Interventional Ablation Device

An energy therapeutics company partners with Meddux to design, develop, and manufacture its soft tissue ablation catheter.

Customer Need

A preclinical energy therapeutics company was developing a pulsed field ablation platform technology for soft tissue ablation treatments. They needed a strategic partner for the ground-up development of an endoscopic ablation catheter that would integrate into existing clinical workflows. Their requirements included user-centered design, product development, a streamlined regulatory pathway to First-in-Human (FIH) clinical trials, and custom manufacturing process development. The customer also required Meddux to establish a parallel path to commercial launch, ensuring a smooth transition from clinical-scale to full commercial manufacturing.

Process

Solution

Meddux's close collaboration with clinical experts focused on enhancing product usability and mitigating potential use error, while simultaneously achieving the demanding technical performance requirements for electrical insulation, catheter flexibility, trackability, pushability, and fluid sealing. An innovative product development strategy enabled short-run manufacturing for an expedited path to clinical trial, followed by a production-intent design and streamlined supply chain for commercial manufacturing.

A key priority for commercial launch was establishing robust production controls from raw material qualification through component validation to critical unit operation process controls and comprehensive test method validations.

The successful deployment of Meddux's Critical Parameter Management process proved instrumental in linking critical functional requirements to downstream critical-to-quality attributes, which are monitored under control plans and statistical process control. By establishing these manufacturing controls early in the development cycle, Meddux created a scalable foundation that minimized technical risk and accelerated the transition from clinical trial to market launch.

Value Delivered

The full breadth of the Meddux offering was leveraged successfully throughout this project. Our vision is to improve patients' lives by accelerating the development and commercialization of innovative medical device technologies and therapies. We serve as an engine for our customers' success from concept through commercialization, providing integrated expertise at every stage of the product lifecycle. Together, we achieved their objective of transforming an idea on the whiteboard into a new therapy on the market that is actively improving care for patients.

Meddux is one of (if not the best) contract manufacturer that I've worked with. The team is proactive, responsive, innovative and wonderful to work with! Every employee is knowledgeable and always willing to help us solve any problems we may encounter!

— Director of Supply Chain, Interventional Startup