A Whole New Way to Operate the Innovation Process

The University of Utah Orthopaedic Center sits high on the mountainside overlooking Salt Lake City. While its view is impressive, what’s inside is even more so: A brand new, 10-station operating theater equipped with all the latest equipment for surgical procedures. The only thing missing is live patients. Instead, world-class faculty at the University of Utah School of Medicine perform mock surgeries on cadavers — testing new orthopaedic devices that their fellows, residents, students and faculty have invented.

A short distance across town lies their prototype lab. But it’s no ordinary lab. Instead of printing 3D plastic prototypes, it produces actual products using the same kind of equipment you’d see on a commercial medical device manufacturing floor.

It’s all part of the Louis S. Peery, MD Orthopaedic Innovation Center (OIC), which is reinventing how a university moves new products out of the lab and into the market. With support from the PIVOT Center at the University of Utah, it provides everything an orthopaedic inventor could want.

Where university innovations meet the private-sector process.
For Charles Saltzman, chair of the University of Utah Department of Orthopaedics, innovation is as essential as research, education and clinical service for fulfilling their department’s mission to improve care for orthopaedic patients. He envisioned a place where they could all come together — a place that would allow their clinical and research faculty to collaborate, ideate, design, manufacture, test and commercialize innovations that improve patient outcomes. And so, in partnership with PIVOT, the Louis S. Peery, MD Orthopaedic Innovation Center was born.

The next step was finding experienced talent to lead the OIC. Turning to the private sector, Saltzman and the PIVOT team tapped Wade Fallin to be executive director. Fallin is a nationally recognized, successful serial entrepreneur and orthopaedic device inventor with over 240 issued patents. That, and his passion for medical device innovation, made him the perfect fit.

The OIC is building on Fallin’s successful orthopaedic innovation model and putting the necessary resources behind it. This includes a team of experienced industry experts, supported by the latest technology for designing, manufacturing and testing their inventions. “What I’m doing here at the Orthopaedic Innovation Center is what I was doing in the private sector since 1996,” says Fallin. Only now, he and university inventors have the full backing of industrial-grade resources and the PIVOT Center’s innovation and relationship management.

A focused innovation factory — with a commercialization engine.
There is a surge of promising orthopaedic technologies coming out of the University of Utah. During the last six months, more than 40 different projects have been suggested by the faculty, and the OIC has already initiated work on six of them, providing a streamlined pathway from invention to commercialization. The partnership between the OIC and the PIVOT Center provides support during the entire life cycle of new medical device product development. It begins in the OIC’s Innovation Studio where students, residents, fellows and faculty can interact with the engineering team to innovate new surgical and patient care solutions. In the OIC’s Prototype Shop, precision computerized numerical control (CNC) machining, coupled with post-machining processes, produce commercial-quality products. These are then tested in the Surgical Knowledge Integration (SKI) Lab, where faculty provide valuable feedback. When necessary, the devices can also go through biomechanical testing in the Harold K. Dunn, MD Orthopaedic Research Laboratory, adjacent to the SKI Lab.

Using the OIC’s quality system, the entire product development process is conducted under full compliance with the FDA Quality System Regulations. By the time a device comes to the University of Utah PIVOT Center for commercialization, it’s been design-verified and validated, it has manufacturing processes established, it’s been approved by the FDA and is market ready. The PIVOT team then provides the support, connections and network required to take the device to market.

With the critical groundwork done and contractual agreements already in place to foster direct, industry-sponsored programs, innovators can hit the ground running when they start the commercialization process.

Casting the mold for orthopaedic innovation.
“The Orthopaedic Innovation Center gives us the ability to not only envision better surgical tools, instruments and devices, but actually create them rapidly, test them almost immediately, and iterate with unparalleled speed and accuracy,” says Saltzman. “We’ve created an innovative model with top surgeons, imaginative trainees and very experienced engineers enthusiastically collaborating on a daily basis to improve our field of surgical care,” says Saltzman.

Saltzman credits leadership at the University of Utah for making the OIC happen: university President Ruth Watkins, Vice President for Research Andy Weyrich, Senior Vice Presidents Michael Good and Dan Reed, and Keith Marmer, executive director of the PIVOT Center, which Saltzman says has been an incredible partner.

It’s a partnership that gets Fallin up in the morning. “I love seeing technology make a difference for patients,” he says. Now that the OIC is up and operating, he’s in an even better place to do that.

To learn more about the Louis S. Peery, MD Orthopaedic Innovation Center,
email wade.fallin@hsc.utah.edu
or visit https://medicine.utah.edu/orthopaedics/innovation/labs/oic/.