ASME V&V 40 Virtual Workshop
Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices. April 7, 20211:00 PM-5:30 PM
ASME V&V 40 — Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices, was published in 2018 to support the credible use of modeling and simulation within the medical device industry. This standard was developed through close collaboration between medical device developers, regulatory agencies, and other device industry stakeholders, and provides modelers in the medical device industry with a framework for establishing model credibility requirements.
This introductory workshop will provide an overview of the standard and highlight its key tenets through a few medical device examples and active breakout discussions.
Instructors are members from the ASME V&V 40 Subcommittee:
- Jeff Bischoff from Zimmer Biomet, V&V 40 Chair
- Marc Horner from ANSYS, V&V 40 Vice-Chair
- Payman Afshari from Depuy Synthes, V&V 40 Vice-Chair
- Kate Hyam from ASME, Project Engineering Manager and V&V 40 Secretary
- Mehul Dharia, Zimmer Biomet
- Mark Goodin, SimuTech Group, Inc.
- Brandon Lurie, W.L. Gore & Associates
- Kenny Aycock, US FDA
The online V&V 40 Workshop will be held via Zoom on April 7, 2021 from 1:00-5:30 PM EDT.
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An In Silico Clinical Trial is the use of individualised computer simulation in the design, development and regulatory evaluation of a medicinal product, medical device, or medical intervention. Currently. Biomedical product development and assessment is almost completely founded on experimental testing throughout all phases of development chain, from in vitro bench testing, to pre-clinical animal models, to human clinical trials that demonstrate safety and efficacy of new medical devices. However, predictive computer simulation has the potential to transform the Biomedical Industry through the development and implentation of In Silico Clinical Trial platforms, which exploit exsiting computer simulation technologies that predict physical, checmical and biological performance of implantatble devices within individual patients. In Silico Clinical Trial platforms have the potential to reduce, refine, and partially replace animal testing and human clinical trials throughout all areas of the sector, significant reducing direct and indirect costs. At this stage, it is crucial that industrial, academic, clinical and regulatory stakeholders engage across Europe to address the technological challenges and advance in silico clinical trials for Biomedical products towards more widespread implementation.
The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 777119
InSiSt is a multidisciplinary Consortium with complementary expertise and experience to support the value chain that the project envisages to achieve. Interventional cardiologists, technical partners with extensive expertise in the field of computer modelling and simulation: (i) biomedical imaging (USFD, FORTH), (ii) coronary fluid dynamics (ERASMUSMC, USFD, CBSET), mechanical modelling and biomechanics (POLIMI, FORTH, NUIG, USFD, BIOIRC), experts in the field of in vitro mechanical testing (BIOIRC) and animal studies (CBSET), biology experts (CNR, FORTH), CRO with significant experience in providing services for regulatory authorizations and clinical trials for biomedical products (MCR), Cloud experts for platforms development and integration (FEOPS), Stent Biomedical Industry with high expertise in the design, development and manufacture of coronary stents (BSL) will join forces to accomplish the InSiSt objectives and deliver all the intermediate and final project expected outcomes. The InSiSt Consortium includes 12 partners from 8 different EU countries and one US partner (CBSET).