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Be Thankful Marketing Isn't Running the R&D Lab

November 4, 2014 3:53 pm | by Sean Fenske, Editor-in-Chief | Comments

In such a highly regulated marketplace that so strongly depends on relationships, is your absence at an industry trade event going to significantly impact the perception your customers or manufacturing partners have? If it does, perhaps you haven’t…

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Developing Devices for Disabled Patients with FDA Encouragement

November 4, 2014 2:15 pm | by William Maisel, M.D., M.P.H., Deputy Center Director for Science, FDA, and Chief Scientist CDRH | Comments

For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can’t help that patient pick up a glass...

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Have a Clear Cost Benefit

November 4, 2014 8:30 am | by Eric Sugalski, Founder, Boston Device Development | Boston Device Development | Comments

The new reality of medical devices is that improved outcomes can no longer justify increased healthcare costs. In the changing healthcare landscape, new medical devices must offer a cost benefit, meaning that the economic value derived from adoption...

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Congress Tackles LDT Regulation: The Roles of FDA v. CMS

November 3, 2014 2:03 pm | by Richard Park, Contributing Editor | Comments

FDA recently released its two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances...

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Integrate Validated Off-the-Shelf Components

November 3, 2014 8:30 am | by Jim Ford, Manager of Corporate Product Management, Southco, Inc. | Comments

In a rapidly consolidating medical device market, the need to quickly release cost effective designs is greater than ever. When considering design options, keeping a focus on the total cost of each design option is essential. Choices between...

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Don't Do It Quickly, Do It Right

October 31, 2014 8:30 am | by Jim Janicki, Executive Vice President of Engineering & Quality, RTEmd | RTEmd | Comments

Regulatory requirements, business pressures (to get products to market faster), and cost implications often cause good teams to take short cuts. Even highly compliant organizations, when rushed, can lose discipline, causing developers to stray...

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Establish Communication Up Front

October 30, 2014 8:30 am | by Dave Beckstoffer, Commercial Program Manager, Portescap | Portescap | Comments

For the motion control of any medical device, cost pressures always exist to keep them as low as feasible while still providing the performance required. The key is early engagement with the motion control manufacturer to ensure the development...

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Cold Deck to Reduce Volume of Material

October 29, 2014 8:30 am | by Jim Ritzema, Director of Operations, Rogan Corporation | Comments

To reduce costs and increase productivity, we have added a cold deck to our vertical liquid silicone rubber (LSR) molding machine. The cold deck reduces the volume of LSR material we use during molding by eliminating the sprue and runner...

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The 2020 Vision: Graphene’s Impact on Heart Health and Other Diseases

October 28, 2014 1:31 pm | by Victoria Tsai, Graphene Frontiers | Comments

There’s a better way to monitor and track heart health. Medical practitioners have vocalized it, scientists understand this, and together many forward-thinking people are working to improve early detection of heart and other diseases...

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Savings Comes from Unexpected Places

October 28, 2014 8:30 am | by David Morse, General Manager, Tube Hollows International | Comments

Cost savings often come from unexpected places. Two examples that come to mind involved the design and processes used to achieve high precision holes in cannulated parts. Tube Hollows International can drill extremely precise holes (as low...

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Decide Where and How it is Best to Reduce Costs

October 27, 2014 8:30 am | by Robert Kim, Strategic Marketing Director, Honeywell Sensing and Control | Honeywell Sensing And Control | Comments

In today’s medical equipment market, one path towards increased competitiveness is to reduce component costs. However, OEMs must be thoughtful and think holistically about where and how to cut costs. For example, sensors are often critical...

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Examining the Physician Office Lab Market: Germany and Switzerland

October 24, 2014 3:44 pm | by Richard Park, Contributing Editor | Comments

A few more observations of the U.S. physician office lab (POL) market. According to the report, non-physician practice test users represent ancillary markets for POL test products. Community clinics are not expected to grow appreciably as an IVD...

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Don't Leave It Until the Last Minute

October 24, 2014 8:30 am | by Scott Levy, Senior Packaging Editor, DDL Inc. | Comments

The “Just-in-Time” mentality that has become more pervasive within the medical device industry has also resulted in many more package validation testing projects being rushed and left to the last minute. This situation can pose a significant...

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NFC Power in a Pin-Sized Package

October 23, 2014 3:11 pm | by Sean Fenske, Editor-in-Chief | Comments

In a recent blog, I highlighted a rapidly charging battery technology that was being developed for electric vehicles, but would certainly have applications in the medical device space as well. Unfortunately, that technology is not here yet, and...

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How Do We Make the Breast Pump ‘Not Suck’?

October 23, 2014 10:28 am | by Melissa Barnes, Associate Editor | Comments

When I read the recent news item about MIT’s “Make the Breast Pump Not Suck Hackathon,” I thought it couldn’t have come at a more relevant time in my life. Having just had a baby under seven months ago, and trying to continue a regular...

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