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.
In Silico Clinical Trials Concepts and Adoption (drugs, devices, the industry and Regulatory)
On March 5th, the InSilc project will host a workshop on In Silico Clinical Trials Concepts and Adoption. This workshop will provide an overview to the InSilc Platform to prospective users by discussing a range of InSilico Scenarios that have been completed by the project partners.
Conceptual architecture of InSilc Cloud platform and the Modules dependencies are depicted in Figure below, whereas the beyond the state of the art activities, which are foreseen to achieve the project objectives are described in detail below.
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.