• Researchers Achieve First Precise Primate Gene Modification

    Graphical abstract of the researchers' work. (Courtesy Niu et al. and Cell)Genetically modified monkeys have been successfully grown by Chinese scientists. In a paper published in the January 30 issue of the journal Cell, the authors describe how they achieved precise gene modification in monkeys for the first time. This milestone could lead to new avenues for the development of more effective treatments for a range of human diseases.The team attempted to modify the genomes of single-cell-stage...
  • Man with 3-D Printed Pelvis Walks Again

    The British press has lately been all a-buzz with the story of Craig Gerrand, MD, consultant orthopedic surgeon at Newcastle-upon-Tyne Hospitals NHS Trust  (Newcastle-upon-Tyne, Northumberland, UK) who used a 3-D printer to replace a large section of a man's pelvis.Craig Gerrand shows off a pelvis model.The unnamed patient, in his 60s, was suffering from chondrosarcoma, a rare form of cancer. Gerrand told Ben Farmer, reporting for The Telegraph (Chatham, Kent, UK), “Since this cancer does...
  • Stretching the Old Biomaterial Paradigms

    Do new biomaterials require new paradigms, or does their introduction to the market create paradigms? It is almost hard to believe that some of the most prominent resorbable biomaterials today have been in use in medical devices since the 1960’s. Although the sum total of human knowledge on material properties and their interactions with human tissues has increased greatly since those days, the final devices used in patients have taken little if any advantage of this new data.Why is that?Most...
  • How Mobile Health Is Changing MedTech—Or Not

    Some say mobile health could make half of existing medical devices obsolete. Some say even more.And while there is plenty of debate on this subject, many say a change is gonna come to the medtech industry.“Perhaps the bottom line is the device market of the future will be markedly different than the past,” says Brian Baum, founder and CEO of Baltimore–based health data startup vitaTrackr Inc.People might call it by different names: mobile health, telehealth, connected health, or iHealth. But...
  • Could Digital Health Make Most Medical Devices Obsolete?

    Don't say you weren't warned about the coming mobile health tidal wave.A recent keynote address at MD&M West suggested that digital health technology could end up displacing half of traditional medical devices. That figure might even be an underestimate, says regulatory expert George Samaras of Samaras & Associates Inc. (Pueblo, CO). In an email, which we have posted below, Samaras stressed the importance of first distinguishing between sales numbers or the number of types of medical...
  • Are You RoHS Ready?

    For the medical device industry, complying with the Restriction of Hazardous Substances (RoHS) directive is anything but simple. The directive, which requires medical device makers to stop using lead and five other hazardous substances from products sold in Europe by July 2014, has lead to growing concerns about tin whiskers in solders. For years, the primary solder used in the device industry was tin-lead—the latter metal helps slow the growth of tin whiskers, small hair-like crystalline...
  • How Nanotubes Could Drive Next-Gen Orthopedic Technology

    Nanomaterial advances are set to greatly increase the performance of orthopedic implants, if a recent presentation at MD&M West in Anaheim, CA is any indication.Peoria, AZ–based Nasseo last fall won FDA clearance for its TiArray Dental Implant System that uses a special titanium dioxide nanotube surface to make its titanium screws more bone growth-friendly, hopefully creating a bond between the implant and bone quickly enough to prevent inflammation from developing.The nanotube surface is...
  • How Software Will Kill or Save Medical Devices

    Don't think your medical device company is facing a BlackBerry-like crisis? Think again.In the same way that smartphones quickly made digital cameras, GPS systems, and even the "CrackBerry" obsolete, the digital health industry could ultimately replace half of traditional medical devices, says Shahid Shah, CEO of Netspective Communications.Shahid ShahDuring his keynote address at MD&M West on February 13, Shah pointed out that this is already happening, as a growing number of...
  • MD&M West Spotlights the Latest in Antimicrobial Materials

    Sure, antimicrobial materials may be more expensive than nano-antimicrobials. But because they are crucial for combating hospital-acquired infections (HAIs), their utility outweighs the cost factor. That's one of the takeaway messages from Evonik Cyro LLC (Parsippany, NJ) at this year's MD&M West exhibition and conference.To meet the growing challenge posed by HAIs, the company has announced the availability of Cyrolite Protect 2, a new antimicrobial material for use in Class I and Class II...
  • Engineering the Perfect PEEK

    While PEEK is an ideal material choice for delivery systems because of its tensile strength, column strength, and radial strength, it lacks the lubricity desired for navigating the tortuous pathways of the vasculature. Tackling this challenge head on, Zeus has developed a technique for producing PEEK surface-engineered tubing that combines the strength of PEEK with the lubricity of fluoropolymers.There are a variety of ways that materials scientists have altered PEEK's properties, Irina Roof,...
  • MD&M West Features World's Smallest Reed Switch

    Reed switches have been around for decades. But now, Coto Technology (North Kingstown, RI), a developer of small signal-switching products, has launched what it bills as the tiniest reed switch ever. Featuring a mere 1.26-mm2 footprint, the MEMS-based RedRock switch is a single-pole, single-throw component with normally open ruthenium contacts. Actuated using an electromagnet, a permanent magnet, or a combination of both, the switch is suitable for miniaturized medical device applications...
  • How Mobile Health Is Changing a MedTech Manufacturer

    Maybe you call it mobile health, telehealth, or connected health. Contract manufacturer Phillips-Medisize calls it “self health.”The Hudson, WI–based company’s CEO Matt Jennings sees it as one of the major technological shifts that will affect Phillips-Medisize and many other medtech manufacturer’s businesses for years to come: people taking control of their own health information and using it to treat themselves, including self-administration of pharmaceuticals.“The trend is really self...
  • Creating an Autofocusing Intraocular Lens

    Think Google has an exciting potential device in the glucose-reading contact lens it has in development? Try having an electronic intraocular lens that automatically refocuses for near, intermediate, and far distances using complex algorithms.That is exactly what serial entrepreneur Rudy Mazzocchi has with the early-stage company Elenza, which Mazzocchi says is presently considering acquisition opportunities. How Elenza got to this device, with plans for CE Mark approval within 18 to 22...
  • Duck with Disability Gets 3-D Printed Prosthetic Foot

    Apparent victims of overbooking, 5-month-old Dudley the duck and his siblings were berthed in a cage at the K9-1-1 Animal and Rescue Shelter (Sicamous, BC, Canada) with some chickens. One of the chickens attacked the ducks and, in a fight that left his siblings dead, Dudley’s leg was seriously injured and had to be amputated. Dudley was left with only a stump.Brandon Schweitser, a relative of the shelter’s owner, is also a jiu jitsu coach. One of his students, Terence Loring, was starting a 3-D...
  • Prosthetic Hand Provides Real-Time Sense of Feeling

    Sørensen tests sensory feedback in the prosthetic hand. (Courtesy Swiss Federal Institute of Technology)Developing prosthetic limbs that can feel has long been a goal of bionics researchers. Now, in “Restoring Natural Sensory Feedback in Real-Time Bidirectional Hand Prostheses,” a paper published February 5 in the journal Science Translational Medicine, researchers at the Swiss Federal Institute of Technology (Lausanne, Switzerland) have added to recent advances in prosthetics that can convey...
  • 3 Strategies for Making Better Batteries

    Batteries appear to be all the rage in Silicon Valley, with innovators taking note that many batteries still rely on a 20th century lithium-ion cocktail that has only improved incrementally over the decades.While microprocessors have exponentially improved under Moore’s Law, batteries have not increased in capabilities substantially, says Mir Imran, a medical device pioneer and venture capitalist who is CEO of San Jose, CA–based InCube Labs. “I’m always looking for new battery technologies,”...
  • How a Double-Amputee Engineer Developed Cutting-Edge Bionic Limbs

    (courtesy BiOM)Looking like they could have been assembled from spare parts for the latest RoboCop, the most advanced lower-leg prosthetics available today are arguably made by BiOM (Bedford, MA). The company's powered artificial ankle is unlike any other commercially available ankle device. The BiOM Ankle System replaces the function of lost muscle and tendon anatomy, stiffening and powering the prosthetic ankle. The idea is to duplicate, as closely as possible, what the muscles do in a...
  • 3-D Printed Device Allows Users Access to Brainwaves

    You probably don't need to start making a tinfoil hat just yet, but an outfit called OpenBCI recently achieved their $200K Kickstarter goal and now plans to move ahead with their open-source brainwave reader project. So what, you might ask, is OpenBCI? To quote their almost-4000-word Kickstarter pitch, “OpenBCI is a low-cost, programmable, open-source EEG [electroencephalography] platform that gives anybody with a computer access to their brainwaves.”In terms of price point, the device was...
  • 3 Big Challenges for Medical Equipment Makers

    As medical device makers face unprecedented opportunities and challenges created by a rapidly-evolving market, they need to consider the following important issues.1. Materials Compliance and International Regulations Device manufacturers must consider the materials and manufacturing processes that go into their products to ensure that they adhere to various regional and global material compatibility regulations. A couple key regulations include the Restriction of Hazardous Substances Directive...
  • Who's Afraid of the Big Bad BPA?

    There have been plenty of public health concerns raised in recent years about bisphenol A (BPA)—a common building block for the polycarbonate plastic and epoxy resins that serve as workhorse materials for disposable medical devices.But such concerns should not weigh heavily on device designers, says Len Czuba, president of design firm Czuba Enterprises (Lombard, IL).Yes, there have been issues raised over potential BPA links to cancer and reproductive problems, especially because it has a...