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
0

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
0

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
0

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
0

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
0

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
0

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
0

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
0

Over at Forbes.com, Zack O'Malley Greenburg details the story of a medical device with a slightly more, well, "groovy" history than most. The Gecko, a nasal pad for people who use sleep-apnea masks, was conceived by a musician who currently tours with former members of the Grateful Dead. The musician, Jeff Chimenti, had a mother who was having trouble with the uncomfortable nature of her mask. He wanted to put something between the mask and his mother's nose; A.J. Santella, an instrument technician, suggested "a gel material used for dampening vibration on drum heads." The material worked, and the discovery eventually turned into The Gecko.

I have to admit, short of enjoying a pint or two of Cherry Garcia every now and then, the Grateful Dead (and jam bands in general) are a long, meandering musical blind spot for me. But Chimenti's innovation is something everyone, especially sufferers of sleep apena, can get down to.

— Thomas...

March 31st, 2011
0

 Apparently, Sen. Amy Klobuchar (D-MN) and Sen. Scott Brown (R-MA) aren't going to let Rep. Erik Paulsen (R-MN) and his Medtech Caucus buddies in the House have all the fun; Klobuchar and Brown have announced today that they are forming a medtech caucus of their own. 
 
Though they are from opposite sides of the aisle, Klobuchar and Brown seem to be simpatico when it comes to supporting medical device makers. They've come together to voice such support before, penning a letter together to try to influence FDA to keep industry in mind when evaluating 510(k) reform. Both represent states that are home to a large medtech presence, so it's not surprising to see them working together on this. 
 
Judging by the names that appeared on that letter in December, such as those of Sen. John Kerry (D-MA) and Sen. Al Franken (D-MN), I would guess that the group Klobuchar and Brown put together will include a mix of moderate Democrats and...

March 30th, 2011
0