Everyone is worried about the tax on medical devices, including hospitals. HIll's Healthwatch blog says that hospital groups— the American Hospital Association, the Federation of American Hospitals, the Catholic Health Association of the United States and the Health Industry Group Purchasing Association—are asking the IRS to prohibit device manufacturers from passing the cost of the tax onto purchasers.

The device tax, which starts in 2013, imposes 2.3% excise tax on most medical devices to help pay for the Patient Protection and Affordable Care Act. 

The push from hospital groups comes on the heels of an 18-page letter to IRS from AdvaMed, which is worried that manufacturers could be subjected to double taxing...

March 30th, 2011
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The following is a response to our post titled "Do Design Controls Help a Firm Produce a Safe and Effective Medical Device?":

Following formal design procedures is always a good thing. However, I  found over and over again that this is not enough. What is even more important is to start documenting your ideas before firing up your CAD. Often documentation is done in hindsight, after the project is wrapped up. Nobody likes to do it, everyone is eager to move on to the next main challenge and in consequence people just wing it. They slap it together and submit the bare minimum.

Years later the inevitable happens. "Why was this circuit done that way?" ... "Oh, I have no clue, so-and-so did that but he doesn't work here anymore" ... "Can we reach him somewhere?" ... "No, he is on a longterm mission trip somewhere in South America".

So my advice is to do what I do on every single...

March 28th, 2011
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Not on their own, no. However, by following good design controls relative to design inputs and design verification and validation, it is far more likely that you will design a safe and effective medical device. The effort put into design input requirements is time well spent. Ensuring that you consider all design input sources – post-market data for a similar design (yours or a competitor’s), human factors engineering, standards, FDA guidance, a predicate device’s specifications, the use environment, user need data from sales, marketing or post-market data, etc.- goes a long way to ensuring your device will be designed to the correct user needs and your intended uses.
 
Performing...

March 28th, 2011
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China has been on the medical device industry's mind this year (well, really for the past decade). And now, a new report from PharmaLive demonstrates that China is well on its way to becoming the behemoth in the medical market.

According to the report, which covers the global medical device market, China's medical device market will grow to $42.8 billion in sales by 2019 and India is expected to reach $10.7 billion during the same period.

The report says that United States is still the market leader, but it faces certain challenges: Stricter guidelines in the 510(k) process. Changes may lead to substantial cost increases and delays for product approvals. And other regulatory and governmental policies threaten to slow product development, and drive R&D offshore to less burdensome...

March 28th, 2011
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AdvaMed certainly does not want the medical device tax to go into effect, not next year, as is currently scheduled, or ever, for that matter. But if the tax does stay on the books, the organization wants to make sure that no one is unfairly taxed. That's the message behind the comments that the organization filed with the Internal Revenue Service earlier this week. The group is concerned about the clarity of the tax and consistency in the way it is applied, but a key comment is about the possibility of over-taxing. From a written statement by Christopher White, the group's executive vice president and general counsel, that was included in a press release on the subject:

“We seek regulatory guidance to ensure implementation of...

March 26th, 2011
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Researchers at Brown University have developed an implantable system that translates brain signals to control assistive devices. The device has enabled a woman with paralysis to control a computer solely with neural activity. They system has continued to work consistently for 1000 days and has enabled the woman, who is also enable to speak, to perform “point-and-click” operations on a computer solely by thinking about them.
 
According to John Simeral, an assistant professor of engineering at Brown University, the ultimate goal of the research is to enable people with disabilities to the same level of performance of a person without a disability.
 
The BrainGate implant has been in development since 2002. Using a silicon electrode array to detect brain activity, the system works by translating the resulting...

March 25th, 2011
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The Human Factors & Ergonomics Society (HFES) has announced that it will award a $10,000 cash prize to the winning paper submitted for publication in its flagship journal, Human Factors. The new award, known as the Human Factors Prize, will recognize innovation in human factors research. Editor-in-Chief William S. Marras said that he is confident that the award will help inspire important contributions to science. The deadline for entries is June 1.

The prize will be formally conferred at a special session at the HFES Annual Meeting

 

March 24th, 2011
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Rep. Erik Paulsen (R-MN) is taking his fight against the medical device tax to the internet, with a Web site that was launched this week for the Congressional Medical Technology Caucus. The site features news about the caucus and its members, links to information about relevant legislation, and a way to "share your medtech story" with the caucus. As would be expected of a caucus chaired by a relentless opponent of the tax that will levy device makers to help fund healthcare reform, much of the content on the site is about that tax and efforts to repeal it. The site is worth a visit, if just to get a look at the list of members, many of whom hail from states with a heavy medtech presence, like California and Minnesota. (Hat-tip to MedCityNews)
 
--Thomas Blair 
 

March 24th, 2011
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A recent study in the journal Spine finds that areas with higher rates of surgeon enthusiasm also have higher rates of surgery. The study linked high surgeon enthusiasm to higher surgery rates. Researchers assessed more than 50,000 degenerative lumbar spine disease cases from healthcare databases in Ontario, Canada that occurred between 2002 and 2006. The results revealed that in counties where there were higher rates of spinal surgery, surgeons also were more apt to advise surgery. The study authors pointed out that patients and family doctors had varying levels of enthusiasm for surgery, but "surgeon enthusiasm was the dominant potentially modifiable factor influencing surgical rates." --Maria Fontanazza

March 24th, 2011
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Update 12/9/11: I wrote this story back in March, and it continues to make me nervous. Alone, it's nothing. Just another example of  industry being excluded in policy shifts. Taken in a larger context, however it demonstrates how vulnerable reputation of the medtech industry is right now, and how the loss of reputation can influence real world concerns. We’ve seen that the result of noninvolvement can be disappointing, as with IOM choosing not to have industry involved in its 510(k) report, or disastrous, as with industry choosing not to be involved with healthcare reform.

Are you as worried about this as I am? 

Heather Thompson

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March 23rd, 2011
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