Industry Perspectives - Design & Development
-
A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
2/3/2025
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
-
Make It A No-Brainer: Designing For Electronic Medical Device Usability
1/14/2025
When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple.
-
How To Prevent Device Misuse Through Formative Studies
12/9/2024
While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.
-
How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?
12/5/2024
FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.
-
A New Approach To ISO 14971 For Better Medical Device Risk Analysis
10/23/2024
This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.
-
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.
-
FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)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The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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.
-
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.
-
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.
-
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.