Information Challenges

The technological advances which allow the development of increasingly more sophisticated medical devices and combination products result in information challenges for researchers. The medical device industry is nontraditional compared to pharmaceuticals in that it encompasses research from so many different fields and technologies. The body of medical device information, never well defined, has now grown to accommodate such areas as biotechnology and drug-device combinations. Device information specialists must gain expertise in several disciplines in order to provide accurate and comprehensive results.

Moreover, the literature devoted specifically to devices is relatively scarce, resulting in a limited number of targeted information sources. Information coverage for instruments is weak, and indexing often inadequate, especially for specific device types and new technologies. Nonstandard device terminology increases the complexity of searches and can limit good retrieval.

Monitoring known or potential competitors is an important part of the job for device information specialists. However, the device industry is comprised of many companies which are small, private, and often funded by venture capital with no published financial statements. This makes identifying competitors and finding substantive information extremely challenging.

Other subjects with significant information gaps include: specific physiologic parameters, such as body/organ/tissue measurements; numbers of surgical and other procedures; reliable international data; and very current statistical data. Data for most topics of interest to the device industry, for example—total number of procedures performed in hospitals, outpatient centers, and physician offices for a given year, and these same figures broken down by procedure type and patient demographics—are several years old by the time they are collected and published. Very current statistical data are usually available only for common morbidity and mortality figures, which the U.S. government publishes in such sources as the Morbidity and Mortality Weekly Report. The American Cancer Institute and the National Cancer Institute regularly publish current statistics for the most common types of cancer. However, most patient and procedure data, even if collected and published, is several years old by the time it becomes publicly available.

A variety of controlled vocabulary codes can be used in some sources for more precise search results. Examples include the North American Industrial Classification System (NAICS), healthcare common procedure coding system (HCPCS), current procedural terminology (CPT), Universal Medical Device Nomenclature System™ (UMDNS), and the International Classification of Disease (ICD). However, it is not always easy to determine which information source uses which code, if any, and which procedure or disease state the codes cover.

Some of the most important document types containing device information include patents, market reports, conference proceedings, analyst reports, venture capital reports, and association publications. The following sections of this chapter will include discussions of specific sources and strategies to address these information challenges.

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