The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices

Journal of Medical Devices
Tina M MorrisonWolfgang Kainz

Abstract

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 C...Continue Reading

References

Sep 17, 2014·Journal of Medical Devices·Chi-Lun LinArthur Erdman

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Citations

Apr 12, 2019·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Tina M MorrisonMarc Horner
Jun 6, 2020·Annual Review of Biomedical Engineering·W Andrew PruettRobert L Hester
Mar 5, 2020·European Heart Journal·Jorge Corral-AceroPablo Lamata
Apr 27, 2020·Current Osteoporosis Reports·Saulo MartelliMark Taylor
Mar 22, 2020·Pediatric Cardiology·Nicole IbrahimVasum Peiris
Oct 7, 2018·Cardiovascular Engineering and Technology·Prasanna HariharanRichard A Malinauskas
Jun 15, 2019·Cardiovascular Engineering and Technology·Giorgia RocatelloPeter Mortier

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