AIAA CbA CoI Members and Interested Individuals,
We are pleased to announce a special topic meeting on December 11 at 8:00 am US Central Time. This month, we will be joined by Dr. Marc Horner, a Distinguished Engineer at Ansys, Inc., who will be presenting his work on Certification by Analysis for the medical device industry. Additional information about the presentation is as follows:
Presentation Topic:
Using Computational Modeling and Simulation to Accelerate the Regulatory Approval of Cardiovascular Devices
Abstract:
The medical device industry has traditionally relied on bench testing, animal testing, and clinical trials as the primary sources of evidence for establishing the safety and effectiveness of medical devices throughout the total product lifecycle. Increased reliance on computational modeling and simulation (CM&S) during product development has led to the need to establish clear and predictable frameworks support the inclusion of this new source of evidence in regulatory submissions. In 2011, the medical device industry, simulation software developers, and the US FDA initiated the development of the ASME V&V 40 sub-committee to address this critical need. Released 7 years later, the ASME V&V 40 standard on “Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices” is central to the utilization of CM&S results in regulatory submissions. This standard provides a risk-based framework for establishing the credibility requirements of a computational model by guiding users in establishing & assessing the verification, validation, and uncertainty quantification requirements for a specific context of use. This presentation will review the ASME V&V 40 standard along with complementary FDA guidance that outlines a clear and consistent pathway for using CM&S in submissions. Progress in the global acceptance of CM&S evidence will also be reviewed.
Speaker Bio:
Dr. Marc Horner is a Distinguished Engineer leading technical initiatives for the healthcare industry at Ansys. Marc joined Ansys after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME VVUQ-40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Marc is also a member of the IEC TC62 ad hoc Working Group whose goal is to develop a globally harmonized standard outlining best practices for model credibility assessment. Marc is also an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine. Lastly, Marc helped to found the ASME VVUQ-80 Sub-Committee focused on computational modeling and simulation for pharma/biopharma manufacturing. In 2022, Marc was elevated to the status of ASME Fellow for his significant contributions to ASME and ASME standards development.
We look forward to seeing you and hearing Marc’s presentation on December 11.
Regards,
the AIAA CbA CoI organizing team