Close tolerances on the Phoneris Inner Cannulae required its parts fit with an existing tracheotomy component from another manufacturer.

Patients with tracheotomies face possible complications from the inserted tracheotomy tubes. Dislodged tubes can cause respiratory problems, so nurses often tape them in place. “This common fix prompted us to look for ways to make tracheotomy tubes less stressful on patients and easy to connect and disconnect for caregivers,” says Brian Worley, CEO and founder of Lazarus Medical., Tulsa, Okla. The result is the Phoneris Inner Cannulae and Aeroflex, a two-piece device consisting of a ventilator connector and an inner cannulae. A lock on the end of the tube holds the Aeroflex in place, but easily disconnects when the apparatus needs suctioning.

Lazarus engineers turned to United Plastics Group Inc., Oak Brook, Ill (upgintl.com) for assistance with design, manufacturing, and assembly. UPG's contribution included engineering support from its Fremont, Calif. facility, and manufacturing to packaging at its ISO 9001/13485 plant in Tijuana. “They had to combine tooling design, design for manufacturability, quality and validation documentation, molding, PAD printing (2D pad to 3D surface), assembly, and final packaging for the Class II medical device,” says Lazarus VP David Seitelman.