• Reducing Medical Device Failures through Risk Management

    Although risk management is a commonly used term, it can be difficult to understand precisely how to implement it during medical device product development.Lisa WeeksRisk management is not a new concept for device makers. ISO 14971, the international risk management standard for medical devices, has been around since 2000. Once it became apparent that absolute product safety was unattainable, meaning, that some level of failure was inevitable, the need arose for a system that would help lessen...
  • The Rise of Contract Development in Medtech

    As they wrestle with evolving consumer needs, medical device firms are turning towards contract firms that can both help design their products and develop them. Ximedica’s recent acquisition of Bridge Design dovetails with this trend.  Hope HopkinsThe traditional product development paradigm is being upended in the medtech sector as the benchmarks for usability increase and a growing number of medical devices incorporate consumer-technology–inspired features. The traditional lines between...
  • How to Prepare for the Internet of Things in Healthcare

    How should medical device developers plan for the integrating the Internet of Things (IoT) into their products? Look to the past, says Bill Betten, principal at Sysgineering Solutions based in the greater Minneapolis–St. Paul area. And then follow the money.Brian BuntzThe IoT of things in healthcare could link ambulances, medical devices, and hospitals with integrated cloud-based services. Image courtesy of Intel.  Proponents of the IoT say that it will revolutionize healthcare,...
  • Are We at the Peak of Medtech 3-D Printing Hype?

    The medical device industry is at the peak of 3-D printing hype—but there are also many applications of the technology already in use, according to a new report.Nancy CrottiMedical technology is at the top of hype when it comes to 3-D printing, but it is also leading the way, according to a report by Gartner Inc.The Stamford, CT–based IT research company Gartner Inc. claims in its newly released “Hype Cycle for 3-D Printing 2015,” that advancements in medtech have spurred the rise of 3-D...
  • 2 Things Next-Gen Sequencing Needs to Meet Its Promise

    Next-generation sequencing has so far been used in a relatively small number of tests, says Mark Borodkin of BioNano Genomics. Here are two challenges that need to be overcome to make it more widespread.Mark BorodkinChris NewmarkerNext-generation sequencing holds the promise of providing a large amount of genomic data, enabling better better understanding of genomes and associations to disease, says Mark Borodkin, vice president of systems development at BioNano Genomics (San Diego).“Thus far,...
  • How Big Data Could Reach Its Medtech Potential

    Here are three things that need to be overcome when it comes to turning raw medical data into actionable information, courtesy of wireless technologies consultant and entrepreneur Upkar J. S. Dhaliwal. Upkar J. S. DhaliwalChris Newmarker Think of how online marketers seem to know your interests better than you do, based on your Internet browsing—or how a major retailer such as Target reportedly creeped out mothers-to-be by determining they were pregnant before that was public...
  • Designing Next-Generation Biomaterials

    A researcher at Penn State has helped develop promising citrate-based biomaterials.Kristopher Sturgis Citrate materials can promote osteo-integration and new bone formation, according to the Penn State researchers. This photo demonstrates that a citrate bone implant prompting bone regeneration and fully integrating with the surrounding bone. (Image courtesy of Jian Yang, Penn State)Biomaterials are the foundation for medical technology innovation, says Jian Yang, PhD, biomedical...
  • How China's Black Monday Hit the Top 10 Medtech Firms

    A handful of medical device companies that do a large amount of business overseas were hit especially hard by Wall Street’s worst day in four years.Chris Newmarker and Brian BuntzMajor medtech companies got their share of the thumping that U.S. stock markets received amid a “Black Monday” in which Chinese stocks saw their worst decline in eight years, with resulting questions about the Chinese government’s managing of of the world’s largest economies.While the U.S. stock market recovered...
  • How to Take 3-D Printing Beyond Prototyping

    Here are three important things that medical device makers should consider as they examine the pros and cons of 3-D printing, courtesy of Andreas Pfahnl of Devicix.Andreas PfahnlAndreas Pfahnl, ScD, DevicixManufacturing a medical device requires carefully selected materials, controlled fabrication and assembly manufacturing processes, and qualified suppliers and contract manufacturing partners. Incorporating 3-D printing or additive manufacturing process into the overall manufacturing of a...
  • Is This the Future of Wireless Power in Medtech?

    WiTricity’s wireless power technology has already sparked some interest in medtech circles. Discover some of the next steps for WiTricity.Chris Newmarker(Infograph courtesy of WiTricity) Eight years after it was founded with MIT-based technology, WiTricity appears ready for the bigtime with its wireless resonant energy transfer system, which is based on finely tuned oscillating magnetic fields between coils at a distance.WiTricity (Watertown, MA) has an agreement with Intel to power...
  • A Device to Tackle Football's Concussion Problem

    The thing with football, it just takes one hit for athletes to face a severe head and neck injury that could threaten their career and possibly life. A company has a device that it hopes can help athletes of nearly all ages, and possibly even help save the sport.Brian BuntzThe Kerr collar was invented help reduce impact to the head and neck in football.  “You have 8 to 13 kids who are either paralyzed or even killed from a broken neck in football every year,” says Patrick Kerr, founder of...
  • Move Over Graphene, Meet the Next Wonder Material

    Black phosphorus, rather than graphene, could be the first material to herald a new era of nanoelectronic devices.Kristopher Sturgis Black phosphorous may end up being a better fit for electronics than graphene. Image from Wikipedia. When it comes to enhancing transistor technology, thinner is theoretically better. This is why graphene — a material one-atom thick — could potentially be an ideal replacement material for silicon transistors. Yet graphene lacks a critical property: in its natural...
  • A Disruptive Device That Treats Vision Loss

    The Silicon Valley startup Oraya Therapeutics offers a case study in innovation in the medical device sector.Brian BuntzOraya Therapeutics (Newark, CA) is unique from a technological perspective. The private company, which won silver at the Medical Design Excellence Awards this year, has developed a noninvasive therapy for wet age-related macular degeneration—one of the most common causes of blindness. The company’s IRay radiotherapy system delivers a precise dose of radiation noninvasively to...
  • 3 Steps to Better Protect Your Devices from Hacking

    Recent hacking worries over Hospira infusion pumps provide even more reason to take medical device cybersecurity seriously. Here are three things to get you started, courtesy of GE Healthcare’s product security engineering director.Steve AbrahamsonChris NewmarkerFDA is focusing more on medical device network security, and so should you, says Steve Abrahamson, director of product security engineering at GE Healthcare.Independent researcher Billy Rios recently confirmed that a Hospira...
  • A DIY Optogenetics Device That Costs $10

    The first completely implantable optogenetics stimulator has a price point so low that research labs with tight budgets can afford to investigate the technology. Brian BuntzThe optogenetic stimulators recently developed at Stanford are the first that are completely implantable. Image: Brian Buntz.One of the hottest research topics in neuroscience, optogenetics has given scientists unprecedented control of the brain. In mice studies, researchers have used the technology to beam light at...
  • The Ins and Outs of Laser Process Validation

    Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or validation for your specific application. Scott Marchand Davis, Resonetics Laser micromachining provides micron-level precision material removal and texturing in metal and polymer parts, allowing for a range of feature geometries to support different functions for both diagnostic and therapeutic...
  • Infographic: Top Tech Advances of 2015

    In June, we asked our audience to pick the most promising technological breakthroughs of the first half of the year. Contenders included injectable brain electronics and Terminator 2–inspired 3-D printing. The four technologies featured here won out in the survey. Qmed partnered with the design team at Worrell Design (Minneapolis, MN) to produce the infographic below, which highlights the four winners while providing context on why the advances are important. Learn more about medical...
  • 3 Medtech Trends You Should Pay Attention to in 2015 (and Beyond)

    Although the medical device industry is poised for incredible possibilities, it must be prepared to deal with some growing pains along the way.Lisa WeeksThese are exciting times to be working in the medical technology industry. Scientists are now beginning to create custom human body parts on demand, breathing new life into the concept of personalized medicine. Mobile health (mHealth) applications have the potential to empower patients to take charge of their own healthcare. And medical devices...
  • 6 Things You Need to Know About Laser Wire Stripping

    Medical device wires are getting increasingly tinier, posing new challenges when it comes to using lasers to strip. Here are the basics to get you started in the world of laser wire stripping for medtech.Glenn Ogura and Sergey Broude, ResoneticsIt was only as recent as 20 years ago that electronic component makers turned to lasers—an elegant non-contact solution—to strip the majority of tiny wires that connected the disk drive head to the drive electronic. These days, the emergence of medical...
  • 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...