Offshoring can help manufacturers cut costs and get their products to patients in emerging economies around the world. But it's not the right move in every instance.

Get more advice on best practices for medtechoutsourcing at MD&M Minneapolis, October 29 & 30, 2014.

In general, says Julia Wall, an analyst with Decision Research Group, medical devices of moderate complexity are best suited for outsourcing to offshore entities.

“If you look at FDA’s classification of devices, Class I, II, and III, the devices...

August 1st, 2014
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In a recent conversation with a device industry professional, it became clear how the reality on the ground for device vendors has shifted in the last few years.

The gentleman enlightened me that the nonprofit Fairview Health Services, a large health system in Minnesota, had dramatically reduced the number of orthopedic vendors.

“I would love to know why they did that,” said Shaye Mandle, President & CEO of Lifescience Alley, in a recent interview.

Mandle knows the answer of course - every hospital and health system in the country is scrutinizing costs, and in many cases either pressuring vendors to lower their cost or share in some operational risk.

Nonetheless, it’s still an interesting exercise to know how hospitals are making these...

July 31st, 2014
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By Stephen B. Wilcox, PhD, FIDSA

There have always been human factors issues associated with medical packaging, particularly packaging designed for use by patients, as opposed to medical professionals. For example, packaging designers have struggled for years with making packaging easy to use for target users while still making it childproof. The catch, of course, is that target users may suffer from disabilities like compromised dexterity or vision problems, or even cognitive deficits, by virtue of the very conditions—such as diabetes, glaucoma, and heart failure—that their medical devices or drugs are designed to address.

Stephen B. Wilcox, Ph.D., FIDSA

Thus, the...

July 30th, 2014
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Today terms such as EMRs and EHRs are ubiquiitous, but the discipline of health informatics, which includes these systems, is not even 100 years old.

The infographic below created by Adelphi University draws on several sources to show that the history of health informatics dates back to 1949 when Dr. Gustav Wagner in Germany established the German Society for Medical Documentation, Computer Science and Statistics, the world's first professional association for informatics.

This led to the spread of health informatics as a formal discipline in Europe and elsewhere. And now, a whole new world has opened up in informatics with the rapid adoption of tablets to maintain and use EMRs.

See below for more milestones...

July 25th, 2014
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Earlier this month the Centers for Medicare and Medicaid Services released four new proposals to amend portions of the Sunshine Act.

There are four proposed changes:

a) Eliminate the continuing medical education (CME) exclusion from reporting requirements.
b) Require companies to specify the marketed name of a drug, device, biologic or medical supply associated with a certain payment whereas previously companies could simply identify the therapeutic area or product category.
c) Require companies to report  to report stock, stock options or any other ownership interest as distinct categories.
d) Eliminate the definition of "covered device."

As many experts responded, the ink is barely dry...

July 23rd, 2014
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Chronic disease is typically not assiciated with slim-legged, flat-bellied beauty.

And yet, that is exactly the conversation that Type 1 Diabetic and Miss Idaho contestant chose to have when she donned a black swimsuit and wore her tslim touchscreen insulin pump from Tandem Diabetes proudly on stage. 

But Sierra Sandison, the newly crowned Miss Idaho, didn't stop there. She posted her picture on Instagram with a short write-up and launched the hashtag #showmeyourpump thereby issuing  a clarion to call to diabetics. Here is what she wrote on Instagram along with posting the above photo: 

There it is. I would never have dreamt of posting a swimsuit picture on social media, but diabetics from all over the country have been asking to see me and my insulin pump on the #MissIdaho2014 stage. Honestly, it is...

July 21st, 2014
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Few surgeons know the price of implantable devices such as orthopedic implants, which are among the most expensive medical devices, often blamed for contributing to rising overall healthcare costs.

Separately, the federal government has been investigating the overuse of implantable defibrillators by surgeons for the past four years and that has lessened the number of procedures.

Still, neither a government investigation nor surprising study results showing the lack of pricing awareness of orthopedic surgeons is going to meaningfully bend the overall cost curve of healthcare. 

Reigning in costs has to...

July 18th, 2014
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It is puncture itself that causes risk.” That is a quote from H.C. Jacobaeus, the first person to perform a laparoscopic surgery on a human. Over a century after Jacobaeus said this we are still grappling with surgical complications from punctures. Trocar insertion errors, for example, account for the largest number of complications related to laparoscopic surgery. Nikolai Begg, a PhD student in mechanical engineering at MIT, hopes that his novel device – a “flexure-based puncture access mechanism” - will take the danger out of procedures that Begg likens to drilling through a piece of wood or inserting a straw into a Capri Sun drink to his TEDxBeaconStreet talk.

...
July 16th, 2014
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Germany has more to brag about than a World Cup championship (thanks to a late-game goal that put the nail in Argentina's coffin in the final). The country is also home to a thriving medical device industry showing impressive strength in all areas ranging from R&D and medtech startups to regulation and market growth. While the eurozone crisis and global recession crippled some countries and brought others to their knees, fiscally conservative Germany has weathered the storm and maintained a growing healthcare sector.
 
Here are some of the must-read stories on the trends and companies that are marking Germany's medical device industry.
 
 
What's Germany's Secret?
 
What...
July 14th, 2014
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St. Jude Medical's CardioMEMS acquisition brought to the Minnesota device a breakthrough heart monitoring device meant to serve as an early alert system for chronic heart failure patients. The FDA recently cleared it.

The CardioMEMS implantable sensor

In a clinical trial of 550 patients, the CardioMEMS system, the world...

July 14th, 2014
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