FEATURED EDITORIAL

Decisions-GettyImages-1391263677 Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?

The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

INDUSTRY INSIGHTS

  • The Mold Is Only Half The Story

    In micro molding, automation isn’t an add-on. Learn how integrated handling, inspection, and packaging enable scalable, high-quality production.

How To Validate And Hold Tolerances When Clinical Risk Lives In The Fit

In micro medical manufacturing, prototype success doesn’t guarantee production success. Learn how tolerance strategy, tooling, and metrology ensure reliable assembly at scale.

​​Extending The Reach Of Critical Care: Remote Sensing

In emergencies, scarce data delays decisions. Remote sensing — radar, thermal, and vision — assesses patients at a distance, enabling faster triage, smarter resource use, and more informed care.

​​Advancing Drug Delivery At Home: Auto IV Cannulation

Autonomous IV therapy extends care beyond clinics, using imaging, precision control, and adaptive intelligence to improve vein access and enable safe treatment in more settings.

Design Freedom Before Steel

Micro 3D printing helps OEMs validate designs, reduce risk, and accelerate development before tooling, enabling more confident decisions and smoother transitions to production.

SOLUTIONS

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

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.

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

Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply.

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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