Computational Modeling & Simulation reinforces science, tools, and practices to drive validity and adoption of models and simulations.
Paving the way for evaluation of 21st-century medical devices.
The Computational Modeling and Simulation (CM&S) Program was developed to achieve the delivery of medical product solutions in a responsible, patient sparing way that balances the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty through the use of computer modeling and simulation as valid scientific evidence.
In vitro testing of hemolysis and thrombosis is essential for the development of various blood-contacting devices. Computational fluid dynamics has also proven to be a useful complementary tool for understanding mechanical sources of damage, i.e. shear stress, exposure time, and recirculation, but lacks clear regulatory impact.
MDIC is an active member of the ENRICHMENT in Silico Clinical Trial Project (ENRICHMENT), which is led by principal investigators from FDA and Dassault Systèmes. In this capacity, MDIC is coordinating the formation of an Industry Advisory Council (IAC) for the project. The role of the IAC is to provide an industry perspective on new clinical trial methodology and tools being developed through ENRICHMENT including the practicality of implementing such approaches at a commercial level so as to ensure ENRICHMENT outputs are relevant to the medical device industry. More specifically, the IAC’s primary function shall be to provide guidance and input on the relevance and utility of the approaches to the regulatory process (rather than those related to technical aspects of the modeling and simulation).
Human body simulation models provide insight into clinical performance of medical devices and can potentially improve patient care by accelerating product development and reducing time to market. However, industry adoption of such advanced simulation models has been limited due to many barriers such as time, cost and expertise required for adoption.
MDIC is leading translation research to bridge the gap between NIH funded academic research models and models for development of medical devices and interventions.
Demands for medical device evidence development addressing patient safety, therapeutic efficacy, and cost-benefit determinations are increasing. These evidence demands are well-documented drivers of medical device clinical trial size, complexity, timelines and costs. At the same time, and seemingly paradoxically, patient and provider demands for faster treatment access, and innovative treatment options are increasing. Given the legitimacy of these stakeholders’ data demands, combined with the realities of resource (budget and time) limitations, historical data acquisition techniques will soon no longer meet patient and provider needs. While numerous solutions have been hypothesized in the literature, adoption of clinical trial solutions which both make clinical trials more efficient, and provide the data necessary to show safety and efficacy, has been scarce.
