Editorial
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Contract Manufacturing
The Evolution of Outsourcing
According to Grand View Research, the global medical device outsourcing market was valued at $94.2 billion last year and is anticipated to grow at a very healthy 10.5 percent CAGR through 2026. That analysis includes contract manufacturing, regulator…Sean Fenske, Editor-in-Chief 05.01.19
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Diagnostics
Fake It Until You Make It: Comments on the Theranos Documentary
Anyone who has already seen the documentary running on HBO, “The Inventor: Out for Blood in Silicon Valley,” will likely recognize the phrase I used as the headline for this issue’s Letter. While it’s not new or unique to that…Sean Fenske, Editor-in-Chief 04.03.19
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Going Beyond the Conversation in Addressing the Skills Gap
Unless you’ve gone willfully about without reading any news, watching television, surfing the internet, or speaking with colleagues, you’ve undoubtedly heard about the growing skills gap (or labor shortage or whatever other term you want…Sean Fenske, Editor-in-Chief 03.07.19
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Continuing on the 510(k) Pathway or Finding a Different Route?
In my last Editor’s Letter, one of my “holiday wish list” items for 2019 was an improved industry image. To the general public, that includes the FDA and its oversight and regulations tied to medical devices. As such, efforts to enh…Sean Fenske, Editor-in-Chief 01.30.19
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The Sun Will Shine Again: Preparing for Change
Change is not typically something many have an easy time with. I know for me personally, it can present a challenge. The changing of clocks after Halloween, for example, can be a bit depressing as the days seem to shorten very quickly. It’s alw…Howard Revitch, Group Publisher 01.03.19
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My Holiday Wish List (for Industry)
It’s unbelievable to realize I’m once again writing an end-of-the-year Editor’s Letter; 2018 seemed to pass by in a blur. All good things…well, you know. The timing does, however, offer the opportunity to consider my 2018…Sean Fenske, Editor-in-Chief 11.26.18
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3D/Additive Manufacturing | Surgical
Regulating the Practice of Medicine
In the latest issue of MPO’s sister publication, Orthopedic Design & Technology (ODT), my Editor’s Letter posed a question regarding regulatory approval of implants. Specifically, I wondered if all implanted devices should be required…Sean Fenske, Editor-in-Chief 10.16.18
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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
