Bloomberg News reports that the Supreme Court has agreed to hear a case against Medtronic that could determine whether patients have the right to press product-liability lawsuits against firms with FDA-approved products. The court has declined to hear five similar cases since 2001. Medtronic and the device industry argue that FDA approval shields firms from liability lawsuits, and many lower courts have agreed. (This applies to PMA products; suits have been allowed to proceed against 510(k) and pre-1976 products, which are less rigorously reviewed.) The case involves a patient who had a Medtronic catheter burst inside of him during an angioplasty, and then required bypass surgery. Medtronic says the doctor was using the catheter off-label.
June 25th, 2007
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Medical devices are designed and tested for adults. How to use them in children -- and whether additional studies are required -- is a problem that has vexed medical device manufacturers and caregivers for decades. But today, according to the Boston Globe, a nonprofit organization is being launched to tackle those issues. Among the goals of the Institute for Pediatric Innovation is to work with children's hospitals to redesign devices to better fit children. The institute is based in Cambridge, MA and its first three hospital partners are based in California, Kansas, and Ohio. Up until now, the options for pediatric-use devices were not great. Either a device company could run expensive pediatric studies, or it could do nothing but sit back and watch hospital personnel improvise ways to use their products on children. Creating a systematic way to retrofit...
June 25th, 2007
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AdvaMed has announced a universal healthcare plan that would give all Americans the option of buying health insurance at an affordable price. Approved yesterday by the trade association's board of directors, the plan seeks to promote quality and the public reporting of provider and health plan performance, along with support for expanding IT in healthcare. It will also offer financial incentives for those providers and plans that give efficient care, especially related to chronic diseases. "Our plan shows you can finance expanded coverage without rationing care or stifling innovation," said AdvaMed President and CEO Stephen Ubl in a statement. AdvaMed estimates that the plan will save $226 billion in national spending and $105 in federal spending as a result of better treatment and disease prevention, medical innovation, and more use of health IT.
June 22nd, 2007
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Health care reform is traditionally considered the province of politicians, bureaucrats, doctors and other caregivers, insurance companies, and consumers. But the medical device industry is a stakeholder, too. With that in mind, AdvaMed later today will unveil its own health care reform plan. It says its plan will include universal coverage and a national multibillion-dollar fund to address health promotion and disease prevention. Most importantly to industry, the plan also includes "mechanisms to promote health quality, effiiciency, and innovation to help improve patient oucomes and control costs." In other words, a cost-control plan to serve as an alternative to gainsharing.  
June 21st, 2007
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Medtronic announced in read more >>
June 20th, 2007
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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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