Marketing
            The IVD market may yet suffer some effects of the depressed economy, according to a report published in May of this year by Kalorama Information (New York City, www.kaloramainformation.com). The report, titled “In Vitro Diagnostics in a Recessionary Economy,” argues that the IVD industry's relative immunity to economic turbulence is not unlimited and may weaken as other industries experience difficulty and patients cut back on seeking...
    Regulations & Standards         Philipp Novales-Li, DMedSc, PhD, DPhil, RAC, is manager of regulatory affairs at Abbott Diabetes Care Inc. He is currently based in the San Francisco Bay area and can be reached at novatika@hotmail.com. The advertising and promotion of medical devices, including IVDs, are subject to both FDA and Federal Trade Commission (FTC) authority. FDA views IVD manufacturers' promotional activities as a form of labeling,...
  Digene's Corp.'s (Gaithersburg, MD) ads appeal directly to patients. To IVD industry observers, the fanfare with which Digene Corp. (Gaithersburg, MD) rolled out a direct-to-consumer (DTC) advertising campaign for its DNAwithPap human papilloma virus (HPV) test in March seemed to herald a new age in diagnostics marketing. Although DTC ads have become commonplace for pharmaceutical companies ever since FDA revised its guidelines for prescription drug advertising on television in...
  "Build a better mousetrap," so the saying goes, "and the world will beat a path to your door." In the IVD industry, better mousetraps come in a wide variety of shapes and sizes. Clinical researchers are constantly discovering markers to detect and diagnose diseases and medical conditions that were previously unfathomable, and product developers in a variety of settings are working hard to improve the sensitivity and specificity of those markers in commercial formats....
Dade Behring’s Chest Pain Perspectives Internet site, at http://www.chestpainperspectives.com, contains practical information used to market the company’s cardiac assays. It's not exactly the dot-com bonanza that device marketers expected several years ago, but IVD manufacturers are discovering that marketing by means of an interactive, informative Web site can help them to reap the benefits of having a more informed public. Dade Behring (Deerfield, IL) recently...
1. Clinical research, specimen procurement services design and conduct clinical trials and field studies, and provide specimens to be used in product evaluation. 2. Laboratory research services provide diverse forms of laboratory support, including analytical testing, specialized product and process development, and materials characterization and evaluation. 3. Legal affairs consultants offer a wide range of support services, including work on intellectual property issues, contracts,...
To keep up with the needs of an ever-expanding and increasingly complex medical marketplace, the IVD industry's efforts to develop new and more-accurate diagnostic tests are also expanding at a rapid pace. Today's challenge to industry is to design and produce practical new laboratory assays that integrate biotechnology, microprocessor, and software technologies. Because bringing such new IVD products to market is becoming increasingly complex and expensive, many IVD companies—especially...