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Articles from 2016 In August

These 3-D Printed Polymers Have Shape-Memory Abilities

MIT engineers have developed three-dimensional structures that can "remember" their original shapes, even after being stretched, bent, and twisted at extreme angles.

Kristopher Sturgis

MIT Shape Memory Gripper

Researchers at MIT have created 3-D printed multimaterial structures, made of shape-memory polymer materials, that are able to spring back to their original form within seconds of being heated to a specific temperature.

Engineers used light to 3-D print a variety of different structures with features as small as the diameter of a human hair--dimensions that are merely one-tenth the size of any previously printed structures from shape-memory materials, according to MIT.

Nicholas X. Fang, associate professor of mechanical engineering at MIT and one of the authors on the research, explained how these structures could have an impact on medical devices and drug delivery vehicles.

"Our technology enables micro-scale 3-D fabrication," he said. "Which, on one hand allows us to print 3-D medical devices whose structure on the millimeter scale is compatible to the human esophagus artery and intestinal canal. On the other hand, the refined microstructure can react quickly to release drugs with a more precise dosage. This technology combines 3-D printing with shape memory polymers, making 3-D printed structures shape-changeable--which could have medical applications such as stents, heart valves, and septal defect occluders."

How 3-D Printing Will Transform Medtech

Find out how process innovations in 3-D printing are enabling next-generation medical devices at the MD&M Minneapolis conference on September 22. Qmed readers get 20% off with promo code Qmed16.

Fang and his colleagues believe that shape-memory polymers that can predictably change shape in response to temperature could be ideal for these kinds of applications. He says that these materials offer the kind of structural shape and resilience to perform valuable functions, and the process is remarkably simple.

"The trick we are playing is pretty similar to inserting a flying Dutch ship into a glass bottle," Fang says. "The class of materials are thermoset polymer networks similar to epoxy. When the network is heated to temperatures above glass transition temperature, the polymer networks can move freely as entangled spaghetti, making the structure soft and deformable. In the reverse process, when you cool the sample to below glass transition temperature, the networks are frozen so the material is rigid and strong."

MIT Shape Memory PolymerFang says that using this mechanism, they can specifically program 3-D printed structures by deforming them at high temperatures, and then freezing the deformed shapes quickly. Then, once the structure is heated back to the higher temperature, the polymer network will spring back to its original shape. The next step was to devise a way to trigger these materials to spring into action inside the body.

"We think one possible way to activate shape memory polymers inside the body is through temperature changes, like a fever," Fang says. "Another possible way to activate shape change is to use pH sensitive materials to replace shape memory polymers. So far our material cannot be absorbed naturally by the body, but we have made plans to use biodegradable shape memory polymers to 3-D print medical devices."

3-D printing technologies continue to evolve, as more and more researchers experiment with new materials to explore the potential and various possibilities of novel 3-D printed solutions. While Fang admits that there are a few other 3-D printing technologies that use shape-memory polymer materials, he maintains that their method uses materials with superior properties when it comes to stretchability and tunability of glass transition temperature. He also says that his group has plans to modify the current system to realize mass production, which should further reduce the cost while also increasing the speed of manufacturing.

"All the devices, parts, and materials used in this technology are commercially available," he says. "In order to move forward with our research, we are looking for collaborators from hospitals and medical schools to help us conduct clinical studies and provide the useful feedback we need about the feasibility of our method, so we can work toward more medical applications." 

Kristopher Sturgis is a contributor to Qmed.

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[Images courtesy of MIT]

Where Is Medtech Pay the Best?

Hint: The answer isn't California.

Money in HandChris Newmarker

Massachusetts is tops when it comes to average salaries for medical device industry professionals, and medtech insiders in Texas appear to be getting a good deal, too, according to a Qmed analysis of data from MD+DI's Medtech Salary Survey 2016. (Download a copy of the full report here.)

Medical device professionals in California? They kind of seem to be getting the short end of the stick. 

This needs more explanation. But first, here's a chart showing the average annual salaries from the five major medtech states that had large response rates in the survey:

United States$126,176

The reason why average medtech salaries aren't looking super in California, even though they are above the national average, is because the Golden State has one of the highest costs of living in the country. In CNBC's America's Top States for Business 2015 scorecard, California had a rank of 46 for cost of living, worse than any of the other four states listed here. (Minnesota was actually No. 1 for cost of living, so its pay is actually competitive.) 

Some playing around on Bankrate's Cost of Living Calculator illustrates the situation even more. A $132,149 a year salary in Los Angeles comes to about $102,000 in Minneapolis and $136,000 in Boston. If the $132,149 salary were in San Francisco, it would be about $81,000 in Minneapolis and $132,000 in Boston.

There's one important caveat related to methodology: California had a much larger sample size than the other states, so perhaps the smaller groups of medtech professionals responding in the other states were skewed more toward those with higher salaries.

Still it's worth noting that California down at third place when it came to the percentage of respondents saying they were satisfied or very satisfied with their jobs:

Texas 77%
United States74%

On the flip side, look how happy the Texans are. And there's little to wonder here. Someone in Austin making $137,000 a year is earning the equivalent of about $200,000 in Los Angeles, $252,000 in San Francisco, $206,000 in Boston, and $154,000 in Minneapolis, according to the Bankrate calculator. So perhaps you need to develop a taste for breakfast burritos and barbecued beef (and a really awesome music scene), and move to the Lone Star State. 

Want to find out more about how the top U.S. medical device hubs stack up? Check out Qmed's roundup of top cities for medtech innovation. And learn more about how your salary stacks up with a full copy of MD+DI's Medtech Salary Survey 2016.

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image courtesy of Tax Credits on Flickr]

St. Jude Medical May Not Have a Cybersecurity Problem After All

Error alerts triggered by simulated attack are actually what show up when the St. Jude cardio device isn't plugged in, researchers say.

Nancy Crotti

University of Michigan Muddy Waters St. JudeUniversity of Michigan researchers have shot some holes into allegations that St. Jude Medical cardiac devices are vulnerable to cyberattacks.

The researchers reproduced experiments that led to the allegations and came to "strikingly different conclusions," according to a report from the university.

Short-selling investment firm Muddy Waters Capital LLC and medtech security firm MedSec Ltd. made the allegations of security flaws in a host of St. Jude cardiac devices last week, prompting a swift denial from St. Jude even as the Minnesota-based company took a hit on its stock price.

Then Muddy Waters posted a video that it claims shows the hacking of a St. Jude pacemaker. St. Jude said the video showed a safety feature, not a flaw, and demonstrated "their fundamental lack of understanding" of the company's technology.

St. Jude said its devices are designed to go into a "safe" mode if unexpected conditions are detected, in which the pre-programmed pacing and defibrillation functions of the devices revert to safe settings. Some devices disable further radio frequency communications for a period of time, "which may appear to the untrained eye as having rendered the device disabled, although it continues to function," the company said in a statement.

Now come the Michigan researchers, who say the error messages that Muddy Waters cites as evidence of a successful "crash attack" into a home-monitored implantable cardiac defibrillator are actually the error alerts that display if the device isn't properly plugged in. The research team includes several leading medical device security researchers and a cardiologist from the the university health system's Frankel Cardiovascular Center.

"We're not saying the report is false. We're saying it's inconclusive because the evidence does not support their conclusions. We were able to generate the reported conditions without there being a security issue," said Kevin Fu,  an associate professor of computer science and engineering and director of the Archimedes Center for Medical Device Security at the university. Fu is also co-founder of medical device security startup Virta Labs.

Structural Heart Opportunities and Challenges

TAVR and TMVR are among the hottest technologies in medtech right now. Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21. Qmed readers get 20% off with promo code Qmed16.

The Michigan team used a new, properly functioning model of the defibrillator that the Muddy Waters study used--the Fortify Assura VR. In several additional instances, they say the device operated properly, but they didn't go as far as to declare the St. Jude devices or any others completely secure.

A defibrillator's electrodes are connected to heart tissue by wires that are woven through blood vessels. The wires enable implantable defibrillators to perform sensing operations and send shocks if necessary.

"When these wires are disconnected, the device generates a series of error messages: two indicate high impedance, and a third indicates that the (device) is interfering with itself," said Denis Foo Kune, a former university postdoctoral researcher and co-founder of Virta Labs.

Muddy Waters claims these error messages are proof of a security breach, but the Michigan researchers said they believe the device is acting correctly.

"To the armchair engineer it may look startling, but to a clinician it just means you didn't plug it in," Fu said in the university statement. "In layman's terms, it's like claiming that hackers took over your computer, but then later discovering that you simply forgot to plug in your keyboard."

The dustup occurs as St. Jude prepares for a $25 billion takeover by Abbott Laboratories. An Abbott spokeswoman said in an email that the company continues to "collaborate with St. Jude to advance the transaction."

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of University of Michigan]

Medtech Salary Survey 2016

Medtech Salary Survey 2016

Is your medtech salary in line with what your colleagues are making? Wondering whether you should ask for a raise or if you're being compensated fairly?

That's where the annual MD+DI Medtech Salary Survey comes in handy.

MD+DI asked medical device and diagnostic industry professionals to share information about how much they make for our annual Medtech Salary Survey. Almost 700 full-time professionals responded. 

Here are this year's results.

Learn about "Best Practices in Developing Products Within a Highly Regulated Environment" at the MD&M Minneapolis Conference, September 21-22.


Medtech Salary Survey 2016: Median Salary

Median Salary

The median salary for a medtech professional in 2016 is $118,750.
Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description. 

Medtech Salary Survey 2016: Median Salary by Company Size

Median Salary by Company Size

The median salaries at the smallest and largest companies are higher than those at mid-sized companies.        
Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description. 

Medtech Salary Survey 2016: Median Salary by Experience

Median Salary by Experience

Median salaries increase as medtech employees gain more experience.
Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description. 

Medtech Salary Survey 2016: Median Salary by Gender

Median Salary by Gender

The gender gap remains in medtech as the median salary for women in the industry is significantly lower than that for men. 
Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description.

Medtech Salary Survey 2016: Median Salary by Employees Supervised

Median Salary by Employees Supervised

More responsibility pays off. Median salaries increase as medtech employees supervise more colleagues.
Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description. 

Medtech Salary Survey 2016: Median Raise

Median Raise

More than 75% of fulltime medtech employees reported receiving a raise over the past 12 months. The median raise among those respondents was 3%.
Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description.