Baxter's new CEO, an industry veteran, drops clues about his vision for the company and why large M&A may not be part of the picture.

Marie Thibault

 

Just a month into his tenure as the CEO of Baxter, seasoned medtech executive José Almeida is already sharing parts of his plan for the company. This path is likely to include M&A transactions, though small deals are expected to be favored over large acquisitions. 

Almeida, who previously headed Covidien, joined Baxter as an executive officer in late October 2015 and filled the top seat at the...

February 3rd, 2016
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Instead of blaming users, device makers should consider that errors might be the result of flaws in the system.

T. Grant Leffingwell

Recent years have seen rapid advancements in healthcare technology, and medical devices are becoming increasingly complex. As a discipline, medical device engineering has entered an era similar to the one aeronautical engineering went through during the mid-20th century. Back then, the increasing sophistication of aircraft and space systems required mastery of a new...

February 2nd, 2016
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A New Zealand digital health company wants more people with chronic asthma and COPD manage their condition better with its smart inhalers.

Arundhati Parmar

New Zealand-based Adherium made it to the 2015 Global Digital Health 100 List published by the Journal of mHealth earlier this year, but the company that has been around since 2001 has loftier goals this year.

It is planning a big, commercial rollout of its Smartinhaler platform, which helps people with asthma and chronic pulmonary obstructive disorder stay adherent to their medication regime by leveraging digital health tools. The company's founder launched the company when he realized that current inhalers had...

February 2nd, 2016
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Device and diagnostics M&A transactions are proving to be popular in 2016, but what one factor might set the successful mergers apart from those that never quite gel?

Marie Thibault

Already this year, a number of announced mergers and acquisitions are altering the medtech landscape. Abbott's planned purchase of Alere will make it the largest point-of-care diagnostics provider. Stryker is focusing on hospital-acquired conditions with its anticipated acquisition of Sage Products. Medtronic's ...

February 2nd, 2016
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With ever increasing part variation and liability at stake in medical device manufacturing, augmented reality technology can help improve quality, increase productivity, and ensure training effectiveness.

Paul Ryznar

An OPS Solutions machine vision engineer assembles clips on an automotive OEM bumper using Light Guide Systems. 

With the nation’s aging Baby Boomer...

February 1st, 2016
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Experts trace the harmonization of Japanese, FDA, and ISO guidelines on biocompatibility testing, as well as key disparities to know.

Zhenghong Tao, Laurence Lister, and Keisuke Suzuki

The process of medical device approval by regulatory agencies requires a biological safety evaluation to be conducted to assure the biological safety of the device. Since FDA released the blue book memorandum in 1995 (#G95-1: "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices'—Part 1: Evaluation and Testing"), medical device approval submissions can be sent, simultaneously, to both European agencies and FDA, using the similar, if not identical, biological evaluation and or testing.

Prior to 2012, Japan had its...

February 1st, 2016
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The miniaturization of medical devices should go hand-in-hand with an expansion of performance and capabilities.

Jens Troetzschel

A rectangular medical component from Heraeus CerMet Composites demonstrates the potential for dramatic miniaturization.

I recently came across a TV documentary on the evolution of the music record industry. Some of us remember buying long-playing (LP) albums at the neighborhood record store. But over the course of a few decades, the industry experienced an unprecedented period of innovation: the bulky LP transformed into smaller, more convenient formats, like eight-track and cassette tapes.

The introduction of the compact disc (CD) was the next step in the industry’s evolution to...

February 1st, 2016
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When dealing with medical device security, it is important to focus on six areas that will ensure that the entire system — the network environment and the device efficacy — is taken into account. 

Ali Youssef

 

When dealing with medical device cybersecurity, three quotes by Bruce Schneier, a prominent security expert and author come to mind.  These are:

If you think technology can solve your security problems, then you don't understand the problems and you don't...

January 28th, 2016
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The device maker is launching a cloud-based, data-driven insights solution in U.K. and Scandinavian countries developed in collaboration with some hospitals and consulting firm Accenture. 

Arundhati Parmar

Last year, Boston Scientific launched its Advantics hospital solutions business to help improve outcomes in cardiovascular patients and reduce the cost of caring for them.

On Thursday, the Marlborough, Massachusetts device maker, announced that it is collaborating with consulting firm Accenture to bring the power of the cloud-based, data-driven digital solution to U.K. and Scandinavian hospitals caring for congestive heart failure patients.

Through the collaboration, hospitals can use the...

January 28th, 2016
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St. Jude Medical was confident that a novel cardiac device with proven outcomes would be adopted quickly, but is facing reimbursement's unrelenting brick wall. 

Arundhati Parmar

Sometimes the best laid plans go awry.

After St. Jude Medical acquired CardioMEMs in 2014, then CEO Daniel Starks informed analysts that October that reimbursement would not be a problem for the novel implantable cardiac device.

After all, the Centers for Medicare and Medicaid Services had created a new technology add-on payment to cover the device meant to empower physicians monitoring heart failure patients remotely to intervene should their symptoms worsen...

January 27th, 2016
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