Newsletter | January 30, 2024

01.30.24 -- Secure By Design And Default: Compliant Medical Device Development


Secure By Design And Default: Compliant Medical Device Development

The Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI, and international partners issued recommendations for tech manufacturers to ensure product security and, thereby, assist medical device designers and manufacturers in meeting the quality system cybersecurity considerations mandated by the FDA. 

Driving Forces In The Laparoscopic Device Global Market

Laparoscopic surgery is a type of minimally invasive surgery that enables surgical procedures to be performed through small incisions, aided by cameras and specialized instruments. This article delves into the drivers fueling the growth of the laparoscopic device market, including the increasing use of direct energy devices and the role played by ultrasonic devices.


Medical Imaging Quality Starts By Selecting The Right Components

MRI machines use a strong magnetic field and computer-generated radio waves to produce its images. Thus, the quality of the MRI depends on field uniformity and the radio components inside.

Soft Or Semi-Hard Tooling For Micromolding?

Do soft/semi-hard tooling and CNC-machined cavities work for micro molding? Achieving small tolerances, sharp corners, and micro features remains challenging for both micro and larger parts.

High-Volume Manufacturing: Points To Consider Before You Scale Up

To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.

Engineering Advances In Needle Geometry To Accommodate Viscous Biologics

Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.

High-Volume Manufacture Of Thin-Wall Medical Device Components With LCP

The advantages of liquid crystal polymer (LCP) thermoplastics are translatable to precision combination drug delivery devices, which incorporate complex mechanisms and wireless connected electronics.

Building Sustainability Into Medical Devices

Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors such as performance, safety, and regulatory compliance.

Overcoming Challenges For Minimally Invasive Cardiovascular Devices

Learn how leveraging a partner with expertise developing and manufacturing a medical-grade fine UHMWPE fiber can accelerate time-to-market for your minimally invasive medical device.


The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA

How To Operate In The AI Compliance Vacuum

Key Regulatory-Fueled Updates On Combination Products As We Enter 2024

Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices

The Secret To Medical Device Development Success: A Mindset For Continuous Learning


Medical Device And OEM Consumables

Powering the trusted identities of the world's people, places, and things with embeddable and custom-designed RFID smart components.


DFM Enables Repeatable Micro Features In Cardiovascular Device Prototyping

Manufacturing Transfer Requires Cross-Functional Leadership, Resources, And Open Communication

The Intersection Of Material Science And Medical Device Design

ComfortCoat Single Layer Coating For Vascular Interventions

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