• Why 3-D Printing Hasn't Reached Its Medtech Promise

    3-D printing holds all kinds of value, benefits, and possibilities for the global medical device arena. But a new day has not fully dawned for the industry. Here are four reasons why. Bart Reitter, QAD7 Radically New 3-D Printing Innovation You Need to KnowThe medical device industry has a proven and storied history of innovation. From x-ray tubes and pacemakers, to CT scanners and mobile electrocardiogram monitors, the medical device sector has always embraced innovation with the...
  • How You Can Stay Compliant With UDI

    Want a sustainable, extendable UDI program? Here are five reasons why your medical device company needs to implement an Enterprise Labeling Solution.Laura Johnson, LoftwareWith a goal of improving patient safety, the FDA initially implemented the Unique Device Identification rule in 2013. UDI labeling regulations are being phased in through 2020 in a concerted effort to provide a comprehensive methodology for medical practitioners, caregivers, and patients to identify, track and monitor...
  • What Apple Really Wants to Do With HealthKit

    Collecting data is one thing. Using it to improve healthcare worldwide is another.Maureen KingsleyApple wants to take its HealthKit software platform to the next level, from simply collecting health and fitness data to analyzing it, interpreting it, and using it to advise users and healthcare providers, reports Bloomberg, citing people familiar with Apple’s plans.HealthKit, launched in September 2014, is Apple’s developer framework that collects data from various iOS-friendly health and fitness...
  • Former Starkey President Pleads Not Guilty to Theft

    Jerry Ruzicka and three other defendants in the case pleaded not guilty to charges that they fleeced the hearing aid manufacturer and its main owner out of $20 million over a nine-year period. Chris NewmarkerJerry RuzickaA December trial date has been set in federal court in Minneapolis for four of the five men accused of stealing from hearing aid maker Starkey and its principal owner and CEO Bill Austin. Former Starkey president Jerry Ruzicka, the company's former human resources senior...
  • BD to Spend $100 Million on Nebraska Syringe Plant

    Becton, Dickinson and Co. plans to expand its ability to manufacture insulin syringes at the factory. Chris Newmarker BD's Holdrege, NE, plant. (Image courtesy of BD)BD recently announced a $100 million investment in new technology and manufacturing equipment at its Holdrege, NE, insulin syringes plant.The goal is to expand capacity to make syringes at the factory. BD already makes more than 2 billion insulin syringes annually. That comes to more than 250,000 syringes per hour.“About 40 percent...
  • DIYers See Opportunity in EpiPen Price Hike Fiasco

    At least two enterprising DIYers have been touting their own low-cost epinephrine injectors in the wake of EpiPen maker Mylan’s price hike controversy.Maureen KingsleyMichael Laufer holds up an "EpiPencil." [Image courtesy of Michael Laufer]A mathematics PhD and a Minnesota physician are among those who have taken it upon themselves to design alternatives to Mylan's EpiPen, a lifesaving device for severe allergy sufferers that has been mired in controversy because of huge price hikes....
  • Trump Versus Clinton: Reforming Medicare/Medicaid

    Trump has promised to “preserve Medicare for future generations,” and to “review basic options for Medicaid and work with states to ensure that those who want healthcare coverage can have it.”He would also administer Medicaid money to the states in the form of block grants, removing “federal overhead.” States would have incentives to seek out and eliminate Medicaid fraud, waste, and abuse, he said.Trump has also said he would take care of low-income people “maybe through concepts of Medicare,”...
  • Trump Versus Clinton: Medical R&D

    Clinton has said she will support investing in science and technology research and development, as well as in technology transfer. She has also pledged to improve the patent system to reward innovators, and ensure an effective copyright system that protects creative content, while unlocking access to orphan works and promoting open-licensing arrangements for materials supported by federal grant funding. She also said she will affirm strong consumer protection values without stifling innovation....
  • Trump Versus Clinton: Obamacare

    Clinton has taken a strong stance against repealing the Affordable Care Act, and has pledged to expand taxpayer-funded health insurance, pushed by Vermont Sen. Bernie Sanders as the “public option.” According to CNN, Clinton has supported a public option for health insurance for years.Trump says that he would “ask Congress to immediately deliver a full repeal of Obamacare” and would work with Congress on passing reforms based on free-market principles to “broaden healthcare access, make...
  • Trump Versus Clinton: 'Inversion' Merger Deals

    Trump has said he does not blame companies for wanting to go overseas to save money on their taxes. Instead, he's blamed high U.S. corporate taxes for prompting them to flee. Trump has proposed cutting the top corporate tax ratefrom 35% to 15% percent as a way to lure businesses back to the United States. He has  also proposed a one-time “repatriation tax holiday” that would allow each company that has money overseas to bring it home tax-free. He later changed that proposal to say he’d...
  • Trump Versus Clinton: Medical Device Tax

    Hillary Clinton has hedged on making the repeal of  the medical device tax permanent, even when she spoke to an AdvaMed conference. Congress granted the medtech industry a two-year reprieve from the 2.3% tax in when it passed a roughly $1 trillion spending bill in December 2015. The industry has described the tax, which went into effect at the beginning of 2013, as a jobs-killer. Trump has spoken broadly about taxes, but not specifically about the medical device tax. He told a...
  • Is Trump or Clinton Better for Medtech?

        With the first U.S. presidential election debate taking place this Monday, we take a look at where Hillary Clinton and Donald Trump stand on issues that matter to the medical device industry. Nancy CrottiWhich major U.S. candidate is best for the medical device industry? Odds are you won't find out the answer during the first debate between Republican nominee Donald Trump and Democratic nominee Hillary Clinton, scheduled for Monday evening at Hofstra University in...
  • Former Starkey Execs Charged With Stealing $20 Million

    An indictment unveiled in Minnesota claims a complicated web of sham companies and dummy entities set up to siphon away money from the privately held hearing aid manufacturer and developer. Chris NewmarkerJerry Ruzicka A year after the president, chief financial officer, and human resources vice president were fired from hearing aid manufacturer Starkey, a federal indictment charges the three men and two others of running a complicated conspiracy that stole $20 million over nine years....
  • Mind-Controlled Exoskeleton Could Help Paraplegic Children

    University of Houston researchers aim to leverage a new, noninvasive brain-machine interface system that taps into human brainwaves to control and command a wearable exoskeleton—a technology that could enable paraplegic kids to walk.Kristopher SturgisA new study out of the Laboratory for Noninvasive Brain-Machine Interface Systems at the University of Houston (UH) has paved the way for a new exoskeleton technology that will be unveiled at Cybathlon in Zurich — an event where the world’s most...
  • How Tiny Are Medical Device Parts Getting? This Tiny

    Miniaturization is a major trend in the medical device industry, and a great example could be found at Heraeus's booth at MD&M Minneapolis.Chris NewmarkerHeraeus (St. Paul, MN) has been machining medical device parts down to the micron level in recent years. Check out this video from MD&M Minneapolis (Booth #2005) to see just how tiny these parts are:A small correction to the story: One of the millimeter-sized device parts in the video was mistakenly described as rivets....
  • A Better Way to Keep Feet Clean in Healthcare Settings?

    Circuit Solutions used MD&M Minneapolis to tout a new device to keep feet from tracking grime into healthcare settings. Chris NewmarkerWhile there has been significant progress preventing some types of infections, about one in 25 U.S. hospital patients still suffer at least one healthcare-acquired infection on any given today, according to the Centers for Disease Control.Circuit Solutions (Minnetonka, MN) used MD&M Minneapolis to roll out its Vortex Air WalkMat, with...
  • How Medical Device Design Is Like Ping Pong

    Kablooe Design turned to table tennis to teach medical device design lessons at MD&M Minneapolis. Here's why. Chris Newmarker"Playing ping pong is like competing in the marketplace. And if you don't go through the process correctly, if you skip parts of the process, you're going to be at a disadvantage in your development. You're going to be at a disadvantage when you compete as well," says Tom KraMer, CEO of Kablooe Design, located north of Minneapolis. That's why Kablooe Design...
  • How Robotically Assisted Surgery Is Gaining Momentum

    Since the Da Vinci surgical robot made its mark at the turn of the millennium, additional medtech companies have turned their attention to advanced-technology surgical systems and tools—with support from FDA and CMS.Maureen KingsleyThe slow but inevitable—and now quickening—trend toward more automated and robotically assisted surgeries began in earnest in 2000, with the launch of Intuitive Surgical’s Da Vinci system, the first such system approved by FDA. Da Vinci, used for soft-tissue...
  • Catheter Materials Innovation Wins Top Prize at MD&M Minneapolis

    Polymer extruder Zeus has created catheter polymer braiding with tensile strength comparable to metallic braiding, enabling MRI to be used during catheter based procedures. The innovation won this year's MD&M Minneapolis Innovation Prize. Chris Newmarker Zeus (Orangeburg, SC) on Wednesday won the MD&M Minneapolis Innovation Prize among exhibitors with the non-metallic catheters it is enabling through LCP monofilament fiber launched at the show. Having...
  • New Human Neural Stem Cells Could Boost Tissue Engineering

    The new technique can generate rapidly-differentiating human neural stem cells that could be used to build three-dimensional models of human tissue and other tissue engineering applications.Kristopher SturgisThis photo shows human induced neural stem cell lines (red) grown in co-culture with skeletal muscle (green) and cell nuclei visualized by blue DAPI staining.A new technique for tissue engineering has been developed by researchers out of Tufts University in Massachusetts that could pave the...