Guest Columns

  1. China’s Medtech Goals

    This article presents challenges facing the Chinese medtech space and details how the country’s government currently manages these issues, as well as how it plans to do so going forward.

  2. FDA Updates Several 510(k) Guidance Documents

    The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

  3. Intro To Prefilled Syringe Selection: Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  4. Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations

    This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”

  5. Market Assessment: Transcatheter Aortic Valve Replacement In The U.S. and EU

    It’s an exciting time for TAVR, as the market has experienced exponential growth due to expanding indications of TAVR devices in recent years. So, what are this market’s long- and short-term projections, and what barriers exist to more widespread use?

  6. Comparing U.S. & EU Guidances On Combination Product Approval ProcessES

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.

  7. FDA Proposes Safer Technologies Program For Medical Devices

    This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.

  8. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  9. RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward

    This is the second article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. In this part, we will explore the challenges and opportunities RWE presents for life sciences companies, review two recent examples, and discuss how this newer way of thinking will transform the way we design and conduct clinical research or evaluate value-based decisions for the better.

  10. India To Enhance Oversight Of Medical Devices

    India's Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices, is forming a new division that works exclusively with medical devices. Here’s what we know so far.