From the Editor

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From the Editor: Medical
When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process for...
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From the Editor: Regulations/Standards
Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But...
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From the Editor: Electronics & Computers
The IoMT has ushered in a new era for connected medical technology. But battery life is often mentioned as one of the impediments to the...
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From the Editor: Medical
With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), medical device makers “lack understanding of the new rules...
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From the Editor: Software
In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and...
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From the Editor: Regulations/Standards
Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid crisis.
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From the Editor: Medical
New research has confirmed what device companies have been saying since the medical device excise tax was imposed on medical devices as part of the Affordable Care Act:...
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From the Editor: AR/AI
The medical device industry’s active M&A market and uncrowded investment space make it attractive for investors looking to get...
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From the Editor: Medical
I am truly excited about this month’s inaugural MedInnovation conference. It’s goal is to present a roadmap for getting innovative — and by that, I mean game changing...
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From the Editor: Software
A virtual reality system for training surgeons is gaining traction with major medical device companies looking to mitigate misuse and liability concerns.
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From the Editor: Medical
A new interactive conference will address key strategies for the commercialization of emerging medical technologies, and its unique...
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From the Editor: Medical
In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design...
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From the Editor: Regulations/Standards
FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant...
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From the Editor: Sensors/Data Acquisition
The integration of robotics into medical devices has seen explosive growth in recent years with new applications in areas such as prosthetics and rehabilitation,...
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From the Editor: Medical
FDA has qualified the first tool under its new Medical Device Development Tool (MDDT) program. According to AAMI, after some 20 years of use, manufacturers of devices...
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From the Editor: Medical
In this world of increasingly smart technology, the one place that interconnectivity is critical is in healthcare. Patients and their care givers should be confident that the...
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From the Editor: AR/AI
The Future of Medical Manufacturing implementing automation. It is embracing 3D printing, Industry 4.0, the Internet of Things, artificial intelligence (AI), and even augmented reality —...
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From the Editor: Medical
Medtech M&A on the Rise Again
It appears that the medtech industry has responded to a healthier market by going on a shopping spree. According to EP Vantage, a service of market analysis firm Evaluate, medtech mergers are back. EP says that the sum spent on deals in the first half of 2017 has already surpassed last year’s total, “putting 2017...
From the Editor: Medical
MedAccred Makes Its Mark
The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute.
From the Editor: Medical
Your Cyberattack Wake-Up Call
We’ve been hacked. Forbes reports that the WannaCry ransomware did, in fact, infect a Bayer Medrad radiology power injector in U.S. hospitals. Thankfully, no safety-related functions were affected directly, but what about next time?
From the Editor: Medical
The Internet of Dangerous Things
“The dangerous world we live in is one where the embedded systems that we build are increasingly a battlefield, a place where anonymous hackers are able to remotely injure and potentially kill people on the other side of the world because dangerous devices are connected to the Internet.” Barr Group CTO Michael...
From the Editor: Regulations/Standards
Permanent Device Tax Repeal Is ‘Highest Priority’
Incoming AdvaMed chairman Nadim Yared will continue AdvaMed’s drive to ensure a permanent repeal of the medical device excise tax, calling it his “highest priority” heading into his term as chairman. Yared, who is president and CEO of CVRx, spoke at a press conference in April.
From the Editor: Medical
Confidence High, but Concerns Remain
A recent forecast indicates a mostly positive outlook for the international medtech industry but highlights a few areas that will present challenges going forward. The “8th Thinking Ahead! LIMEDex Index Report” was authored by Beatus Hofrichter, found - er and managing partner of conceplus, a medtech think...
From the Editor: Sensors/Data Acquisition
And the Winners Are...
In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design engineering community in 2016. The selected products reflect advances that enable new innovations in medical technology. Here are...
From the Editor: Medical
As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of...
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From the Editor: Medical
In late August, short-selling investment firm Muddy Waters issued an alarming report claiming that St. Jude Medical’s pacemakers, ICDs, and CRTs “should be...
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From the Editor: Communications
Building on Success
From its first issue to today, the mission of Medical Design Briefs has been to provide our design engineering readers with information on the latest technology advances in medical devices, instruments, and systems from sources worldwide. With readers at the front end of the product development process, MDB has helped spark the...
From the Editor: Design
Good News/Sad News
For much of our recent Editorial & Sales Meeting, we discussed trends that we are seeing in the marketplace, in the news, and in discussion with contributors to evaluate coverage for this year and to help sharpen our editorial focus for next year. Manufacturing will continue to see greater coverage as we increase the...
From the Editor: Medical
Peeking in on Surgery
Virtual reality (VR) is back in the news again with the recent releases of the Oculus Rift and the HTC Vive, which both offer a realistic VR experience powered by a gaming computer. By wearing a somewhat bulky headset, users are able to immerse themselves into a world that allows them to interact with virtual objects with some...

Ask the Expert

Ralph Bright on the Power of Power Cords
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Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

Inside Story

Inside Story: Trends in Packaging and Sterilization
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Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.

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