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Don't Forget About Patient Isolation to Ensure Safety

March 26, 2015 8:30 am | by Daniel Ruth, Medical Team Leader, TUV Rheinland | Blogs | Comments

The IEC 60601-1 standard for basic safety and essential performance of medical devices deals with many functional issues. They are typically addressed by manufacturers in their risk management files to ensure the device does not harm the...

No One Risk Applies to All Devices

March 20, 2015 8:46 am | by Steven W. Badelt, Ph.D., Director of Outreach, Healthcare Working Group, INCOSE | Blogs | Comments

Medical device companies sometimes fail to follow a robust risk identification process. That...

Consider the Patient to Ensure Safety in Device Development

March 19, 2015 8:30 am | by Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions | Blogs | Comments

It will be no surprise that the most critical consideration to ensuring patient safety when...

Focus On 'Why?' Instead of Just 'How' for Device Design

March 19, 2015 8:30 am | by Ed Trevis, President and CEO, Corvalent | Blogs | Comments

Every facet of the process – from circuit board design and assembly to on-site implementation of...

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Devices Safeguard Patient Safety Only When They Work

March 16, 2015 10:57 am | by Ellen Turner, Market Development Manager, Specialty Plastics, Medical Devices, Eastman Chemical Company | Blogs | Comments

Medical devices are under a lot of pressure — doing more for caregivers and patients with each innovation, all while having to withstand the wear and tear that comes with constant use. A heightened focus on patient safety, resulting from evolving...

Don't Make the Same Device Design Mistakes

March 13, 2015 10:09 am | by Michael Appel, M.D., Anesthesiologist, INCOSE | Blogs | Comments

We must not only anticipate any new hazards, but must also carefully consider the common underlying risks that have already been identified in previous devices. Using more than just a hypothetical risk process, we need to evaluate known problems...

3 Patient Safety Considerations for Medical Device Development

March 12, 2015 8:30 am | by Maria Shepherd, President, Data Decision Group, Medtech Whitespace and Strategy Research | Blogs | Comments

Usability is the piece of the medical puzzle that supports good engineering design. Simply designed devices with simple instructions reduce the possibility of use error, and the CDRH receives approximately 100,000 Medical Device Reports...

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Include Test Application Engineers to Get the Details Right

March 12, 2015 8:30 am | by Jacques Hoffmann, President, InterTech Development Company | Blogs | Comments

Failsafe testing of medical devices is a non-negotiable pre-requisite for release of a device to the market.  Most realize that simplistic truth but there are far too many who do not appreciate the “devils in the details” of test applications...

Make Sure the Optimum Solution is Integrated into the System

February 11, 2015 8:30 am | by Matt Kelly, Key Account Manager, Medical, Watlow | Blogs | Comments

Home healthcare can provide significant benefits to patients in terms of quality of life and cost of care. However, the use of medical devices in the home also presents unique challenges and potential safety risks. Home medical care is outside...

Overcoming Battery Limitations to Conserve Power

February 10, 2015 8:51 am | by Walt Maclay, President, Voler Systems | Blogs | Comments

Gone are the days when laptops drive the definition of low-power. Suppliers rely more and more on consultants to provide specific skills needed to design today’s exploding array of battery operated devices including wearable devices, home health...

Adaptability and a Highly Skilled Engineering and Production Team are Crucial

February 9, 2015 8:30 am | by Perry Sainati, President, Belden Universal | Blogs | Comments

As adaptive technologies enabling patient mobility and portable care are reaching new heights in sophistication and automation, OEMs rightfully expect similarly high levels of performance and quality from their suppliers. For Belden as a...

Smaller, More Portable Home Medical Equipment

February 8, 2015 8:30 am | by Robert Kim, Strategic Marketing Director, Honeywell Sensing and Control | Honeywell Sensing And Control | Blogs | Comments

There is a growing demand for smaller, lighter and more portable home healthcare equipment. For example, smaller respirators, infusion pumps, and vital sign monitors are being designed for home use to improve patient quality of life and reduce...

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Save Money by Avoiding Multiple Failures During Evaluation

February 7, 2015 8:30 am | by Ajay Sankhla, Senior Engineering Consultant, Intertek | Blogs | Comments

The adoption of new and expanded payment and delivery models is spurring demand for home healthcare growth. But navigating the required patient and user safety standards that these technologies require is different than traditional clinical...

Ensuring Data Security and Best Practices for Home Healthcare

February 6, 2015 9:30 am | by Delmar Howard, mHealth Program Manager, Intertek | Blogs | Comments

Data security and patient privacy are top issues facing every medical device company operating in the mHealth landscape. Even with FDA’s recent Guidance on Management of Cybersecurity in Medical Devices, OEMS struggle with the necessary...  

4 Important Security Concerns for Medical Devices

February 6, 2015 8:30 am | by Alan Grau, President, Icon Labs | Blogs | Comments

To meet FDA Guidelines for cyber security, medical device manufacturers need to design security into the device itself. Leveraging ecosystem partners with security expertise allows medical device OEMs to focus on their strengths while building...

3 Likely Trends in MedTech in 2015

February 4, 2015 10:30 am | by John Smith, Partner, Hogan Lovells | Blogs | Comments

FDA’s premarket data requirements continue to increase, with a broader range of devices subject to clinical data requirements and expectations for pre-clinical data continuing to increase. The result has been a significant increase in the regulatory...

3 'Coopetition' Trends for Healthcare in 2015

February 4, 2015 8:30 am | by Neil Smiley, Founder and CEO, Loopback Analytics | Blogs | Comments

The healthcare industry is shifting toward fee-for-value payment models based on outcomes. For fee-for-value to reach its full potential, healthcare providers need to develop systems that span the full continuum of care. In 2015, I foresee three...

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Further UDI and MedWatch Regulation in 2015

February 3, 2015 8:49 am | by Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Blogs | Comments

In 2015, the medical device industry will be focused on meeting the regulations that support the speed and quality of capturing electronic information and the efficiency of sharing information. While 2014 saw the initiation of the Unique Device...

Portable Batteries, Far East Presence, and Antimicrobial Polymers in 2015

February 3, 2015 8:43 am | by Rob Phillips, Managing Director, Accutronics Ltd. | Blogs | Comments

Medical technology is one of the world’s fastest growing industries. We are excited at Accutronics to have launched our latest smart-battery range at COMPAMED, the international trade show. We are looking forward to some great innovations in...

2015 Will Produce Innovative, Cost Effective Cardiovascular Technology

February 1, 2015 8:30 am | by Dr. Mark Carlson, Chief Medical Officer, St. Jude Medical | Blogs | Comments

This year has been a dynamic year as the medical device sector continues to adapt to the changing healthcare environment. As an industry, we are called to develop innovative solutions that address prevalent, devastating, and costly conditions...

Better Control with Flexible Heating Technology in 2015

January 31, 2015 8:30 am | by Sam Pelonis, President, Pelonis Technologies Inc. | Pelonis Technologies, Inc. | Blogs | Comments

Heating technology will continue to become more precise in the New Year. The introduction of heating solutions such as the ultra-thin flexible heater — a product Pelonis Technologies introduced in late 2014. What makes the ultra-thin flexible...

Next-Gen X-ray Imaging Will Proliferate in 2015

January 30, 2015 9:00 am | by Mila Heeman-Iliëva, Ph.D., Senior Marketing Manager, Teledyne DALSA | Teledyne Dalsa | Blogs | Comments

The introduction of thin-film-transistor (TFT) flat X-ray detectors in the late 1990s rapidly changed the landscape of the dynamic X-ray imaging market. In less than 10 years, the incumbent technology, the image intensified CCD (IICCD), has been...

Is Your New Mobile Health App Secure in 2015?

January 30, 2015 8:30 am | by David Surber, VP of Medical Products, TÜV Rheinland | Blogs | Comments

It is estimated that 500 million smartphone users worldwide will use healthcare applications in 2015 – from using the phone to detect glaucoma in the eye to taking cardiac measurements. The users include healthcare professionals, consumers, and...

Automating the Manufacturing Process in 2015

January 29, 2015 9:00 am | by Brian Beahm, CTO, Beahm Designs Inc. | Beahm Designs, Inc. | Blogs | Comments

As the medical device industry continues to face complex challenges in new product development and launch, the trend in 2015 will increasingly migrate toward automation at every level of the medical device manufacturing supply chain. When we...

Speeding Up Diagnosis and Embracing Telehealth in 2015

January 29, 2015 8:30 am | by Dan Piekarz, Vice President of Business Development, Life Sciences, DataArt. | Blogs | Comments

Technology implemented well is greatly increasing our ability to understand the human body and how to care for it. In 2015, next generation genetic sequencing techniques will be revolutionizing diagnosis of infectious disease, but the FDA's...

2015 Will Require Implementation of Thorough Security Programs

January 28, 2015 8:30 am | by Michael McNeil, Product Security & Services Officer, Philips Healthcare | Blogs | Comments

In April of 2014, Wired Magazine made the rattling proclamation that “it’s insanely easy to hack hospital equipment,” citing cybersecurity researcher Scott Erven’s two years of medical device vulnerability investigations and the many ways in...

Next-Gen Home-Use Products Require Small, High-Performing Sensors

January 27, 2015 8:47 am | by Rob Kim, Strategic Marketing Director, Honeywell Sensing and Control | Honeywell Sensing And Control | Blogs | Comments

Medical equipment, driven by patient convenience and cost reduction, is moving from the hospital to the home. In addition, typical home-use products, like CPAP machines are becoming smaller and more sophisticated. In a hospital or clinical...

Finding Some "Sense" in 2015

January 27, 2015 8:30 am | by Walt Maclay, President, Voler Systems | Blogs | Comments

During 2015, sensors will continue to be a driving force for innovative medical devices. We will see advances in chemical sensors, especially "lab on a chip," and paper-based sensors. Driven by faster analysis time and extremely small fluid...

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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