Guest Columns

  1. U.S. Bone Repair Devices: Trochanteric Grip Market Stalls, Cerclage Cables Take Off

    Approximately 75,000 procedures were completed in 2018 using cerclage cables and trochanteric grips, devices used in the repair of broken or surgically altered bones. This procedure volume is increasing every year.

  2. Standard Of Care And The Internet Of Medical Things

    During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).

  3. 4 Important Things To Consider Before Developing A Drug Delivery Device

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.

  4. LATAM Medtech Leaders Podcast Summary Series: Part 1

    This article is the first in a series drawing on highlights from the LATAM Medtech Leaders podcast, with guests imparting advice on topics like commercialization strategy in Latin American markets, pricing, and more.

  5. Understanding Medical Diagnostic Method Patent Eligibility

    Until this area of unsettled law is more fully developed, it will be important to include practical implication details in medical diagnostic patents to maximize the flexibility to claim inventions in multiple ways.

  6. How To Prepare For An FDA Inspection

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.

  7. IVDs And LDTs: Evolving Visions Of FDA Oversight Under The VALID Act

    The Verifying Accurate, Leading edge IVCT Development (VALID) Act represents the latest development in LDT regulation. This article examines how clinical tests have been regulated, as well as an overview of the proposed VALID Act, and where the potential legislation stands.

  8. 3 Surefire Approaches To SOP Harmonization

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  9. The Human Component Of Clinical Trial Technology Implementations

    As part of our ongoing series about best-in-class approaches for rapidly assessing, prototyping, and introducing digital and other clinical trial technologies, we focus our attention in this article on the “human” component of technology-enabled transformation.

  10. Will We Have Harmonized Standards By The MDR’s Date Of Application?

    The EU Commission has requested that EU Standardization Organizations draft revisions to their existing standards, adapt some international standards, and issue new standards in support of the MDR and IVDR before May 26, 2020. Which standards could meet the deadline, and where are there likely to be issues?