• Outsourcing Medical Product Development the Right Way

    Farm Design has advice on how to get the most out of outsourcing medtech development.Chris NewmarkerIt is a trend Qmed/MPMN has noted before: medtech companies increasingly calling on contract manufacturers to take on more responsibilities, including actual design and development.The situation has helped spark a wave of mergers and business partnerships allowing manufacturers to offer a wider menu of services. Farm Design (Hollis, NH) lists a few reasons for this trend, including pricing...
  • 10 Questions Novice Medical Device Inventors Should Ask

    You’ve just had that ah-ha moment, realizing your life’s calling: creating an innovative solution to a healthcare problem. But believe it or not, coming up with your idea is the easy part.Bobby Grajewski, President of Edison Nation MedicalRobert Grajewski, president of Edison Nation Medical, recommends that novice medical device inventors do thorough due diligence when considering commercializing a product idea.  Even though it took large amounts of creativity, ingenuity and...
  • Unleashing the Potential of Conductive Polymers

    Conjugated polymers could potentially be used in an array of electronics applications, but, to date, scientists have puzzled over how the materials can conduct electricity. That may have just changed.  Kristopher Sturgis An MIT research group claims to have discovered how electrical charge moves in conjugated polymer compounds, potentially clearing the way for the materials to be used in all manner of electronic applications including sensors, organic light-emitting diodes, and...
  • How to Maximize the Value of Acquired Technology

    The increasing rate of both mega mergers and startup technology acquisition in today’s med device market brings with it unique and timely challenges.Carolyn RoseCarolyn RoseIn the past couple of years, the medical device industry has witnessed a big uptick in megamergers—with some of the deals being measured in the billions of dollars. In addition, big medtech firms continue to spend considerable sums to acquire on startups as well.Yet the companies doing the acquiring—whether they are merging...
  • Researchers Demand New Safety Standards for Millimeter-Wave Devices

    An NYU research group has called for new FCC rules for future wireless devices.Qmed StaffThe city of Berkeley, CA made news by becoming the first city to require cell phone retailers to post warnings of the devices’ potential to emit radiation.Much of the commentary that followed the news dismissed it city’s rule as being based on junk science.Yet a recent group of researchers at New York University (NYU) has called for new safety standards for next-gen wireless devices, as reported by our...
  • New Robotics Redefine Minimally Invasive Surgery

    Find out about a Vanderbilt researcher’s robot that can perform surgeries at tiny scales.Kristopher SturgisOnly a handful of researchers worldwide have been capable of performing needlescopic surgery, which uses tiny surgical instruments with the diameter roughly the size of a sewing needle.A new surgical robot developed at Vanderbilt University holds promise that such procedures could become much more commonplace someday. That is good news, because minimally invasive needlescopic surgeries are...
  • St. Jude Just Got Another Reason to Really Like LVADs

    Thoratec’s attractiveness to St. Jude Medical, and potentially others, has likely grown after Mayo Clinic researchers found LVADs can help deadly restrictive cardiomyopathy patients.HeartMate II, as shown on Thoratec's websiteNancy CrottiLeft-ventricular assist devices just got a shot in the arm from a Mayo Clinic study showing that LVAD succeeded in treating patients with potentially deadly restrictive cardiomyopathy (RCM).The study results’ release comes a week after St. Jude Medical (Little...
  • German Scientists Question Accuracy of Prominent Blood Glucose Meters

    A recent letter to Diabetes Care called into question the accuracy of blood glucose monitors in measuring low blood sugar.Nancy CrottiA letter to Diabetes Care by four German researchers cited a study that tested the accuracy of Bayer’s Contour Next blood glucose monitor; Roche Diagnostics’ Accu-Chek Aviva Nano; Abbott Diabetes Care. Inc.’s FreeStyle Lite; Nipro Diagnostics, Inc.’s Truetrack; and Johnson & Johnson’s One Touch Ultra 2 and One Touch Verio Pro.The study compared the devices...
  • Polymer Material Opens Door for Novel Stomach-Based Drug Delivery

    Researchers developed a pH-responsive polymer gel that could enable the development of new swallowable devices and capsules with ultra-long drug delivery capabilities. Kristopher SturgisShiyi Zhang, postdoc at Koch Institute, holding a ring-shaped prototype, which can be folded into a swallowable capsule (shown on the right) for safe oral delivery. A new pH-responsive polymer gel could enable long-acting devices to reside in the stomach for days, weeks, or even months on end following...
  • How Philips Made App-based Ultrasound a Reality

    Previous innovations, and collaboration with FDA, helped Philips when it came to creating ultrasound that simply plugs into a smart device, says a Philips vice president who helped lead the project.Randy HamlinChris NewmarkerRoyal Philips in September will start selling an FDA-cleared ultrasound transducer called Lumify that simply plugs into a tablet computer via its USB port. The interface runs off an app on the tablet.Call it the birth of app-based ultrasound.Qmed recently interviewed Randy...
  • Who Has the Most Interesting Desk in Medtech?

    A person’s desk can say a lot about what’s important to them and how they get things done. What can each other’s desks and workspaces teach us about the medical device industry? Let’s find out.Chris NewmarkerMy desk in my home office, outside MinneapolisThey’re the places where many of us get things done. They’re the places where the magic happens.Desks and workspaces also can say a lot about their owners and the industries they work in. (Email me at chris.newmarker@ubm.com with a picture...
  • Synthesizing Graphene Quantum Dots into Bioimaging Probes

    Researchers are exploiting the nontoxic, fluorescent capabilities of quantum dots to enhance medical imaging. Kristopher SturgisA group of researchers from San Jose State University (SJSU) believe graphene quantum dots could be the next big step in bioimaging technology.While working on their masters in biomedical engineering, Aneshkumar Tilwani and Hildegarde Bell teamed up to explore the potentials of small crystals of graphene with a diameter of less than 50 nanometers—something known as...
  • Using Ultrasound to Boost Wound Healing

    Researchers have developed a new handheld ultrasound device that could reportedly accelerate the healing process in skin wounds.The ultrasound device in use (Image courtesy of Sheffield University)Kristopher SturgisScientists from Sheffield University say their low-intensity ultrasound device can reduce the healing time of skin ulcers and bedsores by as much as 30%, according to a university news release.The handheld device was developed by Mark Bass, a PhD in biochemistry at the British...
  • Here's Why 3-D Injection Molding Might Not Work for You

    The technology is a helpful tool, but it has limits for now, says the president of an award-winning medical device design company.Chris Newmarker3-D injection molding seems like a potential godsend for prototyping because it supposedly marries the fast turnaround time of 3-D printing with the reliability of injection molding. You can quickly 3-D print the molding tool and then start injection molding prototypes right away.As is usually the case when a “cool, unique” technology gets hyped, the...
  • Bard Hit with Wide-Ranging Warning Letter

    Bard has announced that it has received a warning letter citing quality system and medical device reporting violations. Qmed StaffThe Bard PV Recovery Cone was mentioned in the warning letter. The Los Angeles District office of the FDA has handed Bard a warning letter, it revealed in an SEC document. The document mentioned quality systems and medical device reporting violations that FDA had identified earlier in Form 483 documents related to audits of its facilities in Glens Falls, NY and Tempe...
  • Why Wearables Aren't Living Up to the Hype

    Wearables aren’t doing what they need to, but there’s a way forward, says an entrepreneur in the space. Penders also told ESC attendees to embrace regulation to a medtech-level stamp of approval.Qmed StaffToday’s wearables still provide “limited information and limited accuracy,” Julien Penders, co-founder and chief operating officer of pregnancy tracking startup Bloom Technologies (San Francisco), said Tuesday at the Embedded Systems Conference in San Jose.One recent review of wearable devices...
  • Is This the Answer to the Superbug Scare?

    Health providers are showing interest in a dishwasher-like device amid superbug deaths related to a tough-to-clean endoscope.The LIC machine (Image courtesy of Proven Process Medical Devices)More Stories:Why Duodenoscope Infections Could Affect Entire Medtech FDA Panel Deems Duodenoscopes to Be UnsafeDOJ Is Investigating Olympus DuodenoscopesChris NewmarkerUCLA’s Ronald Reagan Medical Center plans to install Langford IC Systems’ “LIC” machine to clean endoscopes in the aftermath of a...
  • This Is How You Wirelessly Provide Brain Control

    U.S. scientists have developed a new wireless brain probe made of soft materials that can simultaneously deliver drugs and lights to the brain to help control neurons. (Image courtesy of of Jeong lab, University of Colorado Boulder)Kristopher SturgisA remote-controlled, next-gen tissue implant could enable neuroscientists to inject drugs and shine lights on neurons inside the brain to elicit controlled reactions.The new device—created by researchers at the Washington University School of...
  • Helping Diabetics Deal with Data Overload

    One of type-1 diabetics’ biggest hurdles is making sense of mountains of sometimes chaotic-seeming data.   Brian BuntzChris Snider will be speaking on challenges diabetics face next week at  Stanford Med X Meetup hosted at UBM's San Francisco office. “I have to quantify myself just to stay alive,” says Chris Snider, who serves on the executive board of the Stanford Medicine X conference and has been living with type-1 diabetes since 2002. “That is an interesting perspective to...
  • 6 Robotic Breakthroughs That Could Matter for Medtech

    Science fiction presents visions of robots playing an integral role in society or even waging war against humanity. But what advances will matter for the medical device industry? What is the next frontier for medical robotics?(function(t,e,s,n){var o,c,r;t.SMCX=t.SMCX||[],e.getElementById(n)||(o=e.getElementsByTagName(s),c=o[o.length-1],r=e.createElement(s),r.type="text/javascript",r.async=!0,r.id=n,r.src=["https:"===location.protocol?"https://":"http://","widget.surveymonkey.com/collect/...