Marketing
When developing an IVD device, typically the first thing that comes to mind is the assay: what is the sample being tested for and how is the target detected? This is the central thinking of most companies, whether they are setting out to extend a product’s lifespan or to bring a disruptive new technology to market. However, while the assay is core, focusing exclusively on this can significantly minimize the potential market scope and lead to commercial failure. In this article we will...
The Clinical Lab Expo will feature new science and technology in every area of clinical diagnostics, automation, information systems, point of care, OEM, and biotech. Roughly 750 organizations will occupy about 2000 booths. According to Clinical Lab Expo's Website, "You will see more products in every clinical lab discipline than at any other show." Find What You Need The Clinical Lab Expo will have special sections for special products. Visit the special sections for point-of-...
Ortho Clinical Diagnostics (OCD), in partnership with the National Association of Chronic Disease Directors (NACDD), published consumer-survey results and a report revealing the state of blood test health literacy in the United States, with strategies to support patient education and empowerment. The survey and report are part of the Know Your Numbers campaign, which was launched in conjunction with National Health Literacy Month last year. Among the survey’s findings were that nearly 90...
2010 was a catalyst year for computing. When Apple launched the iPad tablet computer in April, it brought the keyboard and mouse one step closer to extinction. Similarly, with Windows 7, Microsoft added true touch-screen support to desktops, tablet PCs, and smartphones. Google made an entrance as well, with Android, an operating system for smart phones and slates. Touch screen will be the dominant user interface for years to come, according to DisplaySearch.com, which monitors and reports on...
Investment banking firm Goldman Sachs (New York) has initiated coverage on the following six IVD companies: Alere, Cepheid, Gen-Probe, Hologic, Myriad Genetics, and Qiagen. In an equity research report, Goldman Sachs analysts discussed various factors that will affect the IVD industry both positively and negatively. According to the analysts, one of the factors that will contribute positively is the transition to molecular testing. “Advances in knowledge around the genetic underpinnings...
Today a nurse can test a senior citizen for C. difficile in a long-term-care facility. Within hours, the test indicates that special care is required to prevent the spread of this healthcare-associated infection. In the near future, a molecular assay may be able to detect ovarian cancer in a 45-year-old woman with persistent stomach pain, before the cancer spreads to other organs.   Advances in genetic and molecular research are leading to many new and promising technologies like these,...
            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....