Certification of the designs of medical devices requires decisions to be made based on uncertainty. This is true whether the designer is basing the decision on information derived from empirical tests or computational simulations. Design of experiments (DoE) and sensitivity analysis (SA) can be used in both empirical testing and computational simulation to evaluate uncertainty. DoE and SA can be prohibitively expensive for empirical testing if more than just a few parameters are tested. And testing at the statistical limits of the parameters is seldom possible. Because computational simulations are often orders of magnitude less costly than empirical tests, they offer the possibility of fully examining the design space out to all conceivable limits. This provides the data needed to better understand the effect of uncertainty and the probability that a design will meet its desired function over its intended lifetime. Computational simulation allows for risk based designs with increased...
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September 2015
Technical Briefs
Uncertainty Management in Computational Simulations of Medical Devices1
Animesh Dey,
Animesh Dey
VEXTEC Corporation
,Brentwood, TN 37027
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Sanjeev Kulkarni,
Sanjeev Kulkarni
VEXTEC Corporation
,Brentwood, TN 37027
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Sankaran Mahadevan,
Sankaran Mahadevan
Department of Civil and
Environmental Engineering,
Environmental Engineering,
Vanderbilt University
,Nashville, TN 37235
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Robert G. Tryon,
Robert G. Tryon
VEXTEC Corporation
,Brentwood, TN 37027
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Ganapathi Krishnan
Ganapathi Krishnan
VEXTEC Corporation
,Brentwood, TN 37027
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Animesh Dey
VEXTEC Corporation
,Brentwood, TN 37027
Sanjeev Kulkarni
VEXTEC Corporation
,Brentwood, TN 37027
Sankaran Mahadevan
Department of Civil and
Environmental Engineering,
Environmental Engineering,
Vanderbilt University
,Nashville, TN 37235
Robert G. Tryon
VEXTEC Corporation
,Brentwood, TN 37027
Ganapathi Krishnan
VEXTEC Corporation
,Brentwood, TN 37027
DOI: 10.1115/1.4030598
Manuscript received March 3, 2015; final manuscript received May 7, 2015; published online July 16, 2015. Editor: Arthur Erdman.
J. Med. Devices. Sep 2015, 9(3): 030954 (2 pages)
Published Online: September 1, 2015
Article history
Received:
March 3, 2015
Revision Received:
May 7, 2015
Online:
July 16, 2015
Citation
Dey, A., Kulkarni, S., Mahadevan, S., Tryon, R. G., and Krishnan, G. (September 1, 2015). "Uncertainty Management in Computational Simulations of Medical Devices." ASME. J. Med. Devices. September 2015; 9(3): 030954. https://doi.org/10.1115/1.4030598
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