Fort Wayne Medtech Founder Renata Fields Celebrates First FDA Device Approval

Renata Fields's Fort Wayne-based medical device company, Summit Orthopedic Devices, received its first FDA approval this week for a new joint implant designed for patients with early-stage degenerative joint disease, a milestone Fields said validates more than a decade of work since she left a research position at a national orthopedic device manufacturer to start the company.

Fields founded Summit ten years ago with two former colleagues, initially operating out of a small engineering lab space before growing into a 60-person company headquartered in Fort Wayne, a city with a long-standing concentration of orthopedic device manufacturing expertise. The newly approved implant targets patients earlier in disease progression than most existing devices on the market.

"We picked this problem specifically because there was a real gap for patients who weren't sick enough for a full joint replacement but were in serious pain, not because it was going to be an easy regulatory path," Fields said. "It took us longer and cost more than we originally budgeted, but I don't think I could have justified spending a decade of my life on anything else."

The approval triggered a milestone payment from Summit's manufacturing and distribution partner, which will handle commercial production of the device. Fields said the company is using the proceeds to fund research on two additional implant designs currently in earlier stages of clinical trials.

Summit Orthopedic Devices employs the majority of its staff at its Fort Wayne headquarters, drawing heavily from the region's concentration of orthopedic engineering talent. Fields said the company has no immediate plans to relocate despite recruiting interest from medtech hubs elsewhere in the country.