• GAO to FDA: Get Your Act Together

    The investigative arm of congress told FDA to figure out how to use its own improvement plans, coordinate among its medical product centers, and keep better track of money.Nancy CrottiThe U.S. Government Accountability Office issued two reports this week, telling FDA to develop measurable goals for its regulatory science work, coordinate efforts among its medical product centers, and systematically track funding for regulatory science projects.One report criticized the agency for failing to use...
  • Laser Technique Could Enable Discovery of New Functional Materials

    Using a terahertz laser, researchers were able to bring about permanent changes in the molecular structure of a polymer.Kristopher SturgisLow-magnification reflection images obtained by polarized microscope.The dash lines show the irradiated terahertz wave beam size. For the first time ever, scientists have induced permanent changes in the conformation of a polymer using a terahertz laser—a discovery that could have a significant impact on macromolecular science and provide a tool to...
  • Medtronic’s Diabetes Makeover From Device Maker to Disease Manager

    The Irish medtech company wants to become a player in the entire continuum of diabetes care, and not just in selling insulin pumps and sensors.Arundhati ParmarIt’s easy to lose track of the investments, acquisitions and partnerships that Medtronic is engaged in the diabetes space. They are too many to recount.But what’s not that hard to conclude is that the Irish medtech company is shedding its old skin—where it simply sold diabetes widgets—for a new one in which it is aspiring to become a...
  • Medical Device Design Centers: Do or Don't?

    Sometimes called innovation centers, these spaces are cropping up at some device companies that want to encourage creativity among employees. But do they really serve the intended purpose?Jamie HartfordThanks in part to the influence of brands like Apple, whose slick consumer devices have in many ways set the standard for the look and feel of new technology, the world is paying a lot more attention to design these days. Once dismissed as flaky artist-types who did little but tweak color schemes...
  • How Sealing Components Enable Better Insulin Pumps

    Piston seals used in insulin pumps need to provide a strong seal at a low friction rate with a long life, say experts at Trelleborg Sealing Solutions.Brian Nejib and Luis Tissone, Trelleborg Sealing SolutionsAdvancements in insulin delivery devices often require more engineering advancements. (Image courtesy of Trelleborg Sealing Solutions)It’s no wonder that insulin pumps are gaining in acceptance. They have the ability to make a real impact in patients’ lives by eliminating the need for...
  • Where Opportunity Lies in Clinical Wearables

    There are billions of dollars to be made when it comes to particular chronic diseases, according to Frost & Sullivan. Arundhati ParmarThe wearables and the biosensing market raised a sizable $499 million from venture capitalists in 2015, but the field is moving toward being more clinically focused.That trend solidified in the first quarter of the year when that segment within digital health garnered $202 million, according to Greg Caresi, senior vice president of transformational health at...
  • 3M's Super Diverse World of Medtech Patch Backings

    Who knew that there would be so many types of backings for transdermal drug delivery patches? 3M was touting a wide array at MD&M East in New York City.Chris Newmarker3M Co. has decades of experience with transdermal drug delivery patches, back to the creation of the first seven-day drug-release patch. The company was touting a huge variety patch backings at MD&M East in New York City this week. Their backings include a range of occlusivity, patient comfort, and cosmetic...
  • 3 New Wearables You Should Know About

    J&J, Abbott, and GE are cooking up devices that could make life easier and healthier for diabetics and cardiac patients.Nancy CrottiGE Global Research chief scientist Anil Duggal with a sheet of OLEDs. (Image courtesy of GE Global Research)GE is working on a device that could potentially make EKGs wireless. The company said it is developing a wireless skin sensor that sticks like a bandage analyzes sweat, checks vital signs, and tracks patients’ medical progress after treatment.To...
  • Why Connected Health Is Not for the Faint of Heart

    The regulatory process is daunting and is evolving, making experience crucial for whoever you are contracting with, explains Matt Jennings, CEO of Phillips-Medisize. Chris NewmarkerMatt Jennings, CEO of Phillips-MedisizeMedical device contract manufacturing and design giant Phillips-Medisize is further expanding its connected health credentials. The Hudson, WI–based company on May 31 closed on its purchase of Medicom Innovation Partner for an undisclosed sum.With facilities...
  • IBM Watson Could Boost Your Medical Device

    Developing a smartphone or tablet app related to a medical device? IBM is introducing Watson's patient record deciphering know-how services, as well as natural language processing, as a value add, according to the principal investigator for the Watson EMR Analyzer (EMRA). Chris NewmarkerMurthy DevarakondaPicture a smart tablet app that allows radiologists to quickly view images. Now what if the tablet app also listed the patient's medical problems on the left, with...
  • 5 Medical Technologies That Blew an Astronaut's Mind

    After four space flights, it might seem like very little would impress astronaut Leroy Chiao. But in a keynote address at MD&M East, he marveled at these medical technologies. Jamie HartfordChiaoAstronaut Leroy Chiao has traveled to space four times, lived for more than six months on the International Space Station, and logged dozens of hours in spacewalks—pretty mind-blowing stuff. But in a June 14 keynote address at MD&M East in New York City, he marveled at many of the medical...
  • How a Decorative Plant Could Boost Medical Adhesives

    Researchers from Ohio State University aim to exploit the unique molecular properties of the common ivy plant to boost adhesive technologies in wound healing.Kristopher SturgisThe study began, in part, as a quest to find bioadhesives that could aid in wound healing after injury or surgery—but soon evolved into a complete exploration of the tiny particles responsible for one of nature’s most vigorously determined grippers, the English ivy plant. These remarkable plants latch onto trees and...
  • Modifying a Glucose Detecter to Find Zika

        (Image courtesy of University of Alberta)A team of researchers at the University of Alberta is seeking to transform a glucose detector into a point-of-care diagnostic for Zika. Virologists led by Tom Hobman reported in February that they were starting to make antibodies of the virus, identifying peptides required for the assay. The next step is to screen the Zika virus antibodies against the Zika protein that they want to detect. At the same time they need to ensure the...
  • Ignore 3-D Printing at Your Peril

    When it comes to medical devices, 3-D printing is growing up. Worrell Design's Derek Mathers explains how 3-D printing will evolve the next generation of medical technology. Derek Mathers, Worrell DesignGoogle invested $100 million in Carbon to commercialize its high-speed CLIP (Continuous Liquid Interface Production) process, which uses ultra high-performance urethanes. Johnson and Johnson has already forged a medical device partnership with the company. (Image courtesy of Carbon)A...
  • Genetic Modification to Fight Zika

        The Aedes aegypti mosquito is a major spreader of Zika, and is found across much of the southern half of the continental United States. (Image courtesy of Muhammad Mahdi Karim GFDL 1.2)Genetically modified male mosquitoes, encoded with genes that could limit the mosquito population over time, are another option. The males mate with females in the wild, with their offspring dying in the larval stage.British firm Oxitec has found success trying out the technique...
  • Zika Is Spreading: What Medtech Can Do

        Zika infection during pregnancy can cause microcephaly, illustrated above, as well as other severe brain defects. (Image courtesy of CDC)Already a problem in Latin America, the mosquito-born virus could soon be spreading in the continental U.S. Find out some of the medical device solutions for fighting the disease.Chris NewmarkerMosquito-born Zika virus has turned into a pandemic across Latin America, and has already reached the continental United States via travelers....
  • An FDA-Authorized Zika Test

        This digitally-colorized transmission electron micrograph (TEM) shows Zika virus. (Image courtesy of CDC/Cynthia Goldsmith)Quest Diagnostics in April announced FDA emergency use authorization for its Zika virus RNA qualitative real-time test (Zika RT-PCR test).The proprietary molecular test allows for detection of RNA from the Zika virus in serum from human blood. Quest’s test, made by its Focus Diagnostics business, was the first commercial test to receive an...
  • Developing a Practical and Cost Effective Zika Test

        This black cartridge includes the paper-based Zika diagnostic test. (Photo courtesy of MIT)FDA may have granted emergency use authorizations for Zika tests, but these are still tests that need to go to laboratories meeting specific qualifications. The existing tests, which search for pieces of the viral genome in serum from human blood, can also take days to week to produce lab results.What if there could be a practical and cost effective Zika diagnostic tool for widespread...
  • Detecting a Single Virus in Urine

        The researchers demonstrated their new technique on a the murine cytomegalovirus, which is related to a herpes virus, shown here. There could be potential to use the same test to find Zika. (Image courtesy of the University of Texas at Austin)Another potential research avenue involving Zika detection involves work being done at the University of Texas at Austin. The Texas researchers have come up with a test that can rapidly detect a single virus in urine. Their...
  • Testing Both Blood and Urine for Zika

        This marketing image shows one of Altona Diagnostics' RealStar PCR kits in action. (Image courtesy of Altona Diagnostics)In May, FDA granted an emergency use authorization for the RealStar Zika virus RT-PCR kit, made by Altona Diagnostics GmbH (Hamburg, Germany). The test is meant to provide detection of RNA from Zika in serum from human blood, or urine. (The urine is collected alongside a patient-matched serum specimen.)The workings of the RealStar test, as described in the...