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.