Editorial
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Damning Documentary or Tugging at Heartstrings? A Look at ‘The Bleeding Edge’
Recently, I watched the controversial medical device industry documentary, “The Bleeding Edge,” featured on Netflix. For those who have not had the opportunity to view it, I would certainly encourage you to do so. I would also encourage y…Sean Fenske, Editor-in-Chief 09.07.18
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Strategic Refocusing
What was I just saying in my Letter last issue? The more things change…? Well, it holds true going forward in this issue too—our annual Top Companies report. This expansive offering provides an in-depth look at the happenings within the…Sean Fenske, Editor-in-Chief 07.27.18
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The More Things Change…
For many, an anniversary presents an obvious time to reflect on the past—what’s been accomplished, where you’ve been, memories you’ve had. For me, MPO’s 15th anniversary is an unusual situation. While I was writing about…Sean Fenske, Editor-in-Chief 06.04.18
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Diagnostics | Digital Health | Electronics | Patient Monitoring | Software & IT
The Power of My Voice
“Help! I’ve fallen and I can’t get up.” That phrase represents the first experience or familiarity many people have with a voice-enabled medical device. In reality, the Life Alert system is triggered by a button worn around th…Sean Fenske, Editor-in-Chief 05.03.18
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Will Regulatory Transitions Cause Some to Change Course?
Now, perhaps more than ever before, there are significant changes occurring to the worldwide regulatory landscape, all within a relatively small window. This includes FDA, the EU’s MDR, Asia (see the article in this issue on India’s new r…Sean Fenske, Editor-in-Chief 04.03.18
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3D/Additive Manufacturing
A Vision of Healthcare’s Future…in 3D
Additive manufacturing has already made a significant impact in the area of medical device manufacturing, but what we’ve experienced thus far could merely be the tip of the iceberg. I’ve spoken to members of the industry about what I fore…Sean Fenske, Editor-in-Chief 03.14.18
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Investing Time in San Francisco
I considered writing this Letter on the passage of the legislation that suspends the medical device excise tax for another two years (literally just happened last night, at the time I’m writing this), but since we’ve already been down tha…Sean Fenske, Editor 01.29.18
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Fifteen Years Later, the Growth and Vision Continues
It seems like only yesterday I was writing my very first publisher’s letter back in 2003. It’s hard to believe we are about to celebrate 15 years of publishing MPO in 2018. Just like in 2003, I still enjoy reflecting on hig…Howard Revitch, Group Publisher 01.12.18
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Too Big to Fail
That headline is immediately identifiable by many as it has become synonymous with the financial crisis of 2008. The phrase was then made in reference to the banks some thought had grown too large to be allowed to follow Lehman Brothers’ lead a…Sean Fenske, Editor 11.07.17
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Droning on About Medtech
The consumer drones we see today have become quite commonplace in a very short period of time. They help capture spectacular views that can be shared via YouTube, increase the visual dynamic of nightly news stories, and have even provided Peeping Tom…Sean Fenske, Editor 10.05.17
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R&D & Design
The Way Ahead for Outsourcing R&D
The overwhelming consensus of the medtech community is that innovation is the lifeblood of the industry. Without it, company revenues stagnate, healthcare quality and efficiency plateaus, and new challenges go unmet. It is vital for medical device co…Sean Fenske, Editor 09.01.17
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
Perspective (Trends at the Top 2017): Findings of the Top 30
Time breeds perspective if you stare at something long enough. I’ve been staring at the medical device industry since 1999. At that time, the first “trend” I observed was the industry reacting to the threat of Y2K. (I’d ventur…Sean Fenske, Editor 07.26.17
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Digital Health | R&D & Design | Software & IT | Testing
Hire a Hacker
The Internet of Things (IoT) has brought an array of connected technologies that offer a bevy of benefits. From the seemingly superficial, such as a refrigerator that automatically tracks its contents and updates your grocery list appropriately, to t…Sean Fenske, Editor 06.06.17
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Diagnostics | Digital Health | Patient Monitoring
Give and Take with the Tech Industry
There’s been a fair amount said regarding the tech industry’s entrance into healthcare, including the emergence of partnerships with traditional medtech firms. What’s also been discussed are the benefits these tech leaders gain from…Sean Fenske, Editor 05.01.17
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The Tax that Wouldn’t Die
With the recent “pull back” of the Republican healthcare replacement plan, the Affordable Care Act (ACA) doesn’t appear to be on its way out as quickly as some anticipated. While those who keep their coverage as a result may be plea…Sean Fenske, Editor 04.03.17
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical | Testing
In Pursuit of Device Safety or a Call for Whistleblowers?
Late last year, Jeffrey Shuren, M.D., J.D., the U.S. Food and Drug Administration’s (FDA) director of the Center for Devices and Radiological Health, penned a blog for the FDA Voice (http://bit.ly/mpo031750) regarding the coordination between t…Sean Fenske, Editor 03.07.17
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Software & IT
New Year’s Resolutions for Industry
If you’re like me, you balk at making any resolutions at the start of a new year. If you want to make a change to yourself, make it; don’t be held hostage by the date on your calendar. That aside, for the medtech industry as a whole, ther…Sean Fenske, Editor 01.30.17
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Software & IT
Lessons Learned
In a short time, we’ll close out 2016, a year that’s seen change in the medical device industry. Fortunately overall, I’d say there have been more positives than negatives, but there’s still work to be done. The device tax, al…Sean Fenske, Editor 11.08.16
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Software & IT | Testing
Hacking Medtech: Not a Question of When, but Who Will Be First?
Well, it’s happened yet again. I’m not referring to another acquisition (although there were a few of those recently that you’ll find in Top of the News). Rather, I’m speaking of a cybersecurity concern that was much ado about…Sean Fenske, Editor 10.12.16
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Capitalism and Healthcare Make for Strange Bedfellows
Perhaps “strange” isn’t the right word; “inconvenient” bedfellows might be better. Either way, it expresses the intended idea. That is, the goal of capitalism is not always congruent with the idealized goals of healthcar…Sean Fenske, Editor 09.08.16
