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.



Meet Our Faculty, Learn Their Credentials
Mikhail Chkolnik is the project leader for clinical research at Depuy Orthopaedics. He holds a Doctorate in family medicine and specializes in therapeutic knowledge of cardiovascular and orthopaedic devices.

Rodrigo Diaz is the medical safety officer at DePuy Orthopaedics. He earned his Doctor of Medicine in Bogota, Colombia, with an emphasis in family medicine. He has worked over ten years in clinical research.

Jordan Lee is a manager with DePuy Orthopaedics. She holds a Doctorate in the field of biomedical device design and serves as an advisory council member for the Indiana Space Grant Consortium and the Technical Assistance Program at Purdue University.

Mark Piazza  practices law as the owner and managing director of Mark T. Piazza, LLC. He holds a Juris Doctorate and previously served as an assistant general counsel for Johnson & Johnson.
Pamela Plouhar is the vice president of worldwide clinical affairs at DePuy Orthopaedics. She earned her Doctorate in chemistry/biochemistry from the University of Notre Dame and holds ten published patents.

Max Sherman is the president of Sherman Consulting Services, Inc. He holds a Bachelor of Science in pharmacy and is the author and co-author of more than 100 professional publications in numerous pharmacy, regulatory and orthopaedic journals and books.

JoAnn M. Tyson is the CEO and clinical and regulatory affairs director at J. Tyson & Associates, Inc (JTA). JTA specializes in device clinical trials with an emphasis on orthopaedic and cardiovascular products and services. Ms. Tyson is a registered nurse and holds her Master’s in health care services administration. 

Paul Voorhorst is the director of worldwide biostatistics and data management at DePuy Orthopaedics. He holds an M.B.A. and a Master’s in biostatistics and has provided leadership in numerous Investigational Device Exemption and Premarket Approval submissions to FDA.

Ted M. Wendt is a consultant in regulatory affairs, compliance and quality assurance and holds a doctorate in microbiology. He retired as vice president of regulatory affairs and compliance from Zimmer in 2004. Prior to his tenure with Zimmer, he served as director of international regulatory affairs for Johnson & Johnson Medical, Inc.

Learn more about ORCA by attending Professor Decker’s session on Wednesday, June 13 at OMTEC 2012. Allyn will explain key features of the program, share highlights from the inaugural year and answer participant questions.

Apply for ORCA online.