Rochelle RottensteinThe medical device user fee legislation that was recently approved by Congress “shortchanges consumers,” says Rochelle Rottenstein, principal of the Rottenstein Law Group, a New York City-based law firm specializing in consumer product injury cases, including suits against the makers of vaginal mesh and hip implant products. “Perhaps the most significant way it does that is by failing to include provisions that would have made it more difficult for medical device manufacturers to obtain FDA approval for devices that are ‘substantially equivalent’ to devices the FDA has already approved," she adds.

Rottenstein explains that earlier iterations of the Medical Device User Fee Act closed a...

June 27th, 2012
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Innovation is easy, implementation is hard. These are the challenges, opportunities and surprises (a la silly putty) that come about during the medical product development process.

Based on a trend in current programs we are seeing and technologies coming out of academic laboratories it appears more than likely that in the not so distant future medical devices will be stuck somewhere to our bodies as we go about or daily lives. Diagnostic, therapeutic and monitoring devices are not only wearable but also supplying medication, therapies and information alike in real time. Unlike devices of yore these new wearable diddies integrate with our daily routines through real time operation rather than controlling our routines around intermittent regimens. These ‘Smart Band-Aids’ as they’re known are increasingly discreet and have minimal impact on our clothes choices nor the activities that we conduct as part of our normal life. They are connected to...

June 27th, 2012
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The government of Brazil announced today the launch of a stimulus package for in-country medical technology companies and public hospitals. Measures include encouraging public hospitals to buy domestically manufactured medical equipment that is no more than 25% more expensive than comparable imports and increasing the spending capacity of public hospitals. In addition, the Banco Nacional de Desenvolvimento Econômico e Social will open credit lines for hospitals purchasing equipment. To tap into this credit, a minimum of 60% of the money must be spent on domestically produced equipment, said Minister of Health Alexandre Padilha.

"We want to stimulate the domestic industry and expand the service capacity of the National Health Service," Padilha said. "These measures aim to revitalize the national [medtech] industry and reduce dependence on the international market."

The announcement was made as the first...

June 27th, 2012
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Image copyright Bryan Christie/ Takram

When Japanese design studio Takram was tasked with designing a better water bottle, it instead opted to transform the human body. Takram wanted to create a water bottle for post-apocalyptic scenarios – situations in which water will be scarce. But rather than re-invent the water bottle the studio thought it would be better to modify the way the human body regulates and recycles water. The result is the Shenu Hydrolemic System a set of artificial organs. The idea is to enable humans to survive longer with less water. The system...

June 26th, 2012
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 Medical Sales > Medical Practice

  • A recent survey conducted by MedReps.com shows that top salesmen of medical devices, equipment, and disposables are actually out-earning the doctors they sell to.
    Source: MedCity News

Faulty Surgical Clips Leads to Kidney Donor Deaths

  • Since 2001 five kidney donors have died because of a surgical device that was reported as dangerous in 2006. But has FDA done enough? 
    Source: CNN

Swedish Doctoral Student Develops Chemical Circuit

  • A doctoral student at Linköping...
June 22nd, 2012
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At this year's Medical Design Excellence Awards ceremony in Philadelphia, MD+DI honored Dr. Thomas Fogarty with the Lifetime Achievement Award. In his illustrious career, Fogarty has founded or cofounded more than 30 medical companies, and been awarded 135 patents on surgical instruments that have saved countless lives. Among his inventions is the Fogarty embolectomy catheter, which revolutionized vascular surgery and is still in use. On hand to present the award to Fogarty was medtech innovator and entrepreneur Dean Kamen, inventor of the first wearable infusion pump and the first wearable insulin pump.

After the ceremony, Kamen and Fogarty participated in a fascinating question-and-answer session in which they shared their insights about the future of medical device development. If you couldn't...

June 19th, 2012
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At this year's Medical Design Excellence Awards ceremony in Philadelphia, MD+DI honored Dr. Thomas Fogarty with the Lifetime Achievement Award. In his illustrious career, Fogarty has founded or cofounded more than 30 medical companies, and been awarded 135 patents on surgical instruments that have saved countless lives. Among his inventions is the Fogarty embolectomy catheter, which revolutionized vascular surgery and is still in use. On hand to present the award to Fogarty was medtech innovator and entrepreneur Dean Kamen, inventor of the first wearable infusion pump and the first wearable insulin pump.

After the ceremony, Kamen and Fogarty participated in a fascinating question-and-answer session in which they shared their insights about the future of medical device development. If you...

June 19th, 2012
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CareFusion may have been the target of a cyber attack that lasted more than two months and compromised customers that downloaded software updates for its medical device products.

A screenshot of CareFusion's viasyshealthcare.com site around 2 p.m. EST on June 19.

According to the IT security news service Threatpost, data from the Clean MX virus database show viasyshealthcare.com, a CareFusion-owned site that distributes software for its infusion pumps and ventilation and respiratory products,...

June 19th, 2012
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As the video looking at the development of a 3-D medical imaging system illustrates, intuitive, graphical user interfaces and cross-platform support are becoming an increasingly critical element in modern medical devices.

In this case, the team at Eykona Technologies, a medical imaging spin-out from the University of Oxford in the United Kingdom, were looking to create a system for accurate measurement and clinical characterisation of hard-to-heal wounds such as diabetic and pressure ulcers. Their solution, using patented technology based on research from the University, was a handheld imaging system that produces a full colour 3-D model of the wound.

While developing the interface was a critical element of the project it was only one part of the story. The Eykona team also had to take account of the fact that the technology would have to work across multiple platforms, support global deployment, accommodate customer-specific requirements, and be available in the...

June 19th, 2012
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 This Week in Devices [6/15/12]

 

200 Years of Surgery

  • We've truly come a long way in even a comparatively short time. A historical overview of the last 200 years of surgery, including some of the techniques and devices of days gone by. 
    Source: The New England Journal of Medicine

An Artificial Pancreas for Diabetics

  • An artificial pancreas has recently completed a successful human clinical trial and is pointing to potential breakthroughs in healthcare for diabetic patients. 
    Source: io9

Fake Medical...

June 15th, 2012
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