Here’s how to cope with new EU Medical Device Regulations requiring unique device identification.

Peter Rose

Back in 2014, the Department of Health started to take tentative steps towards setting a standard for tracking medical implants, supplies, and instruments. Its Scan4Safety program mandated that all 154 acute trusts adopt GS1 identification keys. These keys, used across many industries, provide a unique identification code to any real-world entity making the process of identifying it completely unambiguous, which helps to reduce errors and streamline the supply process. In 2016, a further step was taken to roll out a barcoding scheme for medical implants such as breast implants and hip replacements. Reducing errors is expected to bring benefits to patients and help reduce costs...

April 10th, 2017
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Here are the four critical questions to ask before taking on the literature search and review process.

Scott Ahlberg

Whether your organization is about to bring a new medical device to market or preparing to submit a periodic safety update report, you must demonstrate that the device complies with all the relevant regulatory requirements. Additionally, more than establishing that the device delivers its intended benefits, you must also identify all known risks, capture any adverse events, and report the findings along with all the appropriate evidence.

It’s a big and difficult job, and one that relies upon efficient and effective processes—as well as experts to run those processes. And where auditors are concerned, process is the name of the game. Consequently,...

April 6th, 2017
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An executive details the applications of MR-guided focused ultrasound, a developing technology for noninvasive surgery.

Maurice R. Ferré, MD

Insightec's Exablate Neuro is used for focused ultrasound treatment.

Advancements in imaging technology over the past 30 years have enabled physicians to see what is happening inside a patient and make accurate diagnoses. The logical next step is to use this technology to facilitate actual treatments, which is becoming a reality as noninvasive surgery gains traction. Today, we find ourselves on the precipice of a major shift in the way physicians approach patient treatment and care.

MR-Guided Focused Ultrasound (MRgFUS): The Next Iteration of Ultrasound...

April 6th, 2017
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Medical device makers are uniquely affected by the 21st Century Cures Act, including at least one immediate impact. Here's what you need to know.

Brian Scogland

The  21st Century Cures Act left much for consideration and learning after being signed into law in December 2016. The Cures Act authorized $6.3 billon in scientific funding and has been closely scrutinized for its impact on patients and the healthcare industry overall. Manufacturers of medical devices were impacted uniquely by the act.

I work closely with several global device manufacturers and my colleagues and I are closely monitoring the long-term impact of...

April 4th, 2017
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Applied Nanoscience Inc.

vs.

Acutus Medical

 

 

Describe your device and how it will benefit healthcare.

 

 

 

...
April 3rd, 2017
0
 

Admetsys

vs.

MedicusTek USA Corp.

 

 

 

Describe your device and how it will benefit healthcare.

 

 

 

 

 

 

 

 

 

 

 

 

 

In the last three decades,...

April 3rd, 2017
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Find out which medtech companies advanced to the third round of our startup tournament. Your votes have gotten them this far. Now, pick the two startups you want to see in the final round!

Marie Thibault

Our Medtech Startup Showdown is underway and readers have voted for their favorites companies from Round 1 and Round 2 of the tournament. Now, it's time for Round 3!

This week, these four remaining companies will face off against each other: Applied Nanoscience Inc., Acutus Medical, Admetsys, and...

April 3rd, 2017
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A physician-researcher details why new digital health products need to be informed by a combination of academic insight, industry innovation, and patient perspectives. Here's what he believes is lacking today and how the industry can move forward.

Michael Cohen-Wolkowiez, MD, PhD

Digital health technologies are enjoying widespread popularity, and the consumer market for these products has seen strong growth in recent years. Recent data from Pew Research shows that roughly 80% of U.S. mobile phone users own a smartphone, and a 2015 national survey of mobile phone users found that nearly 60% had downloaded a...

April 2nd, 2017
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Access is everything when it comes to achieving success in emerging market economies. Here are the challenges and ways to overcome hurdles in emerging markets, and why it may be time for medical device companies to employ a Chief Access Officer.

Robert Hall

It’s been three years since the emerging markets overtook the EU5 economies (Germany, France, Italy, the United Kingdom, and Spain) in healthcare spending. In pharma alone, the emerging markets boast a total market size of $281 billion compared with the EU5’s $196 billion in 2014. As developed economies continue to squeeze healthcare funding, governments in many emerging markets are making healthcare a priority. They are investing in infrastructure, funding...

March 30th, 2017
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Medical technology continues to lead other fields in terms of commercialization, as medical technology innovators remained at the top of the European Patent Office's patent protection rankings last year. 

Thomas Prock

The recent publication of the European Patent Office’s Annual Report shows that medical technology continues to lead other fields in terms of commercialization, as medical technology innovators remained at the top of the patent protection rankings last year. In 2016, more European patent applications were filed for medical technology than for any other type of technology, including digital communication, biotechnology, and pharmaceuticals. Medical technology has led the pack since 2007, when it first overtook computer technology as the field with most...

March 28th, 2017
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