In an opinion letter, Stephen Ubl, clarified a few things the New York Times has gotten wrong about devices in its recent coverage. Ubl, who is the president and CEO of AdvaMed, said that the Jan. 15 article “Report Criticizes F.D.A. on Device Testing” incorrectly characterized the device review process as "lax." In the published letter, Ubl says: FDA’s premarket review process involves extensive review of specifications and performance-testing information, and in many cases clinical data, before being made available to patients. For the higher risk devices, FDA requires comprehensive clinical data for approval. The Government Accountability Office’s report on FDA’s review process, the focus of the article, limited its comments primarily to a small subset of 20 devices that the...
January 23rd, 2009
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A new economic impact study shows that biotechnology, life sciences, and medical research contributed billions of dollars in direct revenue to Oregon's economy. According to the Oregon Bioscience Association, despite Oregon's recessionary slump, the brightest news is the previously underestimated economic effect of Oregon's bioscience industry, including medical device manufacturing. The study shows that the sector contributed nearly $3.5 billion in direct revenue, more than 13,630 jobs and $800 million in biotech workers' personal income to the state economy in 2007. The comprehensive analysis, conducted by ECONorthwest, shows that those employed in the bioscience sector fared substantially better in take-home pay than other workers in Oregon. "With its continued and anticipated growth curve in Oregon, the data show that biotech is likely to beat the current recessionary trends," says Nathan Gibson, vice president of business...
January 23rd, 2009
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Johnson & Johnson has reported lower sales of medical devices in its fourth quarter and forecast lower 2009 profit. The report follows a Jan. 9 forecast by competitor Stryker Corp. in which the firm predicted its 2009 profit would increase by 10–14%. J&J said it earned $4.57 a share for 2008 and predicted 2009 earnings of $4.45 to $4.57. Its fourth quarter sales of medical devices fell by 2%, to $5.6 billion. But J&J's full year sales of medical devices increased 6.4% to $23 billion. Stryker, which has grown its annual per-share profit by at least 20% every year since 2000, had previously lowered its 2008 profit forecast. Stryker said its 2008 profit would be in the range of $2.77 to $2.79 a share. And it forecast 2009 profit of $3.12 to $3.22 a share. Stryker...
January 20th, 2009
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Although it is clear that the medical device market is affected by the recession, it does seem on track to perform better than other sectors, according to Seeking Alpha, a stock market opinion and analysis firm. The firm believes that "on a relative basis, investors will fare better in the stocks of [device] companies, with less risk than other sectors of the stock market, for several reasons." Here are the three factors mentioned: First, the underlying demand for healthcare continues to grow with the continued aging of the population in the U.S. and Europe, noting that 13,000 Americans will turn 60 years of age every day for the next 20 years. Second, much of spending in the U.S. for healthcare is tied to Medicare, which is a stable source of funding. Third, much of the demand for healthcare is not tied to discretionary spending. The firm also points out that "based on 2009 estimates, the...
January 16th, 2009
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A call from a legislator may have prompted FDA officials to override scientists and approve the sale of an imaging device for breast cancer according to agency documents, reports the New York Times. This is the latest is a long line of allegations by FDA scientists who feel officials are shepherding medical devices through approval regardless of scientific evidence for efficacy. The House Committee on Energy and Commerce has begun its investigation, thereby making documents such as e-mails that highlighted the phone call public. In the documents, the Times reports that former representative Christopher Shays, (R–CT) is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that helps radiologists detect breast tumors. The device in question was the iCAD SecondLook Digital...
January 13th, 2009
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DePuy Orthopaedics Inc. (Warsaw, IN) is continuing its commitment to advancing education by providing funding to the Orthopaedic Research and Education Foundation (Rosemont, IL; OREF) in support of graduate medical education. OREF will be reviewing and approving any grant requests and established fellowship program criteria. It put together an Educational Grants Board, which is comprised of orthopedic surgeons who are volunteers and don't receive compensation from the device industry to ensure that the review of applications and determination of awards are conducted in an unbiased way. The board members will not be given compensation for their work on the board either. Funding will be provided for clinical and research fellowships in orthopedic arthroplasty subspecialty areas (hips, knees elbow, trauma, etc.). The partnership is expected to help surgeons receive adequate training in an age in which orthopedic...
January 12th, 2009
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A group of federal scientists is complaining of widespread managerial misconduct in FDA's Center for Devices and Radiological Health (CDRH), according to the Associated Press. The scientists wrote a letter to the Obama transition team, saying, "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's CDRH letterhead. A copy of the letter, with the names of the scientists redacted, was provided to AP by a congressional official. According to AP, the letter alleges that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. The concerns of the nine...
January 9th, 2009
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Northstar Neuroscience Inc., a medical device company developing therapies for the treatment of major depressive disorder, has announced that it is going to dissolve the company. According to a press release, the company's board of directors "has determined, in its best business judgment after consideration of potential strategic alternatives, that it is in the best interests of the company and its shareholders to liquidate the company's assets and to dissolve the company." Its board of directors has approved a plan subject to shareholder approval. It will hold a special meeting of shareholders and will then file related proxy materials with the Securities and Exchange Commission in the near future. Prior to the special meeting, Northstar will reduce its headcount to a limited number of employees who will assist in the termination of operations. Northstar Neuroscience focused on developing neuromodulation...
January 8th, 2009
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During an era of increasing connectivity and wireless, digital communication, the adoption of electronic medical records (EMR) hasn't been picking up speed at a comparable rate. According to the Medical Records Institute (Boston), 20% of U.S. doctors have implemented EMR systems. A study of outpatient electronic health records published last year in the New England Journal of Medicine found that only 13% of doctors reported having a basic electronic record system, and 4% have a fully functional system. According to a Kalorama Information (New York) report released last month, the U.S. EMR market is expected to grow 14.1% annually through 2012. In addition, it identified personal health records (PHR) as a new emerging trend that will "vastly influence" the healthcare industry. PHRs allow patients to get...
January 5th, 2009
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I went looking for some good news this morning, determined to start the new year off right. I was pleasantly surprised to find that GE Healthcare's Reinaldo Garcia is quoted in the The Guardian saying that he is looking to serve those in need. "There are 2 billion people in the world with no access to healthcare," he says. "My ambition is to improve healthcare systems around the world and help these people get the resources." Garcia provides a very upbeat view of the prospects for the industry, pointing to the long-term expansion of demand for healthcare. "Those countries whose economies are developing and where the middle class is becoming a larger part of the population, and communication is more widely available through the Internet, they're seeing this expanding demand for healthcare," he told The Guardian. He says that GE has to provide more basic equipment to countries such as India and...
January 2nd, 2009
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