Counterfeiting: "In the medical device industry, counterfeiting is a new subject. We have a chance to be proactive, rather than reactive as some industries have had to be," said Mark Miller of DuPont Medical & Industrial Packaging, during his presentation, "Counterfeit protection of medical devices."
• "Counterfeiters of pharmaceutical products and medical devices are going after either products with a high value, such as cancer and HIV drugs, or large-volume drugs like Lipitor."
• A trouble spot, he said, is that "once packaged product leaves your dock, it typically doesn't go directly to the end user. Product can change hands 10 times before reaching a hospital."
• He said lost sales dollars are not the only counterfeiting problem, there are also losses in your brand's equity.
• "A consumer, doctor, or nurse may not recognize the difference between a real and a counterfeit product," he noted. In one instance, Miller revealed that a counterfeiter added a holographic feature beyond what the authentic package included to fight counterfeiting, saying the counterfeiter could do that because it doesn't have the overhead costs that a legitimate manufacturer has. Counterfeiters, however, often have sophisticated packaging equipment that's on a par with that used by legitimate manufacturers.
• In short, he said, "If your package designer or engineer can create a prototype of someone else's package, so can a counterfeiter."
Electronic labeling: In her presentation, "E-labeling: An innovative solution," KJ Intl. Resource's Kristen Giovanis pointed out that technological advances, a desire for a paperless society, environmental issues, and interfacing capabilities make e-labeling attractive.
• The advantages for end users included "efficiency, convenience, readily available updates, online training, and cross-referencing capabilities," she said.
• For combination products, medical device makers "may have to follow pharmaceutical labeling requirements for now," she said, though she expected that requirements specific to medical device e-labeling are likely a few years from now.
• The European Union has different requirements concerning device directives.
• Software, the size of documents, language requirements, and Internet security are among the many key considerations for electronic labeling.
• Giovanis recommended the following Internet resources: FDA, Eucomed, Europa, ANSI, and GHTF for more information.
• HealthPack 2006--March 2-3, New Orleans.
--By Jim Butschli, Editor
• "Counterfeiters of pharmaceutical products and medical devices are going after either products with a high value, such as cancer and HIV drugs, or large-volume drugs like Lipitor."
• A trouble spot, he said, is that "once packaged product leaves your dock, it typically doesn't go directly to the end user. Product can change hands 10 times before reaching a hospital."
• He said lost sales dollars are not the only counterfeiting problem, there are also losses in your brand's equity.
• "A consumer, doctor, or nurse may not recognize the difference between a real and a counterfeit product," he noted. In one instance, Miller revealed that a counterfeiter added a holographic feature beyond what the authentic package included to fight counterfeiting, saying the counterfeiter could do that because it doesn't have the overhead costs that a legitimate manufacturer has. Counterfeiters, however, often have sophisticated packaging equipment that's on a par with that used by legitimate manufacturers.
• In short, he said, "If your package designer or engineer can create a prototype of someone else's package, so can a counterfeiter."
Electronic labeling: In her presentation, "E-labeling: An innovative solution," KJ Intl. Resource's Kristen Giovanis pointed out that technological advances, a desire for a paperless society, environmental issues, and interfacing capabilities make e-labeling attractive.
• The advantages for end users included "efficiency, convenience, readily available updates, online training, and cross-referencing capabilities," she said.
• For combination products, medical device makers "may have to follow pharmaceutical labeling requirements for now," she said, though she expected that requirements specific to medical device e-labeling are likely a few years from now.
• The European Union has different requirements concerning device directives.
• Software, the size of documents, language requirements, and Internet security are among the many key considerations for electronic labeling.
• Giovanis recommended the following Internet resources: FDA, Eucomed, Europa, ANSI, and GHTF for more information.
• HealthPack 2006--March 2-3, New Orleans.
--By Jim Butschli, Editor
