When it comes to medical devices, cybersecurity threat vectors aren’t limited to Bluetooth, WiFi, and other wireless technologies; the CPU is also vulnerable to attack.

Robert Caruso, CISSP

A common misconception about medical device cybersecurity is that the threat springs entirely from wireless communication. While Bluetooth, WiFi, Near-Field Communications, and Med Radio have increased the number of threat vectors for medical devices, the rising cybersecurity threat level is actually due to the same component that makes medical devices increasingly useful: the central processing unit (CPU). The smaller size and lower power requirements of today’s CPUs allow them to be placed in more devices, which provides capacity for both increased functionality and malicious intent.

Hackers do not...

March 10th, 2015
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Small and large medtech companies are dealing with the medical device tax in different ways.

A criticism of the 2.3% tax on medical device sales heaped on the medtech industry as part of the Affordable Care Act has been that it disproportionately impacts small companies, which are required to pay the levy even if they don’t turn a profit.

But small medtech firms were less likely than their larger counterparts to take steps to reduce the tax’s impact on their bottom line, according to a recent survey of 685 U.S. medical device executives by Emergo Group.

The reason could be twofold, the consulting firm posited: “Smaller companies have fewer options for dealing with costs of the tax, and it is less noticeable to them than [to] a large company.”

This infographic shows how companies of different sizes are...

March 10th, 2015
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UBM is accepting submissions for the MEDevice San Diego Conference, which will take place September 1–2, 2015. 

The 4th annual MEDevice San Diego Conference & Showcase will take place September 1–2, 2015 at the San Diego Marriott Marquis & Marina. We are pleased to announce the call for speakers to encourage sharing and collaboration on the latest innovations, strategies, and technologies in medical device product development and business development. Leaders in all areas of the medical device/medical technology space are encouraged to submit an application to earn a speaking opportunity at this premier industry forum.

Who Should Submit Papers to the MEDevice San Diego Conference?

...

March 6th, 2015
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Is the medtech industry taking the threat of cybersecurity seriously enough?

Jamie Hartford

Thanks to a software platform that analyzes the traffic to MD+DI’s Web site, we have a pretty good handle on what kinds of articles our audience likes to read. We know, for example, that we’re likely to get a big jump in page views any time we cover a story on jobs or compensation (especially if it involves a CEO). There’s also a predictable bump in traffic following a...

March 5th, 2015
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Orthopedics company Stryker has had a tough time integrating the MAKO business especially on the sales side, but the tide could be turning with a sales ramp.

Arundhati Parmar



Orthopedics company Stryker shelled out $1.65 billion in acquiring MAKO betting on a future where hip and knee surgeries would be robotically assisted.

It was a bold move, but by executives' own admission the sales integration has been tougher that expected. It's no surprise then that MAKO did not contribute much to overall revenue last year. A new...

March 5th, 2015
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To celebrate March Madness, we're pitting medtech startups head to head to see which one has what it takes to succeed.

To celebrate March Madness medtech-style, MD+DI is holding the first ever Medtech Startup Showdown, a tournament that will pit medical device startups head to head to see which one has what it takes to succeed.

Here’s how it works: We’ll organize startups into a tournament bracket, and each week give our readers the chance to vote for their favorites. The team in each bracket that gets the most votes will move on to the next round.

To be considered for the tournament, startups will need to fill out the form below and include a photo or mockup of their device. All answers and materials provided will be made public, with edits if necessary.

The winner...

March 4th, 2015
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Two examples provide clues to how technology is paving the way to tackle big healthcare problems globally. 

Arundhati Parmar

 

The challenges of global health are daunting: huge populations in remote locations with little-to-no infrastructure leading to tortured access to care and poor delivery.  

And yet advances in technology are attempting to narrow the chasm between the care that people can get in well-served locations worldwide and those in far-flung locations.

Here are two such examples, I recently came across:

The first comes courtesy of Smithosonian Magazine. The article talks about how researchers at Columbia University have developed a lab on a chip that can analyze a drop of blood from a fingerprick and when plugged into a smartphone test for HIV and syphilis...

March 4th, 2015
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The line between consumer a consumer mHealth app and a regulated medical device comes down to what kind of user data is being collected and how it’s being used.

Reade Harpham

When is an app more than an app? mHealth is one of the fastest-growing segments of the digital marketplace, with more than 100,000 health and fitness apps available in the Apple iTunes store alone and tens of millions of downloads each year. The vast majority are consumer-focused apps that are not subject to FDA regulation. But when developers cross the line and start providing medical information or advice, they enter a whole new world of liability and regulation. How do you know when your app has become a medical device? And what steps do mHealth developers need to take to reduce their risks?

The line between a...

March 4th, 2015
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Most everyone seems to understand what FDA does, but only a slight majority approve of its performance.

Marie Thibault

FDA comes out on top as the government agency whose role is best understood in a recent Harris Poll, but when it comes to rating how the agency does, opinions are pretty mixed.

Of the 2,232 U.S. adults surveyed, 92% said they understand what FDA does. This continues a trend of FDA being one of the most recognized government agencies in six prior surveys going back to 2000.

However, of those adults who know what FDA does, just 57% awarded the agency an “excellent / pretty good” rating on job performance. The other 43% said FDA does its job...

March 4th, 2015
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A Wall Street Journal article about Apple Watch and its health features leads to misinformation and misinterpretation about the wearable device. 

Arundhati Parmar

Apple is undoubtedly hoping that with its much-hyped Apple Watch set to launch next month, it will make wearables cooler and sticky - consumers wouldn't abandon them a few months after purchase as they are wont to do.

What they probably didn't expect was how misinformation would spread after a report about how some health features that were considered for the Apple Watch didn't make the final cut.

In mid February, the Wall Street Journal reported a story that explained that...

March 3rd, 2015
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