Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps

Abstract

Medical device manufacturers using computational modeling to support their device designs have traditionally been guided by internally developed modeling best practices. A lack of consensus on the evidentiary bar for model validation has hindered broader acceptance, particularly in regulatory areas. This has motivated the US Food and Drug Administration and the American Society of Mechanical Engineers (ASME), in partnership with medical device companies and software providers, to develop a structured approach for establishing the credibility of computational models for a specific use. Charged with this mission, the ASME V&V 40 Subcommittee on Verification and Validation (V&V) in Computational Modeling of Medical Devices developed a risk-informed credibility assessment framework; the main tenet of the framework is that the credibility requirements of a computational model should be commensurate with the risk associated with model use. This article provides an overview of the ASME V&V 40 standard and an example of the framework applied to a generic centrifugal blood pump, emphasizing how experimental evidence from in vitro testing can support computational modeling for device evaluation. Two different contexts of use for the same model are presented, which illustrate how model risk impacts the requirements on the V&V activities and outcomes.

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

“…More rigorous activities may be selected for models that have Some examples of how to map model risk to credibility goals for a specific COU has been provided in medical device applications. [13][14][15] This process requires a team of experts to decide on the appropriate level of rigor and involvement for each V&V activity. To demonstrate the concept at a high level in drug development, some credibility goals and activities of varying rigor are described.…”

“…18 Although this paradigm is germane to the process of establishing and assessing credibility, the framework does not describe model building and refinement and instead focuses on regulatory applications. Further explanation and examples of credibility assessment are provided by Morrison et al 14 and the ASME standard. 13…”

In silico modelling of cancer nanomedicine, across scales and transport barriers

“…The level of rigour of these evidences will depend on both their intended use and the clarity of such use at the outset. Hence, the existence of guidance documents is critical in the successful and safe application of such methods to the clinical setting 120 . In 2013, the International Medical Device Regulators Forum (IMDRF) published the first in a series of guidance documents on 'Software as a Medical Device' (SaMD).…”

Simulation Credibility Assessment Methodology With FPGA-based Hardware-in-the-Loop Platform

“…(i) Traditional simulations are too separated from the actual hardware system, which makes it difficult to compare the simulation results with the experimental results. (ii) The simulation credibility is informal and not accurate enough because it is mainly assessed by the experience of engineers [11]. In summary, the simulation credibility should be ensured from two aspects.…”