Tax experts offer insight into the various government efforts to prevent inversions. Will these measures halt such transactions in the medtech space?

Ori Epstein, Robert Verzi, and Philip Brudney

About a year and a half ago, the pending mega-merger of Covidien and Medtronic was the talk of the medical device industry and, more broadly, the M&A world. The merger would have formed a medical device giant and been one of the largest mergers ever accomplished in the medical device industry.

Amidst all the buzz in the medical device community, there was a different type of buzz growing in our nation’s capital. The Treasury Department, Congress, and the president were all interested in the pending deal for an entirely different reason. The merger was...

April 29th, 2016
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Patent trolls aren't only a U.S. phenomenon. Two legal experts discuss why nonpracticing entities have impacted medical device companies doing business in Europe and ways to defend against such lawsuits.

Marie Thibault

That patent trolls have discovered the medtech industry is no secret. The trend of nonpracticing entities (NPEs) filing lawsuits against medtech companies is well-known in the United States (see MD+DI's February 2014 piece, "Patent Trolls Invade Medtech").

While the practice started in the United States, it certainly isn't limited to domestic shores. That can be seen from high profile cases like ...

April 28th, 2016
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Why doesn't FDA mention its own human factors guidance in another recent technology-specific guidance document?

William A. Hyman

On April 20, 2016, FDA issued a Guidance Document entitled “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.” This technology specific guidance provides a set of detailed “recommendations” for what kind of technical data should be submitted for regulatory evaluation of such a system. These are only recommendations because guidance documents in theory do not establish requirements.

In addition to an...

April 27th, 2016
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The latest round of startups has emerged from Blueprint Health's accelerator with ways to make healthcare more effective and efficient. Here are a few highlights.

Marie Thibault

"It's hard not to think we are living in interesting times," said Jean-Luc Neptune, executive director at NYC-based startup accelerator Blueprint Health. Those interesting times "apply to healthcare as well . . . we are everyday asking fundamental questions about things we haven't talked about in a long time," he continued, addressing an audience of healthcare investors and industry professionals at the accelerator's April 27 Demo Day.

Neptune's comments were an appropriate introduction to the 10 startups from...

April 27th, 2016
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Having beaten all sales and profit expectations in the first quarter, Michael Mussallem says Edwards is poised to do even better. 

Arundhati Parmar

For Edwards Lifesciences, the TAVR or transcatheter aortic valve replacement market is a goose with seemingly an unlimited supply of golden eggs.

Quarter after quarter the Irvine, California company reports better-than-expected transcatheter heart valve sales wowing analysts. This past quarter ended March 31 was no different, with Edwards reporting transcatheter heart valve sales of  $367.8 million, a 37% jump compared with the first quarter last year when it garnered $366.1 million. Overall, the company reported sales of $697.3 million in the first quarter,...

April 27th, 2016
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From prototyping to finished projection, 3-D printing is revolutionizing the way products including medical devices are made.

Gregory Ojeda  

Since the late 1980s, 3-D printing has undergone several stages of fine-tuning to reach its current maturity level. An additive manufacturing process, 3-D printing has garnered a lot of media attention in the past few years, becoming almost a household novelty thanks to efforts like 3DHubs.com that connect enthusiasts and hobbyists with 3-D printers from nearly anywhere. In its current state, it offers unique strategic applications that innovators have worked to see come to fruition. And as manufacturing continues to transition into a future where digital reigns supreme,...

April 25th, 2016
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GE's Healthcare business is rebounding and its equipment orders suggests that that there is some stability in U.S. hospital capital spending that may even be improving.

Arundhati Parmar

On Friday, GE reported its first quarter earnings and while its oil and gas business faces challenges, the diversified company had strong performance in other businesses including healthcare.

In fact, following the company's earnings call, one analyst wrote that it was GE's Healthcare business "posted the best organic growth in 20 quarters." Certain conclusions about the health...

April 22nd, 2016
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Agile methodologies for software development offer a number of benefits for medical device companies. Here are some best practices for making the transition.

Clark Fortney and Rainy Mumper

Many industries and companies have seen the benefits to developing software using Agile methodologies instead of following a more traditional waterfall approach. In the highly regulated world of medical device development, there is sometimes hesitation by companies in adopting Agile methods for software development due to concerns over how process control and safety can be assured. Acceptance of appropriate Agile methods for medical...

April 21st, 2016
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The North Carolina company had communicated far and wide that FDA would clear its surgical robot, ushering in a new robotics era. Except the agency didn't. 

Arundhati Parmar

It's not often that I repeat a headline in a story, but this one is worth hearing again: It ain't over until the fat lady sings.

In a news release Wednesday, surgical robotics company TransEnterix dropped this bombshell: FDA had turned down its FDA 510(k) clearance for the SurgiBot. The FDA clearance was being viewed as a watershed moment given that it would bring Intuitive Surgical's long, solo reign atop of the surgical...

April 20th, 2016
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The medtech company has been hurting because it doesn't have a MRI-compatible cardiac device in the U.S., and now the first launch is delayed. 

Arundhati Parmar

One big reason that St. Jude Medical's cardiac rhythm business has been losing ground in the U.S. recently is that it doesn't have pacemakers and ICDs that are safe to use under MRI.

Medtronic has its Advisa MRI and Revo MRI pacemakers that are MR compatible, which means patients implanted with those devices are no longer prevented from undergoing MRI scans because of fears that the MRI machine and the implanted device would interact. The Irish medtech company also has the Evera implantable cardioverter defibrillator (ICD) that can be safely used under MRI.

By...

April 20th, 2016
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