It is due to the fact that as medical technology has progressed very rapidly for many years, it has become vital to establish the reliability of medical devices. As the medical device goes through the design and development process and then through the clinical usage process, all process steps must be taken into consideration so that they will facilitate patient safety and the desired functionality of the product. Now let us take a closer look at the main factors behind the development of reliable medical devices: from bench to patient.
Reliability – A Critical Component
Unlike in other domains, reliability is not an option in the healthcare domain but rather a requirement. A medical device that operates wrong can be disastrous at times, causing diseased or aching patients to suffer beyond their normal discomfort level and at other times patients develop opportunistic complications that can be lethal. Originally, it was the responsibility of manufacturers to ensure that the products remained safe and effective to use even after being used for some time in the market.
Design and Development
Design and development of the medical device form the basis of a dependable medical device. Engineers and researchers have to contemplate during this stage include the functionality of the gadget, the setting in which it will be used and the consequences that may arise from its utilization. In this process, FMEA is one of the most important tools since it allows identifying failure modes and effects, and thus, helps to take measures that can prevent these failures.
The overall design and development section includes various materials utilised in the construction process and useful components. These materials must have specific characteristics such as biocompatibility, durability and ability to withstand wear and tear. Hence, all the components must be selected carefully as this avoids feasibility issues that may lead to the failure of the device.
Rigorous Testing and Validation
This paper brings out the process followed in designing and developing a reliable medical device. Computer simulation and modelling methodology are used to evaluate the prototype’s behaviour in different environments. As soon as the design and development stage of a
medical device has been reached, the equipment has to go through a series of tests to check on its performance and therefore make it more reliable. This often includes bench testing, animal tests, and clinical trials all of which are in sequential order. Bench testing helps the researcher to determine the effectiveness of the device under optimal conditions while animal testing as well as clinical trials give important details about the safety and effectiveness of the device when used in human subjects.
As with other phases, a proper testing and validation process requires the collection of performance data of the device. Potential failure modes can be determined based on such data, hence the design of the device can be modified to suit appropriate standards. The device’s reliability is checked by reliability prediction and Weibull analysis methods.
Manufacturing and Quality Control
This stage is a very effective way to provide assurance of the reliability of the medical devices in the manufacturing process. In this phase, quality assurance has to be well-checked to ensure that each device conforms to the required standard and does not have any defects. These include inspection, verification, and recording in order to ascertain that the device follows the set procedures of manufacturing.
What Lies Ahead?
Proper systemized measures have to be put into practice in order for medical devices to remain dependable and useful throughout their usefulness by means of institute quality control standards, testing and validation, and recommended use/maintenance procedures. Furthermore, by now and then reporting the cases of failure or malfunction of devices, healthcare providers can help in enhancing the reliability and safety of medical devices.
