VEXTEC Helps Develop Verification and Validation for Computational Modeling of Medical Devices

BRENTWOOD, Tenn. - Oct. 16, 2014 - PRLog -- On October 21 and 22, ASME's V&V 40 Standard sub-committee will meet to finalize the "Verification and Validation of Computational Modeling of Medical Devices" standard. VEXTEC’s Vice President of Sales & Business Development, Dr. Sanjeev Kulkarni will be in attendance.  This activity was nucleated in June 2009, when the need for a guidance document/standard to support the medical device industry was recognized. Rigorous team effort and activity has ensued, spanning many meetings since leading to the eminent release of the baseline version of the V&V 40 Standard. Dr. Kulkarni has been a part of this effort from its initiation, is a member of the V&V 40 subcommittee, chairs the V&V 40 Subgroup on Stents and is a member of the V&V 40 Subgroup on Solid Mechanics.

The fundamental premise for ASME V&V 40 standard is the need for a guidance document and framework to enable appropriate implementation of computational modeling and simulation (CM&S) by the medical device industry for device design, device optimization and root cause failure analysis. To use CM&S in this manner, as well as to enable wider acceptance for regulatory submissions and medical device evaluations requires adequate model verification and validation (V&V), sensitivity analysis and uncertainty quantification (UQ). This necessity aligns with the FDA's strategy of advancing Regulatory Science and forms the cornerstone of the ASME V&V 40 standard document. VEXTEC has developed a patented technology called Virtual Life Management® (VLM®) that supports the highest credibility feature of the V&V 40 standard, namely, it enables sensitivity analysis and facilitates uncertainty quantification. VLM is an integrated computation materials engineering technology which uses probabilistic microstructural fatigue analysis to extend fracture mechanics down to the miniscule crack-like features that initiate fatigue damage. It uses Monte Carlo methods to provide the algorithmic link to connect the microstructural material properties and non-continuum mechanics to the continuum based finite element based structural analysis (FEA) to ultimately predict the true reliability of a component or device.

VEXTEC (http://www.vextec.com) was founded in 2000 and developed its patented technology primarily through Department of Defense Small Business Innovative Research programs. VEXTEC now offers its Virtual Life Management software and services to the medical device industry (http://www.vextec.com/PDFs/VEXTECCaseStudyMedicalImplantW...), including companies such as Boston Scientific.