When Orthobond CEO David Nichols is asked which historical figure he admires most, his answer is Alexander Fleming. “More lives were probably saved in the 20th century by the invention of penicillin than anything else,” he says.
Nichols’ perspective has served Orthobond well, and our proprietary Ostaguard™ antibacterial surface coating has the potential to be this century’s penicillin. This is only possible because of the Orthobond Surface Design Lab and its multidisciplinary approach to making this groundbreaking innovation a reality. It took a village of experts from the fields of chemistry, biology, and several types of engineering to determine the ideal path for achieving this goal.
For much of the research and product development, the Orthobond Surface Design Lab had to think from bacteria’s perspective. Among the initial questions that needed to be answered were how bacteria are getting on the implant (via the air or handling), which surfaces the implant comes in contact with, and if operating-room variables lead to different outcomes. To get the answers to these questions, the Orthobond Surface Design Lab created a control that different clinical scenarios could be compared to.
The lab process may never leave the lab, but the end-product does. The Orthobond Surface Design Lab had to ensure devices treated with Ostaguard maintain their efficacy from the time they leave our manufacturing facility to when an implant is placed in a patient’s body. This meant validating that implants treated with Ostaguard would not be compromised by its packaging, shipping or warehouse conditions.
Rising to the challenges
To address the issue of device contamination, the Orthobond Surface Design Lab set out to create a safe,permanent, stable, uniform, antibacterial coating that would not interfere with device function. The Surface Design Lab also had to ensure that implant components treated with Ostaguard fit together seamlessly—as if no coating has been applied. The human eye may not be able to detect Ostaguard, but bacteria can.
After numerous attempts to address the issue of device contamination by others, Ostaguard was the first antibacterial surface treatment to be grantedDe Novo classification by the FDA with an initial application in the field of orthopedic spinal implants.
Creating testing methods from scratch
A proprietary technology like Ostaguard requires a net-new assessment protocol that needs to be developed and validated. The Orthobond Surface Design Lab pioneered a battery of tests and measurement processes to analyze the coating on a molecular level for quality control, as well as clinically relevant assays that measure its efficacy. The Ostaguard testing protocol is so unique that the Orthobond Surface Design Lab was also required to create new chemistry, glassware, measurement tools, imaging techniques and bioassays required for FDA submission.
Creating the assays required to evaluate efficacy and overall quality control often took longer to create than it did to perform the testing itself. For example, the research team had to develop a test that could measure the amount of Ostaguard that adhered to the implantable device’s surface at a nanometer scale. Further testing was necessary to confirm surface stability under simulated real-life physiological conditions. And then, the results from this testing have to continue to be reproducible time and time again—even after scaling production.
Of course, a critical part of developing Ostaguard was establishing the amount of coating that needs to be applied to an implant to reap its antibacterial benefits. Our testing demonstrated the treatment’s safety and function and used that data to benchmark the criteria for the amount of coating that needs to be applied. Theoretically, this is similar to establishing the dosing of a drug—but drastically different and more difficult because Ostaguard is a drug-free antibacterial surface.
The time is now
After investing $47 million and 15 years, Orthobond has transformed Ostaguard from an idea into a commercially viable reality. Representing a breakthrough for the ongoing problem of implant contamination, we’re here to help give your devices an antibacterial edge.
Contact Orthobond today to learn how Ostaguard can give your implantable devices an antibacterial advantage—and make you among the first to help save thousands of lives every year by minimizing implant contamination.
