RFA Device for ENT Applications

A startup company contracted Meddux to accelerate an innovative radiofrequency ablation (RFA) therapy from concept to clinical trial — compressing roughly six months of development and manufacturing work into under three months.

Customer Need

The customer sought to develop a novel minimally invasive therapy that would allow Ear, Nose, and Throat (ENT) physicians to treat a common nasal condition in an office setting, reducing costs and complications associated with aggressive surgical alternatives.

As a university tech transfer spin-out facing resource constraints and an aggressive investment milestone, the customer needed a turnkey product development partner with relevant experience to efficiently design and manufacture their device for a clinical trial. Meddux was tasked with completing verification and validation builds and a sterile lot release for a First-in-Human trial.

Process

Meddux engaged across three phases of its development model: user-centered design, product development, and contract manufacturing.

Solution

Working closely with the customer, Meddux maintained a vigilant clinical focus, innovating a deployable micro-electrode configuration tailored to the target anatomy. Meddux implemented a composite array structure to achieve critical electromechanical performance requirements while minimizing the device profile. A shapeable shaft and dual-grip handpiece were engineered to allow ENT physicians to personalize patient care.

Quality system and DHF deliverables

Meddux utilized our compliant yet flexible Quality System to generate device DHF deliverables for the handheld device so the customer could maintain responsibility for system-level Risk Management. Meddux staff leveraged decades of experience in energy-delivery devices and relationships with component suppliers to streamline a path to First-in-Human trial and meet the customer's pivotal milestone.

Ramp-up to clinical manufacturing

In the ramp-up toward clinical manufacturing, Meddux developed assembly fixturing that reduced device manufacturing cycle time from days to hours while improving the dimensional stability of the micro-electrode array. Meddux implemented critical manufacturing in-process inspections and end-of-line tests to ensure safety and functionality of the product delivered for clinical trial.

Value Delivered

The customer entrusted the development of the handheld ENT device to Meddux so they could focus on system-level integration and pre-clinical testing. Meddux staffed a passionate team with the right experience and drive to deliver the quality and speed the customer needed to be in a position to execute a successful clinical study.

Meddux is a responsive team with high technical acumen and product development capabilities. They are fast, focused and stay close to be agile and adapt quickly to changing conditions.

— Co-Founder and CTO, ENT Device Startup