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Don't Go It Alone

September 18, 2014 | by David Perry, Engineer, Boston Device Department | Comments

Focus your efforts on identifying the key assumptions or biggest lingering questions around your new medical device, then build something small and focused to test them. Intuition and math can tell you something should work, but you don't...

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Making Light of a Serious Situation

September 19, 2014 8:30 am | by Sam Brusco, Editorial Intern | Comments

The last item on a hospitalized patient’s agenda is to contract more illnesses during their stay. Unfortunately, The CDC estimates that five percent of all hospital admissions result in infections that patients acquire during their stay while...

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Test with a Prototype

September 19, 2014 8:30 am | by Anthony Appling, Senior Director of Research & Development, MedVenture Technology, A Helix Medical Company | Comments

There are a few crucial steps that should be taken before significant investment is made or development efforts are put forth. First of all, one should develop a problem statement. You need to determine what specific problem is being addressed...

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A New Sensor Development Could Aid Those Suffering from Alzheimer’s

September 17, 2014 9:44 am | by A.J. Watts, ECN Editorial Intern | Comments

SmartThings is a DIY home automation system that connects sensors and smart devices with a wireless hub. In addition to sensors, the system can loop in smart thermostats, smart plugs, door locks, and surveillance cameras. Now there isn’t a...

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Ask the Right Questions at the Right Time

September 17, 2014 8:30 am | by Bill Betten, VP Business Solutions, Medical/Life Sciences, Logic PD | Logic PD, Inc. | Comments

I’m going to focus on the initial early stages of the idea generation and concept development. A key aspect of any idea is to understand the problem that is trying to be solved. Is there a real issue that is being addressed or is it a solution...

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The Productization Plan

September 16, 2014 8:30 am | by Dana Demeo, Chief Technical Officer, Intelligent Product Solutions | Intelligent Product Solutions | Comments

Successfully bringing an idea from concept to completion requires coordination, planning, and vision even before you get to square one; we call this the Productization Plan. More often than not, if you were to look back at ideas that seemed...

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

September 9, 2014 9:35 am | 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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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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