ISO 13485: What Early-Stage Medical Device Companies Need to Know
For early-stage medical device companies, quality management systems (QMS) often feel like a “later-stage problem.” In reality, they are a prerequisite for regulatory approval and commercialization. Manufacturing timelines largely determine how quickly patients can access life-saving devices. So, regardless of production goals, budget, or program scope, early concept and design teams must account for International […]
Automating Pre-Analytical Sample Preparation to Clinical Scale
From Concept to FDA Breakthrough A precision diagnostics client sought to dramatically reduce the time required to identify effective antibiotics for critically ill patients — without sacrificing accuracy or throughput. Ascential delivered a three-instrument automated system that achieved FDA Breakthrough Device Designation. Faster reagent dispensing across the full testing workflow 0 x Increase in throughput, […]
Standard Catheter Steps Ripe for Automation eBook
ROI Realities in Catheter Manufacturing
When catheter manufacturers evaluate process improvements, the conversation typically starts with a simple question: “How much can we save on labor?” But the reality is that labor-only justification rarely drives meaningful returns with high-risk medical device manufacturing. The true ROI comes from addressing bottlenecks in quality, yield, and throughput, as well as the hidden costs […]
How to Win PFA Market Share: Explore Strategic Manufacturing Automations
When developing Pulsed Field Ablation (PFA) devices or other innovative medical technologies, the choice between off-the-shelf (OTS) equipment and custom automation can make or break your manufacturing process. Here’s what you need to know to stay ahead of the competition. The PFA Market Opportunity — and the Manufacturing Bottleneck Atrial fibrillation (AFib) affects millions of patients, […]
Contract Manufacturing for Medical Devices: 5 Critical Questions to Ask Before You Scale
Scaling a medical device from prototype to full production isn’t just about volume. It’s about precision, compliance, speed, and reliability. Whether you’re a startup moving toward deployment or an established OEM preparing to launch globally, the contract manufacturing partner you choose can either streamline your path to market or introduce risk at every stage. In […]
Transferring a Legacy Line with Confidence
Product Overview: LaunchPad Instrument Controller
Delivering a Faster Path to Market
Delivering a faster path to market: Staying ahead of the competition in 2025
