By Joe Pustka

Five years ago, makers of automation for assemblies could rarely make much of a dent in China. Labor was so cheap that no matter how time-consuming a task was for human eyes or hands to do it, automation—no matter how fast—could not compete. In just a few short years, that equation has changed. A good example is the automated inspection systems used for financial card manufacturing throughout the United States and Europe. A market previously inaccessible to makers of such sophisticated inspection technology involving high-end cameras, strobe lights, and very rapid handling systems, i.e. expensive components, now have inroads. That is likely also the reason why leading names in global manufacturing such as Caterpillar and NCR are reported to be coming home. Even hula hoops and Frisbees are...
October 4th, 2011
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Good economic news is scant these days. So it may be a bit unexpected that the U.S. manufacturing sector grew in September—for the second month straight. To be fair though, the numbers, which were released from the Institute for Supply Management, aren't overly impressive: the manufacutring index was 51.6 last month—a single point gain over August. A reading higher than 50 reflects growth.

Earlier this year, when the economy was more stable, the index topped 60 for four months running.

A recent report from Ernst & Young found that the medical device industry was mostly flat in 2010 (the 2011 results will be released about this time next year). The reasons for the lackluster results? High...

October 3rd, 2011
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Catherine M. Burzik is president and CEO of KCI. I got a chance to listen to her at AdvaMed 2011, and put together a video blog on her presentation.

Find out what Burzik had to say about mergers and acquisitions in the medical technology space. Her predictions for the rest of 2011 might surprise you.

Heather Thompson

October 3rd, 2011
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MD+DI Salary Survey. Photo by iStockphotoEach December, we release the results of our annual salary survey. This material is one of the most anticipated features of the year. So this year, we've decided to provide a sneak peek of the results. Click the links below to find top-line data on some of the critical factors that contribute to salary determination, as well as the average salaries and total compensation packages among our respondents.

Salary Survey: Regions. Learn where our respondents are most likely to be from. Their location says something about their salary intake.

...

October 3rd, 2011
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This Week in Devices

Here's the scoop on devices this week: FDA commisioner Margaret Hamburg expressed her support for the 510(k) process, EMDT reports on award-winning biomaterials research, Massdevice ran an article on how the device tax would likely affect employment, Medtronic won a big patent settlement, and recent report from Ernst & Young found that medtech markets are mostly flat.

September 30th, 2011
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The AdvaMed Medtech Conference was held September 26–28 in D.C. Drawing nearly 2000 executives from the medical device sector, the event featured a number of insightful presentations on topics ranging from the Affordable Care Act to VC funding. MD+DI editor Heather Thompson and a host of guest bloggers shared their take on our DeviceTalk blog. Below are some of highlights from the event:

September 29th, 2011
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By Tricia Rodewald 

In the medical technology space mergers and acquisitions (M&A) are as prevalent as peas and carrots. But with all the uncertainty in the industry today, will M&A continue to be as ubiquitous? And what do the leaders of companies look for when evaluating a company for potential acquisition or strategic alliance partnerships?
 
Thanks to AdvaMed 2011’s insightful CEOs Unplugged sessions, we were able to hear knowledgeable answers to those very questions:
 
Cathy Burzik (president and CEO, KCI)Regarding M&A, there’s still a strong appetite for technology—whether that be from small companies, universities, etc. I think that will continue. What’s healthcare reform upon us,...
September 29th, 2011
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By Tricia Rodewald

At an insightful AdvaMed 2011 panel discussion, investors weighed in on the state of medical device and diagnostics funding.
 
What’s the current environment for Angel Fund investors?
 
Allan May (Emergent Medical Partners): It’s a difficult time for medical device start-ups. The good news is that there’s a lot of money available in the system and, in general, medical device companies are being financed. Angel investors are particularly active in this area. 30%-35% of all the Angel groups in the country fund early-stage medtech investments and there are about 450 Angel groups active in the U.S. So there’s a strong interest in doing it.
 
The challenge is with Premarket Approvals (PMAs). The FDA,...
September 29th, 2011
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By Tricia Rodewald 

When three medtech industry leaders at AdvaMed 2011 were asked which countries they are likely to move their manufacturing process to, their answers weren’t what you’d expect.
 
There’s a lot of talk about China and India as the hotspots for manufacturing labor intensive products. However, it’s not all about low cost. In medtech especially, quality should not be overlooked.
 
Germany, Switzerland, and Eastern Europe are rapidly emerging as countries that offer high-level precision expertise. Even though they are high-cost labor locations, they have a high engineering component and the approval process is more efficient and timely.
 
According to Caroll Neubauer (B.Braun Medical Inc.) medical technology...
September 29th, 2011
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By Joe Rotino, VP of Quality and Regulatory Affairs at Pro-Dex

An important quote that came out of the AdvaMed panel, “Impact of 510(k) Review Process Changes” was:

“No mountain is insurmountable when you have the right approach.”
 
This appropriate, and timely statement was given by John Linehan, Professor of Biomedical Engineering at Northwestern University. Linehan is one of two investigators of a comprehensive analysis of the 510(k) process.
 
Over 355 people responded to this comprehensive survey which took 90 minutes per person to complete.
 
When asked, 45 percent of respondents said that, in the last three years, they’ve changed the way they’ve been approaching R&D in...
September 28th, 2011
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