IVD Technology Magazine
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Originally published July, 1998

IVD Technology News

Genetic diagnostics top FDA technology hit list

According to a panel of experts surveyed by FDA's Center for Devices and Radiological Health (CDRH), genetic diagnostics will be the most important new medical device technology to be developed over the next decade.

Of the 21 top technologies rated by the panel, four were directly related to emerging areas of diagnostic technology, including biosensors (ranked 19th), home- and self-monitoring and diagnosis (14th), and computer-aided diagnosis (9th). The panel ranked the field of genetic diagnostics first in overall importance, ahead of the fields of microminiaturized devices, medical imaging, and genetic therapy.

The top ranking appears in a report issued by the device center in April. Entitled "Future Trends in Medical Device Technology," the CDRH report was based on a survey of 15 experts, including physicians, engineers, health-care policymakers and payers, manufacturers, futurists, and technology analysts. The panelists assigned scores to the 21 medical technology areas for probability of new product development (within 5 years, and within 10 years), size of the affected patient population, potential benefits, potential risks, and overall importance.

The top 21 emerging technologies for medical devices, according to an expert survey conducted by FDA's Center for Devices and Radiological Health, ranked according to overall importance.

According to the device center's analysis, nearly all of the technologies identified by the panelists are growing because of advances in six major areas affecting the development of new medical products: computer-related technologies, molecular medicine, home- and self-care, minimally invasive procedures, device-drug hybrid products, and organ replacement or assist devices using hardware and tissue-engineered components. Other influential trends identified by the panelists included cost-containment pressures, technologically-tailored product customization, and prevention-oriented health care.

In addition to their ranking of technology areas, the panelists also identified specific products that they expect to become commercially successful over the next decade. Diagnostics-related products and technologies included biosensors, computer-aided clinical laboratory systems, clinical laboratory robotics, and DNA microchip sensors.

For the field of genetic diagnostics, the panelists projected "accelerating growth, especially for single-gene disorders such as cystic fibrosis." The primary medical hardware cited by the experts was the "DNA microchip sensor device," or DNA chip, a technology now under development by more than a dozen companies.

The home-use diagnostics identified by the panelists were mostly tests involving urine and blood chemistry (including blood-glucose monitoring), and tests for monitoring concentrations of therapeutic drugs. Although the experts believed the trend toward greater numbers of home-use diagnostics and devices to be an important one, they thought it "unlikely to produce significant technical advances." The report notes that the panelists had "divided expectations" regarding the future of computers in clinical decision making. While clinicians expected computers to play a larger but still limited role in supporting clinical decision making, engineers were more likely to envision computers as expert systems performing automated consultation. Both groups, however, agreed that there is "an increasing trend toward reliance on automated analysis in the clinical laboratory." The panelists also listed a number of obstacles that computerized systems will need to overcome before new products are likely to be successful, including the accuracy and completeness of stored patient records, and the reliability of diagnostic algorithms. Complete results of the report are available on the CDRH Web site at http://www.fda.gov/cdrh.—Steve Halasey