mHealth apps and wearables have generated a lot of buzz, but is the sector worth the hype?

Marie Thibault

Digital health apps, wearables, and Apple’s iWatch have all contributed to interest in the idea of a future replete with mobile health solutions. mHealth is already being used to make healthcare more convenient for patients and to supplement clinical trials.

The potential of the technology seems to have no limits, if proponents are to be believed. But what about the business potential of mHealth? Is the techy side of health a good investment and will it make money?

This week, one healthcare investing expert acknowledged that while there may be reason to be skeptical, he doesn't yet see a bubble. "We see about five or six mobile health companies seeking...

May 22nd, 2015
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St. Jude Medical is not the only transcatheter aortic valve maker to show an anomaly in its Portico valve that led to the device's sales being briefly halted in Europe. 

Last September, St. Jude Medical announced that it was pausing the implant of its Portico transcatheter aortic valve in Europe after an anomaly was noticed.

Now it appears that St. Jude Medical is not the only TAVR maker with that problem. According to analysts attending EuroPCR, a large interventional cardiology annual meeting in Paris that ends Friday, the anomaly — reduced valve leaflet mobility — is a charge that can be made against all devices, even with surgical valves.

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May 22nd, 2015
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With new draft guidance making it clear that FDA is amenable to it, now may be the right time to take another look at adaptive design for your medical device trial.

Marie Thibault

Earlier this month, FDA published draft guidance on the topic of adaptive design, in an effort to give the medical device industry a better understanding of the agency's views on the concept. The draft document, called “Adaptive Designs for Medical Device Clinical Studies,” offers a detailed look at when adaptive designs make sense for a trial, types of adaptive designs, how data should be analyzed, and challenges and regulatory considerations when such a trial design is used...

May 21st, 2015
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The healthcare industry and by default the medtech world, is undergoing a major metamorphosis. What big trend will the segment see over the next decade?

Arundhati Parmar

The healthcare industry is undergoing a seismic shift and with it the medtech world is encountering some fundamental transformation as well.

Mega deals are occurring in response to pricing pressure and there is an overwhelming need for companies to do more across the healthcare continuum. As a result, large companies are looking to disrupt their medtech...

May 20th, 2015
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Follow these tips to unleash the power of innovative thinking and creative problem solving.

Tom KraMer

Brainstorming may have taken some abuse lately, but it appears that many people do not truly understand brainstorming, its various methods, and when to leverage brainstorming in the product development process.

Remember, the goal is increased innovative thinking and creative problem solving—a worthy endeavor!

But to unleash the true power of brainstorming, there are a few ground rules you should follow.

Teamwork

First of all,...

May 20th, 2015
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Medtronic plc reported partial fourth-quarter revenue results Tuesday and they signal a good future for the combined medtech company. 

Arundhati Parmar

Medtronic reported its first quarterly earnings results Tuesday since the $50 billion megadeal with Covidien closed and though partial, the the general consensus appears to that the future "bodes well" for the Irish company. 

Medtronic had sales of $7.3 billion in the fourth quarter, up 60% from the same period a year ago -— where Medtronic Inc. garnered $4.6 billion in revenue — on the strength of its...

May 20th, 2015
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Medical device manufacturers must be prepared to quantify the value of their devices in terms that can be compared with alternatives. 

Stephanie Kute

If value-based purchasing hasn’t impacted your business yet, chances are it will soon. Purchasing decisions for medical devices and therapies are increasingly based on the demonstrated value they bring to patient outcomes.

What does this mean for medical device manufacturers? Soon you may need to be able to quantify the additional value your device brings to patients compared with other treatment alternatives in terms of specifically developed quality measures. And you may need to be prepared to...

May 20th, 2015
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The Internet of things is coming, and medical device manufacturers that follow these steps can leverage its benefits to improve their service programs.

Joanna Rotter

For today’s medical device manufacturers, quality product support is a major competitive differentiator. Access to diagnostic equipment data is key to creating proactive service programs that help manufacturers pull ahead.

But having the data is only the start. You need to make sense of the incoming information if you want it to work for you. The Internet of things (IoT) is where it all comes together. Machines communicate through sensors and trigger alerts based on the data...

May 19th, 2015
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