The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.
Skip Nav Destination
Article navigation
June 2017
Technical Briefs
The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices
Tina M. Morrison,
Tina M. Morrison
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: tina.morrison@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: tina.morrison@fda.hhs.gov
Search for other works by this author on:
Maureen L. Dreher,
Maureen L. Dreher
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: maureen.dreher@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: maureen.dreher@fda.hhs.gov
Search for other works by this author on:
Srinidhi Nagaraja,
Srinidhi Nagaraja
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: srinidhi.nagaraja@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: srinidhi.nagaraja@fda.hhs.gov
Search for other works by this author on:
Leonardo M. Angelone,
Leonardo M. Angelone
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: leonardo.angelone@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: leonardo.angelone@fda.hhs.gov
Search for other works by this author on:
Wolfgang Kainz
Wolfgang Kainz
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: wolfgang.kainz@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: wolfgang.kainz@fda.hhs.gov
Search for other works by this author on:
Tina M. Morrison
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: tina.morrison@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: tina.morrison@fda.hhs.gov
Maureen L. Dreher
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: maureen.dreher@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: maureen.dreher@fda.hhs.gov
Srinidhi Nagaraja
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: srinidhi.nagaraja@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: srinidhi.nagaraja@fda.hhs.gov
Leonardo M. Angelone
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: leonardo.angelone@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: leonardo.angelone@fda.hhs.gov
Wolfgang Kainz
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: wolfgang.kainz@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: wolfgang.kainz@fda.hhs.gov
1Corresponding author.
Manuscript received August 2, 2016; final manuscript received January 23, 2017; published online May 3, 2017. Assoc. Editor: Marc Horner.
This material is declared a work of the U.S. Government and is not subject to copyright protection in the United States. Approved for public release; distribution is unlimited.
J. Med. Devices. Jun 2017, 11(2): 024503 (5 pages)
Published Online: May 3, 2017
Article history
Received:
August 2, 2016
Revised:
January 23, 2017
Citation
Morrison, T. M., Dreher, M. L., Nagaraja, S., Angelone, L. M., and Kainz, W. (May 3, 2017). "The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices." ASME. J. Med. Devices. June 2017; 11(2): 024503. https://doi.org/10.1115/1.4035866
Download citation file:
Get Email Alerts
Related Articles
Data Communication Pathway for Sensing Guidewire at Proximal Side: A Review
J. Med. Devices (June,2017)
Automated Real-Time Processing of Single Lead Electrocardiogram for Simultaneous Heart Rate and Respiratory Rate Monitoring
J. Med. Devices (June,2017)
Magnetic Chest Tube Positioning System
J. Med. Devices (June,2018)
Ventricular Assist Devices: Current State and Challenges
J. Med. Devices (December,2017)
Related Proceedings Papers
Related Chapters
Decision Making in Two-Dimensional Warranty Planning (PSAM-0186)
Proceedings of the Eighth International Conference on Probabilistic Safety Assessment & Management (PSAM)
mDFA Human Empirical Results
Modified Detrended Fluctuation Analysis (mDFA)
A Human Reliability-Centered Approach to the Development of Job Aids for Reviewers of Medical Devices That Use Radiological Byproduct Materials (PSAM-0299)
Proceedings of the Eighth International Conference on Probabilistic Safety Assessment & Management (PSAM)