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Articles from 2008 In December

Connections and Misconnections

The Boston Globe just published a piece on the topic, describing the lack of connectivity between devices in an operating room, compared with consumer products. Most telling in the story is commentary from Massachusetts General anesthesiologist, Jesse Ehrenfeld: "My bank can notify me via text message if my account has a low balance, but medical devices can't let me know if my patient is having a critical event." John Conroy has written a piece for MD&DI on medical connectivity and the standard IEC 80001 that can help medical manufacturers incorporate connectivity into devices. Read the article in the January issue of MD&DI. Sandy Weininger, with FDA told the Globe that the turning point may be the arrival of a revolutionary application, such as a medical version of an iPod, that changes people's expectations of their devices. Weininger said. "As soon as you get the iPod . . . it just mushrooms."

Covidien Heads to Ireland

The company doesn't expect the move to affect its financial results, or its U.S. operations or employees. The company has 42,000 employees worldwide and about 2000 at its U.S. headquarters in Mansfield, MA.

Top Device Problems in Hospitals

New Skyscraper a Unique Healthcare Spot

Within device manufacturing participants, the center will focus on companies that sell finished medical devices rather than component manufacturers, but this doesn't necessarily rule out those suppliers. The current U.S. economic state might raise concern over such an ambitious plan. However, Michael Resnick, executive vice president of the World Product Centre, says it is a cost-effective tool that provides long-term financial savings. "The nice part of this project is that it's five years until the doors open, so the financial commitment to secure the location is minimal and no risk," he says, adding that the center has received a huge positive response from the companies it has been involved with so far. The center is asking for a 10-year commitment. Companies that want to participate sign a license agreement, which gives them access to all building resources such as executive office space, media space for briefings and analyst presentation, and conference auditoriums for continuing medical education programs. Nearly 200 healthcare companies have been approached, and Resnick expects the first wave of participants to be announced soon.

St. Jude Acquisition Boosts Cardiovascular Platform

This year, RadiMedical is expected to generate about $80 million in sales (19% more than 2007). The company will become part of the St. Jude Medical Cardiovascular Division.

FDA Commissioner Resigns Post

Getty ImagesAndrew von Eschenbach's expected resignation is official. The FDA Commissioner told his staff that he plans to resign effective January 20, 2009. The departure of von Eschenbach will intensify the search for a new FDA leader, which has become the focus of lobbying by industry, members of Congress, consumer-safety advocates, and women's groups. Janet Woodcock's name has been floated as interim commissioner. On December 5, however, Representative Bart Stupak of Michigan asked President-elect Obama in a letter not to name any current FDA officials to acting or permanent posts. The Wall Street Journal reports that von Eschenbach said the incoming administration is responsible for appointing an acting commissioner until Obama nominates, and the Senate confirms, a permanent FDA commissioner.

Turning Cars into Life Saving Devices

The device can be built for less than $1000 and it is designed for use in developing countries. Although many of these nations have more than enough incubators, what they really need are incubators that work. Incubators break through unreliable electrical currents (e.g., surges and brownouts) and through misuse (often caused by lack of training). A device made from cars is more likely to have readily available replacement parts even from junkyards. And auto mechanics can be trained to fix the incubators. The project is being promoted by the Global Health Initiative at the Center for Integration of Medicine and Innovative Technology (Cimit), a nonprofit consortium of Boston teaching hospitals and engineering schools. Design That Matters, a nonprofit firm in Cambridge, MA, designed the machine. The car parts incubator has received $150,000 in initial financing from Cimit. The project team is looking for foundation support to develop a working prototype. Because it does not rely on original products or processes, the incubator will most likely not be patented. Massachusetts General Hospital and Design That Matters share intellectual property rights. Meanwhile, the teamâEUR(TM)s greatest challenges are manufacturing, financing, distribution and regulatory approvals. One hope is that international bodies like the World Health Organization and the United Nations Population Fund will endorse the incubator. If that happens, it would speed global adoption, even without approval from FDA. Heather Thompson

Implantable Lint Brush Kills Cancer Cells

When used with conventional cancer treatment, researcher Michael King says the device could get rid of a significant amount of metastatic cells, which opens the door to treating nearly any type of cancer. Once the researchers reach the human testing phase, King says the device is likely to look like a protein-coated shunt that diverts blood flow. More information about the device has been published by Bioengineering and Biotechnology, a scientific journal.

ImpediMed Named Finalist for 2009 Innovation Shootout

This round takes place at the Business Technology Center, which is run by the Community Development Commission of the County of Los Angeles. The companies will then travel to the Bay Area to participate in the Innovation Shootout on January 15th at the Quadras Conference Center in Menlo Park. The winner will be selected by a panel of judges including technology experts, members of the media, and venture capitalists. ImpediMed's devices use bioimpedance spectroscopy (BIS) technologies in the noninvasive clinical assessment and monitoring of human disorders and diseases. Its primary product range consists of a number of medical devices that aid surgeons, oncologists, radiation oncologists, and therapists to clinically assess secondary unilateral lymphedema. Preoperative assessment in combination with periodic surveillance can assist medical professionals to detect lymphedema before the onset of visible symptoms and potentially before the condition progresses to irreversible forms. Irreversible lymphedema can become a lifelong management issue for patients and can significantly impair their quality of life. "The increasing mantra from U.S. experts in the area of managing breast cancer patients is the recognition that preoperative assessment, early detection, and treatment of lymphedema is the best way to prevent and manage this important medical condition," said Greg Brown, ImpediMedâEUR(TM)s CEO. "ImpediMedâEUR(TM)s L-Dex family of devices has the potential to aid in this critical role in the preoperative assessment and management of lymphedema in female breast cancer patients". ImpediMedâEUR(TM)s technology was developed by The Queensland University of Technology and The University of Queensland. The company was formed in late 1999 by the University of Queensland in order to commercialize this technology.

Short Surgeries Stop Site Infections

Results of the analysis showed that hospitals with high SSI rates performed operations that took significantly longer on average compared with hospitals with low SSI rates (128 +/- 104.3 min. compared with 102.7 +/- 89.9 min., respectively; p<0.001). In addition, hospitals with low SSI rates were less likely to administer transfusions than hospitals with high SSI rates (5.1% versus 9.7%, respectively; p = 0.03). In the article in the December issue of JACS, researchers called for further studies to explore the link between higher transfusion rates in higher SSI incidence hospitals. Overall, results of the study showed that hospitals with low SSI incidence rates were smaller, more efficient in the delivery of care, and experienced little operative staff turnover.