• Senate Committee Votes to Accelerate Device Approvals

    A Senate committee has approved legislation intended to speed regulatory timelines for medical devices in the United States.Qmed StaffThe legislation, known as MEDTECH Act (S. 1101), is intended also to foster medical research at the National Institutes of Health, a goal of Democrats.The legislation will likely be made part of a larger effort to boost FDA and NIH funding and President Barack Obama’s Precision Medicine Initiative, which is intended to help boost research on new cancer treatments...
  • Wrist-Worn Wearable Can Detect and Maybe Prevent Seizures

    A wristband can monitor stress signals in epileptics to detect and warn of impending seizures.Kristopher Sturgis A new device, known as Embrace, is the product of a new company called Empatica— an organization that specializes in the development of wearable devices using medical quality sensing technologies. The project was aimed at providing a novel tool for patients who suffer from epilepsy, a neurological disease that is characterized by unprovoked seizures that can lead to a fatal...
  • Google's Verily Developing Medical Device Hub

    Google’s life sciences company Verily has submitted photos and more information in its quest to land the federal government’s permission to use a “connectivity bridge” to collect patients’ medical data, according to media reports.Nancy CrottiGoogle’s life sciences company Verily has submitted photos and more information in its quest to land the federal government’s permission to use a “connectivity bridge” to collect patients’ medical data, potentially giving Qualcomm a run for the money in...
  • How Lawsuits and M&A Activity Affects Device Firms' Credit Ratings

    There has been a recent uptick in news stories about medical device company mergers, not to mention product liability lawsuits filed against medical device companies. To learn about how these two trends could impact medical device credit ratings, we reached out to an analyst at S&P.Brian BuntzLast year went down as the biggest year for M&A activity on record, and this year is looking similar thus far.  Another trend—albeit an unrelated one—is a growing amount of medical device...
  • 6 Factors That Wreak Financial Havoc for Medtech Companies

         Good old-fashioned fraud, reimbursement cuts—those are but some of the major factors that have doomed medical device companies and sent them on the road to default, according to a new report out of Standard & Poor's.Brian Buntz and Chris NewmarkerIt is rare for medical device companies to default, although the number of defaults in the sector has risen in recent years. Over the past 30 years, the most common causes of default were fraud and accounting problems,...
  • 1. Fraud and Accounting Problems

         1. Fraud and Accounting ProblemsTaken together, fraud and accounting problems were responsible for one third of medical device firm defaults, causing a total of five defaults. In S&P’s report, the consultancy notes that it did not expect to find that fraud would be a common cause of default for medical device companies. In the end, the prevalence of fraud in the sector is higher than in other industries because of the high prevalence of third-party payments in...
  • 2. Reimbursement Cuts

         2. Reimbursement CutsBehind fraud and accounting problems, the most common cause of medical device defaults was a reduction in reimbursement, which has caused three major medical device company bankruptcies in the past three decades.S&P closely monitors decline in price or reimbursement of medical devices, given that many of the products are substantially cheaper in other geographies outside the United States.Reimbursement cuts ultimately led to the defaults of the...
  • 3. Product Liability

         3. Product LiabilityProduct liability is an issue S&P is monitoring closely for high-tech medical device makers, says David Kaplan, director, healthcare group at Standard & Poor's Ratings Services. “That is a prominent issue for a number of medical device companies right now, with the number of companies defending themselves against billions in claims from pelvic mesh and metal-on-metal hip implant related lawsuits.”While not as common as the aforementioned...
  • 4. Decline in Demand

         4. Decline in Demand“Decline in product demand is more of an issue for companies with product concentration,” observes Kaplan, who cites companies like  Zest Anchors (see S&P summary from April 2015 above) and Kinetic Concepts as examples of how product concentration can hurt credit scores.It is rare for new medical products to rapidly gain market share. For that reason, many healthcare companies have time to adapt to market changes.Occasionally, however,...
  • 5. Excessive Debt Levels

         5. Excessive Debt LevelsIn two cases, a “winner’s curse” in a leveraged buyout and the resulting excessive debt level proved too much.“Debt levels are an important part of our analysis,” Kaplan says.Maxxim Medical Group, for example, used a series of acquisitions to become a leading U.S. producer of nonlatex medical gloves and custom procedure trays during the 1990s. It went private in 1999 through a leveraged transaction largely financed by debt, only to then be hit...
  • 6. Rapid Pace of Acquisitions

         6. Rapid Pace of AcquisitionsGraham-Field Health Products Inc. still makes thousands of items for healthcare and home health care settings. But the company had its own run-in with default in 1999 after a rapid series of acquisitions in the late 1990s. Then-CEO Irwin Selinger had the company do eight acquisitions in 1996 and 1997. By 1998, Selinger was resigning as the company struggled to smoothly digest the acquisitions amid a string of unprofitable quarters and...
  • Here's How You Build Biobots

    A new National Science Foundation video shows off the incredible strides made by Illinois researchers when it comes to creating robots powered by living cells.Qmed StaffScientists led by Rashid Bashir at the University of Illinois at Urbana-Champaign have created tiny living machines called biobots that utilize skeletal muscle cells. The biobots are controlled with electrical or optical signals.Work has progressed since Qmed last reported on the technology in 2014. For now, the biobots kind of...
  • Meet Dreamer: One of the Best Humanoid Robots Yet

    Researchers from the University of Texas at Austin have created a new wave of enhanced robotic technologies designed to efficiently perform tasks and interact safely with humans. Kristopher SturgisLuis Sentis, an assistant professor of engineering at UT Austin, shakes hands with Dreamer. (Image courtesy of UT Austin)The latest prototype, called Dreamer, was designed from head to toe by researchers and students at the University of Texas at Austin. The project was designed to create a new...
  • How 3-D Printing Played a Role in the Super Bowl

    In case you missed it, last month's Super Bowl 50 marked the first time an NFL player wore a 3-D printed medical device at the game. Qmed StaffThomas Davis tried out the 3D-printed brace during practice. (Image courtesy Carolina Panthers.)The Carolina Panthers may have fallen to the Denver Bronco's in last month's Super Bowl 50. But Panthers Thomas Davis was still connected to a "first": the first time a football player has worn a 3-D printed medical device during a football game.Qmed's sister...
  • 5 Ways to Design for Murphy's Law

    Bryce Rutter, founder and CEO of Metaphase Design Group, elaborates on five critical success factors to eliminate human error with medical devices. Bryce G. Rutter, Ph.D.We’ve all heard of Murphy’s Law: if someone can use a product the wrong way, then they will. Count on it!  But in the design of medical products. this presents a significant problem. If someone uses a device or instrument incorrectly they can easily cause harm, irreparable damage, and even death. The goal of human factors...
  • Monkey Controls Wheelchair with Mind Alone

     Brain–computer interface technology has made enormous strides in recent years. Only recently, Australian researchers have worked to transform stents into electrodes while scientists at Brown University have developed brain implant technology that can enable paralyzed patients to control computer interfaces with thoughts alone.   Qmed Staff Now, researchers at Duke University have succeeded in having monkeys control robotic wheelchairs with their mind using a brain...
  • How Nikola Tesla Inspired Next-Gen Wearables for Chronic Pain

    Diathermy, a technology with roots stretching back to the late 1800s, could offer significant benefits to legions of chronic pain and arthritis patients as well as athletes with sore muscles.Brian BuntzThe prototype diathermy knee-wrap is known as VIVY is now the subject of a fundraising campaign on Indiegogo.Chronic pain affects more people than patients with cancer, diabetes, heart disease, and stroke, according to figures from the Institute of Medicine. Despite the high numbers of patients...
  • Vascular Solutions CEO 'Outraged' by Federal Prosecution

    Recently acquitted of off-label promotion of medical devices, the attorney and device executive Howard Root has penned an op-ed in the Star Tribune decrying his “malicious” federal prosecution.Brian BuntzVascular Solutions CEO Howard Root is angry. For more than five years, he has been at the receiving end of a Department of Justice trial. Recently acquitted, Root had been accused of orchestrating a scheme of selling one of the company’s products treat perforator varicose veins rather...
  • Why New York City Is a Leader in Healthcare Software

    When most people think of top cities for healthcare innovation in the United States, they think of cities like Boston and Minneapolis with decades of history in innovation, or perhaps San Francisco, which is home to the healthcare incubator Rock Health. But the nation’s biggest city should be added to that short list, as the Brooklyn-based company CredSimple demonstrates.    Brian BuntzMike Simmons is the CEO of CredSimple. The startup CredSimple, which has developed a SaaS...
  • 10 Antique Medical Devices from Earl Bakken's Museum

        There is no museum quite like The Bakken Museum, which houses approximately 2500 artifacts in its instrument collection alone. Named after Medtronic co-founder and legendary inventor Earl Bakken, the museum also includes rare books, manuals, and documents. Click on for 10 medical instrument highlights from the collection. Continue >>All images courtesy of the Bakken MuseumLearn more about cutting-edge medical devices at BIOMEDevice Boston, April 13–...