• Just Arrived: A Practical Tubing Materials Alternative to PVC

    Styrolution touts its diverse styrenics product portfolio as alternates to products commonly used in the medical device market, such as PVC. Chris NewmarkerMicrospec has partnered with Styrolution to use styrenics to replace PVC for its highly flexible multi-lumen tubing. (Image courtesy of Styrolution)Add styrenics to the list of medical device tubing materials being touted as alternatives to PVC and other commonly used products in the space.Styrolution’s Styroflex is...
  • TPEs' New Edge in Medtech: Supporting Blood Contact

    Thermoplastic elastomers (TPEs) are regarded as workhorse materials with an ever-widening scope of applications in the medical device industry. Brian BuntzTPE can be used for a range of medical device applications and is frequently used to make syringes.TPEs are now suitable for use in applications requiring direct blood contact for a limited amount of time. One company offering such a grade is Kraiburg TPE, a German-headquartered firm with U.S. operations based in Duluth, GA. “There are...
  • The Deadly Superbug Outbreak: What It Means for You

    Olympus' TJF-Q180V duodenoscope, as shown on the company's websiteA lawsuit has already been filed against Olympus Corp. over its duodenoscopes, and FDA is facing pressure to do more.Chris NewmarkerMedical device companies may want to pay even more attention to how easy it is to clean their reusable devices—not to mention the instructions they are issuing for cleaning—after a type of endoscope used in half a million U.S. procedures a year was linked to a dangerous “superbug” outbreak...
  • Why You Should Care About Market Research

    Many medical device companies are putting the cart before the horse when it comes to product development.Brian BuntzMany medical device companies have a flawed product development strategy. They develop a product that their engineers personally like, get regulatory approval for it, and then get it on the market as quickly as they can.Medical device professionals should embrace market research early in the product development process, says Jonathan Honiball, senior director, customer research at...
  • Magnetic Nanoparticles Loaded with Drugs Destroy Blood Clots

    Magnetic nanoparticles equipped with drugs could destroy blood clots 100 to 1000 times faster than traditional clot-busting technologies. Kristopher SturgisNanoparticle swathed in albumin and the anti-clotting agent tPA. When it comes to tracking and breaking up blood clots, time is of the essence. Researchers from Houston Methodist hope to address this issue with a new technique that infuses magnetic nanoparticles with drugs that are biochemically camouflaged, in an effort to find and destroy...
  • How to Free Yourself from a Quality System Nightmare

    Software designed specifically for medical device professionals could provide an efficient alternative to clunky paper-based and computerized quality management systems.Brian BuntzMore than half of medical device companies still use paper-based quality systems, according to Jon Speer, cofounder and VP of QA/RA of a startup named greenlight.guru (Indianapolis, IN). And such paper-based systems are often fiendishly hard to use, inefficient, and inaccurate. Many are reminiscent of public libraries...
  • A Practical Lesson from HeartWare's Latest Heart Pump Recall

    What about medical devices used in clinical trials? It is a question that is apparently dogging HeartWare.Chris NewmarkerHeartWare's driveline cable, shown in this illustration from a company video, connects the implanted pump with an externally worn controller. HeartWare International recently announced that it was recalling older controllers used during 2012 clinical trials of its implantable heart pumps.The older controllers, used by about 120 U.S. patients, exhibit a higher...
  • How Tiny Artificial Muscles Could Be Huge Energy Savers

    Electroactive polymer technology could help engineers make lighter longer-lasting medical devices.Brian BuntzParker's EAP technology on display at MD&M West.Imagine a technology that could reduce the amount of energy used to power medical device applications by 25 to 100 times. An electroactive polymer (EAP) from Parker Hannifin’s BioCare business unit could do just that, says BioCare’s business unit manager, Mario Calvo. The technology, which was on display at MD&M West, is a good fit...
  • Has the Age of the Robots Arrived?

    A new report notes that robots cost less and are able to do more—and that their use in manufacturing will quickly grow. Chris NewmarkerThe growing importance of robots in device manufacturing was evident at MD&M West in Anaheim, CA, this month.Robots presently perform only 10% of manufacturing tasks, but that is expected to rise to 25% by 2025 as robots become more affordable and able to perform more tasks, according to a recent prediction from the Boston Consulting Group....
  • FDA Warming Up to DNA Tests for the Masses

    FDA appears to be offering a path forward for companies such as 23andMe that want to market medical-related genetic tests directly to the mass public.Nancy Crotti 23andMe's unique DNA genotyping chips, as shown in a company video.The standoff between 23andMe and FDA is showing signs of easing, with the agency clearing the Mountain View, CA–based genetic testing company to market a test for a rare disorder that causes short stature, sun-sensitive skin changes, and an increased risk of...
  • Superbug Deaths Stoke Reprocessing Fears

    Reprocessed medical devices are already a controversial subject in medical device circles. A recent deadly “superbug” at UCLA may have just made them even more worrisome.Chris Newmarker and Brian BuntzUpdated February 25, 2015A close-up view of an ERCP endoscope tip. (Image courtesy of FDA)Reprocessed medical devices of all stripes could receive more scrutiny than ever in the United States, after news that at least seven patients were infected and two died from a drug-resistant “superbug”...
  • Turning Contact Lenses Into Telescopes at a Wink of an Eye

    A right wink by someone wearing the contact lenses and a complementary set of glasses switches magnification on, and a left wink switches it off.Nancy CrottiA Swiss university has unveiled a contact lens-glasses combination that could allow the visually impaired to switch between normal and telescopic vision in the wink of an eye.Optics specialist Eric Tremblay of École Polytechnique Fédérale de Lausanne (EPFL) introduced a prototype of the telescopic contact lens at the at the American...
  • Tiny Bioengineered Structures Boast Regenerative Powers

    Meet the tiny biodegradable microstructures that can repair damaged heart tissue and work to prevent future heart failure. Kristopher SturgisIt’s no secret that heart disease is one of the leading causes of death for both men and women across the globe, with over 600,000 deaths in the United States alone, according to the CDC. While survival rates are encouraging, the subsequent damage to the heart following a heart attack often leads to eventual heart failure. This is why researchers from the...
  • Bacteria No Match for Nonstick Medical Device Material

    A new solid silicone-infused polymer joins an arsenal of slippery, nontoxic surface coatings used on medical materials to prevent infection. Kristopher SturgisA bacteria-killing coating could be especially useful for catheters. Image from Harvard. These biofilms, where bacteria accumulate into adhesive colonies, are a common occurrence on the surfaces of medical devices, leading to infection and oftentimes rejection of the implant. Recently, researchers at Harvard University developed a...
  • Of Contract Manufacturing, Wearables, and Obamacare

    Contract manufacturers serving medical device firms are rapidly adapting thanks to healthcare reform and the blurring lines between healthcare and consumer technology. In the following Q&A, a manager from Vancive Medical Technologies weighs in on these issues. Brian BuntzMedical device developers are asking more from their contract manufacturers, says Crystal Humphreys, global market segment manager, Vancive Medical Technologies (Chicago). “The bar has really been raised. Rapid prototyping...
  • The Good, Bad, and Ugly of Presidents and Medical Devices

    Don't go searching for President's Day sales just yet. These four stories will get you in the "presidential" frame of mind—and hopefully provide some useful lessons.Chris NewmarkerPresident’s Day in the United States provides a time to draw lessons from the lives of the great people who have led America.That is actually true with medical devices, too. As with most other people, presidents have had their share of encounters with medical devices, with a mix of both tragic and inspiring results....
  • The Uberization of Healthcare

    The Uber business model will soon come to healthcare. Medical device developers should take notice. Stuart KartenStuart Karten is the founder of Karten Design, a firm that works both in the medical device and consumer technology sectors. Just as Uber changed transportation in positive—and sometimes controversial—ways, healthcare will be infiltrated by startups wanting to change the healthcare model from hospital-centric to patient-centric. Medical device companies and other healthcare providers...
  • How to Combine Imaging and Therapy in Nanoparticles to Combat Cancer

    Imaging techniques and tumor treatment therapies have combined to create a potentially powerful tool in cancer research. Kristopher SturgisResearchers from Imperial College London and the National Center for Scientific Research (CNRS) in Paris have designed and developed hybrid gold-silica nanoparticles, which could result in a genuine therapeutic tool providing both imaging capabilities and tumor treatment therapies.The team, consisting of a collection of international chemists and biomedical...
  • Why the Best Medtech Pros Think Big

    Because medical devices are but one piece of the healthcare ecosystem, it makes sense for medtech firms to design healthcare systems rather than devices alone. Brian Buntz“A company that is designing a product for the operating room doesn’t want to just supply, for instance, the operating table. They want to supply the lights, and just about everything else,” said Ben Davenport, site director at Nypro Healthcare, an outsourcing company based in Coppel, TX, in an interview at MD&M West. “...
  • Find Out the Most Innovative Medtech Exhibitor

    There are plenty of amazing things to see at the biggest medical device manufacturing event in the United States.Chris NewmarkerThe Auto-I 360, made by Interface Catheter Solutions, is inspecting a medical balloon for imperfections. This medical balloon can be used to treat peripheral vascular disease.Developers of a medical balloon inspection system, an innovative friction test for single-use medical devices, and a tiny magnetic reed sensor were among finalists vying Wednesday to become...