Guest Columns

1. 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?”

2. 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?

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   This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.

4. 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.

5. 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.

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 Analysis: FDA’s Draft Guidance On Premarket Combination Products Review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

   Guideline on the Quality Requirements for Drug-Device Combinations (EU) and Principles of Premarket Pathways for Combination Products (U.S.) are the latest attempts to regulate combination products. Here, we examine the two guidances in detail, beginning with the U.S. regulatory guidance.

7. 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.

8. 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.

9. Examining FDA’s New Patient Labeling Draft Guidance
   9/9/2019

   The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

10. Do Your Patient Services Align With Your Commercial Objectives?
    9/9/2019

    Support services must be designed to attract and benefit patient and provider targets. Thoughtful consideration and planning must drive patient access and uptake, and mechanisms need to be implemented to evaluate effectiveness.