U.S. Food and Drug Administration
FDA Consumer magazine
May-June 2001
Table of Contents
By William A. Herman
There was a time in the not-too-distant past when ill people mostly lived--and died--at home.
We may be on our way back to the future. After generations of people taking themselves in to see the doctor, things are starting to change. Forces are converging to move health care back into the home, with the aid of cutting-edge medical device technologies.
Demographics--We're getting older fast. Our need for routine monitoring and treatment of chronic disease is rising, compared with our traditional emphasis on acute illness. Notoriously independent baby-boomers insist on taking responsibility for and playing major roles in their own health care.
Economics--Pressures for greater efficiency in delivery of health care are ubiquitous, motivating the development of alternatives to lengthy hospital stays and inpatient services. The same pressures are shifting our health-care focus to prevention, early detection and maintenance strategies within the home.
Technology--Emerging developments now vastly improve our ability to produce high-tech home medical device hardware with on-board intelligence that would have seemed impossible a generation ago. It's this third area--technology--that brings home-care devices that result from these trends squarely into the FDA's bailiwick.
Paradoxically, this shift in health care isn't really new. Nearly all U.S. health care was done at home by nonprofessionals until around 1900. Direct interaction with health-care professionals in institutional settings played a small role in the care of the average patient before then. Dramatic advances in both clinical knowledge and technology made extraordinary resources available in special facilities, and shifted the location of care from homes to centralized locations.
Ironically, it's beginning to seem that this period of apparently normal centralization was a temporary aberration. A century later, gains in technology are moving care back to home settings. Future medical devices will provide many new, reliable, cost-effective options for health care, especially for the home environment.
This emergence of new types of home-care devices presents a textbook case study in real time of the FDA's challenging role in the evolving patterns of health-care delivery.
To deal with new trends like home-care technology, the FDA strives constantly for foresight, even while the agency continues to shoulder its existing responsibilities. This case study of home-care devices falls within the FDA's Center for Devices and Radiological Health (CDRH), which engages the total product life-cycle of some 5,000 different types of products, spanning developments in an immense technological spectrum, ranging from microelectronics to microbiology. To prepare itself for the numerous breakthroughs in these technologies, CDRH works to lay the necessary scientific groundwork in advance and to identify the key scientific questions early in the technology development cycle.
First, to support this forward-looking strategy, in 1998, CDRH used technology-forecasting techniques to identify home-care technology as one of the six major trends of the next decade. (See "Future Trends in Medical Device Technology," www.fda.gov/cdrh/ost/trends/toc.html).
Second, that prediction was confirmed in a subsequent collaboration which leveraged work by FDA scientists with support from the National Science Foundation (NSF) in a nationwide workshop of experts on "Home Care Technologies for the 21st Century." That workshop identified many types of home-care products that the FDA would soon see.
Third, today the products are actually arriving. As described in "Emerging Trends in Medical Device Technology: Home Is Where the Heart Monitor Is,", there is an astonishing range of diagnostic, monitoring, and therapeutic capability that is, indeed, headed for home use.
And fourth, as the future now unfolds, that home-centered capability is expected to become a catalyst for a huge health paradigm shift from "last-minute heroic intervention" to "consumer-driven individualized prediction, prevention, early detection, and maintenance." By anticipating this evolution, the FDA will have acted proactively to prepare for its role in that process. And the case study will be complete.
In conclusion--and in anticipation--we can now ask, "What's the deeper message in these technologies that are driving this home- and self-care revolution?" The answer is that the same technologies that enable these computerized, wireless, sensor-laden, miniaturized home products will also spark many medical device innovations that are outside the home-care arena.
Coupled with other developments--like noninvasive optical technologies, synthetic tissue-hardware hybrid organs, improved medical imaging, neural prostheses, and intelligent microscopic robotics--these technologies are opening the door to a broad range of new products that will be smart, individualized, self-modifying, widely distributed, Internet-linked, and noninvasive.
Stand by: The health-care revolution is coming home.
William A. Herman is director of the division of physical sciences in the FDA's Center for Devices and Radiological Health.
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