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Biocompatibility & Thromboresistance


November 1, 2011

Biomaterials (biostable and biodegradable) for use in the development of medical devices and drug delivery devices can be polymeric, biologic, metallic, ceramic, or their composites, each presenting unique biocompatibility and thrombogenicity characteristics (if in blood contact). Biocompatibility testing is typically addressed in FDA guidance documents and ISO 10993 biocompatibility standards. The concept of biocompatibility is moving from a “do no harm” mission (i.e., nontoxic, nonantigenic, nonmutagenic, etc.) to one of doing “good,” that is, encouraging positive healing responses.

The new generation of implantable and tissue engineered medical devices control biologic interactions by use of bioactive, therapeutic, smart and nano-enabled materials to improve safety and efficacy. Additionally, there is an emerging trend to use the biomechanics of the device in soft tissue and in cardiovascular applications to control outcomes.

With the emergence of combination products, a paradigm shift is occurring that incorporates biocompatibility as part of the functional requirements of the device. Many of these devices are “combination” drug or biologic devices resulting in new regulatory challenges. This current era requires rapid development cycles leading, in many cases, to first-in-man evaluation as part of the exit strategy. The medical and controlled drug delivery expertise at Exponent can be applicable to help understand the challenges and risks being faced during the development phases.

Read more about Exponent’s capabilities.