Guest Columns

  1. You Have A Medical Device Proof Of Concept. Now What? 10/5/2022

    No matter what the medical device in development, the first major milestone is usually proof of concept. How do you go from a build-of-one device to something you can manufacture reliably and at scale? This article shares key considerations in engineering and design, quality systems, and more.

  2. Developing Novel RF Ablation Systems: Challenges and Opportunities in a Mature Market 10/4/2022

    From the perspective of the medical device development community, widespread adoption of RFA has led to a maturing of the market and created challenges for new entrants or to incumbent firms wishing to improve on their existing designs.

  3. Human Factors Methodology In Medical Device Design For FDA Approval 10/3/2022

    Human factors engineering processes are a critical component that should be considered throughout the full medical device development continuum rather than as a final requirement to check off at the end. This article shares tips for methodologies to enable FDA approval of your device.

  4. Life Sciences RIM: Modernization & Moving Ahead 9/28/2022

    Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

  5. Surgical Robotics & Navigation Sees Explosive Growth In Which Region? 9/26/2022

    These authors recently wrote about U.S. market trends in surgical robotics and navigation. Here, they discuss the region of the world where these devices are seeing explosive growth and why. They also provide a regional comparison.

  6. 3 Steps For A Smarter Medtech Supply Chain 9/21/2022

    Our medtech industry has a huge opportunity to make our supply chains “smarter" by making the most of digital technologies and data. But we need to work in an agile manner to adopt and scale technology. This article shares three main steps to take.

  7. Identifying The Early Adopters Of Your Medtech 9/19/2022

    Every medtech company aims to build a successful product and have a seamless launch. But for this to happen, you must first identify early adopters of your new product and engage with them before product launch.

  8. Lab-On-Chip Devices: Materials Considerations 9/15/2022

    Material selection and testing can often be one of the critical challenges to developing microfluidic devices for the healthcare and life sciences markets. This article shares recommendations related to determining which physical properties are needed, potentially suitable materials, processing techniques, and analytical techniques.

  9. Biomarker Testing: A Key Component To Advancing Precision Medicine 9/13/2022

    Biomarker testing isn’t always the standard of care for many people living with cancer today. Providers and patients need to be better educated about biomarker testing, we need a consistent standard of care across oncology institutions, and we need to advocate for equitable access to biomarker testing.

  10. Genetic Testing For Prostate Cancer Tackles The Black Demographic Disparity 9/9/2022

    Inherited factors account for 57% of the risk for developing prostate cancer. Advances in genomic research have an opportunity to improve the health and survival of all men, but the focus of progress has been on people of European ancestry and has excluded Black men, who have a substantially higher incidence of prostate cancer. Genetic testing will help lessen this demographic disparity.