Blogs
FDA States Medical Devices in the US Must Carry a Unique Device Identifier (UDI)
July 17, 2012 1:33 pm | by Warren Ward-Stacey | CommentsHealthcare providers should welcome the recently proposed ruling by the Food and Drug Administration (FDA), which states that medical devices distributed in the United States will be required to carry a Unique Device Identifier (UDI) as part of labeling and packaging.
The Doctor’s Office of 2050, What Can Medtech Expect?
July 17, 2012 10:59 am | by Gillian Davies | CommentsThrough the pre-coffee haze of your morning ritual you notice a red dot blinking on the bathroom mirror that is fogged with shower steam, “oh dear” you think “I wonder what’s wrong.” You press the illuminated mirror and a message pops up letting you know your body temperature is elevated. A menu of options appears on your mirror, and you select ‘speak to health worker.’ Welcome to the doctor’s office of 2050: your home.
Improving New Product Development: Focus on Process and People for Best Results
July 10, 2012 1:11 pm | by Michael Glessner and Cathi Crist | CommentsAs medical device companies engage in the business challenge of creating new products in a highly regulated market, two key factors slow innovation. First, companies too often rely on FDA-required compliance systems to drive innovation. These systems are focused on enabling the automated maintenance of design controls, and do not ensure creativity or good business outcomes for a business.
Is Med-Tech Walking the Global Tightrope? Balancing the Risks and Rewards of Med-Tech Globalization
July 10, 2012 9:12 am | by Daniel R. Matlis | CommentsThe globalization of design, sourcing, manufacturing, and sales of Medical Technology (Med-Tech) has created opportunities and challenges for the entire ecosystem. To assess the impact of globalization and outsourcing in the Medical Technology Industry, Axendia conducted a survey research of 125 Medical Technology Industry Executives representing 89 different companies across 16 countries. This article provides a summary of the project’s research report entitled, “Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.”
Addressing Ergonomics & Repetitive Motion Injuries in Manufacturing Facilities
July 3, 2012 4:34 pm | by Jim Norton | CommentsIn today’s manufacturing environment, ergonomics and repetitive motion injuries are major issues that every business must address to insure production levels remain at expected levels and employee injuries remain as infrequent as possible. Although many of the hand assembly processes have been replaced with automated equipment over the past 20 years, there is still a surprising number of manual operations still required for many applications.
Are Dedicated Sports and Fitness Monitors Still in the Running?
July 3, 2012 10:38 am | by Philip Maddocks | CommentsConsumers want to improve the functionality offered by sports and fitness apps through the use of sensors. A recent study conducted by IMS Research, a company recently acquired by IHS Inc. (NYSE:IHS), found that 62.3 percent of respondents with a smartphone interested in sports and fitness applications and who exercised at least once week, were prepared to purchase sensors to monitor performance and enhance the sports and fitness application on their smartphone.
FDA Regulation of Mobile Medical Apps
July 3, 2012 12:00 am | by Laird Technologies | CommentsHealthcare professionals and patients alike are embracing mobile medical applications for smartphones. Experts project that, by 2015, 500 million smartphone users will be using medical apps. A 2011 press release from the U.S. Food and Drug Administration indicates the FDA’s plan to regulate some smartphone medical apps, a decision that has been met by both positive and negative reviews.
Turning product ideas into reality – a new guide for start-ups
July 2, 2012 1:41 pm | by Duncan Smith and Dr. Derek Wallis | CommentsHow does a start-up company convince investors to help turn a bathtub idea into a warehouse full of products? That’s the question tackled by leading technology design and development firm Cambridge Consultants in a new free guide to help start-ups get their products successfully to market.
Why would a medical device OEM benefit from a tooling audit or a tooling evaluation?
June 27, 2012 1:39 pm | by Paul Mulville | CommentsBeing pro-active when it comes to mold tooling pays dividends. Even with the best of intentions, a solid maintenance program and the ability to react to mechanical breakdowns, tooling with a lot of miles on it becomes a cost and a risk to supply.
The Essential Facts of Essential Performance
June 27, 2012 8:38 am | by Todd Konieczny | CommentsMany medical device manufacturers believe that risk has always been a cornerstone in evaluating device compliance with medical standards. The Second Edition of IEC 60601-1 covered risk management, but Third Edition is taking it up a notch – the word “risk” is included in IEC 60601-1’s Third Edition standard more than 600 times. This increased emphasis on risk is a direct result of two elements of the revised standard – the requirement to review both the risk management processes and the risk management file, and the addition of essential performance.
FCC Allocates Spectrum for MBANs
June 26, 2012 12:00 am | by Laird Technologies | CommentsAccording to the official press release from the FCC, "Wireless devices that operate on MBAN spectrum can be used to actively monitor a patient’s health, including blood glucose and pressure monitoring, delivery of electrocardiogram readings, and even neonatal monitoring systems." Since patients are free of cables, the use of MBANs makes it easier to move patients from one part of the hospital to another for treatment. Further, from the FCC press release, "MBANs allow for ubiquitous and reliable monitoring, and give health care providers the chance to identify life-threatening problems or events before they occur."
Helping Start-Ups Avoid Slow-Downs
June 19, 2012 11:07 am | by Paul Brooks | CommentsBSI Group America, Inc. identifies the 7 Most Common “Rookie” Mistakes Medical Device Companies Make When Preparing for a European Product Launch
Insourcing, Automation, Patents and the Medical Device Industry
June 19, 2012 10:57 am | by Joe Pustka | CommentsEarly this year the Washington Post reported, “In 2010, U.S. manufacturers produced nearly $1.8 trillion in goods (in constant 2005 dollars), about $100 billion more than China did.”
Once Upon a Time…
June 19, 2012 10:52 am | by Joe Pustka | CommentsSometimes I wonder if the publishers of instrument specifications think they are writing fairy tales for children. That would be a kind explanation…
The next revolution in surgery may come from a small, under-the-radar company
June 19, 2012 10:45 am | by Arthur Frederick | CommentsThe next revolution in surgery may come from a small medical equipment company which, according to its own executives, has always preferred to fly a bit under the radar.
