Reliability for medical device product development companies
As a Bay Area medical device design and product development company we understand the importance of reliability. Reliability is integral to our early stage approach to new product development and is one of many Smart Requirements.
In other words, reliability assumes that preliminary thought processes have been completed and the device and its elements are completely defined. If so, the designer’s task is easier and less costly in time and effort, with failure-free or failure-tolerant design principles used. In addition, it predisposes designed manufactured processes that will not reduce the reliability of the device.
We realize that poor reliability is costly, leading to poor client relations and causing the subsequent loss of market share.
Definition of Reliability
The probability at an expected level of confidence is that a device will perform a desired function without failure under predetermined conditions for a specified length of time.
The four following key elements comprise this definition:
To perform a desired function.
Here, the function must have been established through such activities as client and/or market surveys, establishing requirements and documenting and tracing requirements. Thus, reliability requires the device to be fully specified prior to design.
To perform without failure.
In this part, the normal operation of the device must be defined in order to establish what failure is. This activity also includes anticipating the misuse to which the device could be subjected and designing around it.
To perform under stated conditions.
This element examines the environment in which the device will operate and must be specified. This includes typical temperature and humidity ranges, shock and vibration, the shipping environment and interference from associated equipment or to other equipment experienced in normal usage.
To operate for a specified period of time.
In this case, the life expectancy of device must be defined as well as its typical daily usage.