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Weekly Vitals: Stryker Expands Recall, EU to Revamp Medical Device Rules
September 26, 2012 - 3:10PM
Add CommentIn this week’s medical device manufacturing news, Stryker announced that it has expanded the recall of waste management systems because FDA has not given it 510(k) clearance. On the legal front, Revolutions Medical said that is has filed suit against former consultants, alleging that the defendants misled and misrepresented capabilities and progress related to the development and manufacture of the company's autoretractable vacuum safety syringe. Meanwhile, after weak European Union regulations... -
Practical Advice for the Unemployed in Medtech
September 25, 2012 - 5:56PM
The U.S. medical device sector has fallen on tough times. The industry has slashed 2000 jobs in the past two months. In 2011, Medtronic itself announced plans to eventually cut up to 2000 positions, while Boston Scientific, Stryker, Abbott Laboratories, and Johnson & Johnson have also announced job cuts. More layoffs are likely to follow as device companies prepare for healthcare reform and adjust to the shifting needs of the global market.To get some advice for those looking for work, or... -
Drug-Delivery Micropump Relies on Body Heat
September 25, 2012 - 1:29PM
Researchers at Purdue University have developed a new type of micropump that is activated by body heat. Eventually, the researchers foresee that their technology could be used in fermentation-powered drug-delivery patches using microneedle arrays to deliver a wider range of medications than is currently possible using conventional patches.Measuring 1.5 cm in length, the prototype microorganism-powered thermopneumatic pump is made out of layers of polydimethylsiloxane, a rubberlike polymer that... -
Reducing the Cytotoxicity of Silver Nanoparticles
September 24, 2012 - 2:11PM
Commonly used in antimicrobial coatings and wound dressings, silver is a ubiquitous element in medical device applications. However, cytotoxicity concerns have accompanied the precious metal’s emergence as a medical device material. Although much remains to be known about the human and environmental impact of silver ions in medical device applications, researchers at Yeditepe University (Istanbul, Turkey) have demonstrated that the potential risks of silver nanoparticles can be reduced by... -
Where Are the Women Leaders in Medtech?
September 19, 2012 - 6:53PM
Women are responsible for approximately 80% of healthcare decisions for U.S. families. Since 2010, females have made up the majority of the U.S. workforce. Women now earn 57% of bachelor’s degrees and 60% of master’s degrees. But, based on data from the Bureau of Labor Statistics, 73% of medical and health service managers are women while only 4% of healthcare industry CEOs are. Despite that small number, the Medtech Women conference organization recently polled its attendees and found that 53... -
Weekly Vitals: Medtech Layoffs and Medical Device Horror Stories
September 19, 2012 - 1:30PM
Restructuring continues to roil the medical device industry. This week, Covidien and Welch Allyn announced that they would lay off hundreds of workers as a result of reorganizing moves. Also in the news was the story of Synthes's illegal decision to test a bone cement on people, with disastrous results.Finding What Needs Fixing (New York Times)Covidien to Close South Carolina Plant, Lay Off 595 (Qmed)The Pre-IDE Programme Becomes the Pre-Submission Programme (EMDT)Medical Device Innovation... -
Johns Hopkins Researchers Develop Improved Drug-Delivery Nanoparticles
September 18, 2012 - 1:47PM
Drug delivery is one of the hottest areas in medical device R&D, and nanotechnology is one of the hottest candidates for new drug-delivery vehicles. Adding to the heat, a team of bioengineers at Johns Hopkins Medicine (Baltimore) has designed nanoparticles for delivering a drug payload that can safely and predictably infiltrate into the brain, a difficult organ to treat.After doctors perform surgery to remove a brain tumor, standard treatment protocols include the application of... -
Why Consumerization Is Coming to Cardiac Monitoring
September 18, 2012 - 1:14PM
Photo by Sacha ChuaIn cardiology, the traditional paradigm has been: device and test data go to doctors; patients don’t know anything about it. “I think there is a huge impetus to change that,” says iPhone ECG inventor David Albert, MD, who will be speaking on the role of consumerization in cardiology at MedTech Cardio in Minneapolis on October 30. Some patients themselves are clamoring for change. The most visible example of that trend is Hugo Campos, a patient advocate implanted with an... -
Purdue Researchers Develop Nanowire-Shaping Process
September 17, 2012 - 12:26PM
It's no news that medical implantable devices have undergone steady progress toward miniaturization in the last few years. This process has been aided by breakthroughs in a range of enabling technologies, electronics among them. Now, researchers at Purdue University (West Lafayette, IN) have developed a manufacturing technique for shaping nanowires and ultrathin films that could further the trend toward medical device miniaturization.Graphene and nanowires have many potential applications, but... -
MD&M West 2013 Conference: Call for Papers
September 14, 2012 - 1:51PM
The MD&M West 2013 Conference will take place alongside the world’s largest exposition for medical devices February 11–14, 2013 in Anaheim, CA. Researchers, inventors, and incubators of the latest medical device innovations are encouraged to respond to this call in order to speak at this premier meeting for medical device design, development, and manufacturing. For more information, visit the MD&M Conference page.The deadline for abstract submission is October 12, 5:00 p.m. PDT. To... -
Predicted Growth Is Music to Hearing-Aid Market's Ears
September 12, 2012 - 4:04PM
Listen up: The global hearing-aid market is primed for growth, according to a report by GBI Research, which produces business intelligence reports. The company estimates that the global hearing-aid market will increase from $7.2 billion in 2011 to $11.3 billion by 2018 at a compound annual growth rate of 7%.In particular demand, the report notes, are miniature behind-the-ear (BTE), in-the-canal (ITC), and completely in-the-canal (CIC) hearing aids. Such devices are experiencing mounting... -
Weekly Vitals: Medtech Job Cuts Continue, VC's Remarks Spark Controversy
September 12, 2012 - 4:34PM
In the wake of St. Jude's announcement last week, Welch Allyn announced restructuring plans that entail a 10% reduction in workforce over the next three years, which it attributed, in part, to preparing for the impending medical device tax. Unfortunately, this trend does not appear to be slowing down just yet. In other news, famed VC Vinod Khosla sparked controversy at the Rock Health Innovation Summit when he proclaimed that machines could replace doctors. Read about these and more top stories... -
Execs Weigh In: Balancing the Risks and Rewards of MedTech Globalization
September 12, 2012 - 3:30PM
By Sanjay Salunkhe, iGATE Corp.Recently, consultancy firm iGATE Corp., in collaboration with advisory firm Axendia, Inc., announced the results of an exclusive medtech executive survey that highlighted the benefits and risks resulting from the rapid growth of the global medical technology industry.Guided by insight from a 12-member executive advisory council, the survey, “Walking the Global Tightrope: Balancing the Risks and Rewards of MedTech Globalization,” polled 125 medical technology... -
Supplier Develops Biodegradable Metal Alloy for Implantable Devices
September 11, 2012 - 5:21PM
Bio DG (San Diego) has developed a metal alloy that provides high strength when first implanted and then gradually erodes in a predictable and biocompatible manner. Designed for implantable medical devices, the alloy is austenitic so that it will not react in a magnetic field. By dissolving from the exterior surfaces without compromising the internal structure, the material retains its strength in the undissolved portion of the implant throughout the degradation process.The alloy has been... -
Stanford Researchers Develop Wireless Implantable Cardiac Device
September 10, 2012 - 1:34PM
Engineers at Stanford University (Palo Alto) have shown that a miniature implantable cardiac device can forgo the use of batteries and derive its power from radio waves transmitted from outside the body. A cube-shaped device 8/10 mm in diameter, the device was implanted on the surface of the heart—5 cm within the chest. Until now, this depth was considered beyond the reach of wireless power transmission.Developed by assistant professor of electrical engineering Ada Poon, the device combines... -
A Bioabsorbable Metal Stent: What DREAMS Are Made Of
September 5, 2012 - 3:31PM
Abbott's much-anticipated Absorb BVS coronary scaffold system is considered a trailblazer in the bioresorbable stent market, boasting U.S. clinical trials underway and a CE Mark in Europe. Yet despite the polymer-based device's prominence in the sector, the Absorb may face some stiff competition down the road from a novel bioresorbable metal stent with big dreams.Biotronik's bioabsorbable metal stent could someday give Abbott's Absorb a run for its money.Despite still having quite a ways to go... -
Smart Catheter Keeps Biofilms at Bay
September 5, 2012 - 10:23AM
Hospital-acquired infections (HAIs) are among the most pressing issues in healthcare today owing to their role in rising costs, longer recovery times, and preventable patient endangerment. And among the biggest culprits and contributors to HAIs, particularly to blood and urinary tract infections, is the common catheter. Looking to reduce instances of catheter-related infections, researchers at the University of Michigan (U of M) have developed a smart catheter technology that releases a biofilm... -
Weekly Vitals: St. Jude, Boston Sci Face Restructuring and Layoffs
September 5, 2012 - 9:33AM
Sadly, 300 St. Jude Medical employees found themselves suddenly jobless as they headed into the Labor Day holiday this year. The medical device maker announced the job cuts last week as the result of a company restructuring effort that yielded two new operating units: the Implantable Electronic Systems Division (IESD) and the Cardiovascular and Ablation Technologies Division (CATD). "The company estimates that as a result of the organizational changes announced, it will be able to reduce pre-... -
Fraunhofer Researchers Develop New Blood Glucose Biosensor
September 4, 2012 - 1:24PM
Fraunhofer is joining the legions of researchers determined to relieve diabetes patients of the burden of pricking a finger everyday to test their blood glucose levels. For just this purpose, researchers at the Fraunhofer Institute for Microelectronic Circuits and Systems (IMS; Duisburg, Germany) have developed a biosensor combining measurement and digital analysis capability that can relay information to a mobile device.Previous biosensors for measuring blood glucose levels were too large... -
Researcher Develops SOI-CMOS-Compatible Flexible Electronics
September 4, 2012 - 12:36PM
Yong Xu, an associate professor of electrical and computer engineering in the College of Engineering at Wayne State University (Detroit), has developed a silicon-on-insulator (SOI)–complementary-metal-oxide-semiconductor (CMOS) process for fabricating flexible electronics. As reported in Applied Physics Letters, the technology could eventually find its way into a range of wearable health monitoring devices and medical implants. The technology, Xu says, could perhaps be used to manufacture...
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