Modeling And Simulation Powering New Health Solutions

Regulatory Presentation, MCCIA, Wednesday, April 17, 2012

Flex Manufacturing, MCCIA, Wednesday, April 25, 2012

BioFutures, IHIF, Indiana, 2012

Cientive Group Inc. was founded in 1998 (as Indus Simulation Teknology) in Indiana by Ajay Thukral as a data modeling service company. His first project was to model a chute for efficient routing of packages. Shortly after, the companys focus turned to physiological modeling and simulation tools for algorithm development. Today, Cientive is a modeling and simulation company that develops algorithms and in-silico models for simulation and testing where they specifically apply their knowledge in the areas of immunology, diabetes, and clinical trial studies. More specifically, Cientive creates testing platforms to investigating overall system performance and safety. Applied to medical devices, these areas are quite pertinent due to the rapid adoption of technological solutions for the consumers. We believe that this is an area of significant future value creation for companies seeking new, more efficient and effective paths for product development and patient care, says Vijay Thukral, CEO of Cientive.

The new ecosystem consisting of physicians, care planners, nurses, patients and devices is still evolving and putting into place an integrative platform that binds the players together. This integrative platform has allowed for dramatic increase in data collected, and the integrated health systems are increasingly creating and using decision support systems to provide health guidance and automation. The scope and breadth of such systems is expanding to demonstrate system performance as well as safety aspects. In a practical sense only a small subset of the solution space can be tested via clinical trials, says Thukral. To cover the multitude of use cases, modeling and simulation studies can be performed. The simulated results can be used to identify risk and verify performance.

Importantly, the U.S. Food and Drug Administration (FDA) is supportive of modeling and simulation. For instance, under the aegis of Automated Pancreas Critical Path Initiative, the FDA, has promoted the use of patient models for in-silico testing of the algorithms. The testing platform is the prefect tool to understand and analyze the implemented algorithm. Use of a physiological-based model of the patient, elaborating various use cases under varied operational conditions, further expands the use of simulation-based approaches to help study patient-device response. Similar to hardware in the loop one could further have the overall system built and verified to perform, patient-in-the-loop clinical trials. While modeling and simulation is the mainstay of engineering companies, the health industry is now gearing up to its power and use in health solutions.

More information on Cientive Group is available on-line at or (888) 739-8036.