Standards Development Advances the Future of Smart Implants

Achievement date: 
2015
Outcome/accomplishment: 

Biomedical researchers from North Carolina A&T University (NCAT) and the University of Pittsburg (Pitt), partners in the NSF-funded Engineering Research Center (ERC) for Revolutionizing Metallic Biomaterials (RMB), headquartered at NCAT, are lending their expertise in smart surgical implant materials to the standards development process. The objective is to develop new standards that reduce the barriers for developing safe and clinically effective absorbable metal devices. 

Impact/benefits: 

Working with the Biodegradable Metals Standardization (AC 87) Committee, the RMB researchers are helping to develop absorbable metals testing protocols and standards for adoption by the American Society for Testing and Materials (ASTM) and International Standards Organization (ISO). As they collaborate on the standards, the researchers are able to build and strengthen relationships with colleagues and members of ASTM, ISO, and the Food and Drug Administration (FDA). Participation also provides an opportunity for them to engage with industry and the global community, learning and contributing to broader dissemination and increased impact of findings from the Center’s investigations, as well as informing decisions on its research priorities.

Explanation/Background: 

Surgical implants made of advanced bioabsorbable polymers can be absorbed by the body once they have served their purpose, offering great potential to reduce painful and costly removal surgeries for implants made of nonabsorbable titanium or stainless steel. The interface between these devices and the body is sophisticated and affected by various environmental factors surrounding their location in the body, such as changes to the material surface caused by different types of corrosion.

Current standards address relatively inert materials. The new standards will advance testing protocols for metals that recognize and support materials that interact dynamically with their environment and in turn influence that environment. Areas in need of testing standardization include materials, in vitro-in vivo correlation, biological evaluation, in vitro degradation testing, degradation product fate, and bulk corrosion.