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Identafi Oral Cancer Screening System

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The Story

Bringing a life-saving cancer screening technology to market in record time

Oral Cancer is a silent killer with a five-year mortality rate higher than both cervical and prostate cancers. With early detection the cure rate approaches 90%, but symptoms can easily be missed by the naked eye. A scientist discovered that controlled wavelengths of light can allow a dentist to identify abnormal tissue through fluorescence and highlight vasculature through reflectance. Three wavelengths of light are necessary to perform a full exam, and the dentist must be able to easily cycle through them. M3’s challenge was to create the platform and delivery system with this technology and be on the market within 9 months.

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identifi system components
Our Solution

A workflow-driven ecosystem to ease product adoption

  1. The design is based on a form factor that users are already comfortable with – a dental exam mirror. By packaging two LEDs that generate three wavelengths of light, the Identafi is able to screen for oral cancer with superior accuracy.
  2. Through a series of field research activities, the M3 team quickly learned that new devices often get “lost in a drawer” and that counter space in most dental offices are a premium. The M3 team created a docking system that served as a “home” for the Identafi device, disposable mirrors, and glasses that are used during examination. This kept the device top-of-mind and all of the associated accessories tidy in one place.
  3. The product packaging design provided users with an out-of-box experience that presented the device, disposables, optics, docking system, and associated literature in an informative and thoughtful way.
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The Details

Every Touchpoint Considered

Light selection is controlled by a patented selector ring on the body of the wand allowing for ambidextrous actuation. This enables the user to focus on a specific area without removing the Identafi from the oral cavity to switch between wavelengths of lights. A clear disposable mirror attachment allows dentists and hygienists to view hard to reach areas in any light mode. This feature also reduces the complexity of the user work-flow by eliminating the need to autoclave the device while also providing a recurring revenue stream.

patented control switch

Touchpoint Distinction

identafi disposable

Disposable Sleeve

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Healthy Tissue vs. Suspicious Tissue

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Healthy Tissue vs. Suspicious Tissue

Healthy Tissue vs. Suspicious Tissue

The Technology

Early Detection

White Light - Helps illuminate the mouth and locate potential trouble spots. Ultraviolet Light - Enhances normal tissue's natural fluorescence, while suspicious tissue appears dark due to a loss of fluorescence. Green-Amber Light - Enhances normal tissue's reflectance properties so the clinician may directly observe vascular concentration.

Prototype, Iterate, Perfect

Extensive prototyping was performed to validate critical product design decisions, including optical transmission , thermal management , and ergonomics and human factors.

identafi mockup

Where Form Meets Function

Different materials and grip features were tested to ensure maximum usability of the light selector ring while achieving the desired form and balance.

electronics testing

Power Management

Power management and optical solutions were explored and evaluated in the M3 lab.

thermal testing

Thermal Management

The enclosure was designed to dissipate heat from the LED’s and had a back-up heat sensor to ensure patient and clinician safety.

The Results

Staying ahead of the threat of oral cancer

  1. From blank piece of paper to manufacturing hand-off within 6 months.
  2. The Identafi is the only standalone intra-oral soft tissue screener on the market today that eliminates the need for unpleasant dye rinses.
  3. The combination of size, technology and usability helps dentists and hygienists improve early cancer detection. With regular screenings, this device will help save lives.
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