As advances in medicine and medical technologies expand, surgery still remains a somewhat dangerous operation, with many variables coming into play. Spine surgery, as vital as it can be, can be particularly devastating if devices are used inaccurately, and top surgical instruments can be extremely costly. Heidi Frey realized that this problem, and many others, could be addressed through a focused spine technology incubator that applied resources to innovative thinking and emerging technologies.
Frey, who was once a partner at a law firm in Chicago, decided to leave the law and become an entrepreneur. Her husband, Dr. George Frey, is a practicing spine surgeon and inventor of over 50 spine-related patents who invented an interbody cage that became the go-to cage design for spine surgeries around the world. Together, they realized innovations were more valuable when they’ve been prototyped and patented, rather than existing solely as a napkin sketch, and decided to start Mighty Oak Medical, a center for innovation to patent, prototype and validate novel concepts in spine surgery. Mighty Oak is designed to combine the talents of experienced spine surgeons and biomedical engineers to focus on innovative solutions, making surgical outcomes safer, more cost-effective and patient-centered. This close development and feedback cycle enables active collaboration and fosters creativity on a faster timeline than bigger companies can typically achieve.
Beginning in August 2011, Mighty Oak had one engineer and a starting design of a basic pedicle screw navigation guide. While navigation systems did exist with multiple friction points, Mighty Oak aimed for an application that was easier for surgeons to use and less costly. By using simple 3D printed technology, they were able to create just that: an affordable guide used with ease. The FIREFLY® Pedicle Screw Navigation Guide, as it’s called, mechanically constrains the surgeon’s instruments to follow the trajectories selected during the pre-surgical planning process for that individual patient.
“Surgeons have used FIREFLY® in some very challenging scoliosis cases,” says Frey. “We are thrilled that our technology is enabling better outcomes in these tough surgeries; we have a dedicated team of engineers that designs Guides for each vertebral level.”
Since their innovation with FIREFLY®, Mighty Oak Medical has won three Spine Technology Awards, one for the Pedicle Screw Navigation Guide in 2012, another in 2016 for their yet-to-be-cleared cortical screws, which should make screw placement highly accurate, and their most recent in October 2017 for their porous pedicle screw. They’ve also collaborated extensively with companies like OrthoPediatrics, signing an exclusive distribution agreement to represent FIREFLY® in pediatric hospitals in the US, and anticipate signing other milestone agreements in the near future.
“The spine industry has been very receptive to us because we offer an enabling technology that is so unique,” said Frey. “Surgeons can use essentially any pedicle screw system with our Guides. Mighty Oak does not sell pedicle screws or other implants. As a result, we have been talking to several spine companies that see the value in our enabling technology and want to collaborate with us in a meaningful way to bring navigation to standard of care.”
In 2015, Mighty Oak Medical was a recipient of an Early Stage Capital and Retention grant of $250,000, provided by the Colorado Office of Economic Development and International Trade’s (OEDIT) Advanced Industries grant program. With the funds, Mighty Oak was able to fund additional research on their patient-specific 3D printed screw navigation guides, and were later able to apply and receive one of their two 510K clearances.
Starting their business in Colorado was like fate for the Freys. At the time they had moved to Denver, it was still a relatively small city with tremendous potential for growth that later was essential for Mighty Oak, thanks in part to Colorado’s highly-educated, young professional workforce. Colorado has since become a hub for medical 3D printing and an epicenter for spinal navigation technologies. Mighty Oak has since developed strong working relationships with all of its “neighbors” and could not envision a better locale in which to develop its cutting-edge devices.
Colorado is certainly glad they chose Denver as Mighty Oak looks towards the future. The company is looking to expand and provide their 3D printed guides to surgeons all over the world, along with building news guides and safety devices for spine surgery, always aiming for their goal to make surgery safer and more efficient. They currently have 16 employees, and look to grow their team very soon to keep up with the demand.
Spine Technology Award Winner
surgeries have been completed using FIREFLY technology