Brentwood, TN May 15, 2015 – Dr. Sanjeev Kulkarni, Vice President of Sales & Business Development of VEXTEC Corporation, will be presenting VEXTEC’s computational software for predicting the durability of pacemaker leads at the BMES/FDA “Frontiers of Medical Devices Conference: Innovations in Modeling and Simulation” in Washington, DC. The conference, which runs from May 18 – 20, 2015, is hosted by the Biomedical Engineering Society (BMES) and the US Food and Drug Administration (FDA) in partnership as a meeting for researchers, engineers, clinicians and other professionals in the fields of designing, building and using medical devices. This year’s theme is Using Modeling and Simulation at Different Stages in the Total Product Life Cycle.
Dr. Kulkarni will be presenting, “Verification & Validation of Computational Software for Predicting the Durability of Pacemaker Leads” on May 19th. The software model is call a Virtual Twin® and can be created with the initial preliminary design of the device and is refined as the device moves though the detailed design, manufacturing, testing, launch and post market segments of the product life cycle. At any phase of the life cycle, the model is used to prognose the probability of success in the future phases of the life cycle.
The core technology within the durability prediction software is its probabilistic integration of structural analysis with material microstructural damage simulation and test setup. The software allows for three dimensional analysis that is multi-scale in size and time. The software is fully probabilistic with material properties as random fields. The supporting evidence for the Specific Context-of-Use of cyclic bench testing comes from a project that VEXTEC completed for Boston Scientific’s Cardiac Rhythm group on MP35N pacemaker leads. The computational model is capable of simulating the statistical distribution of cyclic lifetimes derived from laboratory tests. With this model, the design engineer can assess the risk of failing the bench test and thus the risk of a device redesign resulting in a saving in the cost and time of the design process.
Dr. Kulkarni will also be giving demonstrations of the software capabilities and functionality at VEXTEC’s exhibitor booth during the conference. During the conference, Sanjeev will also serve on the panel of judges to evaluate student podium presentations and participate in the Medical Devices Special Interest Group meeting.
Further, on May 20 and 21, Dr. Kulkarni will attend the ASME V&V 40 Committee Meeting in Silverspring, MD. Sanjeev has been on the committee to standardize verification and validation for computational modeling of medical devices since its inception in 2010 and chairs the Stent subgroup.
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).