Medical Device Technology Forecast: Introduction
As a science-based regulatory agency, the U. S. Food and Drug Administration (FDA) is responsible for a large and diverse array of products. Since 1976, that responsibility has included insuring the safety and effectiveness of medical devices. The universe of these medical devices is immense, including approximately 5,000 different types of products encompassing a spectrum of technologies from microelectronics to microbiology. That large range of technologies poses a profound scientific challenge to the effective fulfillment of the Agency's responsibilities in this area. As part of its commitment to efficient scientific preparation for upcoming generations of products, FDA's Center for Devices and Radiological Health (CDRH) regularly monitors trends that point toward future product development.
To help clarify these trends, CDRH's Office of Science and Technology (OST) surveyed a diverse group of experts to identify major trends anticipated in medical device technolgies over the next ten years, and beyond. Participants assigned several types of numerical scores to a variety of device-related technologies, identified specific product-types exemplifying the future of each technology, and described a range of issues expected to influence the development of new medical devices.