Newsletter | October 14, 2025

10.14.25 -- Bypass The Barrier With A Pre-MDR Proving Ground In Serbia

SPONSOR

Partnering with Polyzen gives device innovators access to polymer expertise in designing compliant low-pressure balloons for vascular applications. We guide material selection, and manufacturing methods such as extrusion to ensure precise performance, durability, and biocompatibility. These balloons support catheter-based procedures, including fixation to secure catheter position, occlusion to block blood flow, and cardioplegia to facilitate temporary heart arrest during surgery. With Polyzen, companies are innovating solutions for advanced vascular medical devices and delivery systems. More.

FROM THE EDITOR

Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device

The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

INDUSTRY INSIGHTS

Testing To A Trillion And Beyond: Developing Our 17,000+ Hour Pump

Explore how LT Series Disc Pumps achieve over 1 trillion cycles and 17,000 hours through precision design, automated life testing, and continuous performance validation.

Increasing Delivery System Flexibility Through Solvent-Based Processing

Learn how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug-eluting carrier with a wide variety of APIs.

Broadening User Requirements When Selecting Valves For Medical Devices

Selecting the optimal valves for medical devices requires balancing specifications with critical non-technical factors. This includes material compatibility and required shelf life.

SPONSOR

Join 1,000+ pharma, biotech, and drug delivery professionals at the PODD: Partnership Opportunities in Drug Delivery Conference conference, October 27–28 in Boston. Featuring 10 technology tracks, pharma company spotlights, 1:1 partnering, and more. Attendees will also hear from leaders at companies including AbbVie, Amgen, AstraZeneca, Biogen, Eli Lilly, GSK, Moderna, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and others. Register at PODDConference.com with code LSL20 for 20% off.

RESOURCES

Tubing Cutting How-To-Guide

DSM Supercapacitor Modules Now Available In 60V

ARTICLES YOU MAY HAVE MISSED

EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances

The Companion Diagnostic Strategy That Combination Product Leaders Need

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms

RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It?

Considerations For Rapid Prototyping In Medical Device Development

BULLETIN BOARD

Validation - What's Your Level?

Leverage three levels of validation to quickly determine necessary requirements. This framework saves your team valuable development time, allowing them to focus entirely on innovative product design.

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