Background
This project began when a physician approached Porticos with a novel concept for a disposable laryngoscope. A laryngoscope is a tool designed to facilitate visualization of the larynx.
The product in this case is designed with the therapeutic end (“blade”) incorporating a geometry that reduces the difficulty of patient intubation. A faster and easier intubation increases the pace at which doctors become proficient and generally improves surgical outcomes. Making the device disposable eliminates the possibility of cross-contamination.
Challenges
Laryngoscopes must resist high forces, in accordance with medical regulation ISO 7376. Typically, this has led to the blade material of choice being a metal of some kind. Due to the surgical nature of the device, all materials used within the laryngoscope must survive a sterilization procedure after being fully assembled.
The size and complexity requirements inspired Porticos to develop a two-piece injection-molded design and select a plastic resin to meet the stringent load testing of ISO 7376. This resin is suitable for sterilization by gamma ray, e-beam, and ethylene oxide. The solution minimizes the number of costly injection mold details and maximizes the strength of the assembly.
Laryngoscopes also require a light source to improve visibility. Porticos engineers designed the handle side of the device to house batteries and an LED, integrating battery and battery-contact retention features. A fiber optic light provides illumination along the blade, providing visibility to the intubation site.
Outcomes
Medical device development and testing is necessarily a long project. Our client, the physician, is currently evaluating the clinician and patient experience.
Once that evaluation is complete, a second set of functional prototypes will be generated. To move forward with commercialization, we would expect to prepare the device for manufacturing, according to ISO-13485 procedures to meet quality standards for a Class-2 medical device.
