Coloplast is a leading global manufacturer and marketer of innovative medical devices for the management and treatment of urological conditions, including:
Coloplast partnered with Kablooe to develop a revolutionary new urological medical device that makes surgical prolapse treatment via native tissue repair simpler, safer, and more reliable.
Surgical Device Drivers
When Coloplast began working with Kablooe, the goal was to create a urological medical device that would simplify and create a safer surgical procedure for prolapse repair. The design needed to be intuitive and offer reliable control for anchor deployment.
This new surgical medical device is designed for patients who are ideal candidates for transvaginal repair, the surgical repair of a prolapsed uterus or other pelvic organ.
The result is the Saffron Fixation System, which allows surgeons to use their choice of sutures and needles during native tissue repair (attaching ligaments of the pelvic floor).
Kablooe’s Design Solutions
Kablooe was involved in nearly every stage of the urological medical device product development, from initial research to final testing.
Our team conducted competitive product analysis and ideation, including:
-Concept generation
-Formative usability research
-Preclinical cadaver studies
During the design and engineering stages, we provided detailed prototypes, mechanical designs, full CAD package creation, and manufacturing and packaging specifications. We also assisted during the transfer to production, where we were heavily involved in vendor management and communication, as well as test method validation and evaluation.
Outcomes
Coloplast’s collaboration with Kablooe resulted in a revolutionary urological medical device known today as the Saffron Fixation System. The Saffron’s intuitive, easy-to-hold curved design allows for improved navigation to the sacrospinous ligament, providing an ideal treatment option for surgical prolapse. The narrow design of the distal tip results in a cleaner entry into the dissection area, enabling more consistent and accurate anchor placement. Thanks to the increased choice and control the design affords, POP surgeons have already begun reporting high satisfaction and better patient outcomes post transvaginal repair with the Saffron Fixation System.
