How to work with Orthobond

How to work with Orthobond

Orthobond has spent 13 years and $47 million to bring its nanosurface technology for implanted medical devices to market. We believe our proprietary antibacterial coating is an effective, scalable solution for one of the world’s largest healthcare challenges—contaminated implant devices that can lead to thousands of hospital-acquired infections each year.*

In order to share the benefits of our groundbreaking technology with surgeons and patients around the world, we partner with medical-device manufacturers. Orthobond brings its development expertise for applying the surface technology to a new device, our seasoned regulatory and compliance experts pave the path to approval, and our 8,000 square-foot facility handles the manufacturing and pre-market testing. After more than a decade, we have an established protocol of safety and efficacy tests for FDA-regulated medical devices.

There’s no need to make design changes to already-approved devices before they are coated with Orthobond’s nanosurface technology. We enhance your existing device with a first-of-its-kind non-eluting antibacterial coating that has been reviewed as safe and effective—and can take you from contract completion to regulatory submission within 18 months. Orthobond paves an accelerated path to market with established infrastructure and capabilities, as well as seasoned industry insiders who have extensive experience developing surface technology and navigating intricate regulatory requirements. Our goal is to eradicate bacterial contamination while giving you and your product an advantage in the marketplace.

Orthobond’s senior talent has unparalleled expertise in regulatory requirements and compliance. They are skilled at navigating the unique journey associated with the hyper-specific niche of antibacterial technology—including FDA-regulatory medical devices. Our experts ensure that product technology is accurately represented by claim language to create a predictable regulatory pathway. We have also developed proprietary regulatory management, guidelines, protocols, and testing controls that consistently meet required benchmarks to help Orthobond-coated products move swiftly along the approval path.

Headquartered in the heart of the Northeast Biotech Corridor, Orthobond is led by world-renowned PhD microbiologists, chemical engineers, and antimicrobial technology experts. In addition to our scientific advisory board that’s a “who’s-who” of leaders in cutting-edge biotechnology, we work closely with three prestigious universities and the most prominent companies in the chemical industry. 

Orthobond is currently working with partners in a variety of areas, including spine, trauma, oncology and neuromodulation. Beyond the medical space, we foresee our antimicrobial surface treatment becoming the gold standard for textiles, high-touch surfaces (such as those in restaurants, labs, elevators, playgrounds and transportation)  and everyday product packaging.

Contact us today to learn more about how Orthobond can give your implantable devices an antibacterial advantage, and be among the first to help save thousands of lives each year by minimizing implant contamination.

*Darouiche, RO. Treatment of infections associated with surgical implants. N Engl J Med. 1422–1429 (2004); VanEpps, JS & Younger, JG. Implantable Device-Related Infection. Shock 597–608 (2016).

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