Design Control
The design control process is a process designed to outline the user needs, intended uses, and specified requirements in medical device development. The US Food and Drug Administration (FDA) enforce this process to ensure that all medical devices are developed adequately and meet certain standards. The process begins with setting up design inputs that showcase both a requirement dedicated to the device along with a corresponding specification. The process of creating design inputs allows for the device to have a blueprint to follow and stay on track throughout the development of the device.
Device Requirements
- The device must detect early signs of infection
- If the device can detect infection in peritoneal dialysis users before the eye can determine a change in clarity in the dialysis solution, it can alert users to seek medical attention prior to serious infection.
- The device must be lightweight
- The device must function for a day’s use
- If the battery life of the device is any shorter than a day, it will become an inconvenience to the patient
- The device must alert the user with a visual and audible signal when signs of infection are detected
- The device must be easily attachable and detachable from the peritoneal dialysis device
- A person engaging in peritoneal dialysis exchanges may do so 4–6 times a day. The device may need to be removed during these exchanges
- The device must be able to withstand occasional fluid spills.
- The device must have a visual and audible signal to alert the user of low battery
- The device must meet IEC 60601
- To minimize the hazard from potential leakage current to the patient, the device must meet this standard.
- The device must cost less than the budget provided by the TCNJ Engineering department and must be made with readily available materials
- The device must withstand accidental drops.
