Technology Forecasting for Medical Devices Guidance Formulation: A Case Study in Japan.

In the advanced medical field, there is a constant need for efficient guidance formulation by regulators. Technology forecasting as a surveillance for regulation needs may be an effective solution by notifying regulatory authorities of the possible future changes in regulations. However, the lack of tangible frameworks has made the relationship between technology forecasting and regulation difficult to comprehend, and has led to an under-analyzed state of how technology forecasts are implemented into the guidance formulation process. In this study, we introduce a framework built specifically for facilitating the comprehension of the relationship between technologies enlisted in technology forecasting and guidances formulated after the forecasting, and applied the framework to a case of technology forecasting conducted by regulatory authorities in Japan. Four patterns of the relationships between a technology forecasting conducted by regulators and the guidances developed after the forecast are identified. The results and discussions provide suggestions of technology forecast design and application in the guidance formulation process by regulators in the field of medical devices.