i:X Handheld Optical Imaging Device
Thousands of people die every year because of infected wounds. A quick diagnosis is critical for prescribing treatment, yet the process currently available for accurately diagnosing a bacterial infection can take several days.
MolecuLight, an early-stage medical imaging company based in Canada, has developed a handheld fluorescence imaging technology platform called i:X. This breakthrough device reveals the presence of bacterial infection in real time.
i:X is brilliantly simple. The clinician aims the device at the wound and presses a button, causing the device to emit a particular wavelength of light while simultaneously capturing an image of the target area. i:X detects and analyzes the intrinsic fluorescence signals emitted by tissues and microbes when illuminated by this light. The presence of bacteria is immediately displayed on the device as a color difference on the wound.
MolecuLight came to Farm with a proof-of-concept prototype and asked us to help their team design and engineer a patient-ready diagnostic device and prepare it for full-scale production.
Farm’s primary challenges were to develop an industrial design for the system, package MolecuLight’s technology in the appropriate configuration, engineer a mechanism to deploy a proprietary optical filter, and incorporate user-interaction features that would make the product easy to operate.
Throughout the project, our team worked closely with MolecuLight’s development team, as well as their contract manufacturer, injection molder, and various suppliers, to ensure a smooth production ramp-up. In late 2015, MolecuLight received its Medical Device License from Health Canada, and in September 2016, MolecuLight was granted CE Mark approval, which enables the commercial distribution of this technology in the European Union. The news has been eagerly received by EU clinicians, with the product being debuted at the World Union of Healing Societies World Congress being held in Italy. In the United States, an FDA de novo approval is pending. On May 18, 2017, MolecuLight announced the execution of an exclusive global distribution agreement with Smith & Nephew to distribute the MolecuLight i:XTM Imaging Device product line.
“Our goal for the MolecuLight i:X was to develop a world-class medical device, and Farm was a key player in achieving this goal. Not only is the MolecuLight i:X great looking; it is intuitive and easy to use.”
— Craig Kennedy, CEO of MolecuLight