Talk of medical device tax repeal is back in circulation.

What was a bitter pill in 2013 and 2014 that the industry had largely swallowed is now on the front burner given that Congress is now firmly under Republican control. A bipartisan bill in support of the repeal has been introduced in the House and some predict the 2.3% medical device tax can be repealed by March.

The question is how much overall damage has the device tax done? And what is the true tax burden? Numbers like $20 billion and $30 billion in taxes collected over a decade are getting thrown around a fair bit in media coverage, so it's a question worth asking.

Industry proponents and critics of the tax have loudly proclaimed...

January 9th, 2015

Corporate turnaround stories are not that common. Boston Scientific is an exception.

The Natick, Massachusetts company's new management has been hard at work to reverse its fortunes and modify the impression of it as a medtech has-been. Like a phoenix rising from its own ashes, Boston Scientific is well poised to make that ascent in 2015 and beyond.

Wall Street analysts presenting their thoughts on the future of the device market and the outlook for individual companies all point to Boston Scientific as one that will most likely win this year. The company also won upgrades recently from two.

Take Danielle Antalffy, an analyst with healthcare investment Leerink Partners.

"Over the...

January 8th, 2015

Older consumers represent a lucrative market for digital health—if companies can get them to adopt their technology.


With the population of Americans over the age of 65 expected to soar to 19 million by 2050—more than tripling since 2010—makers of digital health technology are homing in on this potentially lucrative demographic.

Digital technologies promise to help older people age at home, hopefully more comfortably than generations past. But there’s one problem: Getting older consumers to adopt digital health solutions.

Today at the Digital Health Summit at CES in Las Vegas, David Inns, CEO of GreatCall Inc., a provider of mhealth solutions for seniors...

January 7th, 2015

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

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

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

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

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

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

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