Guest Columns

31. Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations 10/9/2019

    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?”

32. Market Assessment: Transcatheter Aortic Valve Replacement In The U.S. and EU 10/7/2019

    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?

33. Comparing U.S. & EU Guidances On Combination Product Approval ProcessES 10/4/2019

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products.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.

34. FDA Proposes Safer Technologies Program For Medical Devices 10/2/2019

    This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.

35. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices 9/30/2019

    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.

36. RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward 9/26/2019

    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.

37. India To Enhance Oversight Of Medical Devices 9/25/2019

    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.

38. Analysis: FDA’s Draft Guidance On Premarket Combination Products Review 9/20/2019

    The 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 by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail, starting with the U.S. guidance.

39. Real-World Evidence In Clinical Research: We’re Not In Kansas Anymore 9/19/2019

    This is the first 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.

40. What Happens To ISO 13485 When Annex L Is Adopted? 9/16/2019

    Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.