Colombian SmartBone Provides Accessible Custom Craniofacial Implants #Innovate4Health

This post is one of a series in the #Innovate4Health policy research initiative. #Innovate4Health is a joint research project by the University of Akron IP Center (UAIP), the Information Technology & Innovation Foundation (ITIF), and the Geneva Network. This project highlights how intellectual-property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact UAIP Research Fellow Douglas Park at dpark@uakron.edu for more information.

Douglas Park

Head injuries can have devastating lasting effects, from persistent pain to social discomfort, self-esteem issues, and even risk of death. Implants can repair skull structure, but their cost and availability can be a major obstacle, especially in less wealthy nations. Colombian companies Smartbone and its partner Innmetec are using patented technology to change that, developing customizable and cost-effective prosthetic implants to meet demand in South America.

Craniofacial injuries from accidents or congenital defects such as cleft palate are global problems. Traumatic injuries to the head and face from car and work accidents are distressingly common worldwide, especially in Latin America where intracranial injury occurs at a rate 1.5 times higher than the global average. Similarly, congenital defects causing craniofacial anomalies (CFAs) afflict millions. For example, roughly 1 in 600 newborn infants worldwide are born with cleft lip and cleft palate. These injuries burden individuals with disabilities and social challenges while imposing significant costs on society.

Often, the only effective solution for these injuries is the use of craniofacial implants to replace the damaged or missing parts of the skull. However, implant materials must meet strict standards — they need to minimize rejection risk, resist corrosion, provide sufficient strength, avoid imaging interference, and allow normal bone regrowth. Titanium is the only broadly available material that meets all requirements, but medical grade titanium is an expensive import for most countries.

Smartbone, a university spinoff led by engineer Catalina Isaza, has developed an innovative and patented compound of ceramic and polymer that provides an accessible alternative to titanium. The material combines the polymer polyetheretercentone with a ceramic made from hydroxyapatite. The resulting implant resembles human bone, fuses well with naturally grown bone, and promotes bone growth. This material can even be used in children, reducing the need for replacement as they age. It also avoids issues with metal implants like discomfort from thermal conductivity. Crucially, the compound can be easily shaped for customized patient implants.

Director Isaza, who wanted to be a doctor as a child, saw this unmet medical need in her country and dedicated her engineering expertise to solving it. Smartbone offers customized implant designs that restore both function and aesthetics, while reducing wait times, risks, and costs by a third compared to imported options. By the end of 2020, Smartbone devices had already treated 267 patients, and that total only continues to grow.

Smartbone was spun out of a collaboration between EAFIT University, Colombia’s school of administration, finance, and technology, and CES University, who are both members of the Bioengineering Research Group (GIB). GIB was founded in 1997 as an initiative to promote scientific advancement and design in medical and dental technologies. The initiative has 44 research groups, including the one that resulted in Smartbone.

This collaboration among universities in GIB also created an entity for technology transfer. Technology transfer moves promising discoveries made in research labs into the private sector for translation into applied medical technologies that benefit patients. As university technology transfer offices do in the U.S., Europe, and other countries, GIB manages its researchers’ IP as well as regulatory certifications and compliance. GIB has a portfolio of 52 patents for all its research groups.

IP rights are essential to technology transfer success stories such as Smartbone. Research labs typically do not develop applied technology — it’s a long, risky, and expensive process, often requiring skills and procedures incompatible with researcher’s interests and experience. Fortunately, spinoffs, startups, and established companies are willing to make the necessary investments needed to develop technology fully, but they need a prospect for return on their investment. IP rights provide the necessary security for such investments, providing an opportunity to benefit if development is successful.

The results can be seen in the work of Smartbone. They have procured two patents through the Colombian Superintendence of Industry and Commerce. The 12088195 patent, granted in 2014, covers a technique for the embossing of metal sheets into appropriate shapes for prostheses. The NC2016/0000434 patent, granted in 2019, covers an articulated design for a temporomandibular (jawbone) implant that allows a natural range of motion. These patents were the foundation for Smartbone’s investment in the development of its customizable implants.

The Smartbone patents have also enabled further business collaboration to bring the implants to more patients. In 2021, Innmetec entered a license deal to distribute Smartbone implants, which included a license to the patents. Although the implants had already been used in patients, Jose Rodrigo Isaza, general director of Innmetec, observed that the deal has enabled their national distribution.

IP rights enable such important partnerships to the benefit of both businesses and patients. Adriana García, director of Innovation EAFIT, said that Innmetec was a key strategic ally for broadening the reach of Smartbone implants because of its market share and expertise. IP rights allow such win-win collaboration to happen. Innmetec received access to cutting edge technology, Smartbone was able to reach a larger market, and IP rights provide a basis of trust between partners and security against potential copiers.

Chosen as one of MIT Technology Review’s Innovators Under 35 Latin America in 2023, Catalina Isaza now plans to take Innmetec to other Latin American countries. Her story demonstrates how intellectual property rights can promote and propagate homegrown, accessible medical device innovation, even in resource-limited environments. With IP protection helping to secure investment and collaboration, Innmetec and Smartbone are bringing customized, life-changing implant solutions to hundreds of patients in Colombia and beyond.