We apologize for the delayed update. This delay occurred because additional time is required to analyze the production issues from the previous pilot run. We could not initiate mass production immediately after the pilot run because the following issues caused the yield rate of the pilot run to be less than 50%:
For the past 3 weeks, we have eliminated several production quality issues such as battery power drainage and unsteady pressure performance. During the pilot run and subsequent mass production stages, each iPen unit must be evaluated based on a list of performance check points. If an iPen fails to pass certain check points, it is deemed a defective unit and then inspected for possible causes.
Several production issues cannot be foreseen until we are in the production phase, primarily because most of the assembly process requires trained operators and the application of specific SOPs. Due to the small scale of our initial production, we do not have the resources to utilize the automatic robotic assembly process. Therefore, we must streamline the SOP and train the operators to use assistive fixtures to increase the production yield rate. We are doing our best to ensure that the production quality meets our standards. In order to begin mass production, we require two additional customized fixtures on the assembly line, and the estimated completion date is October 7.
We are currently working closely with our manufacturing partner to resolve all of these production issues. Additional information from the factory side is required to finalize the mass production date. We will issue another update next week as soon as we gather all of the necessary information.