by mddiadmin on February 12, 2009
Most important to the process, said Pietzsch, is the initiation and opportunity-risk assessment that must happen even before development begins. Among those steps are financial review, market analysis, competitive assessment, legal analysis, and assessing the clinical and regulatory steps.
One critical area at this stage that most companies do not incorporate is assessing the reimbursement path. "This is often assessed at a later stage, often when its too late," said Pietzsch.
Research from a group focuses on the best process for device development. The group, headed by John Linehan, Ph.D, interviewed 80 medical device experts to find the best way to properly prepare a device so that it finds success in the marketplace. The group presented its findings to conference attendees at the MD&M West show in Anaheim.
"We found that many device makers have not fully implemented the proper functionality to prepare for late-stage changes," said Jan Pietzsch, Ph.D. who worked as an investigator in the project funded by