• 6 Things You Need to Check to Make Sure Your Supplier's Culture Is a Fit

    Quality audits are routine for medical device OEMs. But “cultural audits” take it to another level.Chris NewmarkerIt is one thing to demonstrate that you’re producing quality products. It’s another thing to understand the people who are behind the quality systems and responsible for delivering on the high levels of quality that are promised.Officials at the OEM Division of B. Braun Medical (Bethlehem, PA) want the latter from the manufacturers they contract with, as well as the customers...
  • How to Get the Most Out of 3-D Printing—and Avoid Rotten Miracles

    In this Q&A, a 3-D printing expert dishes advice on how to keep 3-D printing projects on track and channels advice from the iconic film The Princess Bride.Brian BuntzRon Belknap is president and CEO of ProtoCAM3-D printing, along with the Internet of Things and nanotechnology, could spark the next industrial revolution. The medical device field is poised to see big gains from 3-D printing technology, which is finding growing use for prototyping and production of finished parts.  To get...
  • Your 5 Step Blueprint for Great Medtech Design Reviews

    Design reviews can help your medical device engineers stay on track—if done correctly.Jon SpeerOptimizing the process for design reviews can help product development stay on track, says Jon Speer, cofounder of Greenlight.guru.One of my favorite parts of the design control process is design reviews. If you’ve conducted design reviews of your own, you may think I’m crazy. It is true that, if they’re not done properly, design reviews can seem like a huge waste of time, and developers too often...
  • This Materials Innovation Could Enable Cheap Tests for Pathogens

    A U.S. research team says it has integrated cellulose paper and flexible polyester films to create new diagnostic tools.Nancy CrottiU.S. researchers claim they’ve found a way to quickly and inexpensively diagnose HIV, E-coli, Staphylococcus aureus and other microbes anywhere. The solution involves using a biosensing platform made of paper and flexible substrates to analyze a drop of blood from a finger prick.The researchers—from Florida Atlantic University, Harvard Medical School’s Brigham and...
  • How a Tiny Camera Could Prevent Deadly Superbug Outbreaks

    A new mandate recommended by the firm would prevent reprocessors from relying solely on visual inspection of hard-to-clean reusable medical devices. Kristopher SturgisFollowing the superbug outbreak that killed two patients and infected five more, minimally invasive device maker Sanovas (San Rafael, CA) is calling for a new inspection protocol for reusable devices such as duodenoscopes, which were implicated in the recent hospital acquired infections.The protocol would rely on what the company...
  • 3 Examples of Consumer-Inspired Drug-Delivery Devices

    Qmed sat down with an executive at West Pharmaceutical Services to learn about consumer-friendly injection devices.Brian BuntzThe popularity of consumer devices such as smartphones and tablet computers is fueled by their impressive technology and their ease of use, with the latter being a crucial ingredient. “The user interface on the iPhone, for instance is very intuitive. People of all skill levels can use it,” explains Graham Reynolds, vice president, marketing and communications, delivery...
  • How 3-D Printing Injection Molds Can Save You Time and Money

    A growing number of device firms are using 3-D printing to produce injection molds. Brian BuntzNadav SellaAbout five years ago, Nadav Sella, now director, manufacturing tools at Stratasys, spotted a company using 3-D printing to make injection molds. “I was very enthusiastic about the process and I started working to develop the technology,” Sella says, who at that time was working at Object. (Stratasys and Objet would merge in 2012.)Fast forward to present, and Stratasys now has dozens of...
  • Everything You Need to Know about Medical Robotics in One Infographic

    A new infographic highlighting noteworthy applications for robotics in medicine was produced by Worrell Design (Minneapolis) and physician-scientist Daniel Kraft. Included below are several items routinely covered on Qmed, such as microbots, drones, exoskeletons, and mind-controlled prosthetics. A high-res version of the infographic is also available from the Worrell Design website.Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015.Like what you’re reading?...
  • Q&A: The Story Behind Poultry-Derived Antibacterial Bioplastics

     It turns out that nontraditional bioplastic materials could possibly provide a more efficient solution to the petroleum-based plastics currently in use in hospitals around the country, according to researchers at the University of Georgia (UGA). Kristopher SturgisAlex Jones, a doctoral student from UGA, is studying the antibacterial properties of bioplastics.To learn more about the potential medical applications of bioplastics, we reached out to Alexander Jones, a UGA doctoral student and...
  • As Injectors Evolve, So Does Testing Technology

    Injector pens and autoinjection devices are emerging that meet higher standards of quality, accuracy, and ease of use. Testing equipment is being developed to keep up with this trend.Erik BerndtFor U.S. diabetic patients requiring insulin, the use of the traditional vial and syringe is still predominant, though such syringes are beginning to lose favor. Physicians are concerned that these syringes make it difficult to obtain a high dosing accuracy while patients also find them cumbersome to use...
  • Battery or Supercapacitor: How About a Hybrid Supercapacitor?

    UCLA researchers’ hybrid supercapacitor is meant to combine the best qualities of the two technologies.Qmed StaffUCLA’s California NanoSystems Institute may have hit on a solution to a dilemma involving storing power of electrical devices, according to a report in Qmed’s fellow UBM Canon publication EE|Times.The hybrid supercapacitor the UCLA team developed has the benefits of a supercapacitor in that it is able to withstand more than 10,000 recharge cycles and charges quickly. But it also has...
  • How a Custom Shoe Maker Is Taking on the Orthopedics Industry

    AposTherapy is debuting a foot-worn medical device in the United States after initially launching it in Israel, Singapore, and the United Kingdom. Brian Buntz While in medical school in Israel in the early 1990s, Amit Mor and Avi Elbaz wondered why the role of muscles wasn’t emphasized more in orthopedic classes or in residency. “We learned about the bones, how to fix fractures, and implants. We studied the ligaments and cartilage. Nobody really ever talked much about the function of muscles,...
  • Why MEMS Have a Square Peg, Round Hole Problem

    One of the biggest challenge of integrating MEMS into medical devices lies in their form factor.Brian BuntzMEMS technology is featured in St. Jude's CardioMEMS HF System, which is the first FDA-approved heart failure monitor shown to significantly cut hospital admissions related to heart failure. Used in everything from implantable heart-failure monitors to cutting-edge diagnostics, microelectromechanical systems (MEMS) can give medical devices sophisticated sensing capabilities. Medical device...
  • The Art of Making Antibacterial Bioplastics from Egg Whites and Other Foods

    Alternative bioplastic materials derived from foodstuffs could curb hospital infections. Kristopher SturgisAlex Jones, a doctoral student from UGA, is studying the antibacterial properties of bioplastics.Three nontraditional bioplastic materials—containing albumin (a common protein found in egg whites), whey, and soy protein respectively—have demonstrated promising antibacterial properties, and could potentially serve as an alternative to conventional petroleum-based plastics currently in use...
  • 4 Ways to Ensure Your Temp Workers Preserve Quality

    Managing temporary workers, which has become a fact of life for many medtech companies, has unique challenges.James ReadyMedical device companies and their manufacturing service partners frequently leverage temporary labor in order to keep their operations efficient and cost-effective. It’s also common for projects to ramp-up so quickly that the only way a medical device company can effectively accommodate the needs of their clients is by using temporary labor.If the temporary labor force is...
  • How to Better Prep Medtech Engineers for the Real World

    It turns out that even academic superstars can be bewildered once they start engineering medical devices. Here are some potential answers.Josh Simon, PhDNewly graduated engineers entering the medical device industry should have practical experience, observes Josh Simon, director of business development at Sinclair Research Center. How can a medical device engineer’s education be complete if it only contains academic information?The following story happens to most newly minted engineers sometime...
  • Why Printing a Heart May Be Easier Than You Might Think

    One day, we’ll have little need for many medical devices if a University of Louisville professor is right.Brian BuntzThe heart model developed at the University of Louisville is used for surgical planning. “We’ve been using medical devices for decades in order to keep our tissues and organs going until we figure out a way of reconstructing those tissues and organs,” University of Louisville professor Stuart Williams said at the Bay Area Biomedical Device Conference, held March 31 at San Jose...
  • Introducing a New Method to Stimulate the Brain

    Magnets could be used to induce long-lasting brain tissue stimulation. Kristopher SturgisA novel method of stimulating brain tissue using external magnetic fields allows for the direct stimulation of neurons. Made possible by the manipulations of magnetic nanoparticles, the method could serve as an effective treatment for a variety of neurological diseases.The research, overseen by scientists at MIT, is part of a larger effort at the university to explore alternative methods of delivering...
  • 3-D Printed Prosthetics: This Is How You Get Them to Children

    The international volunteer group E-Nable has become a catalyst when it comes to children receiving 3-D printed “robohands” and other prosthetics.Chris NewmarkerThey aren’t a company. They don’t sell devices. But what the nonprofit volunteer organization E-Nable does provide is a volunteer community with open source information for creating 3-D printed “robohands” and other prosthetics for children.The stories continue to mount. One of the latest involves 7-year-old Faith Lennox, who lives...
  • New Nanoneedles Could Be an Important Tool to Reprogram Cells

    Scientists in England have used “nanoneedles” to successfully deliver nucleic acids into the back muscles of mice.Kristopher SturgisImage of nanoneedles delivering nucleic acids to a human cell (Courtesy of Imperial College London)Researchers from Imperial College London think that a new nanoneedle technique could help deliver nucleic acids to cells. This would then give them the ability to reprogram cells to do many different things, from repairing damaged nerves and organs, to helping...