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The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership

Grace College shares an address with a $38 billion global industry in Warsaw, Indiana, the orthopaedic capital of the world. Today, device innovators like Biomet, DePuy and Zimmer are also getting into the business of education—out of necessity.

The Lilly Endowment, an Indiana-based foundation that exists to support the causes of community development, education and religion, hired research organization Biocrossroads to study the Warsaw/Winona Lake area and propose initiatives for community focus. "One of those initiatives was talent pool development," states Allyn Decker, Program Director for the newly minted Orthopaedic Regulatory and Clinical Affairs (ORCA) program at Grace College. "Those of us who live here love Warsaw, but it is very difficult for the orthopaedic industry to bring highly educated professionals to this community if they don't already understand the value of living here. This is where Grace College came in."

Grace College President Ron Manahan is a leader with a history of community collaboration. Manahan knocked on the doors of Biomet, DePuy and Zimmer and simply asked, “What are your needs?” The immediate and unanimous answer from the companies’ presidents? Training in regulatory and clinical affairs, that is, an initiative that helps develop industry workers who understand the various processes involved in engineering, testing and submitting successful, safe orthopaedic devices to FDA for approval. It’s an industry discipline that grows more and more rigorous every year.

Manahan’s overture for partnership with Grace College was met with resounding enthusiasm, and an agreement took root in the form of a $600,000 grant from OrthoWorx, a Warsaw-based industry, community and education initiative established by funding from the Lilly endowment. 

The ORCA program is the world’s first and only graduate program for studies in orthopaedic regulatory and clinical affairs, and it resides at Grace College. ORCA is also the first of the OrthoWorx initiatives to be implemented and thus, a chance for this partnership to prove that it can and will succeed.

Grace College has done its research and spent the grant money wisely. An advisory board was created; scouts went out to 12 other schools around the country to observe similar programs; cutting-edge technology was brought in and, most importantly, a faculty of the most qualified individuals possible was hired.

The managerial team is par excellence, too. Decker’s oversight has produced a well-oiled, cutting-edge program that involves a 12-month, 12-course schedule, a bi-monthly series of weekend lectures and convenient access to online participation. The program has been running smoothly since its launch in May 2011 and already has a waiting list to get in. It accepts only 30 students per year.