Pietzsch adds that the medical device development process has become increasingly complex in recent years because of the advent of advanced technologies, stricter regulatory requirements, and the increasing importance of reimbursement decisions.

The Role of FDA's Quality System Regulation

The study results demonstrate that a significant portion of the development process is governed by regulations that influence the manner in which medical devices are developed, approved, and brought to market. The pace at which such regulatory requirements can be met determines when the device will reach the clinic.

Specifically, FDA's Quality System Regulation plays a substantial role in the development process and serves to assure the public that critical elements of safe design practices are followed. However, the researchers point out that such standardization does not always permit product developers to streamline their processes where it would make sense. In turn, such rigidity can inhibit innovation, which often occurs in a less-structured way.

"Clearly there are benefits associated with having a rigorous process and clearly defined procedures for all stakeholders in the processfrom investors and engineers to researchers and regulators," says coauthor John Linehan, Ph.D., professor of medicine and biomedical engineering and director of the Center for Translational Innovation at Northwestern University, and a consulting professor of bioengineering in Stanford University's BioDesign Program. "The challenge for companies inventing and developing technologies is to strike a balance between sufficient process rigor and enough room for flexibility and creativity."

Drug-Device Differences

Among the key results of the study is a detailed explanation of the significant differences between medical devices and phar
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