Do recent comments from C.R. Bard's CEO mean a transaction could be on the way soon?

Marie Thibault

 

For the past year, as other large medical device companies undertook major acquisitions and mergers, C.R. Bard had no new transactions to announce. But now, the company's chief executive officer may have publicly hinted that a deal announcement could be coming.

"There is [a] lot of things going on right now, and I wouldn't be surprised if you start hearing more from us soon about those kind of things, but again you got to have two sides to agree and we're very active right now. So we'll let you know as things occur," C.R. Bard chairman and CEO Timothy Ring told analysts during an April 23 earnings call, according to a...

April 24th, 2015
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Daniel Starks is remarkably disciplined in his communications with analysts and prefers to keep many things close to his vest even if its means declining to answer questions repeatedly.   

Arundhati Parmar

St. Jude Medical's CEO Daniel Starks would make for a fascinating interview.

His view of the medtech industry and where it is going and how to succeed in a paradigm-shifting marketplace is decidedly different from say that of Medtronic's CEO, Omar Ishrak. And I have been longing for a deep dive with Starks, similar to the one I had with Ishrak back in 2011.

But so far...

April 23rd, 2015
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Marie Thibault

 

Here at MD+DI, we love medical devices and advances in healthcare technology. Innovative medical devices have helped us live longer, more enjoyable lives.

But unfortunately, a few devices have attracted the ire of some patients and activists for what they allege is causing more harm than good. We've gathered five devices and device categories that have been the subject of negative headlines recently.

Do you agree with the patients or the companies? Do you think these devices are safe? Tell us in the comments below.

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April 22nd, 2015
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Medical device companies need a superior product and patent protection for their medical devices and related methods of use, but also need to consider a few key factors about U.S. and international patents.

Gabriela I. Coman

Medical devices, from bandages to replacement heart valves and surgical robots, as well as methods of using such medical devices and related surgeries have become part of our everyday life and are essential elements of modern medical care. Medical devices are also part of a highly competitive and litigious environment, especially when competitors enter the market.

To be successful in today’s marketplace, a medical device company needs a superior product and patent protection for its medical device and related methods of use, both in the United States and abroad.

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April 22nd, 2015
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Be sure to take advantage of these opportunities at the MD&M East conference and exposition in New York City June 9–11, 2015.

Jamie Hartford

New York City will again play host to the best and brightest minds in medtech when the industry gathers at the Jacob K. Javits Convention Center June 9–11, 2015, for the MD&M East conference and exposition. This three-day interactive event will feature live demonstrations, education programs, and other opportunities you won’t want to miss. Here are a few things we recommend checking out.

Keynotes from Industry Leaders

Anchoring this year’s...

April 21st, 2015
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Medical device companies can increase efficiency by tightening up their risk management practices.

Jamie Hartford

Efficiency is the name of the game for medical device companies today, and one way for manufacturers to get their products to market faster and at lower cost is to take a close look a their risk management practices.

“Addressing risk management deficiencies is a low-hanging fruit that yields positive results across the board,” says David Amor, managing partner at Medgineering, a Minneapolis-based firm providing remote quality systems, regulatory, remediation, and compliance consulting.

That’s because risk management pervades nearly every step of medical device manufacturing.

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April 21st, 2015
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Breast Implants

In January 2011, FDA issued a report saying it was aware of a potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer. At that time, the agency said it was aware of approximately 60 ALCL cases in patients with breast implants. FDA went on to say that it believes implant patients may have a slightly increased risk of developing ALCL in a scar capsule next to the breast implant.

 

Industry Says:

A woman is more likely to be struck by lightning than get this condition. Patients' safety is Allergan's absolute first priority and we continue all efforts to collect and analyze further information about the very rarer occurrence of ALCL in patients with breast implants.”

—Caroline Van Hove, spokeswoman for Allergan, maker of breast implants, in ...

April 20th, 2015
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Power Morcellators

In late 2013, media coverage of power morcellators, a tool used during laparoscopic hysterectomies, drew attention to the controversy around the device. Patient advocates say that use of morcellators to cut up uterine tissue during the laparoscopic procedures may have spread bits of tissue containing undetected cancer, which may in turn have led to upstaging of these cancers.

A physician couple, Dr. Hooman Noorchashm and Dr. Amy Reed, have been loud advocates for banning the device ever since Reed had a hysterectomy with the device and found out soon after that she had advanced stage uterine sarcoma.

In 2014, FDA published safety communications about power morcellation and maker Johnson & Johnson issued a voluntary recall of its power morcellators. Some health insurers, including Highmark and United Healthcare, have said they will not cover use of morcellators during hysterectomies. A number of health systems and hospitals have stopped...

April 20th, 2015
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Essure Permanent Birth Control

The Essure system, now owned by Bayer after it acquired Conceptus in 2013, is intended to provide non-surgical permanent birth control. The Essure nickel-titanium alloy inserts, which look like small springs, are inserted hysteroscopically into the patient's fallopian tubes. After a three month wait, a confirmation test is used to determine that tissue ingrowth around the inserts has blocked the fallopian tubes, resulting in permanent birth control.

FDA reports that it received over 900 adverse event reports between Essure's approval in 2002 and late 2013. Common reported adverse events include pain, hemorrhage, headache, menstrual irregularities, device migration and breakage, among others. FDA reviewed the adverse events reported through late 2013, but said it found no new safety problems or evidence of a link...

April 20th, 2015
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Duodenoscopes

Though there had been dozens of reported cases at several hospitals before, the issue of contaminated duodenoscopes didn't become a mainstream topic until early 2015. In February and the months since, headlines were filled with news of Carbapenem-resistant Enterobacteriaceae (CRE) infections at Los Angeles's Ronald Reagan UCLA Medical Center and up to 179 patients that may have been exposed to the CRE bacteria.

It was found that the bacteria had contaminated a type of endoscope called an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, used to diagnose and treat diseases of the liver, bile duct, and pancreas.

These duodenoscopes can be difficult to sterilize completely becuase they have what FDA calls a "movable 'elevator' mechanism...[that] changes the angle of the accessory exiting the accessory channel," making the procedure easier and more useful, but also creating tiny spaces that can be hard to brush or clean...

April 20th, 2015
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