Jennifer French answers user questions on Reddit. [image via imgur/Reddit]

Prior to sustaining a spinal cord injury in 1998, Jennifer French was, among other sports, an active snowboarder and skier, sailor, fly fisher, and scuba diver. Today, thanks to her neurostimulation implants, she still is. In 1999 French became the first woman to receive the Stand and Transfer implant system created by the Cleveland Functional Electronic Stimulation (FES) Center. The implant uses a series of muscle- and nerve-based electrodes to stimulate muscles in the lower body. By pressing a button on an external control unit, French is able to...

May 27th, 2014
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The infographic below about small businesses is interesting overall, but one factoid stuck out at me. And that's the connection between being a self-employed business person and being healthy.

Apparently 53% small business owners believe that their personal health is better because they run their own business. The infographic seems to be based on this Bank of America study that also shows that 49% say they get between seven to eight hours of sleep at night and 35% report exercising regularly. 

The infographic was created by Dealstruck, a crowdlending site for small business owners. 

...

May 22nd, 2014
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Pricewaterhouse Coopers just released the MoneyTree Report and the results of the first quarter venture capital investment activity, are mixed.

Medtech companies have been complaining that there has been a flight of VC capital from early stage companies. Apparently it is easier to squeeze water out of a stone than get financiers to assume the risk of pouring capital in early stage medical device companies. The PwC and National Venture Capital Association's MoneyTree Report, based on data from Thomson Reuters, would have us believe otherwise.

It found that in the first quarter of 2014, early stage medical device funding increased 11% to $216 million through 25 deals, compared with $194 million in 29 deals for the same period last year. In fact the average deal size for early stage medical device firms - $8.6 million - was...

May 20th, 2014
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Silo is becoming a dirty world in the world of healthcare and medtech as various players realize that keeping patients healthy across the continuum of care requires a greater degree of collaboration than ever before.

In other words, collaboration between groups that barely had much of a direct relationship in the past or if they did, it was quite antagonistic. 

No where is this more apparent than in the results of a survey that PricewaterhouseCoopers released earlier this year. PwC’s 17th Annual Global CEO survey shows that 53% of pharma and life sciences CEOs are planning to enter into a strategic...

May 19th, 2014
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Boston Scientific's subcutaneous implantable defibrillator

 

Boston Scientific has high hopes for its breakthrough S-ICD product, the first and only approved subcutaneous implantable cardioverter defibrillator that has no leads in the heart. The product came to the company from the acquisition of Cameron Health...

May 19th, 2014
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Patient engagement is not where most providers would like it to be. The infographic from Boston Technology below evaluates the current landscape of patient engagement and makes a powerful argument for how mhealth can boost it.

 

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

 

May 15th, 2014
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By Annie Diorio-Blum

Contextual research is an often-overlooked step in the medical device regulatory process, yet one that is critical in overcoming regulatory obstacles. This time-consuming and hands-on, observe-and-analyze process helps medical device companies understand a variety of factors to help move their products from an idea to marketable product.

Contextual research involves the observation and analysis of the way a person uses a medical device in a real-world environment. It helps medical device companies understand a particular patient population, evaluate the performance of a device in its unique environment, or learn about a process or task associated with a specific device. The contextual research process collects data and...
May 13th, 2014
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A polarizing new law that establishes commercial payment benchmarking will alter the IVD reimbursement landscape.  But who will it help and who will it hurt?

By Charles Mathews

Charles MathewsSince the 1980s, Medicare has been in the driver’s seat in terms of payer pricing for clinical diagnostics. Medicare would set values for individual current procedural terminology (CPT) codes on the clinical laboratory fee schedule (CLFS), and commercial payers would simply look up those values and pay a little more or a little less. 

But the traditional system is about to change in a significant way. 

On April 1, the Protecting...

May 12th, 2014
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In vitro diagnostics companies are struggling to navigate an increasingly complex regulatory environment fraught with uncertainty.

By Allyson B. Mullen

Allyson MullenIn vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: uncertainty. 

Many regulatory challenges for IVD companies relate to issues that are evolving and changing. Even where there appear to be clear regulatory requirements, it is not yet known—or not always reasonably foreseeable—how FDA will implement those requirements. In this article, we will examine four significant regulatory challenges facing IVD companies...

May 12th, 2014
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FDA’s presubmission program and meetings present a valuable opportunity for companies to gain clarity and nonbinding feedback on premarket submissions and testing plans.

By Allyson B. Mullen

Allyson Mullen

Earlier this year, FDA issued the final guidance, “Requests for Feedback on Medical Device Submissions: The Presubmission Program and Meetings with Food and Drug Administration Staff.” This program allows for a variety of different presubmissions and meetings with FDA, including those to educate FDA or to discuss the plans for a premarket submission—such as a 510(k...

May 12th, 2014
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