Medtech companies are slowly beginning to embrace risk in contracts with hospitals. Will AdvaMed embrace the change, go along with it grudgingly or try to fight it?

We are a little more than a month away from the premier medtech executive conference - AdvaMed 2015 in San Diego - where the industry association brings together speakers from across the medtech spectrum to address timely topics.

It also is an occasion for AdvaMed to forward its agenda - what the DC lobby feels is beneficial for the industry as a whole. No surprises there.

For example, last year, in Chicago, the group put forward a report that warned of the consequences of pay-for-performance and risk-based reimbursement models charging that these would lead to blocking off access to potential...

August 27th, 2015
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The CEO of Medtronic voices full-throated support of accountable care and an outcomes-based medtech industry in an exclusive interview with MD+DI

Arundhati Parmar

Recently, Medtronic's CEO, Omar Ishrak, made himself available for an interview on a wide range of topics related to medtech, his own company and the changing healthcare paradigm.

In the near 40-minute interview at the company's erstwhile headquarters in Fridley, Minnesota, what became apparent is how the chief executive of the largest medtech company in the world has embraced the concept of accountable care.

Ishrak used the word "outcomes" 29 times in the conversation and "accountable" or "accountability" 11 times. And these were used not just in the context of reimbursement or...

August 26th, 2015
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An expert describes three survival tactics for thriving in the changing healthcare industry.

Tim Bosch

Everyone knows the healthcare industry is changing in dramatic ways. The movement toward an outcomes-based, patient-centric, cost-conscious environment is well underway. The question for manufacturers of diagnostic devices and other clinical laboratory systems is how will this shift impact them—and what do they need to do to compete effectively, maintain or grow market share, and stay profitable?

Based on our experience working with innovators across the laboratory and diagnostics segment, we believe there are three key factors to succeeding—indeed, to surviving—in the transformed healthcare environment taking shape.

1. Get Closer to the Patient, Get...

August 26th, 2015
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Compliance with HIPAA is an ongoing effort coordinating a company’s people, processes, and technologies.

Natalie LeFlore

Medical device manufacturers often overlook the possibility that their devices may be subject to compliance with the Health Insurance Portability and Accountability Act (HIPAA), particularly its privacy and security rules pertaining to protected health information. Information is considered protected health information if it meets two requirements: it is individually identifiable, meaning that it contains identifiers such as a name or date of birth that may identify the individual to which it pertains and it consists of data regarding...

August 25th, 2015
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Following the suit of Edwards Lifesciences and Abbott, Medtronic will buy a transcatheter mitral valve replacement startup for $458 million. 

First it was Edwards Lifesciences.

Then it was Abbott buying two transcatheter mitral valve replacement companies, leading to speculation about a possible wave of acquisitions in te space.

Now medtech heavyweight Medtronic has also jumped on  the bandwagon of acquiring a transcatheter mitral valve replacement company. On Tuesday, the Irish company...

August 25th, 2015
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How often do you need a design review and how many do you need to do? It depends. 

David Amor

Two of the most common questions I get asked in my consulting practice are about design reviews: When do I need them and how many do I need to do? The answer is, “It depends.” However, I do have some recommendations that may help get you to a defensible answer, which, in fact, is the main thing you’ll need in front of a regulator.

Let’s start with the most important consideration: There is no regulation or standard that mandates when and how many design reviews to perform. Design review occurrence and frequency are left to the discretion of the manufacturer. Per 21 CFR 820.30(e) Design Reviews:

“formal documented reviews of the design results are...

August 21st, 2015
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Here are time and money saving patent strategies for early-stage medtech companies.  

Roman Fayerberg and David J. Dykeman

Venture capital (VC) funding for medical technology companies has been challenging in recent years. A strategic patent portfolio is crucial to a medtech company’s growth and survival and can help secure funding. A recent study found that a startup has about a 2.5 times greater chance of achieving success within 10 years of VC investment if it holds patents before the investment. For early-stage medtech companies, patents are often an important way for investors to place a value on a company’s technology and judge the potential success of the...

August 21st, 2015
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Mike Huckabee

Former Arkansas governor Mike Huckabee described the ACA as “a $2.2-trillion disaster that dumps millions of people into a broken, expensive system and does nothing to fix the basic problems everyday Americans face.”

And he called the recent King v. Burwell Supreme Court decision protecting the ACA “an out-of-control act of judicial tyranny," saying "The Supreme Court cannot legislate from the bench, ignore the...

August 20th, 2015
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 Bobby Jindal

 

Bobby Jindal, governor of Louisiana since 2008, signed state legislation authorizing research and development credits of up to 40% for emerging firms and 8% for those with more than 100 employees.

He supports the repeal of ACA and cautions against Republican development of “Obamacare Lite,” a version of the national healthcare program with fewer tax dollars. “The problem with programs that look like Obamacare is that they bring with them many of Obamacare’s problems,” he explains.

 ...

August 20th, 2015
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John Kasich

 

John Kasich called telemedicine and medical devices “cutting-edge industries we must have in Ohio” in his state-of-the-state address this year.

The Ohio governor since 2011 expanded Medicaid to his state’s constituents and last year said full-scale repeal of the ACA “was not gonna happen.”

 

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August 20th, 2015
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