Tracking has become an important topic in medical device discussions, especially when it comes to recalls. At FDA's town hall meeting in Irvine, CA, last week, CDRH director Jeffrey Shuren said, "you need to be able to link the device with the patient's experience with the device." He believes that this can be achieved through the unique device identification system.
 
Tracking is also on the minds of Medical Tracking Solutions, which developed the iTraycer for the iPhone and iPad (Android, Pocket PC, and Blackberry versions are coming, the company says). This app uses advanced GPS technology to provide real-time tracking of medical trays, devices, and biologics, including part and lot numbers. The product debuted at the North American Spine Society meeting last week in Orlando, FL.

October 13th, 2010
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I’m in Minneapolis for the MD&M show. While in town, I took advantage of the opportunity to meet with Ven Manda of Medtronic. I found him to be an interesting guy, and tasked with a fascinating job. As the vice-president of internal ventures, Manda’s job is to uncover internal R&D, determine if it’s viable, then fund that R&D. With an annual budget of $100 million for these ventures, it’s obvious Medtronic is talking these opportunities seriously.

Word on the street is that Medtronic is more interesting in acquiring technology than developing it internally. After speaking to Manda, it’s obvious that this is not true. They really want to come up with their own technology, and are obviously willing to put their money where their mouth is. Manda made it clear that he’s not doling out the money willy-nilly. But he is very interested in helping to discover the next new great technology.

One of the things to keep in...

October 13th, 2010
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Thailand...Malaysia...India...South Dakota?
 
These locales have more in common than it may seem at first. For example, all four would love to have more medical device manufacturers in their midst. There are often small contingents of economic development teams at trade shows, and they are typically from foreign countries that can offer favorable tax breaks or inexpensive labor. But has your company ever thought about relocating (or establishing a facility) in South Dakota? If so, a team from the state will be glad to answer your questions at MD&M Minneapolis. For the third year in a row, the Governor’s Office of Economic Development will attend the show to gauge and generate interest from medical device and bioscience companies.
 
“Medical device manufacturers and bioscience companies are targeted industries for South Dakota,” said Richard Benda, Secretary of the Department of Tourism and State Development....

October 6th, 2010
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Use of advanced imaging devices in the ER to assess injuries has increased threefold over the past 10 years, according to a Johns Hopkins University study. The consequences, researchers say, include increased healthcare costs, longer ER visits, and the potential for additional cancer risk.
 
About 6% of 5,237 ER visitors received computed tomography or magnetic resonance imaging scans in 1998. Fast forward to 2007 and about 15% of 6,567 patients received them.
 
“We need to be smarter about imaging and we need to really look at the clinical situation and ask the question, ‘Does this patient really need the study?’” said David Waldman, chairman of the Department of Imaging Sciences at the University of Rochester Medical Center, in Rochester, New York, who wasn’t involved in the study. “Just because it’s easy now to get a CT scan doesn’t mean it’s the right thing to do.”

October 6th, 2010
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Time flies when you're having fun. It's already time for industry folks to tell FDA what guidance documents they want the agency to publish in FY 2011. From FDA:
 
The Food and Drug Administration (FDA) is announcing the Web site location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances...


Through feedback from stakeholders, including draft language for guidance documents, CDRH expects to be able to better prioritize and more efficiently draft guidances that will be useful to industry and other stakeholders. This will be the fourth annual list CDRH has posted. FDA intends to update the list each year.
 
FDA invites...

October 4th, 2010
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We have just released the call for abstracts for the 2011 DesignMED Conference. DesignMED is aimed at designers and developers of medical electronics systems and subsystems.

The conference is broken down into roughly seven tracks, each of which will contain a series of one-hour classes. The tracks are likely to cover:

  • Imaging
  • Diagnostics and Monitoring
  • Implantable Devices
  • Personal and Home Healthcare
  • Wireless/Networking
  • HCI (Human-Computer Interfaces)
  • Device Safety and Security

As a presenter in a class, you have the opportunity to teach to an audience of medical electronics OEMs. But be sure not to pitch your product or your company. That’s the best way to get your abstract rejected. I’ll be reading and evaluating many of...

October 4th, 2010
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Similar to the BMEIdea, the BMEStart is a competition challenging students to solve some of today's most pressing and interesting issues in medical device design. BMEStart is restricted to undergraduate students.

This year the $10,000 grand prize was awarded to the braniacs at North Carolina State University for their HydrEYE CorneOasis Contact Lens, a hydrating system for patients who have lost control of eyelid function. The product description states that the device is meant for patients with traumatic brain injury.

The other winners are described in the press release:

Coming in second, with a grant of $5,000, went to Columbia University for Procar: A Trocar Worth Trusting. In an effort to decrease malpractice injury...

October 4th, 2010
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Gov. Arnold Schwarzenegger has signed into law a measure that propels California to the forefront of efforts to prevent improper radiation dosages involving CT scans and other high-powered radiation devices.  
 
SB 1237 requires that such radiation mishaps, including overdoses during therapeutic treatments, be reported to the patient and their doctor. Federal law currently regulates only the machines, not the technicians or doctors who use them. The bill would also require that the radiation dose be recorded in medical records, making it more likely that troubles can be more easily detected and corrected.
The legislation was introduced by Sen. Alex Padilla (D–Pacoima) and sponsored by the Consumer Attorneys of California. It was triggered last fall when more than 330 patients at Cedars-Sinai Medical Center in Los Angeles and several other California hospitals had suffered radiation overdoses while undergoing CT scans.
 
“...

October 1st, 2010
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St. Jude Medical's Eon Mini spinal cord stimulation (SCS) system has been approved for use to manage chronic pain in Japan. It is the first spinal cord stimulator to be approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in Japan. Spinal cord stimulators manage chronic pain of the trunk or limbs and pain from failed back surgery by delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals' transmission to the brain.
Chronic pain is a largely undertreated and misunderstood condition that affects millions of patients worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that as many as one in five people suffers from moderate to severe chronic pain.
According to the company, the Eon Mini neurostimulator has the longest-lasting battery life of any rechargeable spinal...

September 30th, 2010
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Earlier this year, MD+DI highlighted the GlowCap as one of the latest in a growing cache of smart, well-designed medical devices. There's always more to a cool device (or medical device start-up) than what meets the eye. To find out more about the device and Vitality Inc., the company behind it, read the interview with Vitality CEO David Rose in the most recent MX Q&A.

September 30th, 2010
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