F. Keefe
Department of Computer Science and Engineering,
e-mail: keefe@cs.umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Fotis Sotiropoulos,
Fotis Sotiropoulos
Saint Anthony Falls Laboratory,
e-mail: fotis@umn.edu
University of Minnesota
, Minneapolis, MN 55414
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Victoria Interrante,
Victoria Interrante
Department of Computer Science and Engineering,
e-mail: interran@cs.umn.edu
University of Minnesota
, Minneapolis, MN 55455
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H. Birali Runesha,
H. Birali Runesha
Minnesota Supercomputing Institute,
e-mail: runesha@msi.umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Dane Coffey,
Dane Coffey
Department of Computer Science and Engineering,
e-mail: coff0097@umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Molly Staker,
Molly Staker
Medical Devices Center and Department of Mechanical Engineering,
e-mail: stake007@umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Chi-Lun Lin,
Chi-Lun Lin
Medical Devices Center and Department of Mechanical Engineering,
e-mail: linxx691@umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Yi Sun,
Yi Sun
Medical Devices Center and Department of Mechanical Engineering,
e-mail: sunxx564@umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Iman Borazjani,
Iman Borazjani
Saint Anthony Falls Laboratory,
e-mail: iman@buffalo.edu
University of Minnesota
, Minneapolis, MN 55414
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Trung Le,
Trung Le
Saint Anthony Falls Laboratory,
e-mail: lebao002@umn.edu
University of Minnesota
, Minneapolis, MN 55414
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Nancy Rowe,
Nancy Rowe
Minnesota Supercomputing Institute,
e-mail: rowe@msi.umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Arthur Erdman
Arthur Erdman
Medical Devices Center and Department of Mechanical Engineering,
e-mail: agerdman@umn.edu
University of Minnesota
, Minneapolis, MN 55455
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Daniel F. Keefe
Department of Computer Science and Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: keefe@cs.umn.edu
Fotis Sotiropoulos
Saint Anthony Falls Laboratory,
University of Minnesota
, Minneapolis, MN 55414e-mail: fotis@umn.edu
Victoria Interrante
Department of Computer Science and Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: interran@cs.umn.edu
H. Birali Runesha
Minnesota Supercomputing Institute,
University of Minnesota
, Minneapolis, MN 55455e-mail: runesha@msi.umn.edu
Dane Coffey
Department of Computer Science and Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: coff0097@umn.edu
Molly Staker
Medical Devices Center and Department of Mechanical Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: stake007@umn.edu
Chi-Lun Lin
Medical Devices Center and Department of Mechanical Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: linxx691@umn.edu
Yi Sun
Medical Devices Center and Department of Mechanical Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: sunxx564@umn.edu
Iman Borazjani
Saint Anthony Falls Laboratory,
University of Minnesota
, Minneapolis, MN 55414e-mail: iman@buffalo.edu
Trung Le
Saint Anthony Falls Laboratory,
University of Minnesota
, Minneapolis, MN 55414e-mail: lebao002@umn.edu
Nancy Rowe
Minnesota Supercomputing Institute,
University of Minnesota
, Minneapolis, MN 55455e-mail: rowe@msi.umn.edu
Arthur Erdman
Medical Devices Center and Department of Mechanical Engineering,
University of Minnesota
, Minneapolis, MN 55455e-mail: agerdman@umn.edu
J. Med. Devices. Dec 2010, 4(4): 045002 (6 pages)
Published Online: November 3, 2010
Article history
Received:
August 19, 2010
Revised:
August 27, 2010
Online:
November 3, 2010
Published:
November 3, 2010
Citation
Keefe, D. F., Sotiropoulos, F., Interrante, V., Runesha, H. B., Coffey, D., Staker, M., Lin, C., Sun, Y., Borazjani, I., Le, T., Rowe, N., and Erdman, A. (November 3, 2010). "A Process for Design, Verification, Validation, and Manufacture of Medical Devices Using Immersive VR Environments." ASME. J. Med. Devices. December 2010; 4(4): 045002. https://doi.org/10.1115/1.4002561
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