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Challenge: When Cypris Medical first approached us, the initial design and development for their minimally invasive surgical suturing tool was almost complete. The product design had a few problem areas that needed to be resolved in order to finish the design and development and get this device ready for market. The small size made it difficult to create a reliable suture mechanism that could perform all the necessary functions. The biggest concerns our team needed to address were device jamming, inadequate tissue capture and needle compatibility.
Approach: Our team of engineers worked to improve the design and functionality of this device in a few key areas. The internal suture mechanism was redesigned to be smaller, more reliable, reproducible and cost effective. Externally, we redesigned the wand portion of the device to make it more functional. The original wand design contained a slot at its distal end to capture and hold tissue. This slot design made it difficult for a patient’s tissue to adequately fill the space prior to passing a needle through. Our design engineers reconstructed the end of the wand with a more open design so that the tool could grab onto a larger amount of tissue and have a more secure hold. This enhanced design provides a more ergonomic shape for the tissue to sit in, making it easier to use and leading to higher rates of success than with the original slot design. Our team also developed a small, custom needle to address compatibility issues and minimize trauma at the surgical site. In addition to the design and development work, we supported Cypris throughout the regulatory process by generating DHFs, assisting with quality documentation and executing a regulatory assessment. We also manufactured products for clinical builds and generated prototypes for tradeshows. Throughout our work on this project, design for manufacturability was kept top-of-mind to ensure a seamless transition to manufacturing.
Outcome: Gilero’s design and development process improved the form and function of this device, leading to the Xact surgical suturing device that is on the market today. Xact is a hand-held device used to approximate and pass suture through soft tissue.