A populous nation that also draws medical tourism, Turkey presents a huge opportunity for medical device companies. But regulations and reimbursement remain a challenge.  

Özge Atılgan Karakulak and Bentley James Yaffe

As the fifteenth largest economy in the world and with a population of 80 million, Turkey presents an exciting opportunity for investment and development in the area of healthcare. In addition to a growing population that is covered by an extensive social healthcare system, Turkey has implemented a policy in recent years to capitalize on its reputation as a regional hub for healthcare tourism. However, despite the financial opportunities that are associated with the Turkish healthcare industry, medical device companies planning to enter this...

June 20th, 2016
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GE Healthcare develops a futuristic training method to help engineers learn how to fix and maintain its capital equipment systems.

Marie Thibault

The Multiple Re-configurable Training System has a touch-sensitive screen that allows engineers to simulate a variety of tasks.

It takes time, money, and travel to train biomedical engineers who work at healthcare facilities on the wide range of medical equipment they maintain. But budget cuts, pressure on hospital margins, packed work schedules, and mergers in the healthcare industry that add more systems to responsibilities, mean time and money are often in short supply.

GE Healthcare, one of the largest providers of imaging systems and medical equipment, has an answer to these challenges: the...

June 20th, 2016
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The ISO 13485:2016 update will have a significant impact. Here's what medical device manufacturers need to know.

Bart Reitter

In March, the International Organization for Standardization (ISO) overhauled the longstanding ISO 13485 global standard for medical device quality management systems. Device manufacturers are now assessing the ins and outs of the overhaul, ISO 13485:2016, and comparing and contrasting it to ISO 13485:2003. Manufacturers will need to make provisions to update their respective systems over the next three years to adhere to the new standard.

Why did ISO update the standard? As the medical device industry continues to grow vigorously around the world, novel technologies emerge that challenge the status quo and supply chains become...

June 20th, 2016
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Physicians are identifying flaws in regulatory oversight of medical devices and publicizing their findings.

Jim Dickinson

The FDA regulatory scheme for medical devices is largely the product of careful industry building since the lethal damage wrought by the Dalkon Shield intrauterine device provoked Congress to enact the 1976 Medical Device Amendments with FDA holding the keys to market entry.

Subsequent mishaps and ambitions brought further industry-tweaked legislative reforms, each crafted and negotiated with potent input from trade associations and lobbyists, and less-potent input from medical and patient groups.

Now,...

June 17th, 2016
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Aspire Bariatrics gets FDA approval for an endoscopic device that prevents extra calories from being absorbed by the body. 

Arundhati Parmar

Moderately or severely obese people have a few options should they wish to find a minimally invasive device that helps to lose weight.

This week FDA announced that it has approved the AspireAssist device from Aspire Bariatrics based in King of Prussia, PA. The device uses a gastric tube that is placed endoscopically that drains a portion of food ingested after every meal and is intended for patients who are 22 and older with a body mass index of 35 to 55....

June 16th, 2016
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The U.S. Preventive Services Task Force has changed its mind on colorectal cancer screening providing a boost to Exact Sciences which makes a non-invasive test as opposed to the standard colonoscopy.

Arundhati Parmar

In the world of politics, a person who flip flops is considered a liability. He or she is a human without a strong, inner core and therefore easily changeable.

In the world of medicine and science, flip flopping may be a sign of adjusting to new...

June 15th, 2016
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A design expert has a sure way to get the device development process rolling. Hint: it involves consumer trends.

Marie Thibault

Here's some practical advice for medical device designers and developers who need a shot of inspiration: consider an existing device and add in a consumer trend.

Medical device + Consumer trend = New idea

That's what Yuhgo Yamaguchi, principal design strategist at global innovation design consultancy Continuum, told an audience this week in a session at the MD&M East Conference in New York City. "We sometimes use a very simple...

June 15th, 2016
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Both Medtronic and Stryker are attempting to drive costs out of joint replacement, but their visions are markedly different. 

Arundhati Parmar

For years, medtech manufacturers tweaked their current products, added a few, bells and whistles, and slapped on a price premium and called it innovation.

With the move to value-based care, those days are well behind us as Stryker's CEO , Kevin Lobo, has himself acknowledged. For the past several years, the orthopedics industry is under tremendous pricing pressure and companies have consolidated and made other market adjustments to remain competitive....

June 8th, 2016
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The medtech giant talks about what procedures its robotics platform will target, when to expect the launch, and the surprising region the company has chosen for the debut.

Marie Thibault

Medtronic's robotics development program has been whispered about for months, but little about the work has been divulged. Earlier this week, the company got onlookers buzzing by revealing information about its platform, which has been under development for a little more than three years and is already on its tenth prototype.

In commentary at the company's annual analyst day, executive Bryan Hanson said he expects the robotics platform to contribute "material revenue growth" by its fiscal year 2019—the company started its 2017 fiscal year at the end of April—and to launch...

June 8th, 2016
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The Indiana company is buying LDR Holdings to boost its spine business, but it and other medtech companies have historically found spine integrations messy, if not a total failure.

Arundhati Parmar

Another day, another medtech mega merger.

Orthopedics giant Zimmer Biomet announced Tuesday that is buying France and Austin, Texas-based LDR Holding for $1 billion in cash. The acquisition makes the Warsaw, IN, company a bigger player in the spine market, a fact that CEO David Dvorak highlighted in the news release. But the question that will need to be answered down the road, is how easily can a spine...

June 7th, 2016
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