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Why Apple’s iWatch Won't Move the Needle on Lowering Healthcare Costs in the U.S.

September 9, 2014 | by Greg Caressi, Senior Vice President of Healthcare & Life Sciences, Frost & Sullivan | Comments

While the industry will be talking, writing and forecasting the impact of Apple's upcoming iWatch release on the healthcare industry, the reality is the iWatch won't move the needle on lowering healthcare costs in the U.S. Why not? There are...

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Congress Tackles LDT Regulation: FDA Authority and Adverse Events

September 15, 2014 10:27 am | by Richard Park, Contributing Editor | Comments

Last week, the House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing on FDA’s notification to Congress at the end of July that it intends to issue draft guidance on a framework for oversight of laboratory...

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Don't Patent Too Soon: Look at the Market

September 15, 2014 8:30 am | by Stephen Knowles, Managing Director, Industrial Design Consultancy (IDC) | Comments

The first step in new product development is to qualify the market for the idea, before doing anything else. Potential developers need to ask the questions: Does the device solve a clinical need? How will it enhance outcomes and save...

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Strategize for Regulatory and Market Approval

September 12, 2014 8:30 am | by Brian Weller, VP of Quality/Regulatory Affairs, D&K Engineering | D&K Engineering | Comments

Clearly define your value proposition. The first critical step in a serious development effort is to show a compelling need in the marketplace for your device. It may seem obvious, but history shows that often the biggest barrier to overcome...

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For a Better Mousetrap, Look to the Mice

September 11, 2014 8:30 am | by Amy Munice, President, ALM Communications | Comments

First step? Backtrack! I’ve seen many engineering-based companies sink considerable time and R&D into products that that they think are nifty and neat. The problem is that the market might not agree. Before you invest significant R&D...

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Plan and Assess

September 10, 2014 8:30 am | by Aidan Petrie, Chief Innovation Officer, Ximedica | Ximedica | Comments

Sit down and take a deep breath. Most ideas for medical devices that we see are driven by a technological breakthrough or a clinical need, but, increasingly, the driver for successful new entries is their ability to deliver a clear economic...

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Google Glass Could Detect, Diagnose Emotion

September 9, 2014 9:25 am | by Jason Lomberg, Digital Editor, ECN | Comments

Well, there you go. Google Glass is more than just an ostentatious gadget for filming things, augmented reality, and generally freaking everyone out within a 50-yard radius. Actually, medical applications like BioGlass could finally move...

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Reducing Risk in New Medical Equipment Development

September 9, 2014 8:30 am | by Robert Kim, Strategic Marketing Director, Honeywell Sensing and Control | Honeywell Sensing And Control | Comments

The idea is the start, but there is a lot of work ahead to make that idea a reality. One key to success is to leverage the expertise of others as much as possible and thereby reduce risk. When equipment requires the use of sensors, far too...

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Congressional Roundtable Recognizes Companion Diagnostics’ Importance

September 8, 2014 9:21 am | by Richard Park, Contributing Editor | Comments

A few weeks ago, the U.S. House of Representatives’ Energy and Commerce Committee held a roundtable discussion on personalized medicine as part of its 21st Century Cures initiative. Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) led...

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Component Manufacturers in the Design Process from the Start

September 8, 2014 8:30 am | by Steven Twork, Global Market Manager, Medical Device, Bal Seal Engineering Inc. | Bal Seal Engineering, Inc. | Comments

So many elements must be in place — the right team, funding, a distribution strategy, a regulatory strategy, and much more — but it is equally important to identify the underlying technologies necessary for design and development and to...

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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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