To allow more convenient delivery of opiate pain killers without compromising patient safety, IDC developed an ergonomic, tamper resistant device with a smart electro-mechanical lockout for dose control.
With challenges in reliability, safety, size and cost (as it is disposable), IDC developed from scratch a unique, patented solution for the lockout mechanism, electronics, firmware and ergonomic plastic covers. Due to the potential risk to the patient, risk analysis on the design and manufacturing process was performed and managed by IDC, working closely with regulatory representatives to ensure approvals for clinical trial studies. IDC also ensured that the designs were manufacturable by closely working with the plastic moulders, PCB manufacturer, electro-mechanical actuator suppliers, drug bottle suppliers and assembly sites (Clean Room).
The team devised assembly procedures, drafted test protocols for each critical manufacturing stage, and employed Six-Sigma techniques to achieve a low percentage in-process reject rates. The end result was a design that provided strong IP assets to Sosei and a quality solution delivering a high throughput of several thousand units per month.