Industry Perspectives - Design & Development

1. Ensuring Privacy & Security In Smart Medical Devices 9/10/2024

   Smart medical devices and at-home care have gathered significant momentum. This article explores how medtech companies can build privacy, security, and ethics by design within medical devices.

2. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

   The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

3. Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection 8/7/2024

   This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

4. Does My Medical Device Design Actually Work? 8/6/2024

   In medical device development, the proof of feasibility stage often includes preliminary testing, but also detailed technical, usability, manufacturability, regulatory, and commercial assessments.

5. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

   The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

6. Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation 7/23/2024

   In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

7. Answer These Questions To Guide Your Prototyping Strategy 7/18/2024

   This article shares key questions for your team to ask yourselves about demonstrating proof-of-concept with a functional prototype of your medical device.

8. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

   All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

9. System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks 6/26/2024

   Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.

10. Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm 6/6/2024

    The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.