It has been a while since a counterfeit medical device has made headlines, but the risk still remains. An Internet search yields references to counterfeit condoms, glucose strips, contact lenses, equipment, and more medical devices, points out David Howard, director of product protection for Johnson & Johnson. “With so many products in this category, specifics are tough, but we have seen strips, mesh, and sutures globally,” he explains. “It is important to remember this is not just a U.S. problem.”
Howard is speaking at this month’s MD&M East 2009 packaging session in New York City. He shares insights on how to protect medical products from counterfeiting, diversion, and tampering threats.
“More needs to be done in our industry to protect our customers and patients,” Howard says. “I offer an opportunity to partner with J&J in this space and effort.”
In his presentation, Howard explains the value of using a “Product Risk Assessment Tool” for determining counterfeiting, diversion, and tampering risks. Tough questions must be asked during such an assessment, including whether there are known instances of counterfeiting in certain product classes and brands.
Manufacturers can use such questions to “drill down into the potential sources as well as market and regional factors that can lead to increased ease in counterfeiting and illegal diversion,” Howard explains. “A team effort is needed to understand how your products are developed, marketed, distributed, repackaged, reprocessed, dispensed, consumed, and disposed.”
No single technology will eliminate all risk, Howard admits. “Layers must be utilized, and features must be changed.” And above all, “no technology should be deployed without a plan for monitoring it in the field, ever.”
Your team could also extend beyond your company’s walls. Howard is eager to share more on J&J’s programs and details on its effectiveness to those companies that step up to partner with J&J. He proposes a “Medical Device Product Protection Leadership Initiative.”
“If our products are at risk, your products could be at risk,” Howard says. “If our patients and customers are at risk, yours could be at risk as well.”
Interestingly, a new pharmaceutical group focusing on securing supply chains that lead into manufacturing and packaging operations is kicking off this month in Washington, DC. More details on Rx-360 can be found on page 22.
If you’d like to help Howard get a medical device group off the ground, e-mail him at DHoward6@its.jnj.com .
And please let me know, too. I would love to spread the word!
Twitter name: daphneallen