Stanford University - Stanford Program in Biodesign

One-year Research Study
$290,000 Grant Awarded in 2006

The key objective of this study was to present a comprehensive description of the medical device development process that could help to inform the public and other interested constituencies about the specific nature of medical devices, the significant differences between devices and pharmaceuticals in general, and their development processes in particular. The study was motivated by the notion that future policy-making could benefit significantly from a detailed understanding of the way medical devices are invented, developed, tested, used and gradually improved.

Findings to Date
Through literature research and a detailed interview process that spanned the various disciplines of medical technologies, a detailed model was developed to describe the various activities and decisions involved in device development. To illustrate and underpin this model, case studies of six devices were written, ranging from deep brain stimulators to medical imaging technologies. Other aspects of the research included a review of device regulation and a discussion of recent policy activities involving adaptive trials and lifecycle risk management.

Impact
The findings will be of value to current and future government initiatives aimed at enhancing the efficiency and efficacy of the regulatory process for public benefit. A smooth and effective bench-to-bedside process that promotes timely availability of safe and effective technologies is one of the cornerstones of the continuing advancement of health care.

Investigators

• Principal Investigator: John H. Linehan, Ph.D., Consulting Professor of Bioengineering in Program in Biodesign and the Department of Bioengineering
• Co-Principal Investigator: Elisabeth Paté-Cornell, M.D., Professor of Engineering and Professor and Chair of the Department of Management Science and Engineering
• Co-Principal Investigator: Paul Yock, M.D., Professor of Medicine, Bioengineering and Mechanical Engineering, and Founding Co-Chair of Department of Bioengineering and Director of Program in Biodesign
• Investigator: Jan Pietzsch, Ph.D., Consulting Assistant Professor in the Department of Management Science and Engineering, and President and co-Founder of Wing Tech, Inc.

Study Areas

Device Development