BioE 297 – Special Study: Physics-Based Modeling and In Silico Clinical Trials [Fall 2019]

What if physicians and surgeons could virtually analyze their patients’ health and plan therapies and

surgeries using the same advanced modeling and simulation (M&S) technology that the automotive,

aerospace, energy and hi-tech industries rely on to test their product before they are built? On 25-

March-2019 the Director of the National Institute of Biomedical Imaging and Bioengineering told the

American Institute for Medical and Biological Engineering that M&S “is at the center of everything we

do.” M&S adds value by providing knowledge and insights not available from existing data modalities

and making evidence generation more efficient by reducing the need for more burdensome types of

data and information. The FDA can more fully utilize M&S to minimize burden on patients, investigators,

manufacturers and regulators with mechanisms that support efficient review of novel products and

approaches without compromising safety or effectiveness.

This course introduces students to: (1) physics-based M&S applied to solve a variety of clinical problems;

and (2) the FDA-funded CDRH Critical Path Project titled “Transforming the Medical Device Innovation

Ecosystem: from ‘In Silico Clinical Trials’ to a ‘Review of the Future’.” The main elements of M&S such as

the derivation and solution of boundary-value problems will be taught in the contexts of multi-physics

and multi-scale. Students will be provided with an overview on the creation of 3D models or “digital

twins” from medical images. The course will be taught by clinicians, theoreticians and industry experts

who will use examples and case studies from their professional experience to apply the concepts being

covered.

Upon completion of the course, students will be able to understand how to more fully harness M&S,

digital evidence, and reduce the size of prospective clinical trials for medical devices.