VEXTEC Presenting at 14th Annual Design of Medical Devices Conference

VLM Software

VEXTEC’s VLM software for leads of defibrillator devices

Brentwood, TN, April 10, 2015 – Dr. Sanjeev Kulkarni, Vice President of Sales & Business Development of VEXTEC Corporation, will be presenting at the 2015 Design of Medical Devices Conference on April 15, 2015. The conference will be held in Minneapolis, Minnesota April 13 – 16. Representatives from world-class medical device designers, researchers, manufacturers, and the public sector will be in attendance to share perspectives and innovations in medical device design.

Dr. Kulkarni will be presenting, Uncertainty Management in Computational Simulations of Medical Devices” which will discuss VEXTEC’s software based uncertainty management tool to virtually manage the life of products.  VEXTEC’s Virtual Life Management® (VLM®) software uses efficient Monte Carlos simulation with system reliability methods to analyze risk and predict failure at component, system and population level for many types of products including medical devices. Based on the tool’s maturity in other industries, the FDA has accepted the tool into the Medical Device Development Tool (MDDT) pilot program. The VLM® tool considers the uncertainty of model parameters and acquired data to serve as a framework to incorporate realism with multi-scale statistical characterization using probabilistic and parallel computational simulation techniques. VEXTEC will also participate in the Scientific Poster Session on April 15

Founded in 2000, VEXTEC Corporation has developed patented technology on virtual material modeling and predicting product durability. As a senior strategic member of VEXTEC’s Leadership Team, Dr. Kulkarni leads commercial Sales & Business Development with a focus on Healthcare/Life Sciences/Medical Devices and Strategic Alliances. Dr. Kulkarni is an industry recognized leader and expert in Computational Mechanics and Computer Aided Engineering, and has supported many industries (Automotive, Aerospace, Defense, Energy, Consumer Products and Medical Devices) and in a variety of roles that include 5 years with Boston Scientific (as R&D Fellow), 10 years with KB Engineering (as President) and 6 years with TRW Automotive (as Principal Engineer).

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.