Minimizing product design and development risk
We are a San Francisco based medical product design and development company that understands that failures occur. By implementing our early stage approach to new product development and using Smart Requirements, we are able to substantially minimize the risk early in the process.
Defining Product Failure
We must precisely define failure so that failure criteria are not ambiguous. A failure must always be related to a measurable parameter or a clear indication.
“To clients, only one failure is important – the one that prevents them from using their device as intended. It doesn’t matter whether the hardware or software ceases to function; the only thing that matters is that the device is not useable.”
The measure of a device’s reliability is the infrequency with which its failure occurs in time.
There are many physical causes collectively or individually that may be responsible for the failure of a hardware component or device at any particular instant.
It is not always possible to isolate these physical causes and mathematically account for all of them. Similarly, it is not always possible to determine the nonphysical causes for failure of software components or devices. However, in both cases, it is not only possible but of utmost importance to define what constitutes a failure for a particular device. In fact, the FDA requires medical devices to spell out failure definitions as part of device specifications and test plans.
Aspects of Failure are as follows:
- Failure Rate
- Causes of Failures
- Systematic Failures
- Random Failures
- Hardware Failures
- Early Failures
- Wear-out Failures
- Software Failures
- Coding Errors
- Design Errors
- Failures Due to Human Error
Product design failure definition
The term “Failure” refers to the degradation of the performance of a device outside a specified value.
It may be defined as the inability or nonperformance of a component or system to perform its intended function for a pre-determined amount of time under specific environmental conditions.
This definition contains several intriguing concepts.
First, it assumes the normal function of the device has been defined. If the function of the device has not been specified, then failure or deviation from the intended function cannot be established.
Second, the definition presumes the environmental conditions under which the system or component will operate have been specified. These include environmental parameters such as temperature, lighting, ambient noise, stress level under which the user is operating, and interference from other equipment in the area.