The best engineering practices are essential during product design and development, together with other considerations to tailor medical devices.
The sooner the people can get hold of a medical device, the faster it can help them. Industrial design has a vital role in determining the success of the medical device. It acts as a bridge connecting people and technology. The mechanism of the device also determines its success. The best engineering practices are essential during product design and development, together with other considerations to tailor medical devices.
Here are some features that help make a medical device successful:
The usability of the mechanism has the power to make or break a medical device. A well-designed device will pass its usability validation and testing. You will want successful usability to provide the users with a satisfying and rewarding experience. There are several factors to consider:
- Is it weak and breaks easily?
- Is it clear and easy to use?
- Is it loud or quiet?
- How much effort is required from a person using it?
There will be some crushing or pinching hazards if a mechanical device is exposed to a patient or user. There must be some protection or mitigation of these hazards. You must follow the general guidelines such as protective guard design, safe distances, usage of emergency stops, usability, and so on.
Regardless of the effectiveness or safety of the medical device, the primary requirement is its accuracy and precision. When precision is related to the efficacy and safety of the product, then it must be extremely considered. Find out how to measure the precision in verification. How much does it need to be precise? What happens if it is not as precise as the specified requirements? After many uses or in case the device is dropped, how will you confirm its precision throughout its lifetime?
For those medical devices that are well-designed, the first point of failure is usually the mechanisms. They help determine the maintenance schedule and the expected lifetime of the device. So, when using a mechanism that has low reliability, think about the implications of field replacements or service calls. Assign the right person to maintain the device regularly, and make sure they can fix it quickly in the event of a failure.
The majority of mechanisms can produce a certain amount of debris from usage or rubbing. This debris may interfere with the optics, electronics, biological samples, gears, etc. Often, oil is present on the mechanical device and may create a similar effect.
Debris and oil can generate small particulates that can travel through the device internally and externally. It may cause interference with optics or electronics, loss of biocompatibility, contamination, and many other problems. Make sure the mechanism works with the expected lifetime of the medical device, the debris is controlled, and it does not affect other devices nearby.
Take into consideration the fringe cases of the intended use setting or condition of a medical device. It is vital to be informed of the potential efficacy and safety issues as part of the risk management procedure. What happens in extreme heat? What will the device do in case of interruption or power off during motion? Problems with the device can cause less user adoption or expensive field failures, and the need for a service call. While predicting the fringe cases may be time-consuming, it can prevent problems from occurring.
After identifying the designing mechanisms for medical devices, you can start planning the actual product design. Make sure to validate and verify your plans to help translate those expectations into a reality.
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