If the federal government shuts down tonight (which is looking more and more likely) how will the device industry be affected?

As with every sector, one can debate the degree to which the government impacts device makers, but the feds do interact with industry in two key ways: as a regulatory authority via FDA and as a source of funding via the NIH.

Those who receive funding from NIH will not notice much of a difference, at least for a little while, according to the American Association for the Advancement of Science's ScienceLink blog. The NIH's intramural funding would be severely limited, and research done directly by the agency will be dramatically reduced. But extramural funding, which is what goes to researchers at universities and institutions outside of the NIH, would not be hampered in the immediate future. A...

April 8th, 2011
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Two undergraduate biomedical engineering students at Ryerson University have developed a prosthetic arm that can be controlled by brain signals. Powered by pneumatic pumps and valves, the arm offers a wide range of movement. The prosthetic limb, which is the brainchild of Thiago Caires and Michal Prywata (both of whom are pictured on the right), draws most of its power from compressed air.
 
To control the device, a user wears a headset that picks up brain signals. The information from the signal is transmitted wirelessly to a computer in the mechanical arm. After the computer interprets the data, a signal is relayed to the pneumatic system to initiate movement.
 
The device has a cost that is 25% of other functional prosthetic arms, which generally use microelectronics or motors
to initiate movement. In addition...

April 7th, 2011
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You have to get up pretty early here in the United States, but if you do, you could find a wealth of knowledge at our upcoming virtual event.

This dynamic event " Developments in Materials for Medical Applications" features a virtual conference and trade show devoted to developments in materials for medical applications. The day is filled with a keynote address on materials insights, and discussions on orthopedic materials, product design, and emerging innovation.In addition, materials experts and suppliers will be onhand to discuss your materials needs and challenges.

 

Developments in Materials for Medical Applications
From European Medical Device Technology, MD+DI...

April 7th, 2011
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To better understand the implications of changes for clinical operations in the medical device and diagnostic industry, PRTM is teaming up with MD+DI to conduct a survey.
This brief survey is designed to reveal the challenges and opportunities medical device companies face as they align their clinical operations with changing market requirements and business strategies.

Critical questions cover several relevant areas, including clinical organization spend and structure, clinical evidence trends, clinical trial performance and productivity, business practices in planning, trial portfolio, and execution management, and clinical trial outsourcing.

Survey participation will require about one hour of your time. All individual company data will be kept confidential—only aggregate industry data will be summarized in the report. Companies that desire
TAKE THE SURVEY

April 6th, 2011
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In June, Malaysia's parliament will introduce a medical device bill aimed at preventing substandard medical devices from reaching the country's market, according to a report in The Star Online.

Malaysian health minister Liow Tiong Lai offered a sobering account of the Southeast Asian nation’s current regulatory standards. “Any company can bring its product into the country and claim it can cure anything without clinical trials,” he said. Lai mentioned that radiology machines, stethoscopes, and surgical gloves were among the devices needing stricter regulation.

On Monday, Lai met with Swedish health and social affairs minister Goran Hagglund; the Malaysian health minister said that his nation could learn from the Scandinavian country’s robust regulatory standards.

This news follows a mid-March report that Thailand,...

April 5th, 2011
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The simple answer is that design controls do not apply to many Class I devices. If the Class I devices you are designing do not need to follow design controls, then this is a business decision. From a practical standpoint, if you have a dedicated design team for the Class I devices from the Class II, then you should only follow 21 CFR Part 820.30 as you believe necessary to prove your Class I devices are safe and effective for their intended use. This may need to include design validation to show performance and functionality with other devices (Class I, II, or III) if labeled to show compatibility with other devices. (You may also need to include compatibility with a drug, biologic, or medical food). 

If your design team is not dedicated to one class or the other, then I would recommend that you have only one design control process in...

April 5th, 2011
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Wright Medical's CEO abruptly resigned before a board meeting to discuss management and how it was handling the company's ongoing compliance program. Gary Henley also resigned from the board of directors. The company also got rid of Frank Bono, senior VP and chief technology officer for "failing to exhibit appropriate regard for the company's ongoing compliance program." David D. Stevens has been named the interim president and CEO of the company.--Maria Fontanazza
 

April 5th, 2011
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Researchers from the University of Southampton demonstrated the efficacy of antimicrobial copper against MRSA in a live experiment that was broadcast on April 4 at www.antimicrobialtouchsurface.com. In the experiment, the scientists deposited 10 million MRSA bacteria, which were stained with a fluorescent dye, onto a piece of copper and a piece of stainless steel, which was used as a control. Using a fluorescent microscope, the scientists showed copper destroying MRSA bacteria (methicillin-resistant staphylococcus aureus) within 10 minutes. While the bacterial quickly died when exposed to a copper surface, it survived on stainless steel—a material frequently used in hospitals. The use of copper could be especially important to the healthcare industry as more and more bacterial strains grow resistant to antibiotics. The researchers report that...

April 4th, 2011
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Infections associated with pacemakers and defibrillators were the subject of a study involving Medicare beneficiaries conducted by the Mayo Clinic, The Johns Hopkins School of Medicine, and TYRX Inc. TYRX, a company specializing in site-specific infections for implantable devices, provided financial support for the study.

The study reveals that surgical infections led to 3 times increase in hospital stays, with 55–118% higher hospitalization costs, and 8–11 fold increases in mortality rates, which is double the mortality rate compared with implantations where no infection occurred.

More than a third of the infections occurred after patients were discharged.More than 200,000 patients receiving pacemaker or defibrillator implants were part of the study presented at the American College of Cardiology 60th Annual Scientific Session.

Daniel Lerner, MD, Chief Medical Officer of TYRX  Inc. said, “This large...

April 4th, 2011
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Researchers at Georgia Tech have announced that a flexible nanogenerator is ready for commercial applications. The breakthrough will enable hand-held electronics to harvest energy from body movements, eliminating the need to use batteries or other electrical inputs. The technology, which was been under development for years, is the brainchild of Zhong Lin Wang, a professor of materials science and engineering at Georgia Tech. The nanogenerator is now strong enough to drive commercial devices such as cellphones, iPods, LCDs, LEDs and laser diodes. Potential medical device applications include embedded insulin pumps that harness the energy of the heartbeat. In the future, the technology could be employed in devices that make use of energy from walking or blood flowing through the body.
 
The nanoelectronic breakthrough was made...

April 1st, 2011
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