• 4. Contract Manufacturers Get Bigger

        There may be a lull in the huge mega-mergers among medical device OEMs. But the contract manufacturers are still playing catchup as they merge and forge partnerships to stay competitive winning business from more streamlined supply chains.Yes, the medtech contract manufacturing industry is facing some near-term turbulence, but the outlook is healthy in the future, according to a recent Standard & Poor’s report. Even officials at publicly traded Integer Holdings Corp...
  • 3. M&A Deals Get Smaller

        The past M&A frenzy in the medical device industry appears to be losing some steam, according to a recent report by EP Vantage.The average monetary value of a medtech acquisition in the first half of 2016 was $401 million; it was more than $2 billion in the first half of 2015, according to EP Vantage. Even when Medtronic’s huge $50 billion purchase of Covidien in early 2015 is taken out of the mix, the aggregate value of all the deals this year is on the way to being less...
  • 2. Cybersecurity Becomes a Real Problem

        Whether in the home or in the hospital, medical devices have become increasingly vulnerable to hacking as they’ve become network aware, says Daniel Mooradian, PhD, of the University of Minnesota’s Technological Leadership Institute.A tremendous need for security has cropped up, with hackers seeking to monetize healthcare data and even engage in ransomeware attacks.“It’s extremely expensive. Most medical devices aren’t adequately secured, because security is not designed into...
  • 1. 3-D Printing Comes of Age

         This year could truly be remembered as the one in which 3-D printing came of age in the medical device industry.Additive manufacturing is already playing an important role when it comes to prototyping and providing anatomical models of patient anatomy to help surgeons prepare.“Probably the majority of my group’s work is not with the device itself, but supporting accessories. There’s creating anatomical models, creating new manufacturing tools, creating sales...
  • 10 Hot Medtech Industry Trends

        Here are 10 important developments that experts say will affect the future of the medical device industry.Chris NewmarkerThere is a trope used by motivational speakers that the Chinese word for “crisis” is a combination of the symbols for “danger” and “opportunity.”It probably isn’t translated that way. But no matter what, times of disruption actually can present great opportunities. Consider all the now-giant companies such as General Electric, Microsoft, and Apple started...
  • Structural Heart Technologies That Have Physicians Excited

    Top cardio doctors weigh in on what structural heart innovations they believe will have the biggest impact on their field.Qmed StaffStructural heart is one of the hottest sectors in medtech right now, with new and emerging technologies bringing life-saving and -improving treatments to patients and opening the door to huge markets for device makers.On September 21, as part of the Structural Heart Challenges and Opportunities track at the MD&M Minneapolis Conference, a group of prominent...
  • Are Bayer, FDA Dragging Their Feet on Essure?

    Activists who claim they were injured by the device are pressing FDA for action.Nancy CrottiSix months have passed since FDA ordered Bayer AG to put a “black box” warning on the labels of its controversial Essure sterilization device, and activists are asking why it hasn’t happened yet.A group of activists called the Essure Sisters intends to lobby the U.S. Senate in mid-September for legislation that would reopen the door to state common-law claims over medical devices with FDA premarket...
  • Muddy Waters: Here's Proof St. Jude Is Vulnerable

    The short-selling investment firm has posted video that it says demonstrates a St. Jude Medical pacemaker being hacked. Chris NewmarkerMuddy Waters on Monday fired back at St. Jude Medical's claims that the investment firm had released a false and misleading report claiming major cybersecurity vulnerabilities with St. Jude implantable cardio devices. "STJ’s response contained very little substance, and actually included admissions to several key points. ... There were two components...
  • EpiPen's Maker Tries to Get Out of a Price Hike Quagmire

    A discount? A generic version? Pharmaceutical giant Mylan is seeking to appease customers and politicians angry over it continually hiking the price of its combo drug and device used to treat severe allergic reactions. Maureen KingsleyThe headlines, screaming from every major news outlet and dominating social-media newsfeeds last week, were impossible to miss: EpiPen manufacturer and marketer Mylan increased the emergency-epinephrine auto-injector device’s retail price by roughly 500% in nine...
  • J&J Is Interested in Surgical Simulations

    The medical device giant is collaborating with Touch Surgery, which has app-based 3-D simulations of surgeries.Chris NewmarkerJohnson & Johnson's Ethicon subsidary recently announced a collaboration with Touch Surgery(London and New York) to develop free surgical training simulations related to Ethicon products. Touch Surgery already boasts a million downloads of its smart device app, available in both iOS and Android. The app already enables surgeons, other health experts, and...
  • New Scope Uses Infrared Light to Image Inner Ear

    The new instrument functions like a conventional otoscope and could improve diagnosis of ear infections.Kristopher SturgisMIT researchers and a physician at Connecticut Children’s Medical Center have developed a new device to help doctors see deeper inside the ear to look for signs of infection.For years, doctors have relied on otoscopes to look inside the ear for signs of infection, but these devices rely on visible light, providing views of only a few millimeters deep into the...
  • Patient Death Numbers Could Be Fudged in the Thousands

    FDA adverse event reports apparently list the deaths as injuries or device malfunctions instead.Nancy CrottiMedtech companies have reported more than 4000 patient deaths to FDA as injuries or device malfunctions, according to a joint report by CNBC and NBC New York.A review of 30,000 adverse event reports going back to 1996 for one type of device, a vagus nerve stimulator, revealed 38 patient deaths reported as injuries or malfunctions, the report said. Five of those patients developed...
  • St. Jude, Activist Investor Lock Horns Over Cybersecurity Report

    Stock trading was halted Friday as St. Jude issued a longer rebuttal to Muddy Waters Capital’s claims that St. Jude implantable cardio devices have major cybersecurity problems.Chris Newmarker St. Jude Medical on Friday accused activist investor firm Muddy Waters Capital and cybersecurity outfit MedSec of releasing a false and misleading report about the security of St. Jude devices. The report had sent St. Jude stock down nearly 5% in value on Thurday after its release. But...
  • Medical Device Recalls Surged in Q2

    More than 40 million Class II units were recalled in the second quarter of 2016, up from less than 10 million in Q1.Qmed StaffAfter falling in the first quarter of 2016, medical device recalls surged 38% in the second quarter, to more than 263, tying Q3 2015 for the most recalls since Q3 2014, according to a report from Stericycle ExpertSOLUTIONS.Did you know: Medical device recalls hit an all-time high in 2014, and nearly a third of manufacturers experience multiple recalls for similar reasons...
  • Alere Sues to Complete Abbott Merger

    The lawsuit in Delaware Chancery Court comes at the same time Alere has more bad news: a Class I designation from FDA for a recall involving a quarter of a million handheld blood clot monitoring devices. Chris NewmarkerAlere said Friday that it is suing Abbott in Delaware Chancery Court in order to compel Abbott to complete its planned $6 billion merger. The diagnostic company's complaint seeks to get Abbott to promptly obtain all the required anti-trust approvals. For their part...
  • No. 83: Edwards Lifesciences

        No. 83 Edwards Lifesciences Innovation Premium: 41.3%Edwards Lifesciences continues to make great strides in the lucrative transcatheter aortic valve market. Just this month, Edwards's Sapien 3 valve became the first TAVR valve to receive an expanded FDA indication that included patients with intermediate risk of dying or suffering serious complications during open-heart surgery, versus the previous indication for only high risk patients. 10 Medtech...
  • No. 70: Smith & Nephew

        No. 70 Smith & NephewInnovation Premium: 43.2%Smith & Nephew in recent years has made major investments in R&D, spending $222 million in 2015 alone. Innovations at the British medtech giant include not only products but new business models, such as the Syncera system for bundling a total joint replacement episode. Syncera includes not only the implant systems but also digital services, performance reviews, and metrics. Continue >>[Image...
  • No. 80: CR Bard

        No. 80 CR BardInnovation Premium: 42%After years of development and clinical research, sales of CR Bard's Lutonix drug coated balloon exceeded the company's expectations during its first full year of U.S. sales in 2015, according to the company's most recent annual report. With all sizes 5F, the Lutonix is touted as the lowest profile drug coated balloon on the U.S. market. CR Bard also boasts that 38 of the 40 products it launched in 2015 were the results of...
  • No. 67: Intuitive Surgical

        No. 67 Intuitive SurgicalInnovation Premium: 43.9%Surgical robots and sensors remain a hot medtech area, as evidenced in the premium investors appear to place in one of the leading companies in the area, Intuitive Surgical. The company’s da Vinci robots enable surgeons to perform complex procedures on a routine basis, all through tiny openings. The da Vinci System includes such innovations as an ergonomically designed console for the surgeon to sit while operating, a patient-...
  • No. 62: Essilor International

        No. 62 Essilor InternationalInnovation Premium: 45.2%The French maker of ophthalmic devices is the largest maker of lenses in the world. It spends 200 million euros (equivalent to $226 million) on innovation annually, and Essilor is also a robust acquirer of other companies.Recent innovations include Varilux Comfort, which boast sharp, natural vision at any distance, even in low lighting conditions. Essilor was able to achieve this through its proprietary WAVE technology that...