Changing landscape requires new models

Industry has been both a beneficiary of research and education projects funded by the Orthopaedic Research and Education Foundation (OREF) and a crucial source of support. How can that relationship continue to flourish under new regulatory requirements and changing standards for best practices?

OREF’s response is a new model for industry support of education and training offerings designed to help orthopaedists at various career stages to sharpen and expand their skills: the OREF Clinician Development Program (CDP).

Introduced in late 2008, the CDP program was reviewed and approved by federal monitors appointed by the U.S. Department of Justice (DOJ) for three of the largest device makers. The program quickly attracted an impressive level of interest on the part of industry, resulting in three partnerships by the end of first quarter 2009 and four more over the next three months. (See “Program Milestones,”below.)

A new landscape
The orthopaedic environment has been in flux for several years as a result of increased scrutiny by legal, regulatory, and legislative bodies. This includes a DOJ probe that led to deferred prosecution agreements with four device companies. Some form of federal legislation mandating transparency may also be in the future.

“Because of the changes driven by the deferred prosecution agreement, monies to fund education opportunities such as fellowships and resident programs are scarce,” said Mr. Carl Winnebald, vice president of professional and institutional affairs for Biomet. “We felt that the best way to continue funding programs ethically and effectively would be to partner with an organization that could administer those funds.”

A good fit
For many companies, OREF’s 50-plus-year track record of grants administration and its tradition of collaboration—both with orthopaedic organizations and industry—figured prominently in their decision to sign onto the OREF Clinician Development Program.

“Formalizing our relationship with OREF allows Smith & Nephew to continue supporting orthopaedic research and education in a comprehensive way while working with an organization dedicated to its own mission, independence, and integrity,” said Mr. Joseph M. DeVivo, president of Smith & Nephew Orthopaedics.

No bias
This new OREF program enables industry to support fellowships by eliminating any influence by the company in the selection of grant recipient institutions. Each of the corporate supporters is expressly prohibited—both by contract and by OREF procedures—from playing any role in the application, evaluation, and selection process.

“We decided to participate in the OREF program to remove ourselves completely from the decision-making process for funding fellowships and residency programs,” said Ms. Jean Bjerke, director of education and grants programs for DePuy.

No conflicts
To further ensure that companies have no influence, OREF has formed an Educational Grants Board comprising three orthopaedic surgeons who have had no conflicts of interest with industry, including financial and managerial relationships, for at least 2 years. This board determines award criteria and makes final funding decisions. Inaugural board members Frank B. Kelly , MD; Jo A. Hannafin, MD, PhD; and William C. McMaster, MD, were appointed in 2009.

“The program is unique because it allows companies to contribute to OREF, which then puts together an independent panel of people to evaluate the various proposals and make funding decisions,” said Mr. Doug Kohrs, president and CEO of Tornier.

Under the OREF fellowship funding program, all grants are for $75,000 to help ensure that all recipient institutions are treated equally. The amount is intended to cover the fellow’s stipend, and some, if not all, related overhead expenses. Funding provided by OREF may not be used for capital improvements, capital equipment purchases, or any endowment fund contributions. In addition, OREF created opportunities for partial funding, which enabled 11 additional fellowships at $25,000 each.

Types of fellowships funded
The number and type of fellowships available are a function of how companies allocate their support. Including both fully and partially funded programs, OREF awarded 50 fellowships—23 in total joint and 27 in other clinical areas—for the 2009–2010 academic year (Table 1). Fellowship recipients are recognized at www.oref.org/cdp

“I look at this as a long-term program,” said Mr. Kohrs. “By contributing [to the OREF Clinician Development Program], we’re ensuring that training is provided for the next generation of orthopaedists. We want to have the best-trained and the highest-skilled physicians taking care of patients.”

Ms. Bjerke concurs. “I’m hoping that in 5 years the process of applying for graduate medical education fellowship and residency program grants is well-accepted, that we’re able to continue to support as many quality fellowships and residency programs as are needed, and that the program grows,” she said.

Institutions and physician groups are encouraged to complete surveys at www.oref.org/cdp to specify the types of graduate medical education fellowships, continuing medical education programs, or residency enhancement programs that need funding. OREF will use responses to make the case for support.

OREF staff members Amy Kile, publications manager, and Sharon Johnson, VP communications, can be reached at communications@oref.org

Apply today for 2010 CDP funding
OREF is now accepting applications for grants supporting 2010-2011 Graduate Medical Education fellowships and resident enhancement programs and 2011 Continuing Medical Education programs under the Clinician Development Program (CDP). Applications are due Oct. 13, 2009. More information and downloadable applications are available at www.oref.org/cdp

Program milestones

• Agreements with Biomet, Inc.; DePuy Orthopaedics, Inc.; DJO Incorporated; Smith and Nephew, Inc.; Synthes, Inc.; Tornier, Inc.; and Wright Medical Group, Inc.
• 50 fellowship grants for 2009–2010, valued at $3.2 million, and awarded in 8 orthopaedic subspecialties
• A total of 159 applications received requesting $980,322 in funding for 2009–2010 residency enhancement and 2009 continuing medical education (CME) grants, scheduled for review in late August