A reader with a username of "steinp1" recently left a comment to our post titled "Goldman Sachs Sees Gloomy Future for Medical Device Industry" that caught my attention. He writes:

When corporations only look to extremely expensive acquisitions for all of their innovation and new sources of revenue, and when corporations shed their most experienced people, the ones who got them to where they are today, to save money for those acquisitions, how else is anyone to view them [but negatively]? Finally, someone is stating the obvious - that the ludicrous business plan that Medtronic, Boston Scientific, St. Jude Medical, etc. have been following for the past couple of decades is unsustainable and, indeed, detrimental.

Real, internal innovation [in the medtech industry] is now non-existent. The major players in the medical device...

August 11th, 2011
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Following up on last month's report detailing general venture capital trends, PricewaterhouseCoopers has released a report focusing on venture capital spending in the life sciences industries specifically, including the medical device industry. The overall numbers still look good; as we discussed previously on the Orthotec blog, life sciences attracted $2.1 billion in the second quarter of 2011 (a 37% increase from the previous quarter), and $841 million went into medical devices (a 26% bump from the first quarter). But a more detailed examination reveals a more complex picture.

First, second-quarter funding in life sciences dipped 3% from 2010 to 2011 in terms of total dollars and fell 21% in terms of deal volume. The...

August 11th, 2011
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When the Institute of Medicine (IOM) recommended that the 510(k) program be scrapped, it came as something of a surprise. FDA quickly defended the program, stating that it had no plans of doing away with it. AdvaMed disputed the finding, as did Minnesota senators Amy Klobuchar and Al Franken and representative Erik Paulsen, who released a joint statement disputing the IOM's decision. 

Now, however, the New England Journal of Medicine is coming to the defense of IOM. The authors of that journal explained that the finding was “insightful, judicious, sensible, and long overdue.” They further recommended that FDA “initiate an action plan with Congressional support to adopt these important recommendations.”

The authors explain their rationale for that conclusion over on Health...

August 10th, 2011
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Recent articles posted to MD+DI consider criticism of FDA's management of device recalls, minimizing static-attraction problems during manufacturing, and pressure on FDA to develop an artificial pancreas.

August 10th, 2011
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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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