The FDA recently developed the Medical Device Development Tools (MDDT) program to allow for new methods for evaluating medical devices to be qualified for use in regulatory submissions to CDRH.
The program aims to provide MDDT developers and medical device manufacturers with a mechanism for discussing early product concepts with FDA, fostering collaboration on tool development as well as increasing the use of the qualified tools.
How can the CDRH leverage realistic simulation technology to further their mission to protect and promote the public health?
Medical device FDA premarket submissions include computational modeling and simulation of the medical devices and their engineering analyses. Examples include finite element analyses of stents, orthopedic implants, anterior chamber intraocular lenses; and computational fluid dynamics of heart valves and ventricular-assist devices.
Although the use of computational modeling and simulation (cm&s) for regulatory purposes has lagged that in other industries, over the past decade we have begun to see a dramatic increase in the use of cm&s, particularly in the following areas:
- Computer models of patients are used to support the approval or clearance of new medical devices. These models of patients, such as the Virtual Family set of virtual anatomical models (VF), have been used in over 120 submissions to the FDA. Most of these submissions have used the VF to demonstrate that an implanted medical device will not cause the heating of tissue when a patient undergoes MRI.
- Population modeling methods enable a more comprehensive understanding of the differences and similarities for a wide range of data sets, which may also lead to improved medical device designs for more people. An example of this type of tool is The Musculoskeletal Atlas Project, a population model of the musculoskeletal system, which was supported in part through FDA extramural support.
- Virtual clinical trials created computational approaches to design virtual patients or simulate a clinical study itself. Virtual patients may be incorporated in clinical study designs, allowing for smaller clinical studies or enrichment of the clinical study with virtual patients having conditions with low prevalence in the clinical study cohort. FDA researchers are developing methodologies for conducting in silico imaging clinical trials. In one such project, Virtual Imaging Clinical Trials for Regulatory Evaluation (VICTRE), an all-digital imaging pipeline will be made available open source for simulating three-dimensional breast imaging systems, now approved only through burdensome clinical trials.
The CDRH recognizes the great potential of computational modeling and simulation as an efficient and effective method for the evaluation of medical devices and believes the MDDT process can be used to support regulatory submissions.
Examples of MDDTs currently being reviewed by FDA include Vextec’s computational durability software for predicting fatigue failure of medical devices and SIMULIA’s Abaqus Knee Simulator for predicting the performance of artificial implants.
