Related Columns

  • Extremities | Large Joint | Spine/Neurology
    Electing a Path Back to Operational Normalcy

    Electing a Path Back to Operational Normalcy

    In deciding whether to allow elective surgeries to resume, states must balance patient needs with safety and equipment requirements.
    Michael Barbella, Managing Editor 05.20.20

  • Illusion of Choice in Orthopedics in a COVID World

    Illusion of Choice in Orthopedics in a COVID World

    The Permanente Medical Groups represent a behemoth compared to the rest of the medical groups in the U.S. Kaiser employs more than three times the number of physicians as the second largest group—Fresenius Medical Care Holdings. The Permanente…
    Maria Shepherd, President and Founder, Medi-Vantage 05.20.20

  • Winning from the Sidelines: What Can We Do Now to Mitigate Pandemic Fallout?

    Winning from the Sidelines: What Can We Do Now to Mitigate Pandemic Fallout?

    Discover a contest to determine the top 10 ideas, technologies, software systems, or other processes that will best serve orthopedic patients.
    Dawn A. Lissy, Founder & President, Empirical 05.20.20


  • Software & Quality
    The 5 Steps Toward Machine Learning

    The 5 Steps Toward Machine Learning

    Many want to use AI/ML applications, but few have the means to do so; the process is a long one, so the best approach is to just take one step at a time.
    Sue Marchant, Director of Product, Machine Learning and Artificial Intelligence, MasterControl 05.20.20

  • Biocompatibility & Testing
    Conducting Chemical Characterization/Risk Assessment for FDA Submissions

    Conducting Chemical Characterization/Risk Assessment for FDA Submissions

    Chemical characterization/risk assessment is a powerful methodology for addressing select biocompatibility endpoints.
    Robert A. Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA LLC 05.20.20

  • Design
    Design Intent Strategy Brings Clarity to Device Development

    Design Intent Strategy Brings Clarity to Device Development

    Communicating clear design intent is an important indicator for success in medical device development.
    Philip Allen, VP Sales and Marketing, Lowell Inc. 05.20.20


  • COVID Strategy for Regulatory and Quality Professionals and Their Leaders

    COVID Strategy for Regulatory and Quality Professionals and Their Leaders

    Great challenges and changes are being wrought by the SARS-CoV-2 virus and mitigation efforts to control its spread. The changes have been relatively sudden and impact every aspect of personal and professional life. While these changes seem abrupt an…
    Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 05.20.20

  • Biologics
    Made-to-Order Muscles Could Be Served in a Hospital Near You

    Made-to-Order Muscles Could Be Served in a Hospital Near You

    Dr. Ali Tamayol recently developed a handheld bioprinter pen that could significantly change the way musculoskeletal procedures are performed.
    Sam Brusco, Associate Editor 03.13.20

  • Design
    The Importance of Usability/Human Factors Testing

    The Importance of Usability/Human Factors Testing

    When is the work of human factors over, and how does your team know they are prepared for summative testing?
    Maria Shepherd, President and Founder, Medi-Vantage 03.13.20


  • Large Joint
    Particle Particulars: Why this Analysis Is Foundational for Successful Devices

    Particle Particulars: Why this Analysis Is Foundational for Successful Devices

    In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.
    Dawn A. Lissy, President & Founder, Empirical 03.13.20

  • Large Joint
    All Knee Implants Are Not Created Equally

    All Knee Implants Are Not Created Equally

    Despite knee replacement being one of the most successful orthopedic procedures, up to 20 percent of patients are dissatisfied with their implant.
    Rajit Kamal, Vice President and Global Franchise Leader, Knees, DePuy Synthes 03.13.20

  • The ABCs of Reimbursement for Breakthrough Devices

    The ABCs of Reimbursement for Breakthrough Devices

    At the cross-section of BDD status are device reimbursement strategy considerations.
    Tonya Dowd, MPH and Simran Madhani, MCRA 03.13.20


  • Design | Instruments
    A Case Study of Design Controls and Orthopedic Instruments

    A Case Study of Design Controls and Orthopedic Instruments

    Most orthopedic instruments are Class I so manufacturers aren’t required to apply formal design controls, but recently, attitudes are changing.
    Victoria Trafka, President & Principal Engineer, Engineering & Quality Solutions Inc. 03.13.20

  • Large Joint
    Joint Replacement Trends Takeaways

    Joint Replacement Trends Takeaways

    In 2019, the American Joint Replacement Registry Annual Report reported aggregate procedural growth of 28.5 percent over 2018.
    Maria Shepherd, President and Founder, Medi-Vantage 02.18.20

  • Recalibrating for 2020: Tips for a Better New Year

    Recalibrating for 2020: Tips for a Better New Year

    In 2019, I had to take a long, hard look at both my businesses and my industry to find balance and a way forward through the ripple effects of big changes.
    Dawn A. Lissy, President & Founder, Empirical 02.18.20