If you don't integrate human factors engineering into your design control, you may face eventual consequences from FDA, regardless of your product's classification, said Pat Patterson of Agilis Consulting (Cave Creek, AZ) last night. She spoke at a meeting of the RAPS New York/New Jersey chapter. Regulatory affairs folks should be aware that PMA applications need to include data on whatever usability tests and other human factors studies were performed, and that failure to include them will raise a red flag, she said. Such data is usually not necessary for 510(k) applications, but if a 510(k) product has a significant use-related problem, FDA will ask to see human factors testing data, she added. And if such testing was never done, a firm could get in serious trouble with the agency. "FDA wants you to show what you did in terms of figuring out what predictable things could go wrong," she said. "`Nothing' is the wrong answer." Clinical...
April 20th, 2007
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With the buzz about stem cells it's easy to forget that the technology is still in early stages and at best it is a promising technology. This is especially true for stem cell grafting of spinal cord injuries. For one thing, explains Scott Wittemore at the Society for Biomaterials annual meeting, in vitro results show that stem cells easily differentiate. However, in vivo stem cells do not. He says that there seems to be a mechanism in the spinal cord that inhibits the necessary differentiation. To combat this difficulty—one among many—Wittemore says bioengineers must turn to biomaterials in combination with stem cells to find successful implants. Fiber and channel-based guidance, as well as incorporating ligands, can help regulate cell interactions as well as control differentiation and function of transplanted cells. Wittemore works at the Kentucky Spinal Cord Injury Research Center and...
April 19th, 2007
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A little bit of controversy flared up during Polymer Technology Group's presentation at the Society for Biomaterials annual meeting in Chicago. The company discussed its self-assembling monolayer end groups (SAMEs). These SAMEs are designed to spontaneously form surfaces that are analogous to self-assembling monomers. Presenters Robert Ward and Keith McRae discussed the company's recent findings, how to enhance existing biomaterial polymers, and how to improve the usability of high molecular weight polyurethanes. Ward said the controversy arose simply because the process is so new. But the process can be applied to nearly any polymer and it makes strong and durable products suitable for long-term material implants. Components can be manufactured by processes such as molding, extrusion, and spraying. Want more news about biomaterials? Look for MD&DI's new blog, BiomaterialsTalk, coming soon.
April 19th, 2007
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Research conducted on certain breast cancer cells suggests that nanoparticles could damage DNA and lead to cancer. The study, performed at the University of Massachusetts, examined how two types of nanoparticles could cause DNA damage in the tissue. Unfortunately one of the main problems in the nanotech area is that there's still not nearly enough information known about how harmful (or harmless) materials could be at the nanoscale.

April 19th, 2007
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FDA announced that it has seized all devices made by Shelhigh, Inc. (Union, NJ) after finding significant manufacturing deficiencies, especially failure to maintain sterility. According to the Associated Press, the agency inspected Shelhigh's plant last fall and found that deficiencies described in warning letters from 2000 and 2005 had not been satisfied. It had told the company that it would seize product if the problems were not corrected, and that is what has happened. Apparently the most egregious offense is a poorly constructed and poorly maintained cleanroom. Shelhigh's products are tissue-based and are used in a number of high-risk surgical settings, which may have contributed to the agency's haste to take action. The products include pediatric heart valves and conduits, surgical patches,...
April 18th, 2007
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Transforming FDA LogoOne of the issues AdvaMed and FDA have been discussing as part of FDA's Postmarket Transformation Initiative is the question of when is the best time to file complex Medical Device Reports, said AdvaMed's Jeff Secunda at an AdvaMed media briefing on postmarket issues today. If an incident with a complex device occurs, only sketchy information will be available at first, he said. Should firms stick with rules that require them to report information immediately, even if it's incomplete, or should they be allowed longer time for MDR preparation? "You must [file MDRs] immediately, but it might be more effective to report more complete information and open up the reporting timeframe if the...
April 17th, 2007
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After reinspecting Guidant's cardiac rhythm management site in St. Paul, FDA has lifted a warning letter on the company. Now a division of Boston Scientific, Guidant received the warning in December 2005 when FDA inspectors found quality control problems at the site. The letter also came following a series of defibrillator recalls by the company. Boston Scientific's quality system improvements paid off, as FDA's reinspection of the facility last year reported no problems. The company is still not in the clear though. It received a warning letter in January 2006 regarding its drug-coated stents. The Boston Globe reports that it doesn't expect that letter to be resolved until the second half of 2007.
April 17th, 2007
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Transforming FDA LogoFDA and AdvaMed today made public the agreement that should form the basis for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA). The new user fee scheme will promote a 6.4% increase each year between FY 2008 and FY 2013. It significantly reduces application fees but adds two new fees. The details can be found in a notice of a public meeting to be held on April 30 for discussion of the topic. As expected, MDUFMA II eliminates the adjustments that made the year-to-year use fee increases so volatile. Instead, to promote more consistent funding, the proposal recommends two new fees...
April 16th, 2007
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Artificial hips are designed to last about 20 years at best. Yet, increasingly, they are being implanted in patients who will outlive the lifespan of their articificial hips. To make them last longer, there is a technique called resurfacing, which offers interim relief and allows doctors to delay the removal of the first artificial hip and the implantation of a new one. The first FDA-approved system, by Smith...
April 16th, 2007
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Teleflex Inc., parent company of Teleflex Medical (Limerick, PA), has acquired HDJ Co., Inc. (Lancaster, PA), parent company of contract manufacturer Specialized Medical Devices, reports the Philadelphia Inquirer. Terms of the agreement were not disclosed. Teleflex Medical sells sleep therapy, respiratory, anaesthesia, surgical instrument, and suture products, and also performs contract manufacturing. Specialized Medical Devices provides a full range of prototyping, engineering and testing services along with full scale production machining, assembly and contract packaging.
April 13th, 2007
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