One man thinks he has a solution to the problem of patient compliance.

Jamie Hartford

Here's a cold, hard truth: Patients often don't take their medication. It's a problem the healthcare industry is well aware of but has not yet been able to solve.

Eric R. Larson, of engineering consultancy Art of Mass Production, thinks he has an answer: We should treat medication like candy.

No, he's not suggesting patients pop a pill whenever we they a craving for sweets. Instead, he believes we need to spice up the boring packaging medication comes in to make it more appealing, kind of like a candy bar wrapper.

You can hear more about Larson's theory at the MEDevice San Diego conference. On September 2, 2015, at 11:15 a.m., he'll participate in a panel discussion on "...

August 28th, 2015
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Helping healthcare stakeholders get in line with requirements of the Affordable Care Act will help speed adoption of your device.

John Walmsley

Innovators need to know their market and target their design to it. In the world of medical devices, there are many more stakeholders than in other technological adoptions. The patient, payer, and provider are rarely the same person. They each have their priorities in addition to their shared goal of a successful health outcome.

Adoption is the process through which your innovative medical device finds—or fails to find—its market. If the device is truly innovative, we know from Geoffrey Moore that there is a chasm to cross before the majority of adopters will...

August 28th, 2015
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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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 Lindsey Graham

 

This year, Lindsey Graham cosponsored Senate Bill 149, the Medical Device Access and Innovation Protection Act, to eliminate the medical device excise tax.

Despite enrolling in the ACA, Graham—a U.S. Senator from South Carolina since 2003—called the federal health insurance program an “albatross” and “lead balloon.”

He says, “...President Obama and his Democratic allies in Congress rammed through their hastily and deeply flawed legislation to create...

August 20th, 2015
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