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Bluetooth Health Device Profile: Compatible Communication for Specialized Devices

Part 1 The Health Device Profile along with the IEEE 11073 protocol is enabling a number of specific medical devices to communicate data via multiple logical channels carried by a single master radio channel for compatible device communication. Profiles play a central role in the Bluetooth Specification. They define the entire protocol stack, usually including...

The Med Tech Food Chain

The medical technology ecosystem is an ever expanding and complex food chain. Most noticeable are the manufacturers building medical devices of FDA class I, II and III such as EKG machines, blood pressure monitors, blood glucose monitors, insulin pumps, ultrasound systems, implantable defibrillators, wearable devices and all sorts of wireless monitors. The list goes on...

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...

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