Bioengineering Seminar Series: Maureen L. Dreher

Friday, April 20, 2012
11:00 a.m.-12:00 p.m.
Room 1200 Jeong H. Kim Engineering Bldg.
Professor Silvia Muro
muro@umd.edu

Preclinical Test Methods for Creep & Degradation of Absorbable Implants

Maureen L. Dreher, Ph.D.
Biomedical Engineer
FDA
Center for Devices and Radiological Health, OSEL/DSFM

While absorbable polymers have been used extensively in medical devices, they are also emerging as the desired material for new devices, many of which perform a structural role. Examples of such devices include cardiovascular stents, spinal implants, and scaffolds for tissue engineering. Despite the extensive impact of these materials in existing medical devices, preclinical evaluation has focused on biocompatibility, degradation kinetics, and strength retention. However, many absorbable materials used in medical devices today are polymers which exhibit complex viscoelastic mechanical behavior. While this viscoelasticity may dominate performance in the short term, comprehensive evaluation of viscoelasticity in absorbable medical devices is not typical. With the emerging use of absorbable polymeric materials for medical devices that are exposed to significant mechanical forces in vivo, evaluation of the viscoelastic properties for these materials becomes critical. For example, in vivo loading of absorbable spinal cages has been linked to premature failure through compressive creep rather than a degradation mediated strength loss or inadequate biocompatibility. Increased quantification of the viscoelastic mechanical behavior of absorbable polymers will generate enhanced failure prediction capabilities. Furthermore, it becomes important to study the interaction of loading with chemical degradation of the implant. This seminar will discuss creep mechanisms for absorbable polymers and in vitro test methods to simulate degradation in the presence of mechanical loading for absorbable implants.

About the Speaker
Dr. Maureen Dreher is currently a Biomedical Engineer at the Center for Devices and Radiological Health within the FDA. Dr. Dreher earned her PhD in Biomedical Engineering from Duke University where she developed novel computational and experimental methods to study cell-matrix mechanics of the knee joint meniscus. After completing her PhD, she joined FDA to apply her expertise in nonlinear and viscoelastic mechanics of tissues to the review and evaluation of medical products. Her role in CDRH continuously blends regulatory research and regulatory support activities. Her primary expertise in CDRH is centered on computational modeling, engineering mechanics of cartilaginous tissues and biomaterials, and cell-matrix interactions. Since arriving at the Agency, she has applied this expertise to study interactions of mechanics and degradation in absorbable polymers. While absorbable polymers have been used in medical devices for decades, they represent a raw material whose use is in devices is increasing due to its properties and biocompatibility, particularly for devices with structural roles such as cardiovascular stents and tissue engineered scaffolds. She is the recipient of an FDA awarded Critical Path Initiative project to define improved methods to study degradation in absorbable implants. In addition, Dr. Dreher is actively involved in promoting and defining the use of computational modeling to support medical device regulatory submissions, particularly for cardiovascular devices.

Audience: Graduate  Faculty  Post-Docs 

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