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The Lead

The ACA Has Directly Impacted Medical Innovations

December 19, 2014 8:23 am | by Sean Fenske, Editor-in-Chief | ODU-USA, Inc. | Blogs | Comments

In my opinion, the Affordable Care Act has held back new research and potential technology breakthroughs that could benefit patients worldwide. Within the past year, I have experienced device manufacturers moving their operations overseas due to the...

Development of Automation and Integration of Robotics

December 19, 2014 7:30 am | by Jason Nelson, Tech Center Manager, ProMed Molded Products | Blogs | Comments

Implantable devices serve a variety of functions from regulating the beat of a heart to...

Lower Cost, Faster Speed to Market, Better Component Consistency

December 18, 2014 7:30 am | by New Product Development Team, Ci Medical | Blogs | Comments

Many new features and functionality are being introduced every month. The medical molding...

6 Key Lessons MedTech Manufacturers Can Learn from Innovation Leaders

December 17, 2014 9:00 pm | by Lukas Zdrazil, Landor Associates | Blogs | Comments

For decades, the medtech industry has been driven by innovation. Now, companies that...

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Infographic: Outsourcing in the Development of Medical Devices

December 17, 2014 10:11 am | by Eileen Whitmore, Art Director, and Sean Fenske, Editor-in-Chief | News | Comments

MDT sent out a survey to readers focused on their experience with outsourcing in the development of medical devices. The following infographic reflects their responses to a number of questions related to the topic. For additional insight...

What Do You Mean You Aren’t Outsourcing?

December 17, 2014 10:07 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

When I started covering this industry more than 15 years ago, using outsourcing service providers was something that was done sparingly and much less of a common practice when compared to today. Medical device manufacturers were not ready...

Reduce and/or Combine Components to Cut Molding Costs

December 17, 2014 7:30 am | by Kelly Peterson, New Product Development Manager, JunoPacific | JunoPacific, Inc. | Blogs | Comments

Molded-in seals, hermetic seals (LIM), multiple components assembled in-mold, anti-microbial additives, RFID tags, electrical conductivity. The ability to micro-mold components is continually driving the miniaturization of implantable and...

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CAM Software Enhances the Quality of Orthopedic Implants

December 16, 2014 10:04 am | by Helene Horent, DP Technology | Articles | Comments

To provide minimally-invasive equipment and high-quality products, it is essential to acquire the best technology for production. To meet these objectives, Stryker chose to use ESPRIT, a computer-aided-manufacturing (CAM) software that comes equipped...

Integrate Vendor Into Product Development Process

December 16, 2014 7:30 am | by Lars Gerding, Technology Director, Helix Medical | Blogs | Comments

One great advantage with molding is the freedom to design various shapes and functional features into a part. This freedom includes the choice of raw material with a wide range of properties that are suitable for various applications. Newly...

Innovative Technologies for DNA Diagnostics and Health Monitoring

December 15, 2014 11:13 am | by Mina Rais-Zadeh, IEDM 2014 Focus Session Chair, Associate Professor, University of Michigan | Blogs | Comments

Several papers on advanced medical electronics technology will be presented at the IEEE International Electron Devices Meeting (IEDM) in San Francisco on Dec. 15-17, including bio-MEMS, bio-sensors, and technology for DNA diagnostics and...

Battle Lines Being Drawn Over LDT Regulation

December 15, 2014 9:54 am | by Richard Park, Contributing Editor | Blogs | Comments

“The heart of Bradley Thompson’s argument rests on, ‘if a company is manufacturing an IVD test, the agency has full authority.’ Developing and performing most LDTs is not ‘manufacturing’ in a recognized sense of the word and never has been (although...

Miniaturization in the Device Market

December 15, 2014 7:30 am | by Tim Reis, VP of Healthcare Business Development, GW Plastics | GW Plastics, Inc. | Blogs | Comments

Some new/additional features that can be incorporated are soft touch molding and gasketing functionality because of two-shot molding, aesthetic features and market branding. Medical devices themselves are being downsized into smaller...

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Nucleosomics Epigenetic Blood Tests to Revolutionize Cancer Detection

December 12, 2014 11:23 am | by Jake Micallef, VolitionRx | Articles | Comments

Cancer, which touches the lives of many, has remained a leading cause of death in the United States. While most cancers are treatable if caught before it has become locally invasive and has spread through the body, many cancers are not diagnosed...

Mobile Vital Signs Monitoring Devices Will Revolutionize Healthcare

December 12, 2014 8:00 am | by Sean Fenske, Editor-in-Chief | Analog Devices, Inc. | Blogs | Comments

Over the next five years, we are likely to see vital signs monitoring as a universal facet of everyday life. The sensing will be discreet, convenient, and painless. Expert systems will sit quietly in the background and occasionally rear their head to warn...

Using Smartphone Cameras as Test Strip Reading Devices

December 12, 2014 7:30 am | by Thomas M. Tsakeris, President, Devices and Diagnostics Consulting Group | Blogs | Comments

In my experience as a regulatory consultant mainly in the IVD area, I have observed over the last year or so an increasing interest in linking traditional IVD home-use test strips such as urinalysis (protein, pH, glucose keytones, nitrite, etc...

Might Portable Clean Air Hold the Key for Better Health?

December 11, 2014 2:39 pm | by Sean Fenske, Editor-in-Chief | @SeanFenske | Blogs | Comments

There’s little argument when it comes to the value of clean air. Air pollution – bad! Clean, fresh air – good! However, is creating an environment where someone is exposed to clean air exclusively a good idea? I happened upon a device that is being...

Apply Toyota’s Innovation Excellence to Accelerate Your Product Development

December 11, 2014 10:02 am | by David Jacobs, Boston Engineering | Articles | Comments

Toyota’s success as the world’s largest automaker is largely attributed to its Toyota Production System, which is rooted in Dr. Edwards Deming’s research to improve quality and business processes. Car brands and medical device companies are both...

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Collaborating With Clinicians to Set Standards

December 11, 2014 7:30 am | by Tom O’Dwyer, Director of Healthcare Technology, Analog Devices | Analog Devices, Inc. | Blogs | Comments

Home healthcare can really be divided into two sub-sections, clinical-grade and non-clinical grade. Clinical grade is currently limited largely to glucose testing and blood pressure cuffs. Non-clinical grade refers to areas such as...

The Pulse: Pain-Free Lancing for Blood Testing and Tracking Surgeons’ Eyes

December 10, 2014 11:36 am | by John Dipierro, Multimedia Production Specialist | Videos | Comments

On this episode of the Pulse, we’re performing a blood draw pain-free, comparing heart vital signs, tracking the eyes of surgeons, and giving the disabled access to smartphones.           

Integrating Patient Devices into Health IT Systems

December 10, 2014 11:20 am | by Charles Settles, Product Analyst, TechnologyAdvice | Articles | Comments

The launch of Apple’s HealthKit platform was the first real sign the fitness and health tracking movement had legs; Apple has always been intentional about its moves, and its fans are usually quick to adopt new offerings. They’ve already announced...

Engineering Live: How Do We Get More Kids Into STEM? (On Demand)

December 10, 2014 10:02 am | by ECN Staff | Videos | Comments

It’s easy to say we need more kids interested in science, technology, engineering, and mathematics (STEM), the challenge comes in finding ways to accomplish it. Whether it’s the toys they play with as kids, or the classes they take as students, we...

Photos of the Day: The Ebola Effect

December 10, 2014 9:51 am | by Study Medicine Europe | News | Comments

The latest outbreak of Ebola has dominated healthcare news in 2014. This infographic provides a rather extensive overview of the virus, the cost, worldwide impact, and more. It also covers the protective equipment that healthcare workers use when treating patients...

Easing the Burden on Healthcare Professionals

December 10, 2014 7:30 am | by Jan Wittenber, Member of IEEE and Fellow at the Center for Medical Interoperability | Blogs | Comments

The following from the Background section of the ISO/IEEE 11073 Personal Health Data (PHD) Standards addresses this topic appropriately: “Demographics changes (the rapidly aging population in many industrialized countries) and an increase...

Addressing the Top Five Software Validation Questions

December 9, 2014 9:48 am | by Penny Goss, Consultant, Penny Goss Technical Solutions | Articles | Comments

The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best...

Home (Healthcare) Is Where the Need Is

December 9, 2014 7:30 am | by Carlos Castillo, Biomedical Engineer & Research Biomedical Engineering Advisor, Loma Linda University Zhang Neuroscience Laboratory | Blogs | Comments

Short answer, where the need is! Perhaps numbers will make this more clear. Sen. Rob Portman (R-Ohio) gives us the first part of this equation “Each day, 10,000 baby boomers retire and begin receiving Medicare and Social Security benefits”... 

6 Tips to Leverage Production Efficiency Using Design for Manufacturability

December 8, 2014 10:19 am | by Gaurang Trivedi, Engineering Consultant, Hi-Tech Outsourcing Services | Articles | Comments

Design for manufacturability is an approach utilized to minimize manufacturing time by incorporating the design process along with the manufacturing processes. To meet the continuous shifting market trends, manufacturers are forced to shrink their...

IVD Companies Join Ebola Fight

December 8, 2014 9:58 am | by Richard Park, Contributing Editor | Blogs | Comments

While the initial hysteria and fear of an Ebola pandemic has quieted down, the fight against this disease is far from over. National Public Radio reported that there were 537 new Ebola infections in Sierra Leone in one week, which is the largest weekly...

Bionic Bra Proves Necessity Is Apparently Not the Mother of Invention

December 8, 2014 9:34 am | by Melissa Barnes, Associate Editor | Blogs | Comments

The recent story about a “Bionic Bra” from the University of Wollongong had me wondering...why?! Of all the medical devices we have a dire need for, a sensor-equipped, “smart yarn”-infused, automatic-tightening bra certainly isn’t one of them. The...

Exploit Opportunities Offered by UDI Initiative

December 8, 2014 7:30 am | by Dave Taylor, Vice President, Global Products, PRISYM ID | Blogs | Comments

Sep. 24 saw the first UDI compliance deadline which means that organizations should now be focusing on the implementation phase, following a thorough preparation phase reviewing all current processes and systems in place. The implementation...

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