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 process-from 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 pharmaceuticals [see sidebar], and the corresponding differences in their development processes and regulatory requirements. Such variations have dramatic downstream effects that distinguish the capital requirements, product development methods, clinical testing requirements, manufacturing methods, and overall life cycle for products in the two sectors.

"Drug-device differences underscore challenges associated with developing combination products, such as drug-eluting stents, which play an increasingly important role in healthcare innovation," says Pietzsch. "It is our aim to contribute to a greater understanding of such differences, particularly as policymakers and regulators work to design the least burdensome approaches to medical device regulation."

The article emerged from research performed by the authors as part of a study, "Medical Device Development Models," funded by the Institute for Health Technology Studies (InHealth). A review of the background, mission, and statutory requirements for medical device regulation in the United States was published by the authors in the December 2007 issue of the Journal of Medical Devices.

J. Pietzsch, L. Shluzas, M. Pate-Cornell, P. Yock, and J. Linehan, "Stage-Gate Process for the Development of Medical Devices," J. Med. Devices 3, 021004 (2009).

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