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issue: December 2006 APPLIANCE Magazine

Medical Appliances
On the Nose


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by Erin Biesen, Associate Editor

Medtronic and Metaphase redesigned the Straightshot surgical handpiece and ended up with an ergonomic award-winner.

Medtronic and Metaphase worked together to create a design for the Straightshot M4 when new technology needed to be incorporated into the surgical tool.

Medtronic, Inc. (Minneapolis, Minnesota, U.S.) had been producing the Straightshot®, a powered handpiece for sinus, nasal and laryngeal surgery, for about 15 years when it felt the time was right for a redesign.
Medtronic approached St. Louis, Missouri, U.S.-based Metaphase Design Group for help with the challenge of redesigning the product to exploit changes in technology and make it easier to use.
“We had identified a clinical need to be able to cut laterally with our debrieder tool, and up until this point the surgeon had to rotate the wrist back and forth to do so,” says Craig Drager, vice president of research and development for Medtronic ENT and Neurological Technologies. “We had developed a blade technology that allowed us to rotate the mouth of the cutter, but we didn’t have a handpiece nor did we have the design ergonomics to implement it.”
Over a period of 10 years Medtronic and Metaphase had worked together on a variety of projects. Drager knew Metaphase specializes in the kinematics of the hand and foot and felt it was the company to handle the design task.
Metaphase started off with research, performing time-motion studies and, with the help of two of the world’s leading rhinoplasty experts, studied how the existing design of the Straightshot performed.
The design company used the results of its investigation to develop three initial conceptual designs, then had its in-house team of experts conduct an ergonomic analysis on the handpieces to help accommodate for variations in hand sizes and strengths and determine what the best grip would be.
 “We noticed that with every design there was rotation, with the surgeon rotating the handpiece to work it higher up into the sinuses,” Bryce Rutter, Ph.D., founder and CEO of Metaphase tells APPLIANCE. “We identified the need for fingertip control of the cutting window on the blade tip—if the surgeon could manipulate or rotate the cutting window at the very tip of the surgical tool, then they wouldn’t have to rotate the entire tool nearly as much.” This would reduce the amount of stress on the surgeon’s arm during a procedure.
Over the course of 9 months, the companies worked together to refine the design. “We developed 3D models of these concepts and put them in the hands of surgeons.  Their feedback helped us identify which of the three designs made the most sense to continue working on,” explains Rutter. “We created designs in 3D using rapid prototyping. All the while we were working in parallel with Medtronic’s engineers who were developing the mechanical engineering and electronics.”
Medtronic has a cadaver lab and it was used extensively throughout the design process. “We would bring surgeons through on a weekly basis to have them use prototypes,” says Drager. “We would iterate a design about every 2 weeks, augmenting sizes, shapes, weights, until we got down to the final design.” More than 30 surgeons eventually evaluated various prototypes at different stages in the development.
Teamwork is what led to the success of this project. “We installed a CAD system at Metaphase so that we are both running the same CAD in order to send files back and forth electronically,” Drager notes. “We had weekly if not daily calls during the peak of the development efforts.”
While teamwork was not a challenge, redefining the feel of the instrument in the surgeons’ hands was an issue. Previous instruments had a pull from the back end due to the weight of the cabling and the location of the instrument’s center of gravity. Metaphase solved this problem by making the device front-end loading and getting rid of the pull from the utility cables at the back of the tool. This was accomplished by first shrinking the design to about 2.5 inches shorter than the old design, which makes the point of attachment closer to the hand and doesn’t create a pull far back beyond the hand. Also, Metaphase worked to bring the center of mass towards the center of the hand by working with Medtronic engineers, tightening up the mechanical package.
The M4 from Medtronic has proved to be a success. According to Metaphase, after the product was launched Medtronic reported that sales increased 243 percent within in the first 60 days. The M4 also won the 2006 Medical Device Excellence Award (MDEA) Silver Award for excellence in medical device design.

 

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