Not according to some analysts. However, companies in recent years have embarked on efforts to educate consumers about options that could enhance their health (and more obviously, help promote their product). For example, Zimmer has placed ads about its Gender Knee implant on TV, in newspapers, and has even been spotted on MySpace, a social networking site. Medtronic Inc. also unleashed a $100-million ad campaign for its defibrillator product six months ago. While analysts are pointing out the effects of ads can't necessarily be immediately seen, a Medtronic spokesman has said the company has received positive feedback from patients and doctors, and that the number of responses has "exceeded" their expectations.
June 4th, 2007
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More than two years after the notorious defibrillator recall, companies continue to experience the lingering effects. After a decrease in defibrillator implants in 2006, Medtronic Inc. announced yesterday that it will be cutting between 350 and 500 jobs in its cardiac rhythm division. According to the Star Tribune, the job cuts will be nationwide, but employees were also be given the chance to either transfer to other parts of the company, retire early, or accept voluntary buyout packages. While Guidant Corp. was mainly responsible for the highly publicized defibrillator recall, Medtronic pulled 87,000 of its devices off the market in February 2005.
June 1st, 2007
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A federal judge refused to grant Shelhigh Inc.'s request that the government release the tissue-based devices it seized last month because of concerns about sterility. Judge William Martini said he could not rule whether Shelhigh's devices met GMP standards without holding a hearing, reports the Star-Ledger of Newark, NJ. He said that hearing will come as soon as possible. Shelhigh executives say the company's future is in jeopardy if it cannot export the seized devices. The judge urged both sides to try to reach a settlement, using a mediator if possible. But, as we predicted, Shelhigh has hired Larry Pilot to help in its defense. Companies who seek out Pilot often do so because he is willing to take on FDA in court. Shelhigh also rejected FDA's request to recall devices it already shipped to hospitals. That's not an indicator of being willing to settle, either.  
May 31st, 2007
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James Mazzo, president and CEO of Advanced Medical Optics, told the media that the recall of its contact lens solution is not related to a manufacturing problem or a contamination issue, reports the Associated Press. Rather, he says, the problem more likely stems from users handling their lenses improperly. But he didn't have a definitive answer, nor a sense of the recall's financial impact on the firm. Meanwhile, the New York Times speculates that this recall, combined with Bausch...
May 30th, 2007
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FDA announced late last week that Advanced Medical Optics (Santa Ana, CA) has voluntarily recalled its Complete MoisturePlus Multi Purpose Solution for soft contact lenses. Consumers who use the solution should stop using it immediately and discard it. They should also replace their lenses and storage container. As a result of a Centers for Disease Control investigation, the solution has been linked to a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. It found that users of the solution were seven times more likely to develop the infection than those who do not use it. A similar scenario last year caused Bausch...
May 29th, 2007
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A Minnesota-based plastic surgeon is developing a diagnostic tool with the intention of detecting a silicone breast implant rupture. The mention of the technology is buried deep within a New York Times story about FDA's requirements for patients with silicone breast implants to undergo routine MRI's and the disagreement about this condition shared by many plastic surgeons. About four pages into the piece, a small paragraph talks about this interesting technology. According to the read more >>
May 24th, 2007
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Legal action that takes place in the drug industry is an indication of areas where device companies need to be cautious. Although the device industry is quite adamant (as it should be) about the differences between drugs and devices, litigation is one area where we're beginning to see similarities. Experts at device conferences during the past year have emphasized that we're next and that it would be wise to look at what's happening to drug companies to see if these problems are present in your organization. Yesterday evening, the Associated Press reported about a subpoena received by the drug company Amgen Inc. over promotional "and other" activities. While not much details were given, it noted that the subpoena sought documents from Amgen's sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications. Experts at a...
May 23rd, 2007
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Medtronic Inc. is beginning a large, randomized trial that will examine the safety of drug-eluting stents. The 8800-patient clinical trial will compare the company's zotarolimus-eluting coronary stent system (Endeavor) with J&J's sirolimus-eluting stent (Cypher). Medtronic enrolled the first patient in the study, called Protect, yesterday. The trial will look at overal stent thrombosis after three years. Other points of analysis will include a composite of death and nonfatal myocardial infarction. According to an investigator of the study, the trial is designed to give doctors the long term safety data that they've been needing.
May 22nd, 2007
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Two New England-based women's health companies are joining forces as Hologic Inc. (Bedford, MA) announced that it will be acquiring Cytyc Corp. (Marlborough, MA). The $6.2 billion deal is expected to be completed in the third quarter. The combined entity will be called Hologic and will carry the torch of both companies. Jack Cumming, chief of Hologic, said that the merger is about creating growth, despite the fact that it will save from $25 to $30 million each year. Their combined portfolio will range from breast and cervical cancer screening, diagnosis, and treatment, to osteoporosis to contraception.
May 21st, 2007
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The relationship between hospitals and the medical device industry needs more integration, proclaimed Mary Ann Hilliard, chief risk counsel for the Children's National Medical Center (Washington, DC) last week. Hilliard spoke at a risk management conference jointly held by AdvaMed, FDA, and Virginia Tech. The disconnected relationship causes problems when it comes to equipment use error among clinicians. Linking both industries would both improve processes and drive down errors. From Hilliard's perspective, although technology in hospitals is incredibly innovative, until there is collaboration between both industries, hospitals won't be able to reduce sentinel events. She suggested the presence of more human factors engineers and reliability experts in hospitals, especially when conducting root cause analysis. Another part of the solution is more transparency in sharing data--however, with current liability issues, this is a major challenge.
May 21st, 2007
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