Newsletter | January 4, 2024

01.04.24 -- How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products

FEATURED EDITORIAL

How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products

This article shares pro tips related to usability studies, design controls, and other human factors engineering best practices to make the FDA happy with your combination product.

Human Factors Considerations For Your Emergency-Use Drug Delivery Device

Emergency-use medical devices have seen the autoinjector EpiPen leading the way, followed by the emergence of naloxone nasal sprays and autoinjectors for the treatment of opioid overdose, and others. There are use-related challenges in emergency situations, so you will need to give careful consideration to the human factors involved regarding who is using the device and how it is accessed.

INDUSTRY INSIGHTS

Using Liquid Injection Molding (LIM) For Medical Device Manufacturing

Within the world of medical device manufacturing, liquid injection molding (LIM) is a process that provides several benefits over other methods, including product strength and reduced weight, all while being more cost effective than some other alternatives and still producing an end product within the set parameters of the device and regulatory bodies.

Precision Molding: Getting It Right The First Time

Precision injection molding ensures that, regardless of the annual production volumes, the process can be consistently repeatable. Learn the critical steps that need to be considered for success with an injection molding project in order to get the process right the first time.

Evaluating Relevance Of Seal Quality Inspection

Seal quality and seal strength of sterile medical device packaging are extremely crucial as well as highly regulated. This medical device package seal contains a flexible barrier joined to the rigid container through an advanced adhesive.

ARTICLES YOU MAY HAVE MISSED

Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices

Understanding The FDA's New Medical Device Cybersecurity Guidelines

Growth Strategies Pushing The Next Wave Of Surgical Robotics

Measurement System Analysis Using Continuous Gage R&R Studies, Part 1

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2

RESOURCES

Sustainable Manufacturing: A Guide To Transformation

A Short Visual Guide To RFID Technology

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