Featured


  • Extremities | Imaging | Software & Quality
    FDA Defines

    FDA Defines 'Radiological Computer Assisted Detection and Diagnosis Software'

    In approving OsteoDetect, FDA enumerated risks that are actually generic to diagnostic software.
    Online Exclusives William A. Hyman, Professor Emeritus of Biomedical Engineering, Texas A&M University, & Adjunct Professor of Biomedical Engineering, The Cooper Union 06.15.18

  • 3-D Printing/Additive Mfg. | Coatings/Surface Modification
    Eurocoating Acquires CoorsTek Medical

    Eurocoating Acquires CoorsTek Medical's Nanosurfaces Industries

    Eurocoating aims at building a "one-stop shop" concept in the area of additive manufacturing parts for the medical industry.
    Eurocoating SpA 06.06.18

  • Trauma/Sports
    Halyard Health to Acquire Game Ready (CoolSystems Inc.) for $65M

    Halyard Health to Acquire Game Ready (CoolSystems Inc.) for $65M

    Pain management and rehabilitation therapies enhance and diversify Halyard's non-opioid pain management portfolio.
    PR Newswire 06.05.18


  • MIS/Robotics | Spine/Neurology
    CoreLink Acquires Israeli Firm Expanding Orthopedics Inc.

    CoreLink Acquires Israeli Firm Expanding Orthopedics Inc.

    CoreLink gains the FLXfit articulating and expanding interbody along with a portfolio of patents and products.
    Business Wire 06.05.18

  • Bracing/Prosthetics
    How We

    How We'll Become Cyborgs and Extend Human Potential

    Bionics designer Hugh Herr details "NeuroEmbodied Design,” a methodology for creating cyborg function.
    Videos TED 06.01.18

  • Extremities | Large Joint | Spine/Neurology | Trauma/Sports
    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis

    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis

    The agency will work closely with selected applicants to accelerate product development.
    U.S. Food and Drug Administration 05.31.18


  • Extremities | Spine/Neurology
    Bioelectronic Medicine Gets on Arthritis’ Last Nerve

    Bioelectronic Medicine Gets on Arthritis’ Last Nerve

    According to Northwell Health, as of 2016 rheumatoid arthritis (RA) affects 1.3 million adults in the U.S. And despite billions of dollars spent annually treating the disease, there has yet to be a therapeutic agent able to universally relieve the jo…
    Sam Brusco, Associate Editor 05.29.18

  • How Do We Make Orthopedic Surgery Easier for Our Physicians?

    How Do We Make Orthopedic Surgery Easier for Our Physicians?

    The practice of orthopedic surgery is still going through a significant transformation. Practice shifts from private to hospital employees and back to private again. This level of turbulence creates ambiguity, questions, threats, and opportunities.…
    Maria Shepherd, President and Founder, Medi-Vantage 05.29.18

  • Assembly & Automation | Coatings/Surface Modification | Contract Manufacturing | Design | Extrusion | Machining & Tooling | Molding | Prototyping
    The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource

    The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource

    I  was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…
    Dawn A. Lissy, President & Founder, Empirical 05.29.18


  • Extremities | Materials | Spine/Neurology
    In Situ Cured Silicone Could Enable Personalized Implants

    In Situ Cured Silicone Could Enable Personalized Implants

    Medical-grade silicone is a highly valued, versatile biomaterial widely used for medical implants. Often associated with applications such as cardiovascular pacemakers, cochlear implants, hydrocephalus shunts, implantable infusion pumps, and even int…
    Brian Reilly and Jim Lambert, Ph.D., NuSil, an Avantor brand 05.29.18

  • Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 1)

    Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 1)

    The latest revision of MEDDEV 2.7/1 was published June 2016 and calls for substantial changes from revision 3. Updating clinical evaluation reports (CER) to meet the new requirements will require a major effort for most manufacturers selling in the E…
    Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 05.29.18

  • Design | Research & Development
    The Hidden Costs of Clinical Trial Agreement Negotiations

    The Hidden Costs of Clinical Trial Agreement Negotiations

    Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…
    Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18

  • Modifications to a Cleared Device: Letter to File or New 510(k)?

    Modifications to a Cleared Device: Letter to File or New 510(k)?

    Change is good, right? Most orthopedic manufacturers have been working under the ISO 13485 umbrella, which stresses the need for continuous improvement. Once a device is in commercial distribution, there are valuable lessons to be learned. Shouldn&rs…
    Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.29.18

  • Design | Research & Development
    Product Development in the Changing Healthcare Environment

    Product Development in the Changing Healthcare Environment

    The healthcare market has been changing over the past 30 years and the speed of change is increasing significantly. During this timeframe, great advances have been made to patient care through new surgical interventions and medical devices. Early on…
    David C. Kelman, President, Kelman & Company Consulting LLC 05.29.18

  • Large Joint | Spine/Neurology
    Where Are the Flying Cars, Hoverboards, and Smart Implants?

    Where Are the Flying Cars, Hoverboards, and Smart Implants?

    Speculation about the future can often result in unrealistic expectations, regardless of the source from which the speculation originates. For example, just look at the second “Back to the Future” movie. Fans of the film gawked at the pro…
    Sean Fenske, Editor-in-Chief 05.29.18