Uson (Houston, TX), a provider of leak detection and testing equipment, now offers two new services to help medical device manufacturers choose equipment to suit their needs. The company’s Leak Detector Express Proposal service is suitable for most OEMs and especially for those looking to get new products to market quickly or equip new operations. It offers a 48-hour return on requests for proposals. Uson’s Leak Detection Equipment Custom Application is more appropriate for companies with unusual or challenging test specifications, such as multiple test pressure requirements. Both services are provided at no cost to customers.

August 9th, 2011
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As if the latest mini apocalypse on Wall Street weren't enough to goose up an ulcer or two, Goldman Sachs today gave the medical device sector an appraisal that was about as lackluster as possible, downgrading top companies and warning investors about the industry's uncertain future. The diagnosis was presented in contrast to the firm's rosy view of the medical supply industry, which it projects will enjoy stable growth.

From the Wall Street Journal:

As for medical-device makers, "Valuations are attractive on an absolute basis, but we struggle to see a near-term catalyst to drive shares higher," Goldman said... It had a more bullish view on the group coming out of the first quarter, but that changed on a weak economy, disappointing...

August 9th, 2011
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This week in medical devices, MPMN's Bob Michaels ponders the IOM's condemnation of the 510(k) process and Medtronic's announcement that it will fund a study by Yale of its controversial Infuse product, EMDT's Norbert Sparrow considers why hospitals may target medical devices when it comes to trimming their budgets, and MED's Jamie Hartford presents a little shot of optimism with a post on the young talent on display at NIWeek in Austin, TX. Enjoy.

  • 510(k) Is Dead—Long Live Medtronic's Review Agreement with Yale? (Medtech Pulse)
  • Why Hospitals Are Like the U.S. Congress (EMDT)
  • Students Shine at NIWeek (MED)
  • Injection molding empowers plastic lab-on-a-chip (Plastics Today)
  • Black hat hacker can remotely attack insulin pumps and kill people (CBS News)
  • Health fight will fire up Main Street (Politico)
     

 

August 5th, 2011
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In the summer of 2001 my 27 year old son, Randy, was at my place on a Sunday evening. We were watching an edition of Sunday night football and having some refreshments. Randy brought up the fact that there was a marathon in Colorado Springs planned for two weeks from that weekend. During the summer, we had both completed a couple of 5k’s but never anything longer. We naively decided that doing a marathon should be no big problem for us. After all, upon reviewing the course map, we noticed that it was all nearly down-hill.

So we enthusiastically signed up and arrived in Palmer Lake, Colorado at the appointed date and time. Needless to say, we had no concept of what we were in for. The first couple of miles were just fine but about the 12 mile marker, bad things began to happen. At mile 16, I totally cramped up in my right hamstring muscle and started to walk. I was unable to run anymore and I finished the course by...

August 5th, 2011
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This week at mddionline.com, William Meathrel and Ranjit Malik examine pressure-sensitive adhesive technologies used in in vitro diagnostics, Jim Dickinson details the gap between industry and FDA when it comes to MDUFA reauthorization, Heather Thompson has the latest on the IOM's 510(k) report, and Kay Sinclair and Natalie Scott discuss the importance of human factors.

August 2nd, 2011
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I’m not too optimistic about the device tax getting repealed. I think it’s best if companies assume that it won’t and I certainly wouldn’t recommend throwing big money at lobbying and policy efforts, at least not at this stage of the game.

I read the comments that were posted in a previous DeviceTalk entry from a worker at a major medical device firm. I’m not sure what firm he/she is working with, but it sounds like the firm is in a tight spot to begin with, regardless of the tax. Obviously the tax is going to have a negative effect on companies that are already teetering. The note is a little confusing because it asserts that the tax will cripple pharma companies as well as medical device companies....

August 1st, 2011
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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
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 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
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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
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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)
 
—Heather...

July 29th, 2011
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