FEATURED EDITORIAL

Innovative Healthcare Technology, Digital Interface, Analyzing Data-GettyImages-2285827921 Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

INDUSTRY INSIGHTS

Minimizing Particulate Risk: Designing For Control

Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.

Protecting Your Drug Product: Integrating Engineering And Quality

Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.

Establishing A Container Closure System — Engineering For Integrity

CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.

Start Packaging Development Early: De-Risk Before You Build

When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.

SOLUTIONS

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency. 

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

For applications in tissue reinforcement and wound support, biomedical textile structures made from a variety of materials can help achieve specific biomimetic and compliance requirements. 

FEATURED SUPPLIERS

The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.

MED DEVICE ONLINE CONTENT COLLECTIONS

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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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