SUPERA® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
IDEV Technologies, an emerging medical device company and developer of endovascular and interventional applications, developed the first transhepatic biliary wire interwoven nitinol self-expanding stent that offers unsurpassed strength, flexibility, durability, and conformability even with joint flexion.
Farm partnered with IDEV Technologies in the development of the SUPERA® delivery system. To gain a deeper understanding of technology and usability issues, Farm conducted a competitive audit of existing devices on the market. We then observed multiple procedures and conducted interviews with physicians and technicians. Each step of the process was evaluated (storage, preparation, positioning, deployment, and removal/disposal) for ergonomics and usability optimization. Our analysis of the resulting data led to key recommendations for design development as well as initial architectures focused on simplifying steps, minimizing hand repositioning, and single-hand use. Farm built three interactive device prototypes for the 2008 Vascular Interventional Advances (VIVA) Conference and conducted preference testing with ten physicians to narrow down the control scenarios and ergonomic form. Rapid iterations of 3D models through the subsequent development process helped us verify the ergonomics as well as the industrial design identity of the device. Farm was also responsible for the engineering development, including all control mechanisms and part design. Key improvements included:
- Packaging that allows flushing of the device prior to removal
- Integrated rear flush ports to reduce snagging of bed sheets and improve access
- Reduction of prep, delivery, and removal steps
- Low-profile handle features that won’t snag
- Handle form and slider design that mitigates hand and thumb repositioning
- Full single-hand use throughout the procedure
The new device not only allows for more precise stent placement, but gives physicians increased accuracy with fewer steps required for preparation and delivery.