Articles

FDA Human Factor Requirements Change the Landscape of Medical Device Development

Get ahead of stringent design cycles by evaluating the human factors and usability of a device early in the process. When the demands for meeting these requirements come from the FDA, as they almost certainly will, your product and your team will be ready. by David Hirning MS and Virginia A Lang, PhD, HirnLan, Inc....

Fuzz Testing Medical Devices: How to Unmask Medical Device System Vulnerabilities to Improve Safety and Privacy Profiles of Medical Devices

Medical devices are critical to our healthcare system. It is becoming increasingly realized that the security profile of many networked medical devices may not be optimal thus rendering the devices vulnerable to hacking or malware. There are a number of examples of medical devices that have been hacked including insulin pumps and implantable defibrillators, and...

Tools for Medical Device Development

      Tools for Medical Device Development  by Peter Thorne, Director, Cambashi Ltd. Advanced technology in medical devices offers the prospect of conversion of laboratory research into practical treatments that can be replicated and delivered in hospitals, at health centers and at home. But the potentially catastrophic results of any device failure demands design,...

Healthcare without Boundaries

Healthcare without Boundaries Video Communications—from room to desktop to cloud, it’s enabling a new wave of video-enabled healthcare applications. by Peter Eggleston, SBR Health Once a complex expensive technology, video communications has gone from being a scarce resource that needs to be scheduled, to one that is inexpensive, pervasive and available to all through the...

Interview of the LifeScience Alley & BioBusiness Alliance of Minnesota by MEDS

Introduction written by the publisher of MEDS (Medical Elec­­tronic Device Solutions), John Koon Minnesota has long been known as a major hub of life science and medical device activities. Many top companies such as GE Healthcare, St. Jude and Medtronic are in the area. One outstanding organization called LifeScience Alley & BioBusiness Alliance of Minnesota...

Interview of Qualcomm Life Fund by MEDS

Introduction written by the publisher of MEDS (Medical Elec­­tronic Device Solutions), John Koon New medical device companies continue to emerge at a rapid pace. Various sources have indicated that while there are more start-ups, the length of time for a company to go from concept to successful product launch with positive cash flow is increasing...

FDA Issues Draft Guidance on Medical Devices Intended for Home Use

On 12 December 2012, the FDA issued a new draft guidance for industry and FDA staff on design considerations (for design and development) for devices intended for home use. Back in April 2010, the FDA launched the Medical Device Home Use Initiative [1], as there were concerns about the growing number of safety issues with...

Amendment to 60601-1 underscores Role of safety in Device Design

For those who design, manufacture, or test electromedical equipment, 60601-1 is one of the most important safety and performance standards in AAMI’s portfolio of industry standards. It is referenced so often in the daily work of medical device engineers that AAMI plans to offer this updated standard in a pocket version. 60601-1 deals with medical...

More than Design: Tips for Successful Medical Device Development

Medical device company executives seeking a 510(k) pre-market approval path, or who have electronics or software included in their product, need to be aware of the most common regulatory affairs, quality and safety components, as well as some frequently overlooked tips that will save money.   by Russ King, MethodSense   Since 2008, the economic...

What does the future of the Medical Electronics industry look like?

MEDS Magazine has contacted the leaders: Philips, the Medical Device Innovation, Safety and Security Consortium (MDISS), West Health, and Continua to hear what they have to say. Philips’s interview by MEDS will be followed by input from other industry leaders. MEDS Magazine Interviews Dr. Brian Rosenfeld, VP and Chief Medical Officer for Telehealth, Philips Healthcare...

Publisher’s Letter: Who Really (Health) Cares?

by John Koon 2013 is upon us. What is ahead of us? Recently I asked a friend who is about to have his physical checkup, “Do you feel that your doctor really cares about you?” “No,” he responded without hesitation. I also read that some patients complain that their doctors (the primary physician) spent more...

RTC Group Taps Industry Leader Clarence Peckham, Brings His Technology/Market Expertise to Publications Team as Senior Editor

SAN CLEMENTE, CALIF., NOVEMBER 28, 2012 – RTC Group, Inc.,—foremost supplier of marketing resources to the embedded computing industry and publisher of premier industry technology publications including RTC, MEDS and COTS Journal —announces industry leader Clarence Peckham has joined the RTC Group’s editorial team. With more than 30 years of engineering and senior management expertise...