FEATURED EDITORIAL

GettyImages-1225215886 Beyond Australia: Why Medtech Startups Are Re-Evaluating FIH Trial Destinations

The advice handed to medtech companies planning a first-in-human (FIH) study has been: go to Australia. That advice is now overdue for a rewrite. Not because Australia stopped working, but because the math changed.

INDUSTRY INSIGHTS

  • The PMCF Decision Guide

    Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.

Accelerating Enrollment For Direct-To-Patient Observational Studies

Removing the handoff between patient self-screening and enrollment changes what a fully virtual observational study can achieve, from conversion at peak intent to completion rates among participants.

Getting Ahead Of PFAS Risk In Pharmaceutical Manufacturing

Pharma can’t simply eliminate essential PFAS uses. A phased, risk-based strategy can address footprint, exposure, and supply risks amid regulatory uncertainty.

PFAS In Medical Devices: What's New And What To Do

Regulators now separate fluoropolymers from other PFAS, but lifecycle risks remain. Readiness starts with knowing which uses, reporting duties, and exposures matter most.

A Risk Management Approach For The Pharmaceutical Industry

Replacing fluorinated chemistries across pharma isn’t simple. Growing pressures make it critical to prioritize risks and take a sequenced, evidence-based approach to mitigation.

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.

B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

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.

Comprehensive analytical and device testing services are available for injectable drugs, ensuring optimal primary packaging, compliance, and reliability throughout the product development lifecycle.

The Melles Griot XPLAN Lens Series fluorescence microscope imaging systems enable the rapid development of breadboard instruments for next-gen sequencing, proteomics, and spatial biology applications.

The High Resolution 2048R SWIR camera with capture rates of 10,000 to 147,000 lines per second for Spectral-Domain Optical Coherence Tomography.

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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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