• How to Make a Disruptive Device That Wins FDA Approval

    Agamatrix and Misfit cofounder Sridhar Iyengar has some advice for medtech professionals hoping to win FDA’s support for innovative new medical devices.Brian BuntzSridhar Iyengar is the cofounder of Misfit and Agamatrix.How can a medical device company create an unprecedented product that can win regulatory approval? Qmed recently had the chance to interview Sridhar Iyengar, the cofounder of Agamatrix (maker of the iBGStar, an iPhone-compatible blood glucose meter) and Misfit (a wearables and...
  • Obama Doubles Down on Paying to Keep People Healthy

    The move could be a boon for health tracker developers, while device makers in general will have to focus more on “value.”Chris NewmarkerThe Obama administration is accelerating the U.S. healthcare system’s shift away from its old fee-for-service model—a move that could have far-reaching ramifications for medical device makers.Health trackers including wearables will likely be more in demand, while medical devices in general will have to demonstrate that they are helping the overall healthcare...
  • 3 Parent Babies Could Be Coming to UK

    The House of Commons' decision has sparked an intense debate, with opponents complaining of "designer babies." Supporters saying the procedure will prevent genetic diseases.Kristopher SturgisBritish lawmakers have approved a controversial and untried in vitro procedure that creates babies made from three people’s DNA. The decision—a first— permits scientists to use genetic material from two women and one man—the goal being to prevent the inheritance of genetic diseases.Lawmakers in the...
  • Peeking inside the Body Using Smallest-Ever CMOS Camera

    Based on CMOS technology, a tiny camera is suitable for a range of medical device applications.Minimally invasive surgery has been facilitated by the development of microcameras that can peer into tiny body cavities. The development of microcameras, in turn, has been facilitated by advancements in the area of integrated circuits. A case in point is the micro ScoutCam line of cameras. Bob MichaelsManufactured by Medigus Ltd. (Omer, Israel), the ScoutCam system is said to be the world smallest...
  • Will AI Be a Savior or a Demon for Medtech?

    The Terminator franchise popularized the notion of artificial intelligence becoming a threat to humanity. Terminator image from Flickr user Dick Thomas Johnson.So how long before artificial intelligence (AI) transcends the realm of gadgetry and makes its way into the workforce—including the medtech workforce? Already, AI is being used to design websites. Could robots design medical devices, say, a decade from now?It might not be as crazy as it sounds. In any event, the medical field is becoming...
  • Using Disarray to Create Order for Lasers, Medtech Sensors

    This illustration from UCLA shows light traveling through a photonic crystal superlattice. The holes have been randomly patterned. The result is a narrower beam of light.Controlling light at nanoscale wavelengths could boost the precision of lasers and data transfer on computer chips—and improve optical communications. Researchers at UCLA and Columbia have managed to do just that, controlling light at a wavelength measuring approximately 500 nm, comparable to the wavelength of visible light...
  • Why the 'Turnaround Test' Matters for Medical Devices and Wearables

    Above is Misfit's Bolt smart light bulb. Below is the Swarovski Shine fitness tracker. Misfit, the Burlingame, CA–based maker of the Shine and a lineup of other innovative products, is making waves in both the wearables and smart home markets. The origins of the company’s philosophy, however, lie in the medical device space--and how company officials cracked what they call the "turnaround test."Before we get into that, however, let’s take a look at what Misfit has accomplished since it was...
  • Making Contract Manufacturing Work for You

    Barry Kazemi will participate in a panel on outsourcing at MD&M West, in Anaheim, CA, February 10-12, 2015.Outsourcing production can be a well-justified decision—potentially resulting in reduced costs in infrastructure and resources, greater efficiencies, and reduced overhead. However, there are important factors to keep in mind along the way.Barry KazemiOne thing medical device firms should keep in mind is that many contract manufacturing organizations (CMOs) are diversifying their scope...
  • A Coating That Could Thwart Infection in Medical Implants

    Researchers believe they may have found a potential game changer when it comes to medical implants, with the development of a bacteria-repelling coating that could help increase the success of implanted devices.In a study from A*STAR (Agency for Science, Technology and Research), researchers reported encouraging results from a material composed of polyelectrolyte multilayers, onto which a number of specific bonding molecules, known as ligands, were attached to create a unique biomedical coating...
  • This Brain-Computer Interface Executes Thought Based Commands

    Brown University's head-worn wireless brain-computer interface transmitter enables patients to control electronic devices with their thoughts. Research out of Brown University has yielded some of the most exciting results in brain-computer interface (BCI) technology yet, with the development of a new wireless transmitter that could give paralyzed patients a practical way to control various electronic devices with their thoughts.A project that is nearly a decade in the making, researchers from...
  • So You Want to Develop a Wearable Device...

    Zephyr Anywhere’s BioPatch, which measures a patient's vital signs and beams them to caregivers, is an example of a medical-grade wearable.Wearables are huge these days, and there is real potential in the field. Not convinced? While it is true that the only wearables to gain traction thus far resemble pedometers on steroids, a growing number of wearables are measuring medically relevant data.And while these are early days for wearable devices and it is anybody’s guess where we end up five to 10...
  • Getting Entangled in Quantum Computing

    Drawing of the silicon ring resonator with its access waveguide. Courtesy of Università degli Studi di Pavia, through The Optical Society.An international team of researchers has reportedly achieved a significant step toward the development of quantum computing, with the creation of a new micro-ring that can entangle individual particles of light, a breakthrough that could pave the way toward quantum computing capabilities.The Optical Society reports that the new micro-ring...
  • 5 Things You Need to Know About Energy Harvesting

    Max DonelanEnergy harvesting seems like a pretty common sense idea: medical devices powering themselves from the human bodies they serve. But it really isn’t that simple, says Max Donelan, PhD, associate professor of biomedical physiology and kinesiology at Simon Fraser University in Vancouver, British Columbia. There are plenty of lessons to be learned.Donelan should know. He is a scientific adviser to a Simon Fraser spinout called Bionic Power that he helped start in 2007. The company’s...
  • How Microsoft Is Getting Wrapped Up in Wearables

    Microsoft has taken an interesting spin on wearable technology, as researchers revealed a smart scarf that has been designed to work in tandem with a smartphone—and eventually work with biometric and emotion sensing devices.The smart scarf contains a sensor that is designed to help determine when you’re feeling down, and react with a warming sensation that helps soothe the body, according to a report from MIT Technology Review. Researchers believe this sensor could be particularly useful for...
  • Validate Your Process Using Design of Experiments

    Design of experiments enables engineers to demonstrate or understand a process while providing information required for achieving regulatory compliance.A valuable method for predicting process variability, design of experiments (DOE) allows medical device engineers to validate their processes in order to improve product quality. On February 12 from 10:45 to 11:15 a.m., Robert Launsby, president of Launsby Consulting, will present a workshop at MD&M West exploring the advantages of the DOE...
  • 5 Risky MIT Research Ventures You Should Know About

    High-risk investments can yield high returns. And such projects are exactly why MIT has set up the Amar G. Bose research grant. The university wants to help fund potentially revolutionary research pursuits that might sound too good to be true and, as such, might encounter difficulties in attracting investment cash.  Many of these ideas are considered impossible to fund through traditional sources, and thus often go unexplored. Such endeavors were of particular interest to Bose, an engineer...
  • Designing Devices to Be More Useful Than You Think

    Andy SchaudtSure, you can build what seems like a really high tech medical device, but is it going to be useful in an actual healthcare environment? And is the wireless functionality you’ve spent so much time integrating into that new device actually going to be useful?With so many changes taking place in the healthcare industry, such answers are rapidly changing for Andy Schaudt, director of usability services for the National Center for Human Factors in Healthcare at the MedStar Institute for...
  • Elastic Waves Boost Medical Imaging

    Elastic waves are an interesting breed of acoustic sound waves that pass through objects leaving a trail of ripples and shockwaves in their path. These elastic waves travel at the surface, or even through material, without causing any permanent changes to the makeup of the substance. In recent years, researchers have been studying these elastic waves, in the hopes of understanding how they move through materials in an effort to better control them to our benefit.Recently, researchers from the...
  • How Lasers Make Super-Hydrophobic Materials

    Researchers from the University of Rochester in New York have taken a significant step in developing hydrophobic materials, with a new technique that enables them to transform metals into extremely water repellent hydrophobic materials, all without the need for temporary coatings.Super-hydrophobic materials have become increasingly desirable for a number of different applications such as rust prevention and anti-icing. Within medtech, hydrophobic materials are of interest for woundcare...
  • Wearable for the Tongue Tackles Traumatic Brain Injury

    This device, which is now in development by Helius Medical and Ximedica, helps people overcome mental deficits caused by traumatic brain injury.Here’s a wearable unlike any you have ever heard of before: a device that connects to the tongue to stimulate the cranial nerves to help treat traumatic brain injury.  The device, which is in development by Helius Medical Technologies (Vancouver) and Ximedica (Providence, RI), was inspired by the work of Paul Bach-y-Rita, an American...