What don't medical device makers do because they have figured out how to get away with not doing it?

By William A. Hyman

 

Back in the ancient days of 2006, I wrote a commentary in MD+DI entitled “What Wouldn’t You Do If FDA Didn’t Make You?” That piece arose from the multiple times I had heard medical device professionals and researchers suggest that they would take a faster (i.e., riskier) course if not for FDA stopping them or, perhaps, catching them.

Learn how to avoid regulatory pitfalls with early clinical involvement at ...
April 17th, 2014
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If the concept of wearable technology has lately entered your consiciousness and you believe that it is a 21st Century phenomenon, you would be dead wrong.

In fact the infographic below, presented by Vandrico Inc., traces the first instance of wearable technology back to 1644 when the Qing Dynasty miniaturized the abacus and put it in a ring. Even back then, they got it right about what constitutes a true wearable - it needs to be controlled by the user/consumer.

Learn more about the new era of consumerization and usability at the MD&M East Conference and Expo, June 9, New York City. 

The abacus-in-a-ring was wearable technologies'...

April 17th, 2014
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MD&M Texas will be hosting Learning Labs aimed at informing and inspiring attendees about the latest trends and technologies that are impacting medical manufacturing and technology.

The conference and trade show takes place May 7–8, 2014, in Fort Worth, TX.

Here are some of the hot topics that will be covered at the conference.
 
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April 4th, 2014
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Managing heart failure patients has become such a priority at hospitals that even device companies like Medtronic have jumped into the fray.

Medtronic bought a telemedicine company last year to help monitor these chronic patients from afar thereby helping hospitals not incur penalties from these same heart failure patients getting readmitted to the hospital within 90 days of discharge.

Other hospitals are looking at heart failure management in different ways. At Cedars-Sinai in Los Angeles, for example, physicians have created a heart failure management program that uses handheld ultrasounds instead of the humble stethoscope and reviews biomarkers of these patients to reduce readmission rates.

Mayo Clinic,...

April 3rd, 2014
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Managing heart failure patients has become such a priority at hospitals that even device companies like Medtronic have jumped into the fray.

Medtronic bought a telemedicine company last year to help monitor these chronic patients from afar thereby helping hospitals not incur penalties from these same heart failure patients getting readmitted to the hospital within 90 days of discharge.

Other hospitals are looking at heart failure management in different ways. At Cedars-Sinai in Los Angeles , for example, physicians have created a heart failure management program that uses handheld ultrasounds instead of the humble stethoscope and reviews biomarkers of these patients to reduce readmission rates.

Mayo Clinic, however, appears to believe that there’s an app for heart failure management.

The venerable institution recently announced results of a small study at the American College of Cardiology meeting in Washington, D.C. that showed that...

April 3rd, 2014
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Innovation as a subject is the topic of numerous expert presentations, internal discussions at corporations large and small. Here is a small and nifty infographic that is also taking a stab at what principles make for a strong innovation engine.
It's created by Brian Solis, principal at Altimeter Group, a research and consulting firm that delves into disruptive technology. 
 
 
-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com
 
 

April 1st, 2014
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business_model, Service_model

No one has ever accused the medical device industry of running ahead of the pack when it comes to implementing business transformation or adopting new approaches to business best practices. Given the level of regulation the industry faces and the levels of capital investment required, it’s no great surprise that “deliberate” and “careful” have trumped “bold” and “innovative” in medical device companies’ DNA.

But today the revolutionary changes that are rippling through all healthcare sectors are pushing change for the medical device business as well. Two big drivers – the consumerization of healthcare, and the increased focus on cost – are combining to create a groundswell of investment in the service functions of the medtech industry...

March 31st, 2014
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FDA's new recall review indicates that medical device companies are more diligent about reporting. But there's still a lot of room for improvement.

                                 

Upon the recent release of FDA’s "Medical Device Recall Report: FY2003 to FY2012," headlines blared the fact that recalls—particularly Class I recalls—have skyrocketed over the past decade. While not inaccurate, the negative slant of these...

March 28th, 2014
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Sometimes its good to remind ourselves of the impact that can be had on patients.

UK resident Joanne Milne was born deaf. She suffers from a rare condition known as Usher Syndrome, a genetic disorder that leads to blindness and deafness. About a month ago Milne received cochlear implants, but has had to wait four weeks for the devices to be activated.

Her mother was on hand to document the powerful and emotional moment when Milne heard for the first time.

 

 

Head to Birmhingham Mail to read more of Milne's story.

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March 28th, 2014
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As a hospital, would you buy your pacemaker and defibrillator online, much like you would a book or a small electronics or diapers from Amazon? 

Swiss startup NayaMed, which launched a few years ago, is betting that hospitals will. At least those in Europe. The company's website shows that hospitals in Italy and Germany are using the company's online platform to source products.

But NayaMed does more than provide an e-marketplace. It offers 24-hour access to digital inventory management, communities, eLearning, product information and technical support. 

The medical device purchasing process is...

March 26th, 2014
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