Researchers at Pacific Northwest National Laboratory (PNNL) developed the first water-based process that allows calcium-phosphate thin-film coatings containing controlled-release bioactive therapeutic agents to be deposited on orthopedic devices for implant.
Expected benefits to the thousands of implant recipients each year will be two-fold: 1) the antimicrobial agent in the coating will help prevent dangerous and costly post-surgical infections, and 2) the water-based deposition process, coupled with the bioactive antimicrobial agent, provides an advanced method for applying thin films containing calcium-phosphate coatings—a natural component of bone—to orthopedic implants.
Army orthopedic surgeons provided PNNL researchers with the preclinical data needed to market the technology. The marketing-to-licensing process encompassed four years of intense effort and dedication.
The additional expense to a licensee of obtaining FDA approval made the technology difficult to license.
However, Bacterin, a medical device- testing laboratory for medical implant manufacturers, sought to expand its product base and possessed the necessary FDA-approved assay to test the technology.
The technology was licensed in 2004 by Bacterin, which has since been listed as one of Fortune magazine's top 25 breakout companies.
The company joined forces with the Department of Defense, receiving a $1.4-million appropriation to further develop the technology for coating metal rods and pins for use on the battlefield. In addition, Bacterin has forged relationships with other medical device manufacturers who have agreed to use the unique coating on their products.
The thin-film technology is expected to play a major role in dramatically reducing post-surgical infections in implant recipients and wounded military personnel, and will greatly increase acceptance of artificial joints by the body.
The prevention of these infections promises billions of dollars of savings to patients and the U.S. government in followup medical care. In addition, significant cost savings and reduced environmental impact will be realized in the manufacturing process as the simplified water-based deposition process does not require use of multimillion dollar instruments and uses very few hazardous materials in its manufacture.
For more information about Bacterin, visit www.bacterin.com.
This micrograph of the antimicrobial thin-film coating, along with a schematic, shows the process for depositing the coating on a medical device that significantly reduces the risk of dangerous infections. (Click image to enlarge)
