Abstract
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.
Highlights
Technology Growth and Regulatory ReformThe rapid growth of life science technologies has prompted increases in investments in the field over the last decade, with no signs of slowing down.[1]
With the intention of promoting innovation related to medicine and health, the US Food and Drug Administration (FDA) established the Critical Path Initiative (CPI) in 2004, in which they identified therapeutic fields and technologies that would provide the best chance of resolving stagnation in the development of innovative therapies and benefit public health; they announced policies to undertake guidance maintenance in prioritized areas.[3,4]
A total of 108 candidate technologies were classified as either S-technologies or N-technologies, and the 40 guidances were classified as P-guidances or A-guidances
Summary
The rapid growth of life science technologies has prompted increases in investments in the field over the last decade, with no signs of slowing down.[1] it is challenging to predict emerging technologies and to select and prioritize subjects that require policy and regulatory changes.[2] With the intention of promoting innovation related to medicine and health, the US Food and Drug Administration (FDA) established the Critical Path Initiative (CPI) in 2004, in which they identified therapeutic fields and technologies that would provide the best chance of resolving stagnation in the development of innovative therapies and benefit public health; they announced policies to undertake guidance maintenance in prioritized areas.[3,4] Many regulatory changes including the formulation of guidances have been made in recent years in the advanced medical field, and the development of appropriate guidances continues to be a priority for guidance formulators.[5].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
