WASHINGTON, DC - In an effort to increase understanding of the medical device development process and help companies execute the bench-to-bedside process of product development more effectively, researchers at Stanford University have published the first comprehensive model representing the medical device development process.

Published in the June 2009 issue of the Journal of Medical Devices, the model was constructed based on best-practice analysis and interviews with more than 85 seasoned experts actively involved in the development, commercialization, regulation, and use of medical devices.

"Medical devices contribute significantly to the continuous improvement of healthcare," says lead author Jan Pietzsch, Ph.D., consulting assistant professor in the department of management science and engineering at Stanford University. "Depending on the type and complexity of the technology, the device development process can take anywhere from 15 months to several years. As a result, successfully bringing innovative products to patients hinges on knowledge of and planning for this process."
Presented in linear form with five major phases and four decision gates, the model describes a process that is applicable to a broad range of medical technologies and innovation settings. According to the authors, the model is used by the developers of both highly sophisticated premarket approval (PMA) and premarket notification (510(k)) devices, for which FDA approval typically requires some risk-appropriate form of bench or clinical data, as well as by the makers of less sophisticated devices that may be exempt from most regulatory requirements. The five major phases and decision gates include:

-Phase 1/Gate 1: Initiation, opportunity, and risk analysis.

-Phase 2/Gate 2: Formulation, concept, and feasibility.

-Phase 3/Gate 3: Design, development, verification, and validation.

-Phase 4/Gate 4: Final validation and product launch preparation.

-Phase 5: Product launch and post-launch assessment.

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.

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