The next hot medical device, one that only lasts a few months and then dissappears without surgery or long-term side effects. Researchers around the globe are using new polymers and metals to design biodegradable medical devices. They do their jobs as long as needed and then dissolve leaving behind health/healed funtioning tissue.
The medical benefit provided by the dissolution makes product development and subsequent safety and efficacy testing a challenge. Traditional fatigue testing methods are not applicable. A new area of research is responding to this challenge.
Dr. Yun at North Carolina A&T believe that "Various physiological factors related the corrosion of biodegradable metal medical device should be taken into consideration to obtain similar results at in vivo when in vitro test is conducted. Because complex environment in the human body such as various physiological salts, flow and diffusion kinetics, proteins absorption and active tissue formation affect the biodegradation process and formation of corrosion products for biodegradable metal implants. In vivo experiments (animal testing) can unfortunately lead to major ethical concerns, costs and limited experimental capacity. Thus, we keenly feel that a new design of elaborate and complicated test-bed should be developed on the basis of massive data acquired from previous tests to reduce the gap of corrosion behavior between in vitro and in vivo test".
ASTM is partnering with NSF and the FDA to form a working group to identify new testing methods for the worlds next generation of medical devices.
BISS bioreactor systems are uniquely suited to assist with the research, development, and ultimate standard testing. The physiologic mechanical and biologic environment can be mimicked and controlled in a reliable and repeatable manner to collect data and standardize protocols throughout the development of these products.
