Gyne Ideas (now Mpathy Medical)

Gyne Ideas is a start-up medical device company, established in 2001. It has developed a concept for an innovative sub-urethral support tape for the cure of female urinary stress incontinence.

The Challenge

To develop the class II implant from concept sketch through to pilot manufacture in line with the required regulatory standards.

Approach

eg technology worked alongside Gyne Ideas throughout development and pilot manufacture providing development resource and commercial support. We were responsible for: conceptual design; detailed design and development of the device, identification of a manufacturing scale up route and subcontract manufacturers; establishment of vendor QA arrangements to allow the product to be CE marked along with the management of the pilot production batch.

The Result

A fully 510(k) approved, CE-marked class II implant now undergoing clinical evaluation in patients.