Discover the Latest Innovations in Computational Modeling and Simulation for Developing In Silico Regulatory Evidence at #ModSim2024
Paving the way for evaluation of 21st-century medical devices
The MDIC Computational Modeling and Simulation Project was developed to achieve the delivery of medical product solutions in a responsible, patient sparing way. Through the use of computational modeling and simulation as valid scientific evidence, this effort balances the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty.
The following seven priority areas were identified for the initial focus of the Computational Modeling and Simulation steering committee:
- Combining simulations and experiments to inform clinical trials.
- Simulation of the heart, vasculature, and related medical devices.
- Neurostimulation electrochemical mechanisms of damage identification.
- Magnetic resonance-induced heating.
- Modeling and simulation in orthopedics.
- Libraries for publicly sharing models, inputs, and validation data.
- Simulation of blood damage, hemolysis, and thrombosis.
The MDIC Computational Modeling and Simulation (CM&S) Program focuses on regulatory science strategies to achieve the delivery of medical product solutions in a responsible, patient sparing way that relies on computational modeling and simulation as valid scientific evidence to provide increased trust in device performance while limiting the delay in patient access that is commonly associated with elevated certainty.
The vision of the CM&S Program is to aid in the creation and approval of safe and effective medical devices by providing access to:
- Regulatory-grade computational modeling and simulations
- Forums for discussing CM&S topics
- The latest CM&S validation and reporting documents
Jithesh Veetil, PhD
Dr. Jithesh Veetil, PhD joined MDIC as a Program Director to lead Data Science and Technology initiatives. His prime focus at MDIC is to aid in the development of regulatory grade tools based on computational modeling & simulation science relevant to clinical applications, This program builds upon the success MDIC has had with the Virtual Patient model that resulted in mock submission for clinical trials augmented with virtual patient data. These exciting programs in the pre-competitive MedTech sector will be carried out in collaboration with MDIC members and their engineers, statisticians, regulatory professionals, and medical doctors. The goal is to utilize the External Evidence Methods (historical, prospective and concurrent data- including but not limited to – Digital Evidence, Clinical Trial Data, Real World Evidence-RWE, Electronic Health Records-EHR, and Patient reported Outcomes-PRO) to better understand safety, efficacy and performance of medical devices. Dr. Veetil also leads the cybersecurity projects at MDIC
Dr. Veetil has extensive experience in designing and development of programs towards modernizing scientific workforce and practices by building academic-industrial-nonprofit collaboration through his work at National Institutes of Health (NIH) campus as the Lead Scientist and Program Manager for the Foundation for Advanced Education in the Sciences (FAES). Previously, Jithesh worked with Global Biological Standards Institute (GBSI), a Washington DC based non-profit as its Scientific Program Manager, leading the development and implementation of multiple programs on science policy, communications, and advocacy, including those related to cell line authentication, antibody validation, and reproducibility in biomedical research and development. Dr. Veetil also served as the Operations Manager for Preludesys Inc., working with international clientele from medical, IT, insurance and paralegal organizations on medical/healthcare data management.
Dr. Veetil completed his PhD in Biomedical Engineering at University of Arkansas, Fayetteville, AR, followed by postdoctoral fellowship at NIH. He has published numerous peer-reviewed manuscripts, reviews and book chapters. He also holds Masters in Biotechnology and Bachelors in Food Technology.
Taylor Metheny serves as Project Manager for the Digital Health initiatives at MDIC. Her project portfolio involves Digital Health Software Vertical as well as Computational Modeling and Simulation (CM&S). The Digital Health Software vertical includes multiple work streams to complement FDA’s efforts to develop an innovative regulatory pathway for software that is tailored to its unique and iterative nature, including leveraging the learnings from the FDA pre-cert pilot program. Similarly, Taylor is bringing together stakeholders from the medical device industry, NIH, regulatory bodies like the FDA, and patient advocacy groups to advance computational modeling and simulation as valid scientific evidence to achieve the faster delivery of medical product solutions by balancing the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty.
Taylor received her Master’s in Biotechnology from Georgetown University and holds a Bachelor’s of Biological Sciences from Louisiana Tech University.