FDA cited device-design issues as one reason medical device recalls are on the rise. Here’s how manufacturers can stop these problems from reoccurring.

Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer

Editor's Note: This is the first installment in a four-part series on the factors behind medtech's recall epidemic. Read Part 2 and Part 3.

Since the 1970 Cooper Committee Report documented thousands of deaths and serious...

June 27th, 2016
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CMS’s new joint replacement mandate includes gainsharing policies that present both opportunities and limits for collaborators.

Ben Torres

While the Comprehensive Care for Joint Replacement rule holds the hospital directly accountable for the lower extremity joint replacement (LEJR) patient episode, Medicare has implemented certain Stark Law and Anti-Kickback statute waivers in order to permit hospitals to enter into written financial arrangements with CJR collaborators. These CJR collaborators include the following:

  • Physicians or non...
June 27th, 2016
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Large medical device companies boast big R&D budgets and world-class engineers. So why does most of the innovation in medtech come from startups?

Jamie Hartford

How do you develop a groundbreaking medical device? If you work at a small company, the answer is put in a lot of blood, sweat, and tears (not to mention some of your own cash and probably a lot of sleepless nights). But if you work at a big medtech company, innovation is just an acquisition away.

Learn how to amp up innovation at your...
June 24th, 2016
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Now that the UK has voted to leave the EU, how might the fallout impact medical device companies?

Jamie Hartford

This week, citizens of the UK took the unprecedented step of voting to leave the EU. The results of the June 23 referendum shocked people and roiled financial markets around the world.

But what might Brexit mean for the country’s medtech industry?

Here are a few theories:

Don't miss the MD&M Minneapolis conference and expo, Septeber 21-22, 2016.

UK Will Lose Life...

June 24th, 2016
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FDA and other global regulatory bodies have been busy in 2016. These are some of the biggest regulatory developments so far this year. 

Marie Thibault

In the first half of 2016 and as of early June, CDRH had released 13 draft guidance and nine final guidance documents covering topics as varied as cybersecurity for medical devices in the postmarket setting to technical considerations for additive manufactured devices. In addition to these official publications, FDA officials have communicated new agency initiatives via the agency’s ...

June 23rd, 2016
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Medical device postmarket surveillance is under a new spotlight, and it’s critical for manufacturers to identify requirements that relate to them and stay on top of changes.

Parminder Kalle

Medical device regulators have made some significant changes to the requirements for postmarket surveillance, and manufacturers need to up their game when it comes to ensuring that they are meeting all compliance requirements. Many regulatory bodies are enforcing proactive requirements for postmarket surveillance, rather than accepting the previous more reactive approach taken by manufacturers. Postmarket surveillance has become specifically important...

June 22nd, 2016
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Foreign medical device companies should follow these steps when working with Chinese partners.

Ames Gross

Sourcing medical devices in China can be a daunting task for companies that are unprepared to deal with cultural differences, differences in time zone, as well as the sheer geographical distance that separates Asia from the United States and Europe. Although sourcing in China can be a cost-effective option for a business, companies should be ready to invest considerable time and resources throughout the entire process, from initial supplier identification to final product delivery.

While many businesses are familiar with basic sourcing guidelines and procedures...

June 22nd, 2016
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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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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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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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