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.

VEXTEC to Present at the 2015 Aircraft Airworthiness & Sustainment Conference

VEXTEC's SCCrack SoftwareBrentwood, TN, March 20, 2015 – VEXTEC Corporation co-founder Robert Tryon will be making two presentations at the 2015 Aircraft Airworthiness & Sustainment (AA&S) Conference. The conference will be held in Baltimore, Maryland March 30 – April 2. Representatives from the Air Force, Navy, NASA, Federal Aviation Administration and industry will be in attendance.

The first paper, “Probabilistic Software Tool to Predict Statistical Distribution of Stress Corrosion Crack Lifetimes” will demonstrate software, SCCrack, developed collaboratively by VEXTEC, University of Virginia and Navmar Applied Science Corporation. SCCrack predicts the statistical distribution of stress corrosion cracking (SCC) in cracked generic components fabricated from various materials [stress corrosion crack size vs. time and SCC life], in particular ultra-high strength steels such as AerMet100, 300M, and 5083 aluminum alloys. The necessary crack growth rate input data was obtained from an experimental effort as well as from the literature.  Random variables including the initial crack size and shape, applied polarization, applied degree of sensitization (when relevant), as well as material SCC rates are also considered.

The second paper, “Uncertainty Propagation in Multi-Disciplinary Computational Analysis” will discuss the uncertainty management analysis framework being developed for the US Air Force under the Airframe Digital Twin program. The analysis methodology, applied to an airframe canopy sill longeron, seeks to optimize computational and testing resources to drive robust predictions at the lowest cost. Uncertainty information is propagated through 3 key disciplines – aerodynamics (magnitude and time of application of the stick forces), structures (computation of the resultant stresses) and fatigue (combines stress input with material microstructural uncertainty). The presentation will also demonstrate how probabilistic virtual inspection can be incorporated in the analysis to predict a condition based maintenance forecast.

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Tennessee’s Best Kept Secret

“Curiosity is lying in wait for every secret”-Ralph Waldo Emerson. 

Perhaps this was the goal of Tennessee Governor Bill Haslam in June when he returned from his economic development trip to Asia unwilling to share details with the public.  Soon after his departure, a flurry of news reports and blogs surfaced wanting to know why he would not share the details of his agenda with the public. His spokesman David Smith’s response was, “we don’t talk about private meetings.”  This left many to speculate if he was courting another automotive manufacturer to open up shop in the mid-state and what incentives and tax breaks were being offered to sweeten the deal. Read more

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Live Webcast of VEXTEC Presentation at ASME Advanced Design and Manufacturing Impact Forum

VEXTEC’s Vice President of Business Development, Dr. Sanjeev Kulkarni is an invited speaker at the ASME Advanced Design and Manufacturing Impact Forum 2014, August 17-20, 2014 at the Buffalo-Niagara Convention Center in Buffalo, NY. He will be presenting a talk entitled “Medical Devices & Life Sciences: Innovative Medical Device Prototyping – 3D Printing and Biocompatibility”. The presentation is one of five talks at the conference that will we be webcast live. Read more

The Manufacturing Maintenance Balancing Act

In a 2006 Nielsen study1, auto industry manufacturing executives reported that stopped production costs averaged $22,000 per minute or $1.3 million per hour of downtime. When surveyed, 53% of the manufacturers agreed that predictive and preventative maintenance was the key to reducing this loss of productivity and revenue. So, what is the best practice for determining how to maintain and operate your manufacturing line to optimize productivity and maximize revenue? Read more

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VEXTEC to Participate in Inaugural Medical Devices Special Interest Group Planning Meeting

Oct. 18, 2014BRENTWOOD, Tenn. — The Biomedical Engineering Society (BMES) is launching the Medical Devices Special Interest Group (SIG). VEXTEC’s Vice President of Sales & Business Development, Dr. Sanjeev Kulkarni, has been invited to participate in the inaugural SIG planning meeting to be held on October 23rd at the BMES Annual Meeting in San Antonio. Click to read full article.

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

Oct. 16, 2014BRENTWOOD, Tenn.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.  Click here to read the full article