Case Study

Where Medical Device Invention and Surgeons Intersect

 

For companies that develop medical devices to be used in critical surgeries, input from the surgeons who will use these devices is critical in the last mile of development before commercialization. At the same time, regulatory agencies, such as the Department of Justice (DOJ) in this example, look very carefully at the nature of the relationship between manufacturers and surgeons.

 

Borman & Company was asked to help when the DOJ challenged the “innovation” relationship between a leading implant manufacturer and the surgeons it selected and compensated to test their orthopedic devices. Clearly, for the success of the devices, surgeon feedback about what did not work well was crucial to shaping the final product.

 

Borman & Company developed a management, governance and evaluation matrix to capture innovation, invention and strategic advisory contributions from internal and external innovation collaborators in a way that satisfied governmental oversight of how doctors were brought into the innovation program.  This methodology positioned the company to effectively track, attribute, value, and substantiate how surgeons were selected to participate in the innovation process while at the same time complying with strict government and regulatory requirements for the industry. 

 

This case study highlights Borman & Company’s advisory capabilities: where innovation centers, governmental oversight and the public’s need to know that the outputs of research have been properly vetted intersect.