FDA Regulatory Science Lecture: Computational Modeling in Regulatory Science
Thursday, October 24, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
Computational Modeling in Regulatory Science
Advisor of Computational Modeling
Office of Device Evaluation (ODE)
This lecture will cover how to obtain regulatory clearance to market devices through the substantially equivalent paradigm.
The Center for Devices and Radiological Health (CDRH) envisions a future of faster, better medical device development and evaluation substantially augmented by modeling and simulation (M&S). The use of M&S to simulate multiple design parameters, use conditions, and to visualize complex processes can revolutionize the way medical outcomes and medical devices are understood and patient data is utilized. In the medical device industry, M&S have been used mainly to aid development and design optimization and left often used to demonstrate final device performance. Modeling studies that are submitted to the Agency are often supplemental and complement animal, bench and human testing provided in
- Investigational Device Exemption (clinical studies of investigational devices),
- 10(k) notifications (class II, moderate risk devices), and
- Pre-Market Approval application (class III, high risk devices).
Some of the challenges with the current practice of M&S in medical device regulatory submissions are:
- reports typically (might) lack sufficient details for adequate assessment because there are no reporting standards for computational modeling;
- lack of sensitivity and uncertainty analyses for crucial input parameters, such as geometry, physical properties, boundary conditions;
- lack of complete understanding of physiological loads and variations of in patient populations;
- lack of adequate validation to support the use of the computational model; and
- lack of elicitation of the consequence of the M&S being incorrect.
During this lecture, we will discuss:
- the current uses of M&S in regulatory applications
- how the community is tackling the challenges, and
- what the future holds for bringing M&S more fully into the total product life cycle of a medical device.
About the Speaker
is a mechanical engineer who studied Cardiovascular Biomechanics for two years as a post doctoral fellow at Stanford University. Her research focused on quantifying the in vivo deformations of the thoracic aorta from CT imaging. She continues her research efforts at the Food and Drug Administration at the Center for Devices and Radiological Health (CDRH) in the Office of Device Evaluation (ODE). Currently she is the Advisor of Computational Modeling for the ODE and is leading the Regulatory Review of Computational Modeling working group at CDRH. She is energetic about 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. She has been a scientific reviewer, 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)-funded project titled "Leveraging the Simulation-Based Engineering and Medical Imaging Technology Revolutions for Medical Devices", where she continues to interact with industry and academic experts through workshops on Computer Methods for Medical Devices. Additionally, she is the principal investigator on a CPI project titled Characterization of Human Aortic Anatomy Project (CHAP), a large multicenter national study examining the anatomical parameters of more than 10,000 diseased aortas. She also provides technical expertise regarding finite element analysis and medical imaging for another CPI project titled Assessment of plaque composition, dynamic biomechanics, and therapeutic outcomes in subjects implanted with endovascular devices (ASPECT). She received her Ph.D. in Theoretical and Applied Mechanics from Cornell University in 2006 and her Masters in Mechanical Engineering in 2002 from the University of Connecticut.