• World's Smallest 3-D Lattice Boasts Serious Strength

    A new 3-D printed lightweight construction materials inspired by the structure of human bones can withstand tremendous pressures.Kristopher Sturgis      Developed at the Karlsruhe Institute of Technology (KIT), new lattice-based structures can withstand unbelievably high pressures — approximately 1.2 billion newtons per square inch. This equates to about 12,000 times the pressure of the atmosphere.It can be used as load-bearing supports in a variety of different...
  • High-Res X-Ray Vision for Spotting Product Defects

    The company Exact Metrology (Cincinnati, OH) offers CT scanning technology of medical device components, which can be used to easily see within and without an array of components.Brian BuntzThe first commercially available CT scanner debuted in the early 1970s and quickly emerged as a powerful medical tool soon. It is finding growing use for product inspection and manufacturing applications as well.Exact Metrology had a video display in their booth at MD&M West showing off the abilities of...
  • Kurzweil on Why Medicine Is Undergoing a Grand Transformation

    Your smartphone is as powerful as a supercomputer from yesteryear. But 25 years from now, computing systems will be one billion times more powerful and 100,000 times smaller, said famed futurist Ray Kurzweil. The implications for the practice of medicine are mind boggling.Brian BuntzIn the mid-1990s, researchers involved in the Genome Project announced that they had completed one percent of the human genome after seven years of work. Mainstream critics complained that finishing the project...
  • Shape-Shifting Polymer Can Life 1000x Its Weight

    University of Rochester researchers are further demonstrating the potential capabilities of shape-shifting polymers, creating a new polymer that can snap back into shape at human body temperatures. Qmed StaffThis multiple-exposure image shows a new shape-memory polymer reverting to its original shape amid exposure to body temperature. (Image courtesy of University of Rochester/J. Adam Fenster)A University of Rochester research team has developed a polymer that can be stretched, and then...
  • Why a Lightning Rod Lawyer Smells a Rat at FDA

    Former FDA commissioner Margaret Hamburg faces serious accusations in a lawsuit filed by the conservative, activist, government watchdog lawyer Larry Klayman. Klayman explains to Qmed why the lawsuit is important when it comes to changing the culture at FDA and Washington in general.Larry KlaymanChris NewmarkerIt is hard to find someone important in Washington, DC whom Larry Klayman has not sued. Add former FDA commissioner Margaret Hamburg, MD, to the list.In a case Hamburg’s lawyers have...
  • U.S. Still Dominates PMAs

         Graphic courtesy of the Medical Alley AssociationMuch of the really hard-to-do U.S. medical device innovations are still homegrown, and the numbers are growing, too, according to the Minnesota-based Medical Alley Association’s new analysis of medical device approval data from FDA and Evaluate Ltd.’s EvaluateMedTech report.Chris NewmarkerOverseas companies may be increasingly seeking 510(k) clearances, but it is heartening for U.S. medical device industry...
  • Geography Matters in the Medical Device Industry

        Graphic courtesy of the Medical Alley AssociationCalifornia and Minnesota dominated PMAs in 2015, but another reminder that medical device innovation could fit the old real estate mantra that it's all about "location, location, location," according to the Minnesota-based Medical Alley Association’s new analysis of medical device approval data from FDA and Evaluate Ltd.’s EvaluateMedTech report.Chris NewmarkerThere are many states from Florida to Pennsylvania to Utah...
  • Opportunities to Apply Cardio Device Tech Elsewhere

        Graphic courtesy of the Medical Alley AssociationNeurology-related PMAs have reached a noticeable level, providing a sign that cardio tech from medical devices such as pacemakers is being employed in other areas, according to the Minnesota-based Medical Alley Association’s new analysis of medical device approval data from FDA and Evaluate Ltd.’s EvaluateMedTech report.Chris NewmarkerAll of this know-how—not to mention tried and true regulatory pathways—has been...
  • 4 Medtech Trends Out of FDA That You Need to Know

       Graphic courtesy of the Medical Alley AssociationThe U.S. medical device industry is starting to see some real overseas competition. That’s but one of a number of important insights gleaned from the Minnesota-based Medical Alley Association’s analysis of FDA approval data.Chris NewmarkerCould the U.S. medical device industry be facing more overseas competition? That is but one of a number of intriguing questions raised by the Minnesota-based Medical Alley Association’s new analysis...
  • Overseas Medical Device Competition Is Mounting

        Graphic courtesy of the Medical Alley AssociationA 510(k) applicant in the U.S. is increasingly as likely to be from South Korea, Japan, or France than homegrown, according to the Minnesota-based Medical Alley Association’s new analysis of medical device approval data from FDA and Evaluate Ltd.’s EvaluateMedTech report.Chris Newmarker“We’ve been approached—I can’t even count—by how many international delegations that wanted to create a medical device cluster...
  • A New Heart Patch for Infants That Is Made from Living Tissue

    The National Institutes of Health is providing a grant to bioengineers at Rice University and Texas Children’s Hospital to develop a new generation of heart patches to repair damaged hearts in infants. Rice bioengineering associate professor Jeffrey Jacot describes his team's work. Jeffrey Jacot, associate professor of bioengineering (Image courtesy of Rice University)Kristopher SturgisThe five-year, $1.9 million grant will allow a team of bioengineers to take their new heart patch...
  • How IBM's Watson Could Make a Difference in Medical Imaging

    Researchers at the high tech giant are retooling imaging software so that the Watson supercomputer can draw insights from medical images.  Nancy CrottiAvicenna is the code name for the Watson-empowered medical imaging software that IBM is developing. (Image courtesy of IBM)IBM researchers are preparing to take software that enables its supercomputer Watson to “see” and “read” images into the realm of real patient data.IBM (Armonk, NY) obtained the software in October through its $1...
  • Could This Virtual 'Guide Dog' Help the Visually Impaired?

    The new technology, developed at MIT, was designed to process 3-D camera data, and could help visually impaired patients navigate the world using an innovatively designed braille interface.Kristopher SturgisThe system includes a braille interface that users could use that communicates with the navigation system and conveys to the user information about obstacles in their environment around them. (Image courtesy of MIT)Those suffering from impaired vision may soon be navigating the world in...
  • Meet the 2016 MD&M West Innovation Prize Winner

    Product Creation Studio won over innovation tour attendees at the Anaheim, CA show with a story of innovative design. Qmed StaffThe LT-300, which Product Creation Studio designed for LumiThera (Image courtesy of Product Creation Studio)Product Creation Studio over several years worked with a company called LumiThera to develop a device that uses low-level light therapy (also called photobiomodulation) to treat age-related macular degeneration. The result of the work—the LT-300—wowed...
  • Philips Could Have an IVD Blockbuster in the Works

    The global in vitro diagnostic test market could exceed $10 billion by 2021, says research and consulting firm GlobalData. And a new hand-held concussions test in the works could give Philips a larger slice of the pie. Nancy CrottiThe handheld concussions test under development will be based on Philips’ Minicare I-20 system. (Image courtesy of Royal Philips)A hand-held blood test to diagnose mild concussions could boost Royal Philips’ share of the in-vitro diagnostic testing market, according...
  • What to Do When Standards Don't Exist

    It is a fact that technology typically evolves faster than standards. A regulatory specialist provides advice on what to do when developing a technology not covered by a specific standard."Moses Breaking the Tables of the Law" (1659) by Rembrandt. (Gemäldegalerie, Berlin)Brian BuntzRegulation can sometimes lag behind the development of novel medical technologies but standards can be even slower. “Stent grafts were approved way before standards related to them existed,” said Brandon Davis of MED...
  • How Linux Can Help Make Medical Devices More Secure

    The open source operating system can help medical device companies improve product security.Brian BuntzMedical device cybersecurity is a “growing concern,” FDA declared while announcing its latest guidance documents related to the subject. The topic has also been getting a considerable amount of attention in the past five years since security researcher Jay Radcliffe hacked his insulin pump on stage at a Black Hat conference in 2011. More recently, infusion pumps have emerged as having...
  • LA Times Slams FDA Over MAUDE Database

    FDA’s method for tracking medical device–related adverse events is so antiquated that it can take years for the agency to detect serious problems such as duodenoscope-related infections, reports the LA Times.Qmed StaffPictures of a contaminated Olympus TJF-Q180V closed-channel duodenoscope. The O-ring shows signs of wear, and the actuator-side area is heavily covered with brown scale. (Image from the Senate Health, Education, Labor, and Pensions Committee report)...
  • John Kasich: A Conservative Approach to Healthcare?

        Ohio Gov. John Kasich has taken heat from fellow conservatives for his decision to expand Medicaid in Ohio under the Affordable Care Act. The Weekly Standard says it is a stretch for Kasich to claim that he rejected Obamacare, even as he took advantage of one of its major measures to expand health insurance to more of the poor. Kasich has called for repealing and replacing Obamacare with a "conservative approach" that frees market forces to make the system more...
  • New Packaging System Can Shift Gears at the Push of the Button

    A new medical band sealer from OK International Corp.'s OKSealer division can accommodate up to 15 recipes for any heat sealable material.    The Supersealer MBS (Image courtesy of OK International Corp.'s OKSealer division)Brian Buntz Packaging specialist OKSealer (Marlborough, MA) is launching novel packaging technology at MD&M East (Booth #1750) designed to enable medical device companies to change packaging materials quickly and...