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Engineering a custom test method to accelerate a medtech product through clinical trials.
Sanner designed and developed the CapnoVue M1 for Monitor Mask, an oxygen delivery mask with integrated CO2 sampling ports. To prove the device, Sanner built a custom breathing simulator that the FDA accepted in place of human clinical testing across multiple 510(k) submissions.
Frustrated with current capnography techniques, anesthesiologist JW Beard, MD knew there had to be a better way to monitor CO2 output while oxygenating a patient. He approached Sanner with the idea to design an oxygen mask with a port to monitor CO2.
The initial mask we designed was exactly what the customer asked for: an oxygen mask with PVC Luers molded into it. Before settling on a mask made up of one large molded PVC piece, Sanner engineers brainstormed other solutions and decided to try adding a Luer to a standard O2 mask. Our engineers prototyped a mask that looked and functioned like a standard O2 mask with the addition of two ports on either side. This idea evolved into the final multipiece design with two twist lock Luers bonded into an oxygen mask that could be hooked up to monitors for capnography. Luers on both sides of the mask provided two points of access so that monitor tubing could be connected on whichever side was more comfortable for the patient.
The harder problem was proving the device worked. To demonstrate efficacy, Sanner built a breathing simulator that replicated human CO2 expiration, producing a controlled, repeatable CO2 profile to test against. The simulator was built specifically for this client and this device. It proved that the mask’s ability to measure CO2 and deliver O2 was equivalent to methods already on the market while being easier to use, and the FDA determined it was a more accurate measure than human clinical testing would have been. That determination allowed us to skip clinical testing entirely across multiple 510(k) submissions covering adult, pediatric, and infant patients. Sanner also executed ISO 594-2 Luer testing, force testing, clip retention testing, accelerated aging, and real time aging.
The CapnoVue M1, a capnography face mask that incorporates CO2 sampling ports into an oxygen delivery mask and can be used on adult, pediatric and infant patients. Dr. Beard’s company, Monitor Mask, was ultimately acquired by Salter Labs.
End-to-end development, manufacturing build and packaging design for an innovative deep lung breath sample collection device.
Developing a new device to improve surgical access without sacrificing sensing accuracy.
