FDA Accepts Virtual Life Management® for Evaluation Into The MDDT Pilot Program.

Virtual Twin of a cardiac rhythm electrical lead.

Virtual Twin of a cardiac rhythm electrical lead.

April 1, 2015, Brentwood, TN-The Food and Drug Administration (FDA) will evaluate VEXTEC’s Virtual Life Management (VLM®) for certification as a Medical Device Development Tool (MDDT). The goal of the MDDT pilot program is to assess and refine the qualification process for tools used to develop and evaluate medical devices. The pilot program is limited to 15 tool developers. The FDA stated that VEXTEC’s, “proposal was accepted because your tool is at a mature stage of development and meets a public health need (major efficiencies to be gained in device development and evaluation time).”

The FDA will work together with VEXTEC to meet the criteria for the proposed program – a Virtual Twin® software of the medical device that manufacturers and the FDA use to assess and measure performance, safety and effectiveness. Once qualified by the FDA, VLM can then be used by the medical device industry in support of their device submissions to the Agency as well as by the FDA to review these premarket applications, potentially reducing time and other resources needed to develop new products. The specific application will be to use VLM as a computational modeling tool to simulate the structural reliability of a component, assembly or system pertaining to a medical device in terms of the probability of failure. The appropriateness of this tool is based on FDA’s preliminary assessment of status of the VLM tool for reducing the design-build-test iterations while increasing safety and maintaining efficacy.

The core technology within VLM’s reliability prediction software is its probabilistic integration of structural analysis with material microstructural damage simulation and field test setup. VLM has a library of software modules and material models used to simulate the required combination of material and device in a particular use condition. The software allows for three dimensional analysis that is multi-scale in size and time. VEXTEC (www.vextec.com) was founded in 2000 and offers its patented Virtual Life Management software and services to a variety of commercial and government customers.

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