It wasn't politics as usual on Friday, when the IOM released its 510(k) report to the public. In many ways, one could argue that the institute took the only path it had left: the high road.

Even before the IOM released its results, the panel had taken considerable fire for not including members of industry. Ralph F. Hall was particularly vocal about including these critical stakeholders.

Further, Hall told EE Times that "most government reports are released in a draft form for public comment before they are made final. I have absolutely no idea of the substance of the report, but I wish I had some insight."

Public comment is what will ultimately decide the worth of the IOM's review. Indeed, David Challoner admitted in the webcast about IOM's report that the goal of the...

August 1st, 2011

 This week in medical device news, MPMN takes a look at six advances in medical imaging technology, including hyperspectral imaging and electromagnetic acoustic imaging. For those of you curious about how the other side lives, Ed Silverman at Pharmalot has a look at the financial state of the biotech industry, and finds that companies are making more and spending less. PMPN's Daphne Allen has information on a program that provides insight into how healthcare practitioners interact with packaging. Over at MassDevice, Westby Fisher has an essay on how sometimes, it's best for doctors to do nothing when pressured to do something.

July 29th, 2011

The big-item news of the day was obviously the IOM's advice to scrap the 510(k). Nevertheless, the medical device tax has been steadily on my mind this week, thanks to a number of e-mails I've received from readers (two of which can be found here: A Reader Weighs in on the the Device Tax).
I also received the a couple of e-mails from a senior R&D engineer who gave me permission to use his quotes here. Considering the politics behind the tax, he writes:

I agree with you that the tax will have a nominal effect on device makers, as it is “only” 2.3%.
What I find interesting is that we are taxing something that the healthcare dollars in turn needs to pay for. And considering how heathcare providers “mark up” various items, one could see how the tax would result in a net loss. 
In a sense, it is simply a hidden sales tax. And since a sales tax is directly proportional to the original selling price, there will be additional...

July 29th, 2011

I'll be updating this list as the day goes on, but here is the best coverage so far on the Institure of Medicine (IOM) report on FDA 510(k)s
Monday Aug 1:

510(k) Rehab? IOM Says: No, No, No (EMDT)
IOM to FDA: It's time to replace the 510(k) (IVDT)
FDA to Seek Public Comment on IOM Recommendations (MPMN)

IOM Says FDA Should Overhaul 510(k) Medical Device Approval Process (California Healthline)
Friday, July 31:
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (IOM) 
IOM Tells FDA 510(k) Too Flawed for Rehabilitation (MDDI)
510(k) reform: IOM report a headache the FDA doesn't need (Mass Device)

AdvaMed Statement on IOM 510(k) Report (AdvaMed)
Controversial IOM Report Highly Critical of 510(k) Process‎(Forbes)
FDA defends 510(k) as debate begins (EE Times)

July 29th, 2011

The Institute of Medicine released its report on the 510(k) with a bigger splash than expected. Rather than make recommendations on how to fix the system, IOM simply copped out.

"The IOM finds that the current 510(k) process is flawed based on its legislative foundation," said the report. "Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report."

FDA was quick to try to allay industry fears that such an important part of the device approval system would be abandoned.


July 29th, 2011

One day before its release, the IOM's report on the 510(k) is the subject of criticism. This is the most anticipated report of the year as the panel's recommendations could have far reaching effects.

Right now, though, it almost seems that what IOM says is beside the point. A story from the New York Times examines the vocal opposition from Congress and Indsutry representatives, reports Rick Merritt at EE Times. Merrit interviewed Ralph Hall, who acts as a legal adviser to medical device companies on a part time basis and has founded his own cardiac implant startup.

"I have absolutely no idea of the substance of the report, it's the IOM process I have concerns about," Hall told Merritt.

The IOM committee consists of physicians, academics, and lawyers who have worked with medical device clients. Hall takes umbrage to the fact that ...

July 28th, 2011

Earlier this week, I wrote a short editorial on the device tax that was sent out in our weekly newsletter. In it, I basically argued that the negative effects of the tax on the domestic medical device industry would be real, albeit not as severe as some have made them out to be.

I received a couple of persuasive e-mails from a professional working at the corporate level at a U.S. medical device / pharma company that provided a detailed look into the negative effects of the tax:


I don't know where you get your information, but I can tell you personally and professionally that it will have a devastating effect on the U.S. economy, U.S.-based medical device, and U.S.-based pharma companies.

A tax of that magnitude, for [our company] would be [millions upon millions] in just the first year and going up from there. [The tax] would cripple U.S. medical device and...

July 28th, 2011

Medical device manufacturer, Boston Scientific, will lay off 5–6% of staff for restructuring over the next two years. After reporting better than expected second-quarter profits, Boston Scientific announced a restructuring that will eliminate unnecessary administrative positions and production work, according to AP.

The company has said it will lose between 1200 and 1400 employees thorough 2013 through layoffs and attrition. The cuts could save Boston Scientific between $225 million and $275 million annually to be reinvested in other areas of the company. The company didn't specify which divisions would be cut.

The announcement is on the heels of Boston Scientific plan to expand operations in China, including the hire of up to 1,000...

July 28th, 2011

Medical device companies including GE Healthcare and Boston Scientific are investing in China to grow their businesses.

GE Healthcare is relocating its x-ray business headquarters from Waukesha, WI, to Beijing in an effort to take advantage of China's growing healthcare market. The company says China represents an important growth market, the Milwaukee Journal Sentinel reports. Around 20% of GE Healthcare's new x-ray products will be developed there, according to the paper.

The move follows the launch earlier this year of GE Healthcare's "Spring Wind" initiative aimed at improving the company's supply chain in China, as well as ramping up product development and training for healthcare providers in the country.

Healthcare Finance News reports that Boston Scientific is also...

July 27th, 2011

The global orthopedics industry has an annual growth rate of about 5% to 7% and approached $30 billion in 2010. Growth is driven by technological advances in implant design and materials, which are resulting in improved durability and are enabling younger patients undergoing surgery. “One of the largest growth segments in orthopedics for years to come is orthobiologics," says Andrew Humphreys, editor-in-chief of UBM Canon Data Products. "These substances are used by orthopedic surgeons to assist in quicker healing of patient injuries. This fast-growing segment unites reasonable costs with the most reliable and newest technology." The U.S. implantable medical device market is predicted to grow more than 8% annually through 2015, resulting from highly anticipated devices for the treatment and management of cardiovascular, orthopedic, neurological, ophthalmic, and other chronic disorders.

The molecular diagnostics market was valued at more than $10 billion...

July 27th, 2011