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Alcon

Research drove a safety-focused product design strategy for the world leader in ophthalmic knives.

We've been developing medical devices to meet rigorous standards for 55 years.

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The ClearCut™ S Safety Series safety scalpel is a disposable incisional instrument used during cataract surgery. 

The patented retractable blade guard protects doctors and nurses from accidental sharps injuries and minimizes the potential spread of infectious disease. Intuitive single-handed activation enables protection with minimal change to typical workflow.
The new design skirts competitors’ broad patents and meets manufacturing requirements. 
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The Challenge: More than three million cataract surgeries are performed in the U.S. each year. And with each procedure performed with traditional scalpels, there is risk of accidental sharps injuries while passing the scalpel from assistant to surgeon. The CDC estimates “between 600,000 and 800,000 needle sticks and other percutaneous injuries occur among healthcare workers annually.” Speed and safety are paramount for the patient and medical staff. 
Generative Research: To understand the way the product is used and identify opportunities to design a safer scalpel, Delve’s team first conducted ethnographic research. This consisted of one-on-one interviews with nurses and surgeons as well as observing pre-surgery prep and more than a dozen surgeries from inside operating rooms.
This contextual inquiry and subsequent documentation of subjects’ workflow surfaced insights about safety issues that could be mitigated with design solutions. Delve’s researchers noted that surgeons’ eyes are focused on the view through a binocular microscope while rapidly using and transferring scalpels and other sharps with an assistant to perform incisions that only take a few seconds.

The surgeons need to be able to detect whether or not they’ve retracted or activated the scalpel shield without removing their eyes from the microscope. With this in mind, Delve’s designers developed features that provide clear tactile and audible feedback about the activation and state of the shielding mechanism.

Evaluative Research: After building rapid, rough prototypes for internal evaluation and client feedback, Delve's project team made three competing “works like, looks like” prototypes to take into the field — and back to the same nurses and surgeons for their evaluation. Formative testing with these realistic prototypes identified immediate risk factors, and ergonomic analysis determined risk of injuries from long-term, repetitive tool use. One-on-one interviews with these original subjects also gave designers a good idea of which key features were most valuable to merge into the final design.
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The Solution: Once the client narrowed down the field of prototypes to a preference for a single solution, the team began building more formal prototypes to aid product development. The solution includes an ambidextrous orientation to accommodate a range of grips and a prominent activation button that can be accessed singlehandedly with either the thumb or pointer finger. For ease of use, an anti-roll rib prevents the round tool from rolling into a facedown position on the prep table, and a non-slip grip helps guide it into position.

Let Delve's multidisciplinary medical device experts assist you with product innovation for Class II and Class III devices.

Sector Page: Medical Devices

Novel housing and casework skirt competitors’ overly broad patents, and, as an extension of Alcon’s reputable ClearCut™ incisional platform, Delve's integrated team of industrial designers, researchers, and engineers optimized the design for efficient manufacturing.
The design, consisting of low-cost materials and few parts, met the client’s manufacturing requirements and resulted in a successful and affordable final product. And the unique look and feel – thanks to the bi-color split housing and emphasis on tactile and audible design – gave Alcon an outstanding product and brand identification in the marketplace.
A year after its release, the product won a Silver from IDSA’s international Design Excellence Awards (IDEA) and was honored as a Notable in Core77’s Design Awards.

Learn more about&nbsp;<a href="https://www.delve.com/medical-devices" target="_blank">Delve Product Development Services for Medical Devices.</a>

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Alcon: Cataract Surgery Scalpel

Cataract Surgery Scalpel

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