Venture capitalist Wainwright Fishburn Jr. says there will be three phases in the digital health revolution: monitoring, organizing and analyzing, and acting.

At the Digital Health Summit at CES today, Wainwright Fishburn Jr., a parter at venture capital firm Cooley LLP, shared his view of the state of digital health today and where it’s heading.

Fishburn explained that there will be three phases in the digital health revolution: monitoring, organizing and analyzing, and acting.

We’re already past the monitoring phase, which saw the rise of sensors and wearable devices for tracking health metrics. Pioneers of that era included companies such as Fitbit, Jawbone,...

January 7th, 2015
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The secret to designing useful mobile health devices is identifying the end-user and having a clear understanding of what problem your product solves for them.

By Alexa Konstantinos

A key theme at last month’s HIMSS mHealth Summit was “engagement.” Engaging patients. Engaging healthcare providers and administration. Engaging the worried well and quantified selfers. In contrast to a few years ago when the buzz was the whiz-bang app of the day, this year was all about people. And the message was this: Your technology doesn’t matter if the intended users don’t, won’t or can’t use it.

In this very human-centric approach, the profile of the end-user depends on the product, the user scenario, and the...

January 6th, 2015
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What's in store for the medtech industry this year? Share your predictions.

When the calendar turns over to a new year, everyone gets out their crystal ball in an attempt to predict what the next 12 months will bring. Here on MD+DI, we've already looked at Cleveland Clinic's top innovations in 2015,  5 medical technologies to watch in 2015, top health industry issues for the year, and...

January 5th, 2015
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The Indian government has a present for foreign medical device companies that may spur them to delve deeper into the emerging market.

On Dec. 24, the Indian government decided to allow 100% foreign direct investment in the medical device sector under what is known as the "automatic route," according to several Indian news reports. The move is a special carve out for medical devices from policies that regulate foreign direct investment in pharmaceuticals.

In India, medical devices are regulated by a division that is part of the pharmaceutical regulatory body, although outsiders are calling for a...

January 5th, 2015
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We may agree that political assassination of a demented and despotic world leader as a premise for a movie represents inanity and arrogance at its worst.

We may even have little sympathy for the powers at be at Sony.

However, cybersecurity should be on top of mind of everyone given the bold hack that the movie company suffered apparently at the behest of North Korea.

In fact moving into 2015 and beyond, when smart devices will increasingly proliferate our world and more attempts are made to integrate device data in the electronic medical record, cybersecurity of healthcare information should be top priority....

December 23rd, 2014
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A new MD+DI ebook sponsored by Sparton provides tips for managing medical devices from the cradle to the grave.  

The key to success in the medtech industry is managing every aspect of your product from beginning to end. But while product lifecycle management is easy in theory, it's actually much more difficult in execution.

Medical device OEMs have to consider everything from design and compliance to manufacture in order to manage a product's lifecycle effectively. The process involves parties as diverse as designers, regulatory affairs professionals, and production staff—all of which bring their own goals, expertise, and bias to the table.

To help medical device OEMs...

December 19th, 2014
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Complaints that FDA’s busiest pathway to market for medical devices is anything but straight piled up in 2014.

By Jim Dickinson

Looking back, 2014 will be remembered as the year when FDA’s busiest medical device route to market, the 510(k) “substantially equivalent” process, came under unprecedented challenge amid calls for structural change and even general abandonment.

There is dissatisfaction with the 510(k) status quo both within FDA (if unexpressed) and throughout industry and patient activist communities.

Industry Complaints

Kicking off the argument in January was a petition from the Minneapolis-based DuVal & Associates law firm on behalf of the Minnesota Medical Device Alliance and the medical device industry generally asking FDA to...

December 17th, 2014
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 Biomerics microcatheter
 

Significant technological progress, favorable reimbursement conditions, and the medical device industry's windfall—the massive army of aging baby boomers—will spur the U.S. neurovascular market to exceed $600 million by 2020, according to market research firm iData Research

 And a critical driver of growth in this sector has been the various advancements in microcatheter design and development. "Almost every device placement or therapy taking place in or above the neck will require a microcatheter to support the intervention,"...

December 12th, 2014
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To realize the benefits of big data in healthcare, technical, regulatory, and financial hurdles must be overcome.  

By Bill Betten

Today we hear a lot about big data and how it will revolutionize our lives in variety of ways. In healthcare, big data offers breakthrough possibilities from increased efficiencies and better outcomes to lower costs and more personalized care. But as connected applications provide us with more data than ever before, many organizations are struggling with what to do with that data to take full advantage of its potential.

This article explores some common pitfalls of big data in the medical industry and discusses strategies to leverage this data to affect change and improve healthcare.

The amount of information being generated in the healthcare...

December 10th, 2014
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Large Consolidators

It was the year of the megamerger. In an effort to better compete in the new healthcare landscape, several major players sought to gain scale, complement their product portfolios, and extend their reach into the hospital.

In a $42.9-billion deal that rocked the industry, tax inversion and the resulting access to overseas cash became the focal point of Medtronic’s intent to acquire Covidien. But the synergies between the two companies and long-term business strategy proved to be a primary driver.

Prior to Medtronic’s big news, Zimmer set off the wave of megamergers when it announced plans to acquire cross-town rival Biomet for $13.35 billion. The deal is expected to secure the orthopedic giant’s stronghold in the large joint market and better position itself to compete with...

December 8th, 2014
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