Stanford researchers develop model for medical device development process

RESEARCHERS at Stanford University have published a comprehensive model representing the medical device development process, in an effort to help companies execute the bench-to-bedside process of product development.

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

According to the researchers, the model is presented in linear form with five major phases and four decision gates. It describes a process that is applicable to a broad range of medical technologies and innovation settings.

The authors say the model is used by the developers of both highly sophisticated premarket approval and premarket notification devices. US Food and Drug Administration (FDA) approval typically requires some risk-appropriate form of bench or clinical data.

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

The researchers claim the medical device development process has become increasingly complex in recent years because of the advent of advanced technologies and stricter regulations.

The study results demonstrate that a significant portion of the development process is influenced by regulations. The pace at which such regulatory requirements can be met determines when the device will reach the clinic.

Specifically, the 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 this standardisation can inhibit innovation and can sometimes prevent processes from being streamlined.