Silo is becoming a dirty world in the world of healthcare and medtech as various players realize that keeping patients healthy across the continuum of care requires a greater degree of collaboration than ever before.

In other words, collaboration between groups that barely had much of a direct relationship in the past or if they did, it was quite antagonistic. 

No where is this more apparent than in the results of a survey that PricewaterhouseCoopers released earlier this year. PwC’s 17th Annual Global CEO survey shows that 53% of pharma and life sciences CEOs are planning to enter into a strategic...

May 19th, 2014
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Boston Scientific's subcutaneous implantable defibrillator

 

Boston Scientific has high hopes for its breakthrough S-ICD product, the first and only approved subcutaneous implantable cardioverter defibrillator that has no leads in the heart. The product came to the company from the acquisition of Cameron Health...

May 19th, 2014
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Patient engagement is not where most providers would like it to be. The infographic from Boston Technology below evaluates the current landscape of patient engagement and makes a powerful argument for how mhealth can boost it.

 

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

 

May 15th, 2014
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By Annie Diorio-Blum

Contextual research is an often-overlooked step in the medical device regulatory process, yet one that is critical in overcoming regulatory obstacles. This time-consuming and hands-on, observe-and-analyze process helps medical device companies understand a variety of factors to help move their products from an idea to marketable product.

Contextual research involves the observation and analysis of the way a person uses a medical device in a real-world environment. It helps medical device companies understand a particular patient population, evaluate the performance of a device in its unique environment, or learn about a process or task associated with a specific device. The contextual research process collects data and...
May 13th, 2014
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A polarizing new law that establishes commercial payment benchmarking will alter the IVD reimbursement landscape.  But who will it help and who will it hurt?

By Charles Mathews

Charles MathewsSince the 1980s, Medicare has been in the driver’s seat in terms of payer pricing for clinical diagnostics. Medicare would set values for individual current procedural terminology (CPT) codes on the clinical laboratory fee schedule (CLFS), and commercial payers would simply look up those values and pay a little more or a little less. 

But the traditional system is about to change in a significant way. 

On April 1, the Protecting...

May 12th, 2014
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FDA’s presubmission program and meetings present a valuable opportunity for companies to gain clarity and nonbinding feedback on premarket submissions and testing plans.

By Allyson B. Mullen

Allyson Mullen

Earlier this year, FDA issued the final guidance, “Requests for Feedback on Medical Device Submissions: The Presubmission Program and Meetings with Food and Drug Administration Staff.” This program allows for a variety of different presubmissions and meetings with FDA, including those to educate FDA or to discuss the plans for a premarket submission—such as a 510(k...

May 12th, 2014
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In vitro diagnostics companies are struggling to navigate an increasingly complex regulatory environment fraught with uncertainty.

By Allyson B. Mullen

Allyson MullenIn vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: uncertainty. 

Many regulatory challenges for IVD companies relate to issues that are evolving and changing. Even where there appear to be clear regulatory requirements, it is not yet known—or not always reasonably foreseeable—how FDA will implement those requirements. In this article, we will examine four significant regulatory challenges facing IVD companies...

May 12th, 2014
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It’s the “Atlas shrugged” moment in healthcare.

The mythological Greek character carrying the planet on his shoulders has shrugged. And the world of healthcare, with all its old assumptions, is coming crashing down. Nowhere is this fundamental shift being felt more closely than in the medical device world, where innovation, to a large extent, has often meant tweaking an existing product and charging a premium for it. And now the end user of the device - physician - no longer has the preeminent position he or she once did in purchasing decisions at hospitals.

In the new world, companies need to prove their device has economic and clinical benefits to a wide ranging group of actors.That requires disrupting how innovation has been done previously in order to build a new model of an innovation pipeline that can be...

May 12th, 2014
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Watch this video from the Milken Institute Global Conference 2014 where IBM's Watson supercomputer demonstrates its debate skills.

In a session, “Why Tomorrow Won't Look Like Today: Things that Will Blow Your Mind."  John Kelly III, senior VP and director of IBM Research was asked if it was possible for a computer to draw upon information from a large database like Wikipedia to reason and form context-based arguments in natural language.
 
Dr. Eric W. Brown, Director, Watson Technologies, IBM will deliver a keynote, "IBM Watson: A true healthcare game changer" at the MD&M East Conference...
May 8th, 2014
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Few device, or any other publication for that matter, reported on the news that Boston Scientific has joined Optum Labs as its founding medical device partner.

And when they did, they missed the point of the partnership altogether.

Yes, Boston Scientific becomes the first medical device company to join forces with Optum Labs, which is UnitedHealth’s healthcare research and innovation group. Optum Labs was co-founded by the Mayo Clinic, and Optum, UnitedHealth’s the health IT and services unit. Late last year, the AARP came on board as...

May 8th, 2014
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