Minimally Invasive Electrosurgical Device

Electrosurgical device company needing technically diverse CDMO partners with Meddux to help drive product development to manufacturing transfer.

Customer Need

A startup company proposed a minimally invasive electrosurgical device to change the OB-GYN surgical space by addressing new regulatory requirements and drastically shortening procedure times. Their needs included designing and developing a disposable dual-device RF instrument, complex supply chain management, timely delivery of sterile devices for First-In-Human clinical trials, and system integration with a concurrently developed electrosurgical unit. Supplementary opportunities included identification of future cost savings and ease of transfer to volume manufacturing.

Process

Solution

Design-for-Manufacturability Concept Generation led to iterative quick-turn prototyping, tooling development, and further DFM/DFA refinement coupled with Critical Parameter Management to deliver fully functional devices for V&V and clinical use. Consideration for future manufacturing scalability and semi-automation was incorporated, saving the customer money upfront and in the future.

The Meddux Quality System offered the flexibility needed for a successful partnership with the customer, including shared responsibility for design, development, and testing activities. The modular approach enabled the collaborative completion of DHF deliverables and accommodated mid-task execution changes. The Meddux team ensured a successful program by providing a tailored approach to meet individual program needs while maintaining compliance to ISO 13485, 21 CFR 820, and other applicable standards.

Value Delivered

This customer chose Meddux as their CDMO partner for their complex multi-device sterile product, including design refinement, full development and design controls, and manufacturing. This novel product fully leveraged Meddux's expertise in mechanical design, RF energy delivery, and electronics integration. This partnership allowed the customer to focus on system integration and to complete First-In-Human clinical trials, FDA De Novo regulatory submission, and plan for market entry.

We really appreciate the fantastic technical expertise and responsiveness of the Meddux team. As an early startup, this support has been so valuable in helping us drive our first product through FDA submission and early manufacturing.

— Co-Founder & CTO, Minimally Invasive Surgery Startup