Anzen Safety Scalpel – A Cut Above the Rest?September 15, 2019
Throughout the design and development of the Anzen Safety Scalpel, we’ve learned how important it is to seek out and act on our users’ feedback. As such, the design team conducted user validation studies in 2 phases – alpha testing and beta testing. Surgeons’ and surgical technologists’ feedback on our Anzen Safety Scalpel in the alpha testing allow the Anzen design team to improve upon the initial design of the Anzen Safety Scalpel, and implement improvements before carrying out beta testing – the second phase of our user validation process.
Voice of the Customer – Surgeons Need Sharp Scalpels
During alpha testing, surgeons and surgical technologists scored the Anzen Safety Scalpel positively overall, however, surgeons expressed concerns about the sharpness of the blades.
Blade sharpness is important to surgeons for a number of reasons. A dull blade causes the surgeon to press harder to make the cut, increasing their risk for injury. A sharp blade ensures a clean incision, limiting the number of injured cells and ensuring the incision heals cleanly.
Sourcing New Blades
With the surgeons’ concerns in mind, Anzen product engineers and designers sourced new surgical blade suppliers. Two new blade suppliers were selected and assessed. To prevent any bias, the research team developed a blind study protocol to allow surgeons to compare the blades with the leading blade manufacturer in the market.
Blade Blind Study
The blind study was designed to test these blades against the original Anzen blades, the blades the surgeons were currently using, as well as the leading blade manufacturer in the market. During the study, surgeons did not know which supplier blade they were using. Afterwards, the surgeons ranked the blades on a scale from one to five, one being the dullest and five the sharpest.
The blind study was conducted from December 2017 through August 2018. Thirty-seven surgeons at fifteen different facilities participated in the blade sharpness testing. Surgeons performed simulated use testing with #10, #11, and #15 size blades.
Blind Study Results
After the testing was complete, the surgeons’ ratings of blade sharpness were analyzed. Blades from new supplier #2 scored the highest for the #10 size blades. The current Anzen blade scored highest for #11 size blades, and new supplier #2 scored second highest for the #15 size blades.
Supplier #2 was selected to supply the #10 and #15 blades, and the current Anzen blade supplier was selected for the #11 size blade. Although the blades from supplier #2 scored slightly lower than the leading blade manufacturer for blade #15, they were selected because they scored higher on average when compared to the facility’s blade.
Ready for Beta Testing
Redesigned to address surgeons’ needs with sharper blades, the Anzen Safety Scalpel has similar weight, balance and feel of a regular scalpel. The moving blade design is easy to use and intuitive, like a box cutter.
The Anzen Safety Scalpel is now ready to move forward into the next stage of design validation – beta testing. During beta testing, the refinements made to the design during alpha testing will be validated and we will acquire feedback on our final production units before market introduction.
Click here to read more about the first part in our design validation process: Alpha Testing.
Click here to read more about the second part in our design validation process: Beta Testing.