2024 FDA/MDIC Symposium on Computational Modeling and Simulation Presentations

A review of the risk-informed credibility assessment framework will be provided, highlighting the concepts of context of use, model risk, and model credibility. Several case studies will be used to illustrate how these concepts can be applied in practice in support of medical device development. 

This session will provide an overview of the recently published FDA Guidance “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”. The guidance is closely related to ASME V&V40 and provides a general framework for risk-informed credibility assessment of computational modeling. It is applicable to any physics-based or mechanistic (i.e., first principles-based) computational model, and any medical device regulatory application of these models. 

Recommendations for reporting CM&S evidence will be reviewed from two FDA guidance documents, “Reporting of Computational Modeling Studies in Medical Device Submissions” (2016) and “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” (2023). Examples will be provided to illustrate reporting of model implementation details, model credibility activities, and model results.

As modelers, we are used to building trust in our simulations and we appreciate the strengths and limitations of our models. However, when the goal of CM&S is to advance clinical practice, building trust among clinicians and simulation experts through close collaboration and shared decision-making is just as important. Moreover, to establish whether the model helps achieve a specific clinical goal, the modeler must show that the simulation outputs corroborate both clinical observations and controlled physical experiments. Finally, simulation outputs must be linked with high quality clinical outcomes on the specific patient population of interest. The guest speakers will describe their experiences working closely with clinicians over the last decade utilizing CM&S in both clinical and translational research and product development at a major orthopaedics hospital.

In this talk I will show how we are using 3D modeling, virtual surgery, and computational fluid dynamics analysis to model the anatomy and physiology of patients with complex congenital heart disease. Using these clinical workflows, we are planning reconstructive operations with great precision. I will also describe how the 3D models and planned patches are being utilized in the OR for intraoperative guidance.

In this interactive panel discussion, we will apply the ASME V&V 40 risk-informed credibility assessment framework to two case studies. For each case study, we will characterize the model risk, present possible strategies for demonstrating model credibility, explore the potential adequacy of the credibility evidence, and discuss the practical feasibility of acquiring such evidence. This session will be informative for both CM&S experts and non-experts in better understanding the practical application of ASME V&V 40. 

In this talk I will discuss FDA’s perspective on Software as a Medical Device (SaMD). I will introduce SaMDs, discuss when computer modeling becomes a SaMD, and describe our ongoing efforts to shape standards and safeguard SaMD development and integration in healthcare delivery.

A panel of CM&S leaders from the medical device industry will discuss the opportunities of CM&S in bringing medical devices to the market faster, making them cheaper and more effective, and the associated challenges. 

Digital twins hold immense promise in accelerating scientific discovery and revolutionizing industries. This report of the Committee on Foundational Research Gaps and Future Directions for Digital Twins is the result of a study that addressed the following key topics: Definition of the use cases for digital twins; Foundational mathematical, statistical, and computational gaps for digital twins; Best practices for digital twin development and use; and Opportunities to advance the use and practice of digital twins. The report’s recommendations are particularly targeted towards what agencies and researchers can do to advance mathematical, statistical, and computational foundations of digital twins. 

GxP documents are quality guidelines enforced across a variety of regulated industries including cosmetics, food, medical devices, and pharmaceuticals. Domains covered by GxP include laboratory studies (GLP), clinical trials (GCP), and manufacturing (GMP). To similarly standardize the use of CM&S, international efforts are underway to establish good simulation practices (GSP). In this expert-led panel, we will discuss the implementation and adoption of GSP. Our panel, comprising experts from international regulatory agencies, industry, and authors of the recent book “Towards Good Simulation Practices” by Nature-Springer, will share insights on how GSP will shape the use of CM&S for medical devices. This session will be invaluable for professionals aiming to leverage CM&S for streamlining medical device development and faster market entry. 

Finite element analysis (FEA) is widely used to understand the mechanical integrity and durability of orthopaedic implants. The ASME V&V 40 standard and supporting FDA guidance provide a framework for establishing model credibility.  Examples of how to apply the principles outlined in the ASME V&V 40 standard are important to facilitating greater adoption by the medical device community.  Therefore, we present an end-to-end (E2E) example of the ASME V&V 40 standard applied to an orthopaedic implant.  The objective of this study was to illustrate how to establish the credibility of a computational model intended for use as part of regulatory evaluation. This study focused on whether a design change to a spinal pedicle screw construct would compromise the rod-screw construct mechanical performance. This E2E example provides a realistic scenario for the application of the ASME V&V 40 standard to orthopedic medical device applications. 

Come learn from a panel of international regulatory agency and industry experts about the uses of computational modeling and simulation (CM&S) data to help bring medical devices to market faster. CM&S has an established history of use in the orthopaedic and cardiovascular device space, but there are many more opportunities to utilize these methods for other device types. In this panel discussion we will discuss and explore the use of CM&S in regulatory submissions, including covering some common pitfalls to avoid when using this type of evidence.