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 Carlo 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).

Dr. Kulkarni discussed two major challenges facing the medical device industry, which are:

• High cost and time of testing
• Risk of recall

He then showed how VEXTEC’s Virtual Life Management software can be used to calculate the statistical distribution of the lifetime of medical devices. VEXTEC’s approach had been shown to reduce the amount of testing needed, which reduces cost and time to market. It also improves the accuracy of life calculations, which reduces the risk of recall, which is expensive and damaging to a company’s reputation.

The event was MDIC’s first public summit devoted entirely to advancing the use of computational modeling and simulation in the development and evaluation of medical devices.  The meeting featured panel sessions and podium presentations on combining experiment and simulation to inform clinical trials, creating data repositories to support the industry-wide use of M&S, and other relevant topics. The summit brought together people from the medical device and software industries, academia, and government regulators.  Session chairs included:

• Dawn Bardot: Senior Program Manager, Modeling and Simulation, MDIC
• Tina Morrison, Advisor of Computational Modeling, Office of Device Evaluation, FDA
• Kyle Myers, Director of the Division of Imaging and Applied Mathematics, Office of Science and Engineering Laboratories, FDA
• Randy Schiestl, Vice President, Global Technology, Boston Scientific Corporation

Starting this summer, MDIC will host a series of teleconferences to share success stories and discuss future applications of modeling and simulation in the development and regulation of medical devices. MDIC has also formed working groups to investigate six priority issues in the arena of modeling and simulation:

• Combining simulation and bench experiments to inform clinical trials.
• Creating a library of models and data to support the industry-wide use of modeling and simulation.
• Simulation of the heart, vasculature, and related medical devices.
• Modeling of magnetic resonance-induced heating.
• Modeling and simulation in orthopedics.
• Simulation of blood damage.

About MDIC:

The Medical Device Innovation Consortium (http://mdic.org/) is a public-private partnership to advance regulatory science in the medical device industry. The MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.