Rome Hall 771
Hosted by: Dr. Michael Plesniak (email@example.com)
In the medical device industry, computational modeling and simulation (CM&S) has been used mainly to aid development and design optimization and less often to evaluate device performance and patient safety. CM&S studies that are provided to CDRH in pre-market submissions are often supplemental and complement animal, bench and human testing. Some of the challenges with the current practice of CM&S have led us to address the need for:
standards on documentation and reporting CM&S results in pre-market submissions;
systematic assessment and understanding of device-use conditions;
methodologies to experimentally validate CM&S;
sensitivity analyses and uncertainty quantification; and
better elicitation of the consequence of the CM&S being incorrect.
By facing these challenges, CDRH is moving towards a future of faster, better medical device development and evaluation substantially augmented by CM&S. But before substantial advances in the use of CM&S can be harnessed to inform regulatory decision making, a strong community effort is needed to tackle data and credibility issues.
CDRH has launched initiatives to address some of the challenges above. The draft Guidance titled Reporting of Computational Modeling Studies in Medical Device Submissions (January 2014) was created to address the first issue. Development of the FDA Library of Models and Simulations began in 2013 to address the second issue. The last three issues speak to fostering confidence and managing expectations of CM&S. CDRH recognizes that adequate verification and validation (V&V) and uncertainty quantification are necessary to achieve wider acceptance of CM&S in medical device evaluation. Thus, CDRH, in collaboration with industry through ASME, drafted a strategy to assess CM&S credibility. It is a framework for determining the risk of using CM&S in a specific context of use and for determining ‘how much’ V&V is necessary to support CM&S within that context. CDRH hosted a public meeting in June 2013 with relevant stakeholders to openly discuss these efforts1. One major outcome from the meeting is the initiation of a Pilot Program (Spring 2014) to implement and qualify the credibility strategy.
The first seminar, on April 14, 2014, will be an overview of the different initiatives. The second seminar, on April 28, 2014, will be an overview of the Credibility Strategy. The use of CM&S to simulate multiple design parameters, use conditions, and to visualize complex processes can revolutionize the way medical devices are investigated and patient data are utilized. The future of digital patients, virtual surgeries and clinical studies, and personalized medicine are only possible if stakeholders have confidence in CM&S. The success of our initiatives to support regulatory decision making with CM&S will take us one step closer to that future.
Dr. Morrison is a mechanical engineer who studied Cardiovascular Biomechanics for two years as a post-doctoral fellow at Stanford University. During that time, she investigated the in vivo biomechanics of the aorta using gated CT imaging; those data are now used as boundary condition inputs for computational modeling and bench-testing of endovascular devices. Her research efforts continue at the Center for Devices and Radiological Health (CDRH). Currently she is the chief Advisor of Computational Modeling for the Office of Device Evaluation, and is leading the Regulatory Review of Computational Modeling working group at CDRH. She dedicates much of her energy towards advancing regulatory science through modeling and simulation because she believes the future of medical device design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization. Additionally, she has been a scientific reviewer on a variety of medical device pre-market application, principal investigator on two projects, and a technical expert on another since 2008. She is a co-principal investigator on a Critical Path Initiative (CPI) project titled "Leveraging the Simulation-Based Engineering and Medical Imaging Technology Revolutions for Cardiovascular Devices", where she is greatly involved in an effort to enhance the use of simulation-based engineering and computational modeling in the evaluation of medical devices. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.