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

Components with a copper barrier and a tin finish on top provide a fully non-magnetic component to be used in medical applications where non-magnetic components are required.

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.

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.

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

To help you bring your medical products to market accurately and on schedule, Donatelle provides 24/7 assembly and packaging as part of their suite of integrated services. They have an impeccable track record of meeting project deadlines and maintain a 99%+ on-time delivery rate.

FEATURED SUPPLIERS

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

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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