Columns


  • Extremities | Large Joint | Materials | Spine/Neurology
    Recycling Implanted Metals From Beyond the Grave

    Recycling Implanted Metals From Beyond the Grave

    Ever wonder what happens to devices implanted in the body after their users pass away? Probably not, because the thought of it tends to make most people who aren’t ODT editors cringe. But as medical implants become more common, people are dy…
    Sam Brusco, Associate Editor 09.19.18

  • MIS/Robotics
    Premium Medtech Price Stategies for the Orthopedic Robotics Segment

    Premium Medtech Price Stategies for the Orthopedic Robotics Segment

    Growth in the market for surgical robots used in hip and knee orthopedic procedures was forecasted at $222 million in 2015 with anticipated growth to reach $5 billion by 20221 (Table 1). A substantial number of next- generation robotic devices, syste…
    Maria Shepherd, President and Founder, Medi-Vantage 09.19.18

  • A Different Class of Engineer: How to Connect with Rising Medtech Talent

    A Different Class of Engineer: How to Connect with Rising Medtech Talent

    My grandfather—a World War II veteran who worked at GE in my native Cleveland—was one of my most beloved family members. When I told him I wanted to study engineering in college, he told me to find a university where I could get real, on-…
    Dawn A. Lissy, President & Founder, Empirical 09.19.18

  • Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials

    Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials

    Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…
    Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18

  • Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 2)

    Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 2)

    Whether writing a clinical evaluation report (CER) for a new device or updating one for an existing device, compliance with MEDDEV 2.7/1 Revision 4 requirements is integral. As part of the general planning associated with CERs, first perform a gap as…
    Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 08.15.18

  • Design
    Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments

    Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments

    Five years ago, I shuddered to read the headlines about “dirty” endoscopes being used in colonoscopies and the speculation that followed. Are colonoscopies really safe? Is this what’s creating new superbugs? Why weren’t hospit…
    Dawn A. Lissy, President & Founder, Empirical 08.15.18

  • Innovation in the 510(k) Space: A Case for Incrementalism

    Innovation in the 510(k) Space: A Case for Incrementalism

    Although the term “innovative technology” often evokes images of a breakthrough, radical discovery, or inventive cure-all, the certainty associated with incremental improvements to established, higher-risk technologies such as implantable…
    Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18

  • Design | Research & Development
    Tips to Help Ensure a Successful Surgeon Design Team

    Tips to Help Ensure a Successful Surgeon Design Team

    Design surgeons and surgeon design times have been at the core of the significant advances that have occurred in the medical device market in the last few decades. Working with surgeon design teams is inspirational, mentally demanding, and exciting.…
    David C. Kelman, President, Kelman & Company Consulting LLC 08.15.18

  • FDA’s Educational Opportunities Abound

    FDA’s Educational Opportunities Abound

    As a former U.S. Food and Drug Administration (FDA) reviewer, I have spent a considerable amount of time learning the system from the “inside.” There are many avenues of training offered by the FDA, and if you know where to look, you may…
    Elizabeth O’Keeffe, Ph.D., Director, Engineering and Technical Services, Secure BioMed Evaluations 08.15.18

  • Imaging | MIS/Robotics
    The Promising Future for AI in Orthopedics

    The Promising Future for AI in Orthopedics

    In their most simple form, AI applications in healthcare consist of a collection of technologies that will enable machines to sense, comprehend, predict, act, and learn. The first application for AI-based machines, as discussed at the World Medical I…
    Maria Shepherd, President and Founder, Medi-Vantage 08.15.18

  • Stoking the Corner Office Compensation Controversy

    Stoking the Corner Office Compensation Controversy

    If only the real world functioned as it does in academia. Or in human imagination. Consider the possibilities: world peace, racial/gender harmony, financial security, and perfect health are just a few that come to mind. Even eternal youth wouldn&r…
    Michael Barbella, Managing Editor 08.15.18

  • 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

  • 3-D Printing/Additive Mfg.
    Will Additive Manufacturing Revolutionize Orthopedic Product Manufacture?

    Will Additive Manufacturing Revolutionize Orthopedic Product Manufacture?

    Additive manufacturing is a disruptive fabrication process impacting an array of industry sectors, including healthcare. As such, members of this industry have made bold claims and predictions on the potential for this innovation. How much of this, h…
    Ali Madani, CEO, Avicenne Medical 05.29.18