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Quality Products/Services to our Aging, Technologically Astute Population

September 5, 2014 8:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Software | Comments

As the world population’s average age is increasingly rising, the home health industry is continuing to grow and mobile healthcare-related technology is evolving. As a result, more digital health companies and mobile devices will emerge...

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Keeping Pace: A Continuous Improvement Process

September 4, 2014 8:30 am | by Bill Betten, VP of Business Solutions, Medical/Life Sciences, Logic PD | Comments

I believe it is important that the FDA continuously revisit their decision regarding medical device apps. As of 2013, the FDA had cleared and registered just over 100 medical apps, nowhere near the current pace of app development, which...

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Higher Risk and Longer Investment Window

September 3, 2014 8:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Farm | Comments

In some ways, venture capitalists and high net worth individuals are already doing this by funding syndicates that number anywhere from six to 20 investors. However, these are seasoned investors who possess a vast knowledge of the competitive...

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Gaming and Good Health

September 2, 2014 11:05 am | by Sam Brusco, MDT Editorial Intern | Comments

The term “gamer” does not typically bring to mind the picture of health. Actually; it often seems to conjure images of unhealthy behavior -- prolonged periods of limited to no movement, vision problems, and the development of a colorful vocabulary...

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IVD Market Continues to Be Steady and Solid

September 2, 2014 8:53 am | by Richard Park, Contributing Editor | Comments

According to the report, the global IVD market generated $54.6 billion in revenues in 2013. During the next few years, the market is expected to grow 4% annually and reach $65 billion by 2018. Compared with the usual 5-6% growth rate for...

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Necessary to Understand Market Demand

September 2, 2014 8:30 am | by David Bratvold, Founder, Daily Crowdsource | Comments

I believe crowdfunding for medical device development is not only viable, but it's an absolute necessity. However, the biggest benefit of crowdfunding is not the money you receive to develop your device, but rather a concrete understanding...

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Voting with Their Dollars

August 28, 2014 8:30 am | by Jonathon Kemnitzer, Principal, KEM STUDIO | Comments

At KEM STUDIO, we’ve successfully funded an industrial design project, called “Skate Bench No. 1,” through Kickstarter in 2011. This skateboard-inspired bench was noticed by professional skateboarders Mike V (Vallely) and Tony Hawk who used...

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Opportunities for Attraction

August 28, 2014 8:30 am | by Alex Fair, Chief Crowdologist, MedStartr.com | Comments

I run the leading crowdfunding site for medical innovations and about a third of our clients have some sort of medical device. So far, we have helped about a dozen medical device companies get found and funded just with rewards and donations...

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Solving a Customer's Problem

August 27, 2014 8:30 am | by Walter Hock, Director, Product Management, Portescap | Portescap | Comments

In today’s rapidly changing market, clinicians and aspiring entrepreneurs with an idea for a medical device should first be very clear in understanding the problem they are solving for the customer. Often, clinicians and entrepreneurs are...

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Risky Device MMAs Should Be Regulated

August 25, 2014 2:31 pm | by Steven G. Richter, Ph.D., President and Chief Scientific Officer, Microtest Laboratories Inc. | Microtest Laboratories, Inc. | Comments

I agree that the FDA should regulate mobile medical apps (MMA) because there is a potential that certain apps used to treat and diagnosis disease states can be harmful to patients when not working properly. When the FDA published the current...

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Assessing FDA’s Final Guidance on Companion Diagnostics

August 22, 2014 2:28 pm | by Richard Park, Contributing Editor | Comments

On the same day that FDA released its draft guidances on regulating laboratory-developed tests (LDT), the agency also issued a final guidance on the development, review, and clearance of companion diagnostics. According to FDA, this guidance...

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Design Innovation vs. The ‘What If?’

August 22, 2014 2:03 pm | by Sean Fenske, Editor-In-Chief | Comments

There are many obstacles to a successful product design getting into the marketplace (in the medical device space, some would argue that the FDA needlessly creates even more, however, that’s for another day’s discussion). Therefore, designers...

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Experts: 90% of Medical Records Are Vulnerable to Hackers

August 21, 2014 3:18 pm | by A.J. Watts, ECN Editorial Intern | Comments

Many tech-savvy people take major precautions to guard themselves against hackers by encrypting their personal data and protecting their Wi-Fi at home. Sadly, hospitals and clinics haven’t taken those same precautions and are under attack...

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Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

August 20, 2014 2:03 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. Section 907 of the...

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Providing Easy Access to Medical Device Reports Submitted to FDA Since the Early 1990s

August 19, 2014 2:06 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA and Jeffrey Shuren, M.D., Director – CDRH, FDA | Comments

In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential...

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