The Sacramento Bee today reports on a new knee replacement system from OtisMed (Fremont, CA) that uses 3D imaging and computer software to achieve a level of customization not possible before. The technology aims to enable doctors to use more of the patient's own bone, and to shorten recovery times. The procedure begins with an MRI of the patient's knee. The software then takes the images and makes a three-dimensional model of the knee's bones and cartilege. Using that model, the surgeon discerns what areas must be strengthened. Plastic guides are used to tell the surgeon where to cut. This could be the most significant innovation in knee-replacement technology in 10 years.
June 18th, 2007
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Did you know that CDRH can regulate your outsourcing arrangements? Well, it can, and attendees at the MD&M East conference this week learned how from Christy Foreman of CDRH's Office of Compliance. The authority is granted in section 50 of CFR 820 (the Quality System Regulation), which covers purchasing controls. Also relevant is section 80 of the QSR, which covers receiving, in-process, and finished device acceptance. Particularly important is that device manufacturers keep records of acceptable suppliers, contractors, and consultants, she said. CDRH will not look at the results of audits of suppliers. But it does want to see documentation of when audits occurred, and it will check the CAPA system to ensure that findings from audits were fed back into it. CDRH also urges that firms include an agreement that suppliers, contractors, and vendors will notify the firm of changes in their products or services.
June 15th, 2007
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Master Control has released four document control software modules specifically tailored to meet the needs of start-up medical device companies. The modules include DHF Express, DHF JumpStart, Complaints MD, and CAPA MD. The Salta Lake City-based company announced the release at MD...
June 14th, 2007
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Today marks the start of the conference sessions at MD&M East, the East Coast's largest show for medical device design and manufacturing. Most of the MD&DI staff is attending. Today's sessions will impart crucial information on such topics as nanotechnology and combination products. The Tuesday, Wednesday, and Thursday sessions will be equally vital, and we would be remiss if we did not mention that Wednesday's session on collaborative outsourcing will be chaired by MD&DI Editor-in-Chief Erik Swain. Wednesday also will feature the Medical Design Excellence Awards ceremony. The exhibit hall opens tomorrow and runs through Thursday.  
June 11th, 2007
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Tyco International Ltd.'s board and the Securities and Exchange Commission have approved the company's plan to spin off its healthcare and electronics units, reports Bloomberg News. As previously reported, the healthcare unit will be renamed Covidien. Shareholders will get one share of Covidien and one share of Tyco Electronics for every four shares of Tyco International stock they own. Will a name change restore Tyco's public image? Judging from comments to previous items on this blog, it will be tough.
June 8th, 2007
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The private equity consortium in line to buy orthopedics player Biomet Inc. has increased its bid by 4.5% to $11.4 billion, reports the Associated Press. This comes after an independent proxy adviser recommended that shareholders reject the consortium's $10.9 billion offer, on the grounds that the firm's value has increased since the offer was accepted in December. The firm is recommending that shareholders approve the new offer.
June 7th, 2007
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The Bush Administration wants to revamp the nation's patent system by requiring better information from applicants and allowing the public to review pending applications, Jon Dudas, the director of the U.S. Patent and Trademark Office, told Congress and the New York Times. Patent reform would have a major impact on the device industry, which derives much of its value from intellectual property. Both houses of Congress are considering patent reform legislation. The Bush Administration wants to reduce patent-related litigation and has several proposals to that end. One would standardize what supporting information is needed in an application. Another would require applicants to do a thorough search of related patents and technical journals. Dudas wants language that would make the requirements not too burdensome for small inventors, and implied that his office might be willing to do patent...
June 7th, 2007
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Transforming FDA LogoFDA this week announced the formation of a 15-member committee to advise it on how to improve communication regarding risks and benefits of medical devices and other products the agency regulates. The committee is based on a recommendation from the Institute of Medicine. There's no question that the agency needs to do a better job in this regard. The public has mistakenly come to understand that a product with FDA approval should have zero risk. This perception is part of why the agency has taken such heat over products that have proven too risky after approval. The question is whether the goal of clear, concise, consistent, and contextual communication can be achieved by a committee...
June 6th, 2007
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Transforming FDA LogoDr. Steven Nissen, head of the Cleveland Clinic's department of cardiovascular medicine, has made a name for himself as an FDA watchdog in recent years. He was one of the first to raise alarms about safety issues for Vioxx and drug-eluting stents. Today's Boston Globe has an interesting read on why Nissen has become such a prominent voice. His critics say it's because he's angling to become the next FDA commissioner. (Beltway insiders expect Andrew von Eschenbach, a friend of the Bush family, to step down when President Bush leaves office.) His critics seem to fear...
June 5th, 2007
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Today's Boston Globe has a piece about the rise of Inverness Medical Innovations, Inc. (Waltham, MA), which has made an incredible eight acquisitions so far this year, including yesterday's puchase of Cholestech Corp. for $326 million. Inverness is, among other things, the market leader in home pregnancy tests. (Cholestech's products measure cholesterol and other signs of heart disease.) As part of the drive to keep medical costs down, inexpensive point-of-care tests such as those made by Inverness can be a powerful tool. As demand for these tests rises, expect Inverness to become even more of a force.
June 5th, 2007
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