A team of researchers from Penn State working on a novel orthopedic implant for healing long bone fractures was awarded $50,000 by the National Science Foundation to complete its National Innovation Corps (I-Corps) Teams program, an intensive, seven-week training for researchers exploring the commercial potential of their inventions.
Connor Huxman, Ph.D. candidate and fellow in entrepreneurship, piloted the team as the entrepreneurial lead with Jared Butler, assistant professor in Engineering Design and Innovation, as the technical lead. Jeffrey Brandt, prosthetist and orthotist, medical device entrepreneur, and Penn State alum, was introduced to the team through James Delattre, the university’s associate vice president for research and director of the Office of Entrepreneurship and Commercialization, to act as the industry mentor.
National I-Corps Teams supports researchers interested in commercializing their technology by guiding them through the customer discovery process. Through conversations with potential customers, partners, and other stakeholders, researchers assess whether their innovations could translate into successful products.
The Penn State team, dubbed Axi-FLEX, is investigating whether their novel implant design, which provides controlled axial flexibility (Axi-FLEX) to facilitate long bone fracture healing, would be readily adopted by orthopedic and trauma surgeons to help improve fracture healing outcomes. The team's goal with this new design is to minimize the number of fractures that result in nonunion, a failure to heal. Initial anatomies of interest include distal femur fractures and humeral shaft fractures, but the technology is designed to be scalable.
“Existing implants do a pretty good job of stabilizing fractures and bringing the bone fragments back together,” said Huxman. “However, what we are learning is that, for many [long bone] fractures, overly rigid fixation can actually inhibit bone healing. So, to optimally stimulate new bone growth at the fracture site, especially in complex, multi-fragmented fractures, you want a controlled amount of motion between the fragments.”
Axi-FLEX’s device combines the core elements of existing rigid fracture fixation devices with compliant mechanisms—devices designed to bend or move while maintaining their structural integrity. The outcome is a plate that looks and feels similar to what is currently used, but is designed to allow controlled motion, up to a certain point, to facilitate healing.
“We’re really incorporating compliance into the plate itself without changing the shape, material, surgical technique, or locking screw technology,” shared Huxman.
After attending an regional I-Corps short course in the fall of 2021, the team was recommended for the national cohort by Derek Gross, program manager of the Penn State I-Corps site.
During the National I-Corps Teams program, which ran February 26-April 12, 2024, Axi-FLEX traversed six states, conducting over 60 hours of interviews with potential customers and stakeholders at all points of impact, from end users and purchasing decision makers to technology developers.
The interviews confirmed the team’s hypothesis that a solution is desired to reduce the occurrence of fracture nonunions.
“I-Corps has really grown my understanding of how to use the scientific method to approach commercialization, but it has also highlighted the intangibles of entrepreneurship,” said Huxman. “Conducting in-depth interviews with surgeons, hospital decision makers, and fellow entrepreneurs in this space highlights the importance of building relationships, trust, and loyalty, and gives direct exposure to the lifestyle that leading a startup entails. These elements of growing a business are difficult to fully grasp in a typical academic setting, so I-Corps is a great program for both developing a business model and entrepreneurial self-discovery.”
Additional collaborators from the Penn State College of Medicine include: April Armstrong, professor and chair, Orthopaedics; Gary Updegrove, associate professor, chief shoulder and elbow surgeon; and Gregory Lewis, associate professor, Orthopaedics.
Next steps for Axi-FLEX include preclinical testing and further advancing the development and regulatory clearance strategy for the technology.
The team has a pending international PCT patent application for the technology, and is considering forming a startup company and pursuing small business funding through both the NSF and the National Institutes of Health.
